What is mechanism of action?

mechanism of action is Programmed Death Receptor-1-directed Antibody Interactions [MoA]

Keytruda (Pembrolizumab)

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Dosage & administration

* Melanoma: 200 mg every 3 weeks or 400 mg every 6 weeks; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA in combination with RT with or without cisplatin. * Continue KEYTRUDA as a single agent. * Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)
* NSCLC: 200 mg every 3 weeks or 400 mg every 6 weeks. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA in combination with RT with or without cisplatin. * Continue KEYTRUDA as a single agent. * Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)
* MPM: 200 mg every 3 weeks or 400 mg every 6 weeks. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA in combination with RT with or without cisplatin. * Continue KEYTRUDA as a single agent. * Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)
* HNSCC: 200 mg every 3 weeks or 400 mg every 6 weeks. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA in combination with RT with or without cisplatin. * Continue KEYTRUDA as a single agent. * Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)
* cHL or PMBCL: 200 mg every 3 weeks or 400 mg every 6 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA in combination with RT with or without cisplatin. * Continue KEYTRUDA as a single agent. * Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)
* Urothelial Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA in combination with RT with or without cisplatin. * Continue KEYTRUDA as a single agent. * Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)
* MSI-H or dMMR Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA in combination with RT with or without cisplatin. * Continue KEYTRUDA as a single agent. * Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)
* MSI-H or dMMR CRC: 200 mg every 3 weeks or 400 mg every 6 weeks. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA in combination with RT with or without cisplatin. * Continue KEYTRUDA as a single agent. * Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)
* Gastric Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA in combination with RT with or without cisplatin. * Continue KEYTRUDA as a single agent. * Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)
* Esophageal Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA in combination with RT with or without cisplatin. * Continue KEYTRUDA as a single agent. * Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)
* Cervical Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA in combination with RT with or without cisplatin. * Continue KEYTRUDA as a single agent. * Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)
* HCC: 200 mg every 3 weeks or 400 mg every 6 weeks. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA in combination with RT with or without cisplatin. * Continue KEYTRUDA as a single agent. * Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)
* BTC: 200 mg every 3 weeks or 400 mg every 6 weeks. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA in combination with RT with or without cisplatin. * Continue KEYTRUDA as a single agent. * Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)
* MCC: 200 mg every 3 weeks or 400 mg every 6 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA in combination with RT with or without cisplatin. * Continue KEYTRUDA as a single agent. * Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)
* RCC: 200 mg every 3 weeks or 400 mg every 6 weeks as a single agent in the adjuvant setting, or in the advanced setting with either:

* axitinib 5 mg orally twice daily or
* lenvatinib 20 mg orally once daily. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA in combination with RT with or without cisplatin. * Continue KEYTRUDA as a single agent. * Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)

* Endometrial Carcinoma: 200 mg every 3 weeks or 400 mg every 6 weeks

* in combination with carboplatin and paclitaxel regardless of MMR or MSI status, or
* in combination with lenvatinib 20 mg orally once daily for pMMR or not MSI-H tumors, or
* as a single agent for MSI-H or dMMR tumors. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA in combination with RT with or without cisplatin. * Continue KEYTRUDA as a single agent. * Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)

* TMB-H Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA in combination with RT with or without cisplatin. * Continue KEYTRUDA as a single agent. * Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)
* cSCC: 200 mg every 3 weeks or 400 mg every 6 weeks. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA in combination with RT with or without cisplatin. * Continue KEYTRUDA as a single agent. * Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)
* TNBC: 200 mg every 3 weeks or 400 mg every 6 weeks. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: * Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: * Administer KEYTRUDA in combination with RT with or without cisplatin. * Continue KEYTRUDA as a single agent. * Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)
* Administer KEYTRUDA as an intravenous infusion over 30 minutes after dilution. (

2.4 Preparation and Administration

Preparation for Intravenous Infusion

* Visually inspect the solution for particulate matter and discoloration. The solution is clear to slightly opalescent, colorless to slightly yellow. Discard the vial if visible particles are observed.
* Dilute KEYTRUDA injection (solution) prior to intravenous administration.
* Withdraw the required volume from the vial(s) of KEYTRUDA and transfer into an intravenous (IV) bag containing 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP.

Mix diluted solution by gentle inversion.

Do not shake. The final concentration of the diluted solution should be between 1 mg/mL to 10 mg/mL.
* Discard any unused portion left in the vial.

Storage of Diluted Solution

The product does not contain a preservative.

Store the diluted solution from the KEYTRUDA 100 mg/4 mL vial either:

* At room temperature (temperatures at or below 25°C) for no more than 6 hours from the time of dilution. This includes room temperature storage of the diluted solution, and the duration of infusion.
* Under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 96 hours from the time of dilution. If refrigerated, allow the diluted solution to come to room temperature prior to administration. Do not shake.

Discard after 6 hours at room temperature or after 96 hours under refrigeration.

Do not freeze.

Administration

* Administer diluted solution intravenously over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter.
* Do not co-administer other drugs through the same infusion line.

)
* See Full Prescribing Information for dosage modifications for adverse reactions and preparation and administration instructions. (

2.3 Dose Modifications

No dose reduction for KEYTRUDA is recommended. In general, withhold KEYTRUDA for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue KEYTRUDA for Life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks of initiating steroids.

Dosage modifications for KEYTRUDA for adverse reactions that require management different from these general guidelines are summarized in Table 2.

Table 2: Recommended Dosage Modifications for Adverse Reactions
Adverse Reaction	SeverityBased on Common Terminology Criteria for Adverse Events (CTCAE), version 4.0	Dosage Modification
ALT = alanine aminotransferase, AST = aspartate aminotransferase, DRESS = Drug Rash with Eosinophilia and Systemic Symptoms, SJS = Stevens Johnson Syndrome, TEN = toxic epidermal necrolysis, ULN = upper limit normal
Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1)]
Pneumonitis	Grade 2	WithholdResume in patients with complete or partial resolution (Grades 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.
Pneumonitis	Grade 3 or 4	Permanently discontinue
Colitis	Grade 2 or 3	Withhold
Colitis	Grade 4	Permanently discontinue
Hepatitis with no tumor involvement of the liver	AST or ALT increases to more than 3 and up to 8 times ULN or Total bilirubin increases to more than 1.5 and up to 3 times ULN	Withhold
For liver enzyme elevations in patients treated with combination therapy with axitinib, see Table 3.	AST or ALT increases to more than 8 times ULN or Total bilirubin increases to more than 3 times ULN	Permanently discontinue
Hepatitis with tumor involvement of the liverIf AST and ALT are less than or equal to ULN at baseline, withhold or permanently discontinue KEYTRUDA based on recommendations for hepatitis with no liver involvement.	Baseline AST or ALT is more than 1 and up to 3 times ULN and increases to more than 5 and up to 10 times ULN or Baseline AST or ALT is more than 3 and up to 5 times ULN and increases to more than 8 and up to 10 times ULN	Withhold
	ALT or AST increases to more than 10 times ULN or Total bilirubin increases to more than 3 times ULN	Permanently discontinue
Endocrinopathies	Grade 3 or 4	Withhold until clinically stable or permanently discontinue depending on severity
Nephritis with Renal Dysfunction	Grade 2 or 3 increased blood creatinine	Withhold
Nephritis with Renal Dysfunction	Grade 4 increased blood creatinine	Permanently discontinue
Exfoliative Dermatologic Conditions	Suspected SJS, TEN, or DRESS	Withhold
Exfoliative Dermatologic Conditions	Confirmed SJS, TEN, or DRESS	Permanently discontinue
Myocarditis	Grade 2, 3, or 4	Permanently discontinue
Neurological Toxicities	Grade 2	Withhold
Neurological Toxicities	Grade 3 or 4	Permanently discontinue
Hematologic toxicity in patients with cHL or PMBCL	Grade 4	Withhold until resolution to Grades 0 or 1
Other Adverse Reactions
Infusion-related reactions [see Warnings and Precautions (5.2)]	Grade 1 or 2	Interrupt or slow the rate of infusion
	Grade 3 or 4	Permanently discontinue

The following table represents dosage modifications that are different from those described above for KEYTRUDA or in the Full Prescribing Information for the drug administered in combination.

Table 3: Recommended Specific Dosage Modifications for Adverse Reactions for KEYTRUDA in Combination with Axitinib
Treatment	Adverse Reaction	Severity	Dosage Modification
ALT = alanine aminotransferase, AST = aspartate aminotransferase, ULN = upper limit normal
KEYTRUDA in combination with axitinib	Liver enzyme elevationsConsider corticosteroid therapy	ALT or AST increases to at least 3 times but less than 10 times ULN without concurrent total bilirubin at least 2 times ULN	Withhold both KEYTRUDA and axitinib until resolution to Grades 0 or 1Based on Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Consider rechallenge with a single drug or sequential rechallenge with both drugs after recovery. If rechallenging with axitinib, consider dose reduction as per the axitinib Prescribing Information.
KEYTRUDA in combination with axitinib	Liver enzyme elevationsConsider corticosteroid therapy	ALT or AST increases to more than 3 times ULN with concurrent total bilirubin at least 2 times ULN or ALT or AST ≥10 times ULN	Permanently discontinue both KEYTRUDA and axitinib

Recommended Dose Modifications for Adverse Reactions for KEYTRUDA in Combination with Lenvatinib

When administering KEYTRUDA in combination with lenvatinib, modify the dosage of one or both drugs. Withhold or discontinue KEYTRUDA as shown in Table 2. Refer to lenvatinib prescribing information for additional dose modification information.

2.4 Preparation and Administration

Preparation for Intravenous Infusion

Mix diluted solution by gentle inversion.

Do not shake. The final concentration of the diluted solution should be between 1 mg/mL to 10 mg/mL.
* Discard any unused portion left in the vial.

Storage of Diluted Solution

The product does not contain a preservative.

Store the diluted solution from the KEYTRUDA 100 mg/4 mL vial either:

Discard after 6 hours at room temperature or after 96 hours under refrigeration.

Do not freeze.

Administration

)

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Keytruda prescribing information

Indications and Usage (

1 INDICATIONS AND USAGE

KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated:

Melanoma

for the treatment of patients with unresectable or metastatic melanoma.
for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection.

Non-Small Cell Lung Cancer (NSCLC)

in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC.
as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is:
- Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
- metastatic.
as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
as a single agent, for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.

Malignant Pleural Mesothelioma (MPM)

in combination with pemetrexed and platinum chemotherapy, as first-line treatment of adult patients with unresectable advanced or metastatic MPM.

Head and Neck Squamous Cell Cancer (HNSCC)

for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.
in combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC.
as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test.
as a single agent for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma (cHL)

for the treatment of adult patients with relapsed or refractory cHL.
for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma (PMBCL)

for the treatment of adult and pediatric patients with refractory PMBCL, or who have relapsed after 2 or more prior lines of therapy.
Limitations of Use
: KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Cancer

in combination with enfortumab vedotin, for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
as a single agent for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:
- are not eligible for any platinum-containing chemotherapy, or
- who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment of adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.
as a single agent for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer (CRC)

for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test.

