Trazimera
(Trastuzumab-Qyyp)Dosage & Administration
Administer according to one of the following doses and schedules for a total of 52 weeks of TRAZIMERA therapy:
Do not substitute TRAZIMERA (trastuzumab-qyyp) for or with ado-trastuzumab emtansine or fam-trastuzumab deruxtecan. (
Administer according to one of the following doses and schedules for a total of 52 weeks of TRAZIMERA therapy:
Perform HER2 testing using FDA-approved tests by laboratories with demonstrated proficiency. (
TRAZIMERA is a HER2/neu receptor antagonist indicated in adults for:
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.
TRAZIMERA is indicated in adults for adjuvant treatment of HER2-overexpressing node positive or node negative (ER/PR negative or with one high risk feature
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product
TRAZIMERA is indicated in adults:
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product
TRAZIMERA is indicated in adults, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product
Select patients based on HER2 protein overexpression or HER2 gene amplification in tumor specimens
Assessment of HER2 protein overexpression and HER2 gene amplification in metastatic gastric cancer should be performed using FDA-approved tests specifically for gastric cancers due to differences in gastric vs. breast histopathology, including incomplete membrane staining and more frequent heterogeneous expression of HER2 seen in gastric cancers.
Improper assay performance, including use of suboptimally fixed tissue, failure to utilize specified reagents, deviation from specific assay instructions, and failure to include appropriate controls for assay validation, can lead to unreliable results.
Select patients based on HER2 protein overexpression or HER2 gene amplification in tumor specimens
Assessment of HER2 protein overexpression and HER2 gene amplification in metastatic gastric cancer should be performed using FDA-approved tests specifically for gastric cancers due to differences in gastric vs. breast histopathology, including incomplete membrane staining and more frequent heterogeneous expression of HER2 seen in gastric cancers.
Improper assay performance, including use of suboptimally fixed tissue, failure to utilize specified reagents, deviation from specific assay instructions, and failure to include appropriate controls for assay validation, can lead to unreliable results.
Administer at either:
Administer according to one of the following doses and schedules for a total of 52 weeks of TRAZIMERA therapy:
Administer according to one of the following doses and schedules for a total of 52 weeks of TRAZIMERA therapy:
Trazimera Prescribing Information
Dosage and Administration, Evaluation and Testing Before Initiating TRAZIMERA ( Assess left ventricular ejection fraction (LVEF) prior to initiation of TRAZIMERA and at regular intervals during treatment [see Boxed Warning , Dosage and Administration (2.5)and Warnings and Precautions (5.1)] . Verify the pregnancy status of females of reproductive potential prior to the initiation of TRAZIMERA [see Warnings and Precautions (5.3)and Use in Specific Populations (8.1, 8.3)]. | 8/2025 |
TRAZIMERA is a HER2/neu receptor antagonist indicated in adults for:
• The treatment of HER2-overexpressing breast cancer. (,1.1 Adjuvant Breast CancerTRAZIMERA is indicated in adults for adjuvant treatment of HER2-overexpressing node positive or node negative (ER/PR negative or with one high risk feature
[see Clinical Studies (14.1)]) breast cancer• as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel• as part of a treatment regimen with docetaxel and carboplatin• as a single agent following multi-modality anthracycline based therapy.
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product
[see Dosage and Administration (2.2)].)1.2 Metastatic Breast CancerTRAZIMERA is indicated in adults:
• In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer• As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product
[see Dosage and Administration (2.2)].• The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. ()1.3 Metastatic Gastric CancerTRAZIMERA is indicated in adults, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product
[see Dosage and Administration (2.2)].
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product. (
TRAZIMERA is a HER2/neu receptor antagonist indicated in adults for:
• The treatment of HER2-overexpressing breast cancer.• The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.
TRAZIMERA is indicated in adults for adjuvant treatment of HER2-overexpressing node positive or node negative (ER/PR negative or with one high risk feature
• as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel• as part of a treatment regimen with docetaxel and carboplatin• as a single agent following multi-modality anthracycline based therapy.
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product
TRAZIMERA is indicated in adults:
• In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer• As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product
TRAZIMERA is indicated in adults, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product
Select patients based on HER2 protein overexpression or HER2 gene amplification in tumor specimens
Assessment of HER2 protein overexpression and HER2 gene amplification in metastatic gastric cancer should be performed using FDA-approved tests specifically for gastric cancers due to differences in gastric vs. breast histopathology, including incomplete membrane staining and more frequent heterogeneous expression of HER2 seen in gastric cancers.
Improper assay performance, including use of suboptimally fixed tissue, failure to utilize specified reagents, deviation from specific assay instructions, and failure to include appropriate controls for assay validation, can lead to unreliable results.
• TRAZIMERA is for intravenous infusion only. Do not administer as an intravenous push or bolus.• TRAZIMERA has different dosage and administration instructions than subcutaneous trastuzumab products.• Do not mix TRAZIMERA with other drugs.• Do not substitute TRAZIMERA (trastuzumab-qyyp) for or with ado-trastuzumab emtansine or fam-trastuzumab deruxtecan.
