Herzuma Prescribing Information
WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY
If the patient has missed a dose of HERZUMA by one week or less, then the usual maintenance dose (weekly schedule: 2 mg/kg; once every three week schedule: 6 mg/kg) should be administered as soon as possible. Do not wait until the next planned cycle. Subsequent HERZUMA maintenance doses should be administered 7 days or 21 days later according to the weekly or once every three week schedules, respectively.
If the patient has missed a dose of HERZUMA by more than one week, a re-loading dose of HERZUMA should be administered over approximately 90 minutes (weekly schedule: 4 mg/kg; once every three week schedule: 8 mg/kg) as soon as possible. Subsequent HERZUMA maintenance doses (weekly schedule: 2 mg/kg; once every three week schedule 6 mg/kg) should be administered 7 days or 21 days later according to the weekly or once every three week schedules, respectively.
Trastuzumab products can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death
There is a 4 to 6 fold increase in the incidence of symptomatic myocardial dysfunction among patients receiving trastuzumab products as a single agent or in combination therapy compared with those not receiving trastuzumab products. The highest absolute incidence occurs when a trastuzumab product is administered with an anthracycline.
Withhold HERZUMA for ≥ 16% absolute decrease in LVEF from pre-treatment values or an LVEF value below institutional limits of normal and ≥ 10% absolute decrease in LVEF from pretreatment values
Patients who receive anthracycline after stopping trastuzumab products may also be at increased risk of cardiac dysfunction
Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan. The following schedule is recommended:
- Baseline LVEF measurement immediately prior to initiation of HERZUMA
- LVEF measurements every 3 months during and upon completion of HERZUMA
- Repeat LVEF measurement at 4 week intervals if HERZUMA is withheld for significant left ventricular cardiac dysfunction[see Dosage and Administration (2.5)]
- LVEF measurements every 6 months for at least 2 years following completion of HERZUMA as a component of adjuvant therapy.
In NSABP B31, 15% (158/1031) of patients discontinued trastuzumab due to clinical evidence of myocardial dysfunction or significant decline in LVEF after a median follow-up duration of 8.7 years in the AC-TH (anthracycline, cyclophosphamide, paclitaxel, and trastuzumab) arm. In HERA (one-year trastuzumab treatment), the number of patients who discontinued trastuzumab due to cardiac toxicity at 12.6 months median duration of follow-up was 2.6% (44/1678). In BCIRG006, a total of 2.9% (31/1056) of patients in the TCH (docetaxel, carboplatin, trastuzumab) arm (1.5% during the chemotherapy phase and 1.4% during the monotherapy phase) and 5.7% (61/1068) of patients in the AC-TH arm (1.5% during the chemotherapy phase and 4.2% during the monotherapy phase) discontinued trastuzumab due to cardiac toxicity.
Among 64 patients receiving adjuvant chemotherapy (NSABP B31 and NCCTG N9831) who developed congestive heart failure, one patient died of cardiomyopathy, one patient died suddenly without documented etiology and 33 patients were receiving cardiac medication at last follow-up. Approximately 24% of the surviving patients had recovery to a normal LVEF (defined as ≥ 50%) and no symptoms on continuing medical management at the time of last follow-up. Incidence of congestive heart failure (CHF) is presented in Table 1. The safety of continuation or resumption of trastuzumab products in patients with trastuzumab product-induced left ventricular cardiac dysfunction has not been studied.
| Incidence of Congestive Heart Failure % (n) | |||
|---|---|---|---|
| Study | Regimen | Trastuzumab | Control |
| NSABP B31 & NCCTG N9831Median follow-up duration for NSABP B31 and NCCTG N9831 combined was 8.3 years in the AC→paclitaxel + trastuzumab arm. | ACAnthracycline (doxorubicin