Gastric Cancer

in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.
in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

Esophageal Cancer

for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:
- in combination with platinum- and fluoropyrimidine-based chemotherapy for patients whose tumors express PD-L1 (CPS ≥1), or
- as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test.

Cervical Cancer

in combination with chemoradiotherapy, for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III-IVA).
in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.
as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

Hepatocellular Carcinoma (HCC)

for the treatment of patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen.

Biliary Tract Cancer (BTC)

in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer.

Merkel Cell Carcinoma (MCC)

for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.

Renal Cell Carcinoma (RCC)

in combination with axitinib, for the first-line treatment of adult patients with advanced RCC.
in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC.
for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

Endometrial Carcinoma

in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
in combination with lenvatinib, for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
as a single agent, for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Tumor Mutational Burden-High (TMB-H) Cancer

for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.¹
Limitations of Use
: The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma (cSCC)

for the treatment of patients with recurrent or metastatic cSCC or locally advanced cSCC that is not curable by surgery or radiation.

Triple-Negative Breast Cancer (TNBC)

for the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test.

¹This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

1.1 Melanoma

KEYTRUDA^®is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection.

1.2 Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test

[see Dosage and Administration (2.1)]

, with no EGFR or ALK genomic tumor aberrations, and is:

Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test

[see Dosage and Administration (2.1)]

, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.

1.3 Malignant Pleural Mesothelioma

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).

1.4 Head and Neck Squamous Cell Cancer

KEYTRUDA is indicated for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test

[see Dosage and Administration (2.1)]

, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test

[see Dosage and Administration (2.1)]

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

1.5 Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

1.6 Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy.

Limitations of Use

: KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

1.7 Urothelial Cancer

KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma:

who are not eligible for any platinum-containing chemotherapy, or
who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

1.8 Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options

[see Dosage and Administration (2.1)]

1.9 Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test

[see Dosage and Administration (2.1)]

1.10 Gastric Cancer

KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test

[see Dosage and Administration (2.1)]

KEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA approved test

[see Dosage and Administration (2.1)]

1.11 Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:

in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with tumors that express PD-L1 (CPS ≥ 1)
[see Dosage and Administration (2.1)]
, or
as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
.

1.12 Cervical Cancer

KEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III-IVA).

KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test

[see Dosage and Administration (2.1)].

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test

[see Dosage and Administration (2.1)]

1.13 Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen.

1.14 Biliary Tract Cancer

KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).

1.15 Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

1.16 Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC.

KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions

[see Clinical Studies (14.16)]

1.17 Endometrial Carcinoma

KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.

KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation

[see Dosage and Administration (2.1)]

KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation

[see Dosage and Administration (2.1)]

1.18 Tumor Mutational Burden-High Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test

[see Dosage and Administration (2.1)]

, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

This indication is approved under accelerated approval based on tumor response rate and durability of response

[see Clinical Studies (14.18)]

. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Limitations of Use

: The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

1.19 Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.

1.20 Triple-Negative Breast Cancer

KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test

[see Dosage and Administration (2.1)]

)

11/2025

Indications and Usage (

1 INDICATIONS AND USAGE

KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated:

Melanoma

for the treatment of patients with unresectable or metastatic melanoma.
for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection.

Non-Small Cell Lung Cancer (NSCLC)

in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC.
as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is:
- Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
- metastatic.
as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
as a single agent, for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.

Malignant Pleural Mesothelioma (MPM)

in combination with pemetrexed and platinum chemotherapy, as first-line treatment of adult patients with unresectable advanced or metastatic MPM.

Head and Neck Squamous Cell Cancer (HNSCC)

for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.
in combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC.
as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test.
as a single agent for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma (cHL)

for the treatment of adult patients with relapsed or refractory cHL.
for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma (PMBCL)

for the treatment of adult and pediatric patients with refractory PMBCL, or who have relapsed after 2 or more prior lines of therapy.
Limitations of Use
: KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Cancer

in combination with enfortumab vedotin, for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
as a single agent for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:
- are not eligible for any platinum-containing chemotherapy, or
- who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment of adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.
as a single agent for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer (CRC)

for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test.

Gastric Cancer

in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.
in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

Esophageal Cancer

for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:
- in combination with platinum- and fluoropyrimidine-based chemotherapy for patients whose tumors express PD-L1 (CPS ≥1), or
- as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test.

Cervical Cancer

in combination with chemoradiotherapy, for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III-IVA).
in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.
as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

Hepatocellular Carcinoma (HCC)

for the treatment of patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen.

Biliary Tract Cancer (BTC)

in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer.

Merkel Cell Carcinoma (MCC)

for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.

Renal Cell Carcinoma (RCC)

in combination with axitinib, for the first-line treatment of adult patients with advanced RCC.
in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC.
for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

Endometrial Carcinoma

in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
in combination with lenvatinib, for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
as a single agent, for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Tumor Mutational Burden-High (TMB-H) Cancer

for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.¹
Limitations of Use
: The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma (cSCC)

for the treatment of patients with recurrent or metastatic cSCC or locally advanced cSCC that is not curable by surgery or radiation.

Triple-Negative Breast Cancer (TNBC)

for the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test.

1.1 Melanoma

KEYTRUDA^®is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection.

1.2 Non-Small Cell Lung Cancer

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test

[see Dosage and Administration (2.1)]

, with no EGFR or ALK genomic tumor aberrations, and is:

Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test

[see Dosage and Administration (2.1)]

KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.

1.3 Malignant Pleural Mesothelioma

1.4 Head and Neck Squamous Cell Cancer

KEYTRUDA is indicated for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test

[see Dosage and Administration (2.1)]

, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.

[see Dosage and Administration (2.1)]

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

1.5 Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

1.6 Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy.

Limitations of Use

: KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

1.7 Urothelial Cancer

KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma:

who are not eligible for any platinum-containing chemotherapy, or
who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

1.8 Microsatellite Instability-High or Mismatch Repair Deficient Cancer

[see Dosage and Administration (2.1)]

1.9 Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test

[see Dosage and Administration (2.1)]

1.10 Gastric Cancer

[see Dosage and Administration (2.1)]

1.11 Esophageal Cancer

in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with tumors that express PD-L1 (CPS ≥ 1)
[see Dosage and Administration (2.1)]
, or
as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
.

1.12 Cervical Cancer

[see Dosage and Administration (2.1)].

[see Dosage and Administration (2.1)]

1.13 Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen.

1.14 Biliary Tract Cancer

KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).

1.15 Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

1.16 Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC.

[see Clinical Studies (14.16)]

1.17 Endometrial Carcinoma

[see Dosage and Administration (2.1)]

1.18 Tumor Mutational Burden-High Cancer

[see Dosage and Administration (2.1)]

, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

This indication is approved under accelerated approval based on tumor response rate and durability of response

[see Clinical Studies (14.18)]

. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Limitations of Use

: The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

1.19 Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.

1.20 Triple-Negative Breast Cancer

[see Dosage and Administration (2.1)]

), Removed

7/2025

Dosage and Administration (

2 DOSAGE AND ADMINISTRATION

Melanoma: 200 mg every 3 weeks or 400 mg every 6 weeks; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics.
NSCLC: 200 mg every 3 weeks or 400 mg every 6 weeks.
MPM: 200 mg every 3 weeks or 400 mg every 6 weeks.
HNSCC: 200 mg every 3 weeks or 400 mg every 6 weeks.
cHL or PMBCL: 200 mg every 3 weeks or 400 mg every 6 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics.
Urothelial Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks.
MSI-H or dMMR Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics.
MSI-H or dMMR CRC: 200 mg every 3 weeks or 400 mg every 6 weeks.
Gastric Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks.
Esophageal Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks.
Cervical Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks.
HCC: 200 mg every 3 weeks or 400 mg every 6 weeks.
BTC: 200 mg every 3 weeks or 400 mg every 6 weeks.
MCC: 200 mg every 3 weeks or 400 mg every 6 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics.
RCC: 200 mg every 3 weeks or 400 mg every 6 weeks as a single agent in the adjuvant setting, or in the advanced setting with either:
- axitinib 5 mg orally twice daily or
- lenvatinib 20 mg orally once daily.
Endometrial Carcinoma: 200 mg every 3 weeks or 400 mg every 6 weeks
- in combination with carboplatin and paclitaxel regardless of MMR or MSI status, or
- in combination with lenvatinib 20 mg orally once daily for pMMR or not MSI-H tumors, or
- as a single agent for MSI-H or dMMR tumors.
TMB-H Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics.
cSCC: 200 mg every 3 weeks or 400 mg every 6 weeks.
TNBC: 200 mg every 3 weeks or 400 mg every 6 weeks.
Administer KEYTRUDA as an intravenous infusion over 30 minutes after dilution.
See Full Prescribing Information for dosage modifications for adverse reactions and preparation and administration instructions.

2.1 Patient Selection

Information on FDA-approved tests for patient selection is available at:

http://www.fda.gov/CompanionDiagnostics

Patient Selection for Single-Agent Treatment

Select patients for treatment with KEYTRUDA as a single agent based on the presence of positive PD-L1 expression in:

Stage III NSCLC who are not candidates for surgical resection or definitive chemoradiation
[see Clinical Studies (14.2)]
.
metastatic NSCLC
[see Clinical Studies (14.2)].
first-line treatment of metastatic or unresectable, recurrent HNSCC
[see Clinical Studies (14.4)]
.
previously treated recurrent locally advanced or metastatic esophageal cancer
[see Clinical Studies (14.11)]
.
recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
[see Clinical Studies (14.12)]
.

For the MSI-H/dMMR indications, select patients for treatment with KEYTRUDA as a single agent based on MSI-H/dMMR status in tumor specimens

[see Clinical Studies (14.8, 14.9)].

For the TMB-H indication, select patients for treatment with KEYTRUDA as a single agent based on TMB-H status in tumor specimens

[see Clinical Studies (14.18)].

Because subclonal dMMR mutations and microsatellite instability may arise in high-grade gliomas during temozolomide therapy, it is recommended to test for TMB-H, MSI-H, and dMMR in the primary tumor specimens obtained prior to initiation of temozolomide chemotherapy in patients with high-grade gliomas.

Additional Patient Selection Information for MSI-H or dMMR in Patients with non-CRC Solid Tumors

Due to discordance between local tests and FDA-approved tests, confirmation of MSI-H or dMMR status is recommended by an FDA-approved test in patients with MSI-H or dMMR solid tumors, if feasible. If unable to perform confirmatory MSI-H/dMMR testing, the presence of TMB ≥10 mut/Mb, as determined by an FDA-approved test, may be used to select patients for treatment

[see Clinical Studies (14.8)]

Patient Selection for Combination Therapy

For use of KEYTRUDA as a single agent as neoadjuvant treatment, then in combination with radiotherapy (RT) with or without chemotherapy then continued as a single agent as adjuvant treatment, select patients based on presence of positive PD-L1 expression (CPS ≥1) in resectable locally advanced HNSCC

[see Clinical Studies (14.4)].