Administer according to one of the following doses and schedules for a total of 52 weeks of TRAZIMERA therapy:
• Initial dose of 4 mg/kg as an intravenous infusion over 90 minutes then at 2 mg/kg as an intravenous infusion over 30 minutes weekly during chemotherapy for the first 12 weeks (paclitaxel or docetaxel) or 18 weeks (docetaxel and carboplatin).• One week following the last weekly dose of TRAZIMERA, administer TRAZIMERA at 6 mg/kg as an intravenous infusion over 30 to 90 minutes every three weeks.
• Initial dose at 8 mg/kg as an intravenous infusion over 90 minutes.• Subsequent doses at 6 mg/kg as an intravenous infusion over 30 to 90 minutes every three weeks.• Extending adjuvant treatment beyond one year is not recommended[see Adverse Reactions (6.1)].
• Administer TRAZIMERA, alone or in combination with paclitaxel, at an initial dose of 4 mg/kg as a 90-minute intravenous infusion followed by subsequent once weekly doses of 2 mg/kg as 30-minute intravenous infusions until disease progression.
• Administer TRAZIMERA at an initial dose of 8 mg/kg as a 90-minute intravenous infusion followed by subsequent doses of 6 mg/kg as an intravenous infusion over 30 to 90 minutes every three weeks until disease progression.
Do not substitute TRAZIMERA (trastuzumab-qyyp) for or with ado-trastuzumab emtansine or fam-trastuzumab deruxtecan. (
• TRAZIMERA is for intravenous infusion only. Do not administer as an intravenous push or bolus.• TRAZIMERA has different dosage and administration instructions than subcutaneous trastuzumab products.• Do not mix TRAZIMERA with other drugs.• Do not substitute TRAZIMERA (trastuzumab-qyyp) for or with ado-trastuzumab emtansine or fam-trastuzumab deruxtecan.
Administer according to one of the following doses and schedules for a total of 52 weeks of TRAZIMERA therapy:
• Initial dose of 4 mg/kg as an intravenous infusion over 90 minutes then at 2 mg/kg as an intravenous infusion over 30 minutes weekly during chemotherapy for the first 12 weeks (paclitaxel or docetaxel) or 18 weeks (docetaxel and carboplatin).• One week following the last weekly dose of TRAZIMERA, administer TRAZIMERA at 6 mg/kg as an intravenous infusion over 30 to 90 minutes every three weeks.
• Initial dose at 8 mg/kg as an intravenous infusion over 90 minutes.• Subsequent doses at 6 mg/kg as an intravenous infusion over 30 to 90 minutes every three weeks.• Extending adjuvant treatment beyond one year is not recommended[see Adverse Reactions (6.1)].
• Administer TRAZIMERA, alone or in combination with paclitaxel, at an initial dose of 4 mg/kg as a 90-minute intravenous infusion followed by subsequent once weekly doses of 2 mg/kg as 30-minute intravenous infusions until disease progression.
• Administer TRAZIMERA at an initial dose of 8 mg/kg as a 90-minute intravenous infusion followed by subsequent doses of 6 mg/kg as an intravenous infusion over 30 to 90 minutes every three weeks until disease progression.
Perform HER2 testing using FDA-approved tests by laboratories with demonstrated proficiency. (
TRAZIMERA is a HER2/neu receptor antagonist indicated in adults for:
• The treatment of HER2-overexpressing breast cancer.• The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.
TRAZIMERA is indicated in adults for adjuvant treatment of HER2-overexpressing node positive or node negative (ER/PR negative or with one high risk feature
• as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel• as part of a treatment regimen with docetaxel and carboplatin• as a single agent following multi-modality anthracycline based therapy.
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product
TRAZIMERA is indicated in adults:
• In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer• As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product
TRAZIMERA is indicated in adults, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product
Select patients based on HER2 protein overexpression or HER2 gene amplification in tumor specimens
Assessment of HER2 protein overexpression and HER2 gene amplification in metastatic gastric cancer should be performed using FDA-approved tests specifically for gastric cancers due to differences in gastric vs. breast histopathology, including incomplete membrane staining and more frequent heterogeneous expression of HER2 seen in gastric cancers.
Improper assay performance, including use of suboptimally fixed tissue, failure to utilize specified reagents, deviation from specific assay instructions, and failure to include appropriate controls for assay validation, can lead to unreliable results.
Select patients based on HER2 protein overexpression or HER2 gene amplification in tumor specimens
Assessment of HER2 protein overexpression and HER2 gene amplification in metastatic gastric cancer should be performed using FDA-approved tests specifically for gastric cancers due to differences in gastric vs. breast histopathology, including incomplete membrane staining and more frequent heterogeneous expression of HER2 seen in gastric cancers.
Improper assay performance, including use of suboptimally fixed tissue, failure to utilize specified reagents, deviation from specific assay instructions, and failure to include appropriate controls for assay validation, can lead to unreliable results.