For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression (CPS ≥1) in locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, and esophageal or gastroesophageal junction (GEJ) carcinoma

[see Clinical Studies (14.10), (14.11)].

An FDA-approved test for the detection of PD-L1 for the selection of patients with PD-L1 (CPS ≥ 1) expression in esophageal carcinoma in combination with platinum- and fluoropyrimidine-based chemotherapy is not available.

For use of KEYTRUDA in combination with chemotherapy, with or without bevacizumab, select patients based on the presence of positive PD-L1 expression in persistent, recurrent, or metastatic cervical cancer

[see Clinical Studies (14.12)].

For the pMMR/not MSI-H advanced endometrial carcinoma indication, select patients for treatment with KEYTRUDA in combination with lenvatinib based on MMR or MSI status in tumor specimens

[see Clinical Studies (14.17)]

For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression in locally recurrent unresectable or metastatic TNBC

[see Clinical Studies (14.20)]

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: Administer KEYTRUDA in combination with RT with or without cisplatin. Continue KEYTRUDA as a single agent. Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

2.3 Dose Modifications

Dosage modifications for KEYTRUDA for adverse reactions that require management different from these general guidelines are summarized in Table 2.

Table 2: Recommended Dosage Modifications for Adverse Reactions
Adverse Reaction	SeverityBased on Common Terminology Criteria for Adverse Events (CTCAE), version 4.0	Dosage Modification
ALT = alanine aminotransferase, AST = aspartate aminotransferase, DRESS = Drug Rash with Eosinophilia and Systemic Symptoms, SJS = Stevens Johnson Syndrome, TEN = toxic epidermal necrolysis, ULN = upper limit normal
Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1)]
Pneumonitis	Grade 2	WithholdResume in patients with complete or partial resolution (Grades 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.
Pneumonitis	Grade 3 or 4	Permanently discontinue
Colitis	Grade 2 or 3	Withhold
Colitis	Grade 4	Permanently discontinue
Hepatitis with no tumor involvement of the liver	AST or ALT increases to more than 3 and up to 8 times ULN or Total bilirubin increases to more than 1.5 and up to 3 times ULN	Withhold
For liver enzyme elevations in patients treated with combination therapy with axitinib, see Table 3.	AST or ALT increases to more than 8 times ULN or Total bilirubin increases to more than 3 times ULN	Permanently discontinue
Hepatitis with tumor involvement of the liverIf AST and ALT are less than or equal to ULN at baseline, withhold or permanently discontinue KEYTRUDA based on recommendations for hepatitis with no liver involvement.	Baseline AST or ALT is more than 1 and up to 3 times ULN and increases to more than 5 and up to 10 times ULN or Baseline AST or ALT is more than 3 and up to 5 times ULN and increases to more than 8 and up to 10 times ULN	Withhold
	ALT or AST increases to more than 10 times ULN or Total bilirubin increases to more than 3 times ULN	Permanently discontinue
Endocrinopathies	Grade 3 or 4	Withhold until clinically stable or permanently discontinue depending on severity
Nephritis with Renal Dysfunction	Grade 2 or 3 increased blood creatinine	Withhold
Nephritis with Renal Dysfunction	Grade 4 increased blood creatinine	Permanently discontinue
Exfoliative Dermatologic Conditions	Suspected SJS, TEN, or DRESS	Withhold
Exfoliative Dermatologic Conditions	Confirmed SJS, TEN, or DRESS	Permanently discontinue
Myocarditis	Grade 2, 3, or 4	Permanently discontinue
Neurological Toxicities	Grade 2	Withhold
Neurological Toxicities	Grade 3 or 4	Permanently discontinue
Hematologic toxicity in patients with cHL or PMBCL	Grade 4	Withhold until resolution to Grades 0 or 1
Other Adverse Reactions
Infusion-related reactions [see Warnings and Precautions (5.2)]	Grade 1 or 2	Interrupt or slow the rate of infusion
	Grade 3 or 4	Permanently discontinue

The following table represents dosage modifications that are different from those described above for KEYTRUDA or in the Full Prescribing Information for the drug administered in combination.

Table 3: Recommended Specific Dosage Modifications for Adverse Reactions for KEYTRUDA in Combination with Axitinib
Treatment	Adverse Reaction	Severity	Dosage Modification
ALT = alanine aminotransferase, AST = aspartate aminotransferase, ULN = upper limit normal
KEYTRUDA in combination with axitinib	Liver enzyme elevationsConsider corticosteroid therapy	ALT or AST increases to at least 3 times but less than 10 times ULN without concurrent total bilirubin at least 2 times ULN	Withhold both KEYTRUDA and axitinib until resolution to Grades 0 or 1Based on Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Consider rechallenge with a single drug or sequential rechallenge with both drugs after recovery. If rechallenging with axitinib, consider dose reduction as per the axitinib Prescribing Information.
KEYTRUDA in combination with axitinib	Liver enzyme elevationsConsider corticosteroid therapy	ALT or AST increases to more than 3 times ULN with concurrent total bilirubin at least 2 times ULN or ALT or AST ≥10 times ULN	Permanently discontinue both KEYTRUDA and axitinib

Recommended Dose Modifications for Adverse Reactions for KEYTRUDA in Combination with Lenvatinib

2.4 Preparation and Administration

Preparation for Intravenous Infusion

Visually inspect the solution for particulate matter and discoloration. The solution is clear to slightly opalescent, colorless to slightly yellow. Discard the vial if visible particles are observed.
Dilute KEYTRUDA injection (solution) prior to intravenous administration.
Withdraw the required volume from the vial(s) of KEYTRUDA and transfer into an intravenous (IV) bag containing 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP.
Mix diluted solution by gentle inversion.
Do not shake. The final concentration of the diluted solution should be between 1 mg/mL to 10 mg/mL.
Discard any unused portion left in the vial.

Storage of Diluted Solution

The product does not contain a preservative.

Store the diluted solution from the KEYTRUDA 100 mg/4 mL vial either:

At room temperature (temperatures at or below 25°C) for no more than 6 hours from the time of dilution. This includes room temperature storage of the diluted solution, and the duration of infusion.
Under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 96 hours from the time of dilution. If refrigerated, allow the diluted solution to come to room temperature prior to administration. Do not shake.

Discard after 6 hours at room temperature or after 96 hours under refrigeration.

Do not freeze.

Administration

Administer diluted solution intravenously over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter.
Do not co-administer other drugs through the same infusion line.

)

11/2025

KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated:

Melanoma

for the treatment of patients with unresectable or metastatic melanoma. (
1.1 Melanoma
KEYTRUDA^®is indicated for the treatment of patients with unresectable or metastatic melanoma.
KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection.
)
for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. (
1.1 Melanoma
KEYTRUDA^®is indicated for the treatment of patients with unresectable or metastatic melanoma.
KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection.
)

Non-Small Cell Lung Cancer (NSCLC)

in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations. (
1.2 Non-Small Cell Lung Cancer
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
, with no EGFR or ALK genomic tumor aberrations, and is:
- Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
- metastatic.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.
)
in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC. (
1.2 Non-Small Cell Lung Cancer
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
, with no EGFR or ALK genomic tumor aberrations, and is:
- Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
- metastatic.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.
)
as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is:
- Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
- metastatic. (
  1.2 Non-Small Cell Lung Cancer
  KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
  KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
  KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test
  [see Dosage and Administration (2.1)]
  , with no EGFR or ALK genomic tumor aberrations, and is:
  Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
  metastatic.
  KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test
  [see Dosage and Administration (2.1)]
  , with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
  KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
  KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.
  ,
  2.1 Patient Selection
  Information on FDA-approved tests for patient selection is available at:
  http://www.fda.gov/CompanionDiagnostics
  .
  Patient Selection for Single-Agent Treatment
  Select patients for treatment with KEYTRUDA as a single agent based on the presence of positive PD-L1 expression in:
  Stage III NSCLC who are not candidates for surgical resection or definitive chemoradiation
  [see Clinical Studies (14.2)]
  .
  metastatic NSCLC
  [see Clinical Studies (14.2)].
  first-line treatment of metastatic or unresectable, recurrent HNSCC
  [see Clinical Studies (14.4)]
  .
  previously treated recurrent locally advanced or metastatic esophageal cancer
  [see Clinical Studies (14.11)]
  .
  recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
  [see Clinical Studies (14.12)]
  .
  For the MSI-H/dMMR indications, select patients for treatment with KEYTRUDA as a single agent based on MSI-H/dMMR status in tumor specimens
  [see Clinical Studies (14.8, 14.9)].
  For the TMB-H indication, select patients for treatment with KEYTRUDA as a single agent based on TMB-H status in tumor specimens
  [see Clinical Studies (14.18)].
  Because subclonal dMMR mutations and microsatellite instability may arise in high-grade gliomas during temozolomide therapy, it is recommended to test for TMB-H, MSI-H, and dMMR in the primary tumor specimens obtained prior to initiation of temozolomide chemotherapy in patients with high-grade gliomas.
  Additional Patient Selection Information for MSI-H or dMMR in Patients with non-CRC Solid Tumors
  Due to discordance between local tests and FDA-approved tests, confirmation of MSI-H or dMMR status is recommended by an FDA-approved test in patients with MSI-H or dMMR solid tumors, if feasible. If unable to perform confirmatory MSI-H/dMMR testing, the presence of TMB ≥10 mut/Mb, as determined by an FDA-approved test, may be used to select patients for treatment
  [see Clinical Studies (14.8)]
  .
  Patient Selection for Combination Therapy
  For use of KEYTRUDA as a single agent as neoadjuvant treatment, then in combination with radiotherapy (RT) with or without chemotherapy then continued as a single agent as adjuvant treatment, select patients based on presence of positive PD-L1 expression (CPS ≥1) in resectable locally advanced HNSCC
  [see Clinical Studies (14.4)].
  For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression (CPS ≥1) in locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, and esophageal or gastroesophageal junction (GEJ) carcinoma
  [see Clinical Studies (14.10), (14.11)].
  An FDA-approved test for the detection of PD-L1 for the selection of patients with PD-L1 (CPS ≥ 1) expression in esophageal carcinoma in combination with platinum- and fluoropyrimidine-based chemotherapy is not available.
  For use of KEYTRUDA in combination with chemotherapy, with or without bevacizumab, select patients based on the presence of positive PD-L1 expression in persistent, recurrent, or metastatic cervical cancer
  [see Clinical Studies (14.12)].
  For the pMMR/not MSI-H advanced endometrial carcinoma indication, select patients for treatment with KEYTRUDA in combination with lenvatinib based on MMR or MSI status in tumor specimens
  [see Clinical Studies (14.17)]
  .
  For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression in locally recurrent unresectable or metastatic TNBC
  [see Clinical Studies (14.20)]
  .
  )
as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. (
1.2 Non-Small Cell Lung Cancer
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
, with no EGFR or ALK genomic tumor aberrations, and is:
- Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
- metastatic.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.
,
2.1 Patient Selection
Information on FDA-approved tests for patient selection is available at:
http://www.fda.gov/CompanionDiagnostics
.
Patient Selection for Single-Agent Treatment
Select patients for treatment with KEYTRUDA as a single agent based on the presence of positive PD-L1 expression in:
- Stage III NSCLC who are not candidates for surgical resection or definitive chemoradiation
  [see Clinical Studies (14.2)]
  .
- metastatic NSCLC
  [see Clinical Studies (14.2)].
- first-line treatment of metastatic or unresectable, recurrent HNSCC
  [see Clinical Studies (14.4)]
  .
- previously treated recurrent locally advanced or metastatic esophageal cancer
  [see Clinical Studies (14.11)]
  .
- recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
  [see Clinical Studies (14.12)]
  .
For the MSI-H/dMMR indications, select patients for treatment with KEYTRUDA as a single agent based on MSI-H/dMMR status in tumor specimens
[see Clinical Studies (14.8, 14.9)].
For the TMB-H indication, select patients for treatment with KEYTRUDA as a single agent based on TMB-H status in tumor specimens
[see Clinical Studies (14.18)].
Because subclonal dMMR mutations and microsatellite instability may arise in high-grade gliomas during temozolomide therapy, it is recommended to test for TMB-H, MSI-H, and dMMR in the primary tumor specimens obtained prior to initiation of temozolomide chemotherapy in patients with high-grade gliomas.
Additional Patient Selection Information for MSI-H or dMMR in Patients with non-CRC Solid Tumors
Due to discordance between local tests and FDA-approved tests, confirmation of MSI-H or dMMR status is recommended by an FDA-approved test in patients with MSI-H or dMMR solid tumors, if feasible. If unable to perform confirmatory MSI-H/dMMR testing, the presence of TMB ≥10 mut/Mb, as determined by an FDA-approved test, may be used to select patients for treatment
[see Clinical Studies (14.8)]
.
Patient Selection for Combination Therapy
For use of KEYTRUDA as a single agent as neoadjuvant treatment, then in combination with radiotherapy (RT) with or without chemotherapy then continued as a single agent as adjuvant treatment, select patients based on presence of positive PD-L1 expression (CPS ≥1) in resectable locally advanced HNSCC
[see Clinical Studies (14.4)].
For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression (CPS ≥1) in locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, and esophageal or gastroesophageal junction (GEJ) carcinoma
[see Clinical Studies (14.10), (14.11)].
- An FDA-approved test for the detection of PD-L1 for the selection of patients with PD-L1 (CPS ≥ 1) expression in esophageal carcinoma in combination with platinum- and fluoropyrimidine-based chemotherapy is not available.
For use of KEYTRUDA in combination with chemotherapy, with or without bevacizumab, select patients based on the presence of positive PD-L1 expression in persistent, recurrent, or metastatic cervical cancer
[see Clinical Studies (14.12)].
For the pMMR/not MSI-H advanced endometrial carcinoma indication, select patients for treatment with KEYTRUDA in combination with lenvatinib based on MMR or MSI status in tumor specimens
[see Clinical Studies (14.17)]
.
For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression in locally recurrent unresectable or metastatic TNBC
[see Clinical Studies (14.20)]
.
)
for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. (
1.2 Non-Small Cell Lung Cancer
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
, with no EGFR or ALK genomic tumor aberrations, and is:
- Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
- metastatic.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.
)
as a single agent, for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. (
1.2 Non-Small Cell Lung Cancer
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
, with no EGFR or ALK genomic tumor aberrations, and is:
- Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
- metastatic.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.
)

Malignant Pleural Mesothelioma (MPM)

in combination with pemetrexed and platinum chemotherapy, as first-line treatment of adult patients with unresectable advanced or metastatic MPM. (
1.3 Malignant Pleural Mesothelioma
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).
)

Head and Neck Squamous Cell Cancer (HNSCC)

for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent. (
1.4 Head and Neck Squamous Cell Cancer
KEYTRUDA is indicated for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.
KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
)
in combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC. (
1.4 Head and Neck Squamous Cell Cancer
KEYTRUDA is indicated for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.
KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
)
as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test. (
1.4 Head and Neck Squamous Cell Cancer
KEYTRUDA is indicated for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.
KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
,
2.1 Patient Selection
Information on FDA-approved tests for patient selection is available at:
http://www.fda.gov/CompanionDiagnostics
.
Patient Selection for Single-Agent Treatment
Select patients for treatment with KEYTRUDA as a single agent based on the presence of positive PD-L1 expression in:
- Stage III NSCLC who are not candidates for surgical resection or definitive chemoradiation
  [see Clinical Studies (14.2)]
  .
- metastatic NSCLC
  [see Clinical Studies (14.2)].
- first-line treatment of metastatic or unresectable, recurrent HNSCC
  [see Clinical Studies (14.4)]
  .
- previously treated recurrent locally advanced or metastatic esophageal cancer
  [see Clinical Studies (14.11)]
  .
- recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
  [see Clinical Studies (14.12)]
  .
For the MSI-H/dMMR indications, select patients for treatment with KEYTRUDA as a single agent based on MSI-H/dMMR status in tumor specimens
[see Clinical Studies (14.8, 14.9)].
For the TMB-H indication, select patients for treatment with KEYTRUDA as a single agent based on TMB-H status in tumor specimens
[see Clinical Studies (14.18)].
Because subclonal dMMR mutations and microsatellite instability may arise in high-grade gliomas during temozolomide therapy, it is recommended to test for TMB-H, MSI-H, and dMMR in the primary tumor specimens obtained prior to initiation of temozolomide chemotherapy in patients with high-grade gliomas.
Additional Patient Selection Information for MSI-H or dMMR in Patients with non-CRC Solid Tumors
Due to discordance between local tests and FDA-approved tests, confirmation of MSI-H or dMMR status is recommended by an FDA-approved test in patients with MSI-H or dMMR solid tumors, if feasible. If unable to perform confirmatory MSI-H/dMMR testing, the presence of TMB ≥10 mut/Mb, as determined by an FDA-approved test, may be used to select patients for treatment
[see Clinical Studies (14.8)]
.
Patient Selection for Combination Therapy
For use of KEYTRUDA as a single agent as neoadjuvant treatment, then in combination with radiotherapy (RT) with or without chemotherapy then continued as a single agent as adjuvant treatment, select patients based on presence of positive PD-L1 expression (CPS ≥1) in resectable locally advanced HNSCC
[see Clinical Studies (14.4)].
For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression (CPS ≥1) in locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, and esophageal or gastroesophageal junction (GEJ) carcinoma
[see Clinical Studies (14.10), (14.11)].
- An FDA-approved test for the detection of PD-L1 for the selection of patients with PD-L1 (CPS ≥ 1) expression in esophageal carcinoma in combination with platinum- and fluoropyrimidine-based chemotherapy is not available.
For use of KEYTRUDA in combination with chemotherapy, with or without bevacizumab, select patients based on the presence of positive PD-L1 expression in persistent, recurrent, or metastatic cervical cancer
[see Clinical Studies (14.12)].
For the pMMR/not MSI-H advanced endometrial carcinoma indication, select patients for treatment with KEYTRUDA in combination with lenvatinib based on MMR or MSI status in tumor specimens
[see Clinical Studies (14.17)]
.
For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression in locally recurrent unresectable or metastatic TNBC
[see Clinical Studies (14.20)]
.
)
as a single agent for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. (
1.4 Head and Neck Squamous Cell Cancer
KEYTRUDA is indicated for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.
KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
)

Classical Hodgkin Lymphoma (cHL)

for the treatment of adult patients with relapsed or refractory cHL. (
1.5 Classical Hodgkin Lymphoma
KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.
)
for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. (
1.5 Classical Hodgkin Lymphoma
KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.
)

Primary Mediastinal Large B-Cell Lymphoma (PMBCL)

for the treatment of adult and pediatric patients with refractory PMBCL, or who have relapsed after 2 or more prior lines of therapy. (
1.6 Primary Mediastinal Large B-Cell Lymphoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy.
Limitations of Use
: KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.
)
Limitations of Use
: KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Cancer

in combination with enfortumab vedotin, for the treatment of adult patients with locally advanced or metastatic urothelial cancer. (
1.7 Urothelial Cancer
KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma:
- who are not eligible for any platinum-containing chemotherapy, or
- who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
KEYTRUDA, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
)
as a single agent for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:
- are not eligible for any platinum-containing chemotherapy, or
- who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. (
  1.7 Urothelial Cancer
  KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
  KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma:
  who are not eligible for any platinum-containing chemotherapy, or
  who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
  KEYTRUDA, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.
  KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
  )
in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment of adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. (
1.7 Urothelial Cancer
KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma:
- who are not eligible for any platinum-containing chemotherapy, or
- who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
KEYTRUDA, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
)
as a single agent for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. (
1.7 Urothelial Cancer
KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma:
- who are not eligible for any platinum-containing chemotherapy, or
- who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
KEYTRUDA, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
)