Administer at either:
• Initial dose of 4 mg/kg over 90 minutes intravenous infusion, then 2 mg/kg over 30 minutes intravenous infusion weekly for 12 weeks (with paclitaxel or docetaxel) or 18 weeks (with docetaxel and carboplatin). One week after the last weekly dose of TRAZIMERA, administer 6 mg/kg as an intravenous infusion over 30 to 90 minutes every three weeks to complete a total of 52 weeks of therapy, or• Initial dose of 8 mg/kg over 90 minutes intravenous infusion, then 6 mg/kg over 30 to 90 minutes intravenous infusion every three weeks for 52 weeks.
• TRAZIMERA is for intravenous infusion only. Do not administer as an intravenous push or bolus.• TRAZIMERA has different dosage and administration instructions than subcutaneous trastuzumab products.• Do not mix TRAZIMERA with other drugs.• Do not substitute TRAZIMERA (trastuzumab-qyyp) for or with ado-trastuzumab emtansine or fam-trastuzumab deruxtecan.
Administer according to one of the following doses and schedules for a total of 52 weeks of TRAZIMERA therapy:
• Initial dose of 4 mg/kg as an intravenous infusion over 90 minutes then at 2 mg/kg as an intravenous infusion over 30 minutes weekly during chemotherapy for the first 12 weeks (paclitaxel or docetaxel) or 18 weeks (docetaxel and carboplatin).• One week following the last weekly dose of TRAZIMERA, administer TRAZIMERA at 6 mg/kg as an intravenous infusion over 30 to 90 minutes every three weeks.
• Initial dose at 8 mg/kg as an intravenous infusion over 90 minutes.• Subsequent doses at 6 mg/kg as an intravenous infusion over 30 to 90 minutes every three weeks.• Extending adjuvant treatment beyond one year is not recommended[see Adverse Reactions (6.1)].
• Administer TRAZIMERA, alone or in combination with paclitaxel, at an initial dose of 4 mg/kg as a 90-minute intravenous infusion followed by subsequent once weekly doses of 2 mg/kg as 30-minute intravenous infusions until disease progression.
• Administer TRAZIMERA at an initial dose of 8 mg/kg as a 90-minute intravenous infusion followed by subsequent doses of 6 mg/kg as an intravenous infusion over 30 to 90 minutes every three weeks until disease progression.
• Initial dose of 4 mg/kg as a 90 minutes intravenous infusion followed by subsequent weekly doses of 2 mg/kg as 30 minutes intravenous infusions.
• TRAZIMERA is for intravenous infusion only. Do not administer as an intravenous push or bolus.• TRAZIMERA has different dosage and administration instructions than subcutaneous trastuzumab products.• Do not mix TRAZIMERA with other drugs.• Do not substitute TRAZIMERA (trastuzumab-qyyp) for or with ado-trastuzumab emtansine or fam-trastuzumab deruxtecan.
Administer according to one of the following doses and schedules for a total of 52 weeks of TRAZIMERA therapy:
• Initial dose of 4 mg/kg as an intravenous infusion over 90 minutes then at 2 mg/kg as an intravenous infusion over 30 minutes weekly during chemotherapy for the first 12 weeks (paclitaxel or docetaxel) or 18 weeks (docetaxel and carboplatin).• One week following the last weekly dose of TRAZIMERA, administer TRAZIMERA at 6 mg/kg as an intravenous infusion over 30 to 90 minutes every three weeks.
• Initial dose at 8 mg/kg as an intravenous infusion over 90 minutes.• Subsequent doses at 6 mg/kg as an intravenous infusion over 30 to 90 minutes every three weeks.• Extending adjuvant treatment beyond one year is not recommended[see Adverse Reactions (6.1)].
• Administer TRAZIMERA, alone or in combination with paclitaxel, at an initial dose of 4 mg/kg as a 90-minute intravenous infusion followed by subsequent once weekly doses of 2 mg/kg as 30-minute intravenous infusions until disease progression.
• Administer TRAZIMERA at an initial dose of 8 mg/kg as a 90-minute intravenous infusion followed by subsequent doses of 6 mg/kg as an intravenous infusion over 30 to 90 minutes every three weeks until disease progression.
• Initial dose of 8 mg/kg over 90 minutes intravenous infusion, followed by 6 mg/kg over 30 to 90 minutes intravenous infusion every 3 weeks.
• For injection: 150 mg of TRAZIMERA as a white lyophilized powder in a single-dose vial.• For injection: 420 mg of TRAZIMERA as a white lyophilized powder in a multiple-dose vial.
Females and Males of Reproductive Potential: Verify the pregnancy status of females prior to initiation of TRAZIMERA. (
Verify the pregnancy status of females of reproductive potential prior to the initiation of TRAZIMERA.
Trastuzumab products can cause embryo-fetal harm when administered during pregnancy. Advise females of reproductive potential to use effective contraception during treatment with TRAZIMERA and for 7 months following the last dose of TRAZIMERA
None.