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. (
1.8 Microsatellite Instability-High or Mismatch Repair Deficient Cancer
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options
[see Dosage and Administration (2.1)]
.
,
2.1 Patient Selection
Information on FDA-approved tests for patient selection is available at:
http://www.fda.gov/CompanionDiagnostics
.
Patient Selection for Single-Agent Treatment
Select patients for treatment with KEYTRUDA as a single agent based on the presence of positive PD-L1 expression in:
- Stage III NSCLC who are not candidates for surgical resection or definitive chemoradiation
  [see Clinical Studies (14.2)]
  .
- metastatic NSCLC
  [see Clinical Studies (14.2)].
- first-line treatment of metastatic or unresectable, recurrent HNSCC
  [see Clinical Studies (14.4)]
  .
- previously treated recurrent locally advanced or metastatic esophageal cancer
  [see Clinical Studies (14.11)]
  .
- recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
  [see Clinical Studies (14.12)]
  .
For the MSI-H/dMMR indications, select patients for treatment with KEYTRUDA as a single agent based on MSI-H/dMMR status in tumor specimens
[see Clinical Studies (14.8, 14.9)].
For the TMB-H indication, select patients for treatment with KEYTRUDA as a single agent based on TMB-H status in tumor specimens
[see Clinical Studies (14.18)].
Because subclonal dMMR mutations and microsatellite instability may arise in high-grade gliomas during temozolomide therapy, it is recommended to test for TMB-H, MSI-H, and dMMR in the primary tumor specimens obtained prior to initiation of temozolomide chemotherapy in patients with high-grade gliomas.
Additional Patient Selection Information for MSI-H or dMMR in Patients with non-CRC Solid Tumors
Due to discordance between local tests and FDA-approved tests, confirmation of MSI-H or dMMR status is recommended by an FDA-approved test in patients with MSI-H or dMMR solid tumors, if feasible. If unable to perform confirmatory MSI-H/dMMR testing, the presence of TMB ≥10 mut/Mb, as determined by an FDA-approved test, may be used to select patients for treatment
[see Clinical Studies (14.8)]
.
Patient Selection for Combination Therapy
For use of KEYTRUDA as a single agent as neoadjuvant treatment, then in combination with radiotherapy (RT) with or without chemotherapy then continued as a single agent as adjuvant treatment, select patients based on presence of positive PD-L1 expression (CPS ≥1) in resectable locally advanced HNSCC
[see Clinical Studies (14.4)].
For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression (CPS ≥1) in locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, and esophageal or gastroesophageal junction (GEJ) carcinoma
[see Clinical Studies (14.10), (14.11)].
- An FDA-approved test for the detection of PD-L1 for the selection of patients with PD-L1 (CPS ≥ 1) expression in esophageal carcinoma in combination with platinum- and fluoropyrimidine-based chemotherapy is not available.
For use of KEYTRUDA in combination with chemotherapy, with or without bevacizumab, select patients based on the presence of positive PD-L1 expression in persistent, recurrent, or metastatic cervical cancer
[see Clinical Studies (14.12)].
For the pMMR/not MSI-H advanced endometrial carcinoma indication, select patients for treatment with KEYTRUDA in combination with lenvatinib based on MMR or MSI status in tumor specimens
[see Clinical Studies (14.17)]
.
For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression in locally recurrent unresectable or metastatic TNBC
[see Clinical Studies (14.20)]
.
)

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer (CRC)

for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test. (
1.9 Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer
KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
.
,
2.1 Patient Selection
Information on FDA-approved tests for patient selection is available at:
http://www.fda.gov/CompanionDiagnostics
.
Patient Selection for Single-Agent Treatment
Select patients for treatment with KEYTRUDA as a single agent based on the presence of positive PD-L1 expression in:
- Stage III NSCLC who are not candidates for surgical resection or definitive chemoradiation
  [see Clinical Studies (14.2)]
  .
- metastatic NSCLC
  [see Clinical Studies (14.2)].
- first-line treatment of metastatic or unresectable, recurrent HNSCC
  [see Clinical Studies (14.4)]
  .
- previously treated recurrent locally advanced or metastatic esophageal cancer
  [see Clinical Studies (14.11)]
  .
- recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
  [see Clinical Studies (14.12)]
  .
For the MSI-H/dMMR indications, select patients for treatment with KEYTRUDA as a single agent based on MSI-H/dMMR status in tumor specimens
[see Clinical Studies (14.8, 14.9)].
For the TMB-H indication, select patients for treatment with KEYTRUDA as a single agent based on TMB-H status in tumor specimens
[see Clinical Studies (14.18)].
Because subclonal dMMR mutations and microsatellite instability may arise in high-grade gliomas during temozolomide therapy, it is recommended to test for TMB-H, MSI-H, and dMMR in the primary tumor specimens obtained prior to initiation of temozolomide chemotherapy in patients with high-grade gliomas.
Additional Patient Selection Information for MSI-H or dMMR in Patients with non-CRC Solid Tumors
Due to discordance between local tests and FDA-approved tests, confirmation of MSI-H or dMMR status is recommended by an FDA-approved test in patients with MSI-H or dMMR solid tumors, if feasible. If unable to perform confirmatory MSI-H/dMMR testing, the presence of TMB ≥10 mut/Mb, as determined by an FDA-approved test, may be used to select patients for treatment
[see Clinical Studies (14.8)]
.
Patient Selection for Combination Therapy
For use of KEYTRUDA as a single agent as neoadjuvant treatment, then in combination with radiotherapy (RT) with or without chemotherapy then continued as a single agent as adjuvant treatment, select patients based on presence of positive PD-L1 expression (CPS ≥1) in resectable locally advanced HNSCC
[see Clinical Studies (14.4)].
For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression (CPS ≥1) in locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, and esophageal or gastroesophageal junction (GEJ) carcinoma
[see Clinical Studies (14.10), (14.11)].
- An FDA-approved test for the detection of PD-L1 for the selection of patients with PD-L1 (CPS ≥ 1) expression in esophageal carcinoma in combination with platinum- and fluoropyrimidine-based chemotherapy is not available.
For use of KEYTRUDA in combination with chemotherapy, with or without bevacizumab, select patients based on the presence of positive PD-L1 expression in persistent, recurrent, or metastatic cervical cancer
[see Clinical Studies (14.12)].
For the pMMR/not MSI-H advanced endometrial carcinoma indication, select patients for treatment with KEYTRUDA in combination with lenvatinib based on MMR or MSI status in tumor specimens
[see Clinical Studies (14.17)]
.
For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression in locally recurrent unresectable or metastatic TNBC
[see Clinical Studies (14.20)]
.
)

Gastric Cancer

in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. (
1.10 Gastric Cancer
KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
.
KEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA approved test
[see Dosage and Administration (2.1)]
.
)
in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. (
1.10 Gastric Cancer
KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
.
KEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA approved test
[see Dosage and Administration (2.1)]
.
)

Esophageal Cancer

for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:
- in combination with platinum- and fluoropyrimidine-based chemotherapy for patients whose tumors express PD-L1 (CPS ≥1), or
- as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test. (
  1.11 Esophageal Cancer
  KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:
  in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with tumors that express PD-L1 (CPS ≥ 1)
  [see Dosage and Administration (2.1)]
  , or
  as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test
  [see Dosage and Administration (2.1)]
  .
  ,
  2.1 Patient Selection
  Information on FDA-approved tests for patient selection is available at:
  http://www.fda.gov/CompanionDiagnostics
  .
  Patient Selection for Single-Agent Treatment
  Select patients for treatment with KEYTRUDA as a single agent based on the presence of positive PD-L1 expression in:
  Stage III NSCLC who are not candidates for surgical resection or definitive chemoradiation
  [see Clinical Studies (14.2)]
  .
  metastatic NSCLC
  [see Clinical Studies (14.2)].
  first-line treatment of metastatic or unresectable, recurrent HNSCC
  [see Clinical Studies (14.4)]
  .
  previously treated recurrent locally advanced or metastatic esophageal cancer
  [see Clinical Studies (14.11)]
  .
  recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
  [see Clinical Studies (14.12)]
  .
  For the MSI-H/dMMR indications, select patients for treatment with KEYTRUDA as a single agent based on MSI-H/dMMR status in tumor specimens
  [see Clinical Studies (14.8, 14.9)].
  For the TMB-H indication, select patients for treatment with KEYTRUDA as a single agent based on TMB-H status in tumor specimens
  [see Clinical Studies (14.18)].
  Because subclonal dMMR mutations and microsatellite instability may arise in high-grade gliomas during temozolomide therapy, it is recommended to test for TMB-H, MSI-H, and dMMR in the primary tumor specimens obtained prior to initiation of temozolomide chemotherapy in patients with high-grade gliomas.
  Additional Patient Selection Information for MSI-H or dMMR in Patients with non-CRC Solid Tumors
  Due to discordance between local tests and FDA-approved tests, confirmation of MSI-H or dMMR status is recommended by an FDA-approved test in patients with MSI-H or dMMR solid tumors, if feasible. If unable to perform confirmatory MSI-H/dMMR testing, the presence of TMB ≥10 mut/Mb, as determined by an FDA-approved test, may be used to select patients for treatment
  [see Clinical Studies (14.8)]
  .
  Patient Selection for Combination Therapy
  For use of KEYTRUDA as a single agent as neoadjuvant treatment, then in combination with radiotherapy (RT) with or without chemotherapy then continued as a single agent as adjuvant treatment, select patients based on presence of positive PD-L1 expression (CPS ≥1) in resectable locally advanced HNSCC
  [see Clinical Studies (14.4)].
  For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression (CPS ≥1) in locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, and esophageal or gastroesophageal junction (GEJ) carcinoma
  [see Clinical Studies (14.10), (14.11)].
  An FDA-approved test for the detection of PD-L1 for the selection of patients with PD-L1 (CPS ≥ 1) expression in esophageal carcinoma in combination with platinum- and fluoropyrimidine-based chemotherapy is not available.
  For use of KEYTRUDA in combination with chemotherapy, with or without bevacizumab, select patients based on the presence of positive PD-L1 expression in persistent, recurrent, or metastatic cervical cancer
  [see Clinical Studies (14.12)].
  For the pMMR/not MSI-H advanced endometrial carcinoma indication, select patients for treatment with KEYTRUDA in combination with lenvatinib based on MMR or MSI status in tumor specimens
  [see Clinical Studies (14.17)]
  .
  For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression in locally recurrent unresectable or metastatic TNBC
  [see Clinical Studies (14.20)]
  .
  )

Cervical Cancer

in combination with chemoradiotherapy, for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III-IVA). (
1.12 Cervical Cancer
KEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III-IVA).
KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test
[see Dosage and Administration (2.1)].
KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
.
)
in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. (
1.12 Cervical Cancer
KEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III-IVA).
KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test
[see Dosage and Administration (2.1)].
KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
.
,
2.1 Patient Selection
Information on FDA-approved tests for patient selection is available at:
http://www.fda.gov/CompanionDiagnostics
.
Patient Selection for Single-Agent Treatment
Select patients for treatment with KEYTRUDA as a single agent based on the presence of positive PD-L1 expression in:
- Stage III NSCLC who are not candidates for surgical resection or definitive chemoradiation
  [see Clinical Studies (14.2)]
  .
- metastatic NSCLC
  [see Clinical Studies (14.2)].
- first-line treatment of metastatic or unresectable, recurrent HNSCC
  [see Clinical Studies (14.4)]
  .
- previously treated recurrent locally advanced or metastatic esophageal cancer
  [see Clinical Studies (14.11)]
  .
- recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
  [see Clinical Studies (14.12)]
  .
For the MSI-H/dMMR indications, select patients for treatment with KEYTRUDA as a single agent based on MSI-H/dMMR status in tumor specimens
[see Clinical Studies (14.8, 14.9)].
For the TMB-H indication, select patients for treatment with KEYTRUDA as a single agent based on TMB-H status in tumor specimens
[see Clinical Studies (14.18)].
Because subclonal dMMR mutations and microsatellite instability may arise in high-grade gliomas during temozolomide therapy, it is recommended to test for TMB-H, MSI-H, and dMMR in the primary tumor specimens obtained prior to initiation of temozolomide chemotherapy in patients with high-grade gliomas.
Additional Patient Selection Information for MSI-H or dMMR in Patients with non-CRC Solid Tumors
Due to discordance between local tests and FDA-approved tests, confirmation of MSI-H or dMMR status is recommended by an FDA-approved test in patients with MSI-H or dMMR solid tumors, if feasible. If unable to perform confirmatory MSI-H/dMMR testing, the presence of TMB ≥10 mut/Mb, as determined by an FDA-approved test, may be used to select patients for treatment
[see Clinical Studies (14.8)]
.
Patient Selection for Combination Therapy
For use of KEYTRUDA as a single agent as neoadjuvant treatment, then in combination with radiotherapy (RT) with or without chemotherapy then continued as a single agent as adjuvant treatment, select patients based on presence of positive PD-L1 expression (CPS ≥1) in resectable locally advanced HNSCC
[see Clinical Studies (14.4)].
For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression (CPS ≥1) in locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, and esophageal or gastroesophageal junction (GEJ) carcinoma
[see Clinical Studies (14.10), (14.11)].
- An FDA-approved test for the detection of PD-L1 for the selection of patients with PD-L1 (CPS ≥ 1) expression in esophageal carcinoma in combination with platinum- and fluoropyrimidine-based chemotherapy is not available.
For use of KEYTRUDA in combination with chemotherapy, with or without bevacizumab, select patients based on the presence of positive PD-L1 expression in persistent, recurrent, or metastatic cervical cancer
[see Clinical Studies (14.12)].
For the pMMR/not MSI-H advanced endometrial carcinoma indication, select patients for treatment with KEYTRUDA in combination with lenvatinib based on MMR or MSI status in tumor specimens
[see Clinical Studies (14.17)]
.
For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression in locally recurrent unresectable or metastatic TNBC
[see Clinical Studies (14.20)]
.
)
as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. (
1.12 Cervical Cancer
KEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III-IVA).
KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test
[see Dosage and Administration (2.1)].
KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
.
,
2.1 Patient Selection
Information on FDA-approved tests for patient selection is available at:
http://www.fda.gov/CompanionDiagnostics
.
Patient Selection for Single-Agent Treatment
Select patients for treatment with KEYTRUDA as a single agent based on the presence of positive PD-L1 expression in:
- Stage III NSCLC who are not candidates for surgical resection or definitive chemoradiation
  [see Clinical Studies (14.2)]
  .
- metastatic NSCLC
  [see Clinical Studies (14.2)].
- first-line treatment of metastatic or unresectable, recurrent HNSCC
  [see Clinical Studies (14.4)]
  .
- previously treated recurrent locally advanced or metastatic esophageal cancer
  [see Clinical Studies (14.11)]
  .
- recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
  [see Clinical Studies (14.12)]
  .
For the MSI-H/dMMR indications, select patients for treatment with KEYTRUDA as a single agent based on MSI-H/dMMR status in tumor specimens
[see Clinical Studies (14.8, 14.9)].
For the TMB-H indication, select patients for treatment with KEYTRUDA as a single agent based on TMB-H status in tumor specimens
[see Clinical Studies (14.18)].
Because subclonal dMMR mutations and microsatellite instability may arise in high-grade gliomas during temozolomide therapy, it is recommended to test for TMB-H, MSI-H, and dMMR in the primary tumor specimens obtained prior to initiation of temozolomide chemotherapy in patients with high-grade gliomas.
Additional Patient Selection Information for MSI-H or dMMR in Patients with non-CRC Solid Tumors
Due to discordance between local tests and FDA-approved tests, confirmation of MSI-H or dMMR status is recommended by an FDA-approved test in patients with MSI-H or dMMR solid tumors, if feasible. If unable to perform confirmatory MSI-H/dMMR testing, the presence of TMB ≥10 mut/Mb, as determined by an FDA-approved test, may be used to select patients for treatment
[see Clinical Studies (14.8)]
.
Patient Selection for Combination Therapy
For use of KEYTRUDA as a single agent as neoadjuvant treatment, then in combination with radiotherapy (RT) with or without chemotherapy then continued as a single agent as adjuvant treatment, select patients based on presence of positive PD-L1 expression (CPS ≥1) in resectable locally advanced HNSCC
[see Clinical Studies (14.4)].
For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression (CPS ≥1) in locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, and esophageal or gastroesophageal junction (GEJ) carcinoma
[see Clinical Studies (14.10), (14.11)].
- An FDA-approved test for the detection of PD-L1 for the selection of patients with PD-L1 (CPS ≥ 1) expression in esophageal carcinoma in combination with platinum- and fluoropyrimidine-based chemotherapy is not available.
For use of KEYTRUDA in combination with chemotherapy, with or without bevacizumab, select patients based on the presence of positive PD-L1 expression in persistent, recurrent, or metastatic cervical cancer
[see Clinical Studies (14.12)].
For the pMMR/not MSI-H advanced endometrial carcinoma indication, select patients for treatment with KEYTRUDA in combination with lenvatinib based on MMR or MSI status in tumor specimens
[see Clinical Studies (14.17)]
.
For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression in locally recurrent unresectable or metastatic TNBC
[see Clinical Studies (14.20)]
.
)

Hepatocellular Carcinoma (HCC)

for the treatment of patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. (
1.13 Hepatocellular Carcinoma
KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen.
)

Biliary Tract Cancer (BTC)

in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer. (
1.14 Biliary Tract Cancer
KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).
)

Merkel Cell Carcinoma (MCC)

for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma. (
1.15 Merkel Cell Carcinoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
)

Renal Cell Carcinoma (RCC)

in combination with axitinib, for the first-line treatment of adult patients with advanced RCC. (
1.16 Renal Cell Carcinoma
KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC.
KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions
[see Clinical Studies (14.16)]
.
)
in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC. (
1.16 Renal Cell Carcinoma
KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC.
KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions
[see Clinical Studies (14.16)]
.
)
for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. (
1.16 Renal Cell Carcinoma
KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC.
KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions
[see Clinical Studies (14.16)]
.
)

Endometrial Carcinoma

in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. (
1.17 Endometrial Carcinoma
KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation
[see Dosage and Administration (2.1)]
.
KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation
[see Dosage and Administration (2.1)]
.
)
in combination with lenvatinib, for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. (
1.17 Endometrial Carcinoma
KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation
[see Dosage and Administration (2.1)]
.
KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation
[see Dosage and Administration (2.1)]
.
,
2.1 Patient Selection
Information on FDA-approved tests for patient selection is available at:
http://www.fda.gov/CompanionDiagnostics
.
Patient Selection for Single-Agent Treatment
Select patients for treatment with KEYTRUDA as a single agent based on the presence of positive PD-L1 expression in:
- Stage III NSCLC who are not candidates for surgical resection or definitive chemoradiation
  [see Clinical Studies (14.2)]
  .
- metastatic NSCLC
  [see Clinical Studies (14.2)].
- first-line treatment of metastatic or unresectable, recurrent HNSCC
  [see Clinical Studies (14.4)]
  .
- previously treated recurrent locally advanced or metastatic esophageal cancer
  [see Clinical Studies (14.11)]
  .
- recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
  [see Clinical Studies (14.12)]
  .
For the MSI-H/dMMR indications, select patients for treatment with KEYTRUDA as a single agent based on MSI-H/dMMR status in tumor specimens
[see Clinical Studies (14.8, 14.9)].
For the TMB-H indication, select patients for treatment with KEYTRUDA as a single agent based on TMB-H status in tumor specimens
[see Clinical Studies (14.18)].
Because subclonal dMMR mutations and microsatellite instability may arise in high-grade gliomas during temozolomide therapy, it is recommended to test for TMB-H, MSI-H, and dMMR in the primary tumor specimens obtained prior to initiation of temozolomide chemotherapy in patients with high-grade gliomas.
Additional Patient Selection Information for MSI-H or dMMR in Patients with non-CRC Solid Tumors
Due to discordance between local tests and FDA-approved tests, confirmation of MSI-H or dMMR status is recommended by an FDA-approved test in patients with MSI-H or dMMR solid tumors, if feasible. If unable to perform confirmatory MSI-H/dMMR testing, the presence of TMB ≥10 mut/Mb, as determined by an FDA-approved test, may be used to select patients for treatment
[see Clinical Studies (14.8)]
.
Patient Selection for Combination Therapy
For use of KEYTRUDA as a single agent as neoadjuvant treatment, then in combination with radiotherapy (RT) with or without chemotherapy then continued as a single agent as adjuvant treatment, select patients based on presence of positive PD-L1 expression (CPS ≥1) in resectable locally advanced HNSCC
[see Clinical Studies (14.4)].
For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression (CPS ≥1) in locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, and esophageal or gastroesophageal junction (GEJ) carcinoma
[see Clinical Studies (14.10), (14.11)].
- An FDA-approved test for the detection of PD-L1 for the selection of patients with PD-L1 (CPS ≥ 1) expression in esophageal carcinoma in combination with platinum- and fluoropyrimidine-based chemotherapy is not available.
For use of KEYTRUDA in combination with chemotherapy, with or without bevacizumab, select patients based on the presence of positive PD-L1 expression in persistent, recurrent, or metastatic cervical cancer
[see Clinical Studies (14.12)].
For the pMMR/not MSI-H advanced endometrial carcinoma indication, select patients for treatment with KEYTRUDA in combination with lenvatinib based on MMR or MSI status in tumor specimens
[see Clinical Studies (14.17)]
.
For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression in locally recurrent unresectable or metastatic TNBC
[see Clinical Studies (14.20)]
.
)
as a single agent, for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. (
1.17 Endometrial Carcinoma
KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation
[see Dosage and Administration (2.1)]
.
KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation
[see Dosage and Administration (2.1)]
.
,
2.1 Patient Selection
Information on FDA-approved tests for patient selection is available at:
http://www.fda.gov/CompanionDiagnostics
.
Patient Selection for Single-Agent Treatment
Select patients for treatment with KEYTRUDA as a single agent based on the presence of positive PD-L1 expression in:
- Stage III NSCLC who are not candidates for surgical resection or definitive chemoradiation
  [see Clinical Studies (14.2)]
  .
- metastatic NSCLC
  [see Clinical Studies (14.2)].
- first-line treatment of metastatic or unresectable, recurrent HNSCC
  [see Clinical Studies (14.4)]
  .
- previously treated recurrent locally advanced or metastatic esophageal cancer
  [see Clinical Studies (14.11)]
  .
- recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
  [see Clinical Studies (14.12)]
  .
For the MSI-H/dMMR indications, select patients for treatment with KEYTRUDA as a single agent based on MSI-H/dMMR status in tumor specimens
[see Clinical Studies (14.8, 14.9)].
For the TMB-H indication, select patients for treatment with KEYTRUDA as a single agent based on TMB-H status in tumor specimens
[see Clinical Studies (14.18)].
Because subclonal dMMR mutations and microsatellite instability may arise in high-grade gliomas during temozolomide therapy, it is recommended to test for TMB-H, MSI-H, and dMMR in the primary tumor specimens obtained prior to initiation of temozolomide chemotherapy in patients with high-grade gliomas.
Additional Patient Selection Information for MSI-H or dMMR in Patients with non-CRC Solid Tumors
Due to discordance between local tests and FDA-approved tests, confirmation of MSI-H or dMMR status is recommended by an FDA-approved test in patients with MSI-H or dMMR solid tumors, if feasible. If unable to perform confirmatory MSI-H/dMMR testing, the presence of TMB ≥10 mut/Mb, as determined by an FDA-approved test, may be used to select patients for treatment
[see Clinical Studies (14.8)]
.
Patient Selection for Combination Therapy
For use of KEYTRUDA as a single agent as neoadjuvant treatment, then in combination with radiotherapy (RT) with or without chemotherapy then continued as a single agent as adjuvant treatment, select patients based on presence of positive PD-L1 expression (CPS ≥1) in resectable locally advanced HNSCC
[see Clinical Studies (14.4)].
For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression (CPS ≥1) in locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, and esophageal or gastroesophageal junction (GEJ) carcinoma
[see Clinical Studies (14.10), (14.11)].
- An FDA-approved test for the detection of PD-L1 for the selection of patients with PD-L1 (CPS ≥ 1) expression in esophageal carcinoma in combination with platinum- and fluoropyrimidine-based chemotherapy is not available.
For use of KEYTRUDA in combination with chemotherapy, with or without bevacizumab, select patients based on the presence of positive PD-L1 expression in persistent, recurrent, or metastatic cervical cancer
[see Clinical Studies (14.12)].
For the pMMR/not MSI-H advanced endometrial carcinoma indication, select patients for treatment with KEYTRUDA in combination with lenvatinib based on MMR or MSI status in tumor specimens
[see Clinical Studies (14.17)]
.
For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression in locally recurrent unresectable or metastatic TNBC
[see Clinical Studies (14.20)]
.
)

Tumor Mutational Burden-High (TMB-H) Cancer

for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.¹ (
1.18 Tumor Mutational Burden-High Cancer
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
This indication is approved under accelerated approval based on tumor response rate and durability of response
[see Clinical Studies (14.18)]
. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Limitations of Use
: The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.
,
2.1 Patient Selection
Information on FDA-approved tests for patient selection is available at:
http://www.fda.gov/CompanionDiagnostics
.
Patient Selection for Single-Agent Treatment
Select patients for treatment with KEYTRUDA as a single agent based on the presence of positive PD-L1 expression in:
- Stage III NSCLC who are not candidates for surgical resection or definitive chemoradiation
  [see Clinical Studies (14.2)]
  .
- metastatic NSCLC
  [see Clinical Studies (14.2)].
- first-line treatment of metastatic or unresectable, recurrent HNSCC
  [see Clinical Studies (14.4)]
  .
- previously treated recurrent locally advanced or metastatic esophageal cancer
  [see Clinical Studies (14.11)]
  .
- recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
  [see Clinical Studies (14.12)]
  .
For the MSI-H/dMMR indications, select patients for treatment with KEYTRUDA as a single agent based on MSI-H/dMMR status in tumor specimens
[see Clinical Studies (14.8, 14.9)].
For the TMB-H indication, select patients for treatment with KEYTRUDA as a single agent based on TMB-H status in tumor specimens
[see Clinical Studies (14.18)].
Because subclonal dMMR mutations and microsatellite instability may arise in high-grade gliomas during temozolomide therapy, it is recommended to test for TMB-H, MSI-H, and dMMR in the primary tumor specimens obtained prior to initiation of temozolomide chemotherapy in patients with high-grade gliomas.
Additional Patient Selection Information for MSI-H or dMMR in Patients with non-CRC Solid Tumors
Due to discordance between local tests and FDA-approved tests, confirmation of MSI-H or dMMR status is recommended by an FDA-approved test in patients with MSI-H or dMMR solid tumors, if feasible. If unable to perform confirmatory MSI-H/dMMR testing, the presence of TMB ≥10 mut/Mb, as determined by an FDA-approved test, may be used to select patients for treatment
[see Clinical Studies (14.8)]
.
Patient Selection for Combination Therapy
For use of KEYTRUDA as a single agent as neoadjuvant treatment, then in combination with radiotherapy (RT) with or without chemotherapy then continued as a single agent as adjuvant treatment, select patients based on presence of positive PD-L1 expression (CPS ≥1) in resectable locally advanced HNSCC
[see Clinical Studies (14.4)].
For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression (CPS ≥1) in locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, and esophageal or gastroesophageal junction (GEJ) carcinoma
[see Clinical Studies (14.10), (14.11)].
- An FDA-approved test for the detection of PD-L1 for the selection of patients with PD-L1 (CPS ≥ 1) expression in esophageal carcinoma in combination with platinum- and fluoropyrimidine-based chemotherapy is not available.
For use of KEYTRUDA in combination with chemotherapy, with or without bevacizumab, select patients based on the presence of positive PD-L1 expression in persistent, recurrent, or metastatic cervical cancer
[see Clinical Studies (14.12)].
For the pMMR/not MSI-H advanced endometrial carcinoma indication, select patients for treatment with KEYTRUDA in combination with lenvatinib based on MMR or MSI status in tumor specimens
[see Clinical Studies (14.17)]
.
For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression in locally recurrent unresectable or metastatic TNBC
[see Clinical Studies (14.20)]
.
)
Limitations of Use
: The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma (cSCC)

for the treatment of patients with recurrent or metastatic cSCC or locally advanced cSCC that is not curable by surgery or radiation. (
1.19 Cutaneous Squamous Cell Carcinoma
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.
)

Triple-Negative Breast Cancer (TNBC)

for the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. (
1.20 Triple-Negative Breast Cancer
KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
.
)
in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test. (
1.20 Triple-Negative Breast Cancer
KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test
[see Dosage and Administration (2.1)]
.
,
2.1 Patient Selection
Information on FDA-approved tests for patient selection is available at:
http://www.fda.gov/CompanionDiagnostics
.
Patient Selection for Single-Agent Treatment
Select patients for treatment with KEYTRUDA as a single agent based on the presence of positive PD-L1 expression in:
- Stage III NSCLC who are not candidates for surgical resection or definitive chemoradiation
  [see Clinical Studies (14.2)]
  .
- metastatic NSCLC
  [see Clinical Studies (14.2)].
- first-line treatment of metastatic or unresectable, recurrent HNSCC
  [see Clinical Studies (14.4)]
  .
- previously treated recurrent locally advanced or metastatic esophageal cancer
  [see Clinical Studies (14.11)]
  .
- recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
  [see Clinical Studies (14.12)]
  .
For the MSI-H/dMMR indications, select patients for treatment with KEYTRUDA as a single agent based on MSI-H/dMMR status in tumor specimens
[see Clinical Studies (14.8, 14.9)].
For the TMB-H indication, select patients for treatment with KEYTRUDA as a single agent based on TMB-H status in tumor specimens
[see Clinical Studies (14.18)].
Because subclonal dMMR mutations and microsatellite instability may arise in high-grade gliomas during temozolomide therapy, it is recommended to test for TMB-H, MSI-H, and dMMR in the primary tumor specimens obtained prior to initiation of temozolomide chemotherapy in patients with high-grade gliomas.
Additional Patient Selection Information for MSI-H or dMMR in Patients with non-CRC Solid Tumors
Due to discordance between local tests and FDA-approved tests, confirmation of MSI-H or dMMR status is recommended by an FDA-approved test in patients with MSI-H or dMMR solid tumors, if feasible. If unable to perform confirmatory MSI-H/dMMR testing, the presence of TMB ≥10 mut/Mb, as determined by an FDA-approved test, may be used to select patients for treatment
[see Clinical Studies (14.8)]
.
Patient Selection for Combination Therapy
For use of KEYTRUDA as a single agent as neoadjuvant treatment, then in combination with radiotherapy (RT) with or without chemotherapy then continued as a single agent as adjuvant treatment, select patients based on presence of positive PD-L1 expression (CPS ≥1) in resectable locally advanced HNSCC
[see Clinical Studies (14.4)].
For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression (CPS ≥1) in locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, and esophageal or gastroesophageal junction (GEJ) carcinoma
[see Clinical Studies (14.10), (14.11)].
- An FDA-approved test for the detection of PD-L1 for the selection of patients with PD-L1 (CPS ≥ 1) expression in esophageal carcinoma in combination with platinum- and fluoropyrimidine-based chemotherapy is not available.
For use of KEYTRUDA in combination with chemotherapy, with or without bevacizumab, select patients based on the presence of positive PD-L1 expression in persistent, recurrent, or metastatic cervical cancer
[see Clinical Studies (14.12)].
For the pMMR/not MSI-H advanced endometrial carcinoma indication, select patients for treatment with KEYTRUDA in combination with lenvatinib based on MMR or MSI status in tumor specimens
[see Clinical Studies (14.17)]
.
For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression in locally recurrent unresectable or metastatic TNBC
[see Clinical Studies (14.20)]
.
)

¹ This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Melanoma: 200 mg every 3 weeks or 400 mg every 6 weeks; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: Administer KEYTRUDA in combination with RT with or without cisplatin. Continue KEYTRUDA as a single agent. Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)

NSCLC: 200 mg every 3 weeks or 400 mg every 6 weeks. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: Administer KEYTRUDA in combination with RT with or without cisplatin. Continue KEYTRUDA as a single agent. Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)

MPM: 200 mg every 3 weeks or 400 mg every 6 weeks. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: Administer KEYTRUDA in combination with RT with or without cisplatin. Continue KEYTRUDA as a single agent. Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)

HNSCC: 200 mg every 3 weeks or 400 mg every 6 weeks. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: Administer KEYTRUDA in combination with RT with or without cisplatin. Continue KEYTRUDA as a single agent. Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)

cHL or PMBCL: 200 mg every 3 weeks or 400 mg every 6 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: Administer KEYTRUDA in combination with RT with or without cisplatin. Continue KEYTRUDA as a single agent. Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)

Urothelial Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: Administer KEYTRUDA in combination with RT with or without cisplatin. Continue KEYTRUDA as a single agent. Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)

MSI-H or dMMR Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: Administer KEYTRUDA in combination with RT with or without cisplatin. Continue KEYTRUDA as a single agent. Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)

MSI-H or dMMR CRC: 200 mg every 3 weeks or 400 mg every 6 weeks. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: Administer KEYTRUDA in combination with RT with or without cisplatin. Continue KEYTRUDA as a single agent. Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)

Gastric Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: Administer KEYTRUDA in combination with RT with or without cisplatin. Continue KEYTRUDA as a single agent. Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)

Esophageal Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: Administer KEYTRUDA in combination with RT with or without cisplatin. Continue KEYTRUDA as a single agent. Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)

Cervical Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: Administer KEYTRUDA in combination with RT with or without cisplatin. Continue KEYTRUDA as a single agent. Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)

HCC: 200 mg every 3 weeks or 400 mg every 6 weeks. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: Administer KEYTRUDA in combination with RT with or without cisplatin. Continue KEYTRUDA as a single agent. Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)

BTC: 200 mg every 3 weeks or 400 mg every 6 weeks. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: Administer KEYTRUDA in combination with RT with or without cisplatin. Continue KEYTRUDA as a single agent. Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)

MCC: 200 mg every 3 weeks or 400 mg every 6 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: Administer KEYTRUDA in combination with RT with or without cisplatin. Continue KEYTRUDA as a single agent. Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)

RCC: 200 mg every 3 weeks or 400 mg every 6 weeks as a single agent in the adjuvant setting, or in the advanced setting with either:

axitinib 5 mg orally twice daily or

lenvatinib 20 mg orally once daily. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: Administer KEYTRUDA in combination with RT with or without cisplatin. Continue KEYTRUDA as a single agent. Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)

Endometrial Carcinoma: 200 mg every 3 weeks or 400 mg every 6 weeks

in combination with carboplatin and paclitaxel regardless of MMR or MSI status, or
in combination with lenvatinib 20 mg orally once daily for pMMR or not MSI-H tumors, or

as a single agent for MSI-H or dMMR tumors. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: Administer KEYTRUDA in combination with RT with or without cisplatin. Continue KEYTRUDA as a single agent. Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)

TMB-H Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: Administer KEYTRUDA in combination with RT with or without cisplatin. Continue KEYTRUDA as a single agent. Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)

cSCC: 200 mg every 3 weeks or 400 mg every 6 weeks. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: Administer KEYTRUDA in combination with RT with or without cisplatin. Continue KEYTRUDA as a single agent. Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)

TNBC: 200 mg every 3 weeks or 400 mg every 6 weeks. (

2.2 Recommended Dosage

Administer KEYTRUDA as a 30-minute intravenous infusion. The recommended dosages of KEYTRUDA are presented in Table 1.

Table 1: Recommended Dosage
Indication	Recommended Dosage of KEYTRUDA	Duration/Timing of Treatment
Monotherapy
Adult patients with unresectable or metastatic melanoma	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression or unacceptable toxicity
Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease recurrence, unacceptable toxicity, or up to 12 months
Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC	200 mg every 3 weeks or 400 mg every 6 weeks	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with high-risk BCG- unresponsive NMIBC	200 mg every 3 weeks or 400 mg every 6 weeks	Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease progression, unacceptable toxicity, or up to 24 months
Pediatric patients (12 years and older) for adjuvant treatment of melanoma	2 mg/kg every 3 weeks (up to a maximum of 200 mg)	Until disease recurrence, unacceptable toxicity, or up to 12 months
Combination Therapy Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
Adult patients with resectable NSCLC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity
Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with locally advanced or metastatic urothelial cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with MIBC	200 mg every 3 weeks (neoadjuvant) 200mg every 3 weeks or 400 mg every 6 weeks (adjuvant) Administer KEYTRUDA after enfortumab vedotin when given on the same day.	Neoadjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: Administer KEYTRUDA 200 mg every 3 weeks for 14 doses or 400 mg every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity
Adult patients with locally advanced HNSCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to cisplatin when given on the same day.	Neoadjuvant: Administer KEYTRUDA for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: Administer KEYTRUDA in combination with RT with or without cisplatin. Continue KEYTRUDA as a single agent. Continue KEYTRUDA until disease recurrence or unacceptable toxicity or up to one year
Adult patients with HER2-positive Gastric Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months
Adult patients with Cervical Cancer	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with RCC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with Endometrial Carcinoma	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily.	Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months
Adult patients with high-risk early-stage TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.
Adult patients with locally recurrent unresectable or metastatic TNBC	200 mg every 3 weeks or 400 mg every 6 weeks Administer KEYTRUDA prior to chemotherapy when given on the same day.	Until disease progression, unacceptable toxicity, or up to 24 months

)

Administer KEYTRUDA as an intravenous infusion over 30 minutes after dilution. (
2.4 Preparation and Administration
Preparation for Intravenous Infusion
Visually inspect the solution for particulate matter and discoloration. The solution is clear to slightly opalescent, colorless to slightly yellow. Discard the vial if visible particles are observed.
Dilute KEYTRUDA injection (solution) prior to intravenous administration.
Withdraw the required volume from the vial(s) of KEYTRUDA and transfer into an intravenous (IV) bag containing 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP.
Mix diluted solution by gentle inversion.
Do not shake. The final concentration of the diluted solution should be between 1 mg/mL to 10 mg/mL.
Discard any unused portion left in the vial.
Storage of Diluted Solution
The product does not contain a preservative.
Store the diluted solution from the KEYTRUDA 100 mg/4 mL vial either:
At room temperature (temperatures at or below 25°C) for no more than 6 hours from the time of dilution. This includes room temperature storage of the diluted solution, and the duration of infusion.
Under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 96 hours from the time of dilution. If refrigerated, allow the diluted solution to come to room temperature prior to administration. Do not shake.
Discard after 6 hours at room temperature or after 96 hours under refrigeration.
Do not freeze.
Administration
Administer diluted solution intravenously over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter.
Do not co-administer other drugs through the same infusion line.
)

See Full Prescribing Information for dosage modifications for adverse reactions and preparation and administration instructions. (

2.3 Dose Modifications

Dosage modifications for KEYTRUDA for adverse reactions that require management different from these general guidelines are summarized in Table 2.

Table 2: Recommended Dosage Modifications for Adverse Reactions
Adverse Reaction	SeverityBased on Common Terminology Criteria for Adverse Events (CTCAE), version 4.0	Dosage Modification
ALT = alanine aminotransferase, AST = aspartate aminotransferase, DRESS = Drug Rash with Eosinophilia and Systemic Symptoms, SJS = Stevens Johnson Syndrome, TEN = toxic epidermal necrolysis, ULN = upper limit normal
Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1)]
Pneumonitis	Grade 2	WithholdResume in patients with complete or partial resolution (Grades 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.
Pneumonitis	Grade 3 or 4	Permanently discontinue
Colitis	Grade 2 or 3	Withhold
Colitis	Grade 4	Permanently discontinue
Hepatitis with no tumor involvement of the liver	AST or ALT increases to more than 3 and up to 8 times ULN or Total bilirubin increases to more than 1.5 and up to 3 times ULN	Withhold
For liver enzyme elevations in patients treated with combination therapy with axitinib, see Table 3.	AST or ALT increases to more than 8 times ULN or Total bilirubin increases to more than 3 times ULN	Permanently discontinue
Hepatitis with tumor involvement of the liverIf AST and ALT are less than or equal to ULN at baseline, withhold or permanently discontinue KEYTRUDA based on recommendations for hepatitis with no liver involvement.	Baseline AST or ALT is more than 1 and up to 3 times ULN and increases to more than 5 and up to 10 times ULN or Baseline AST or ALT is more than 3 and up to 5 times ULN and increases to more than 8 and up to 10 times ULN	Withhold
	ALT or AST increases to more than 10 times ULN or Total bilirubin increases to more than 3 times ULN	Permanently discontinue
Endocrinopathies	Grade 3 or 4	Withhold until clinically stable or permanently discontinue depending on severity
Nephritis with Renal Dysfunction	Grade 2 or 3 increased blood creatinine	Withhold
Nephritis with Renal Dysfunction	Grade 4 increased blood creatinine	Permanently discontinue
Exfoliative Dermatologic Conditions	Suspected SJS, TEN, or DRESS	Withhold
Exfoliative Dermatologic Conditions	Confirmed SJS, TEN, or DRESS	Permanently discontinue
Myocarditis	Grade 2, 3, or 4	Permanently discontinue
Neurological Toxicities	Grade 2	Withhold
Neurological Toxicities	Grade 3 or 4	Permanently discontinue
Hematologic toxicity in patients with cHL or PMBCL	Grade 4	Withhold until resolution to Grades 0 or 1
Other Adverse Reactions
Infusion-related reactions [see Warnings and Precautions (5.2)]	Grade 1 or 2	Interrupt or slow the rate of infusion
	Grade 3 or 4	Permanently discontinue

The following table represents dosage modifications that are different from those described above for KEYTRUDA or in the Full Prescribing Information for the drug administered in combination.

Table 3: Recommended Specific Dosage Modifications for Adverse Reactions for KEYTRUDA in Combination with Axitinib
Treatment	Adverse Reaction	Severity	Dosage Modification
ALT = alanine aminotransferase, AST = aspartate aminotransferase, ULN = upper limit normal
KEYTRUDA in combination with axitinib	Liver enzyme elevationsConsider corticosteroid therapy	ALT or AST increases to at least 3 times but less than 10 times ULN without concurrent total bilirubin at least 2 times ULN	Withhold both KEYTRUDA and axitinib until resolution to Grades 0 or 1Based on Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Consider rechallenge with a single drug or sequential rechallenge with both drugs after recovery. If rechallenging with axitinib, consider dose reduction as per the axitinib Prescribing Information.
KEYTRUDA in combination with axitinib	Liver enzyme elevationsConsider corticosteroid therapy	ALT or AST increases to more than 3 times ULN with concurrent total bilirubin at least 2 times ULN or ALT or AST ≥10 times ULN	Permanently discontinue both KEYTRUDA and axitinib

Recommended Dose Modifications for Adverse Reactions for KEYTRUDA in Combination with Lenvatinib

2.4 Preparation and Administration

Preparation for Intravenous Infusion

Visually inspect the solution for particulate matter and discoloration. The solution is clear to slightly opalescent, colorless to slightly yellow. Discard the vial if visible particles are observed.
Dilute KEYTRUDA injection (solution) prior to intravenous administration.
Withdraw the required volume from the vial(s) of KEYTRUDA and transfer into an intravenous (IV) bag containing 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP.
Mix diluted solution by gentle inversion.
Do not shake. The final concentration of the diluted solution should be between 1 mg/mL to 10 mg/mL.
Discard any unused portion left in the vial.

Storage of Diluted Solution

The product does not contain a preservative.

Store the diluted solution from the KEYTRUDA 100 mg/4 mL vial either:

At room temperature (temperatures at or below 25°C) for no more than 6 hours from the time of dilution. This includes room temperature storage of the diluted solution, and the duration of infusion.
Under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 96 hours from the time of dilution. If refrigerated, allow the diluted solution to come to room temperature prior to administration. Do not shake.

Discard after 6 hours at room temperature or after 96 hours under refrigeration.

Do not freeze.

Administration

Administer diluted solution intravenously over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter.
Do not co-administer other drugs through the same infusion line.

)

Lactation: Advise not to breastfeed. (

8.2 Lactation

Risk Summary

There are no data on the presence of pembrolizumab in either animal or human milk or its effects on the breastfed child or on milk production. Maternal IgG is known to be present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to KEYTRUDA are unknown. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with KEYTRUDA and for 4 months after the last dose.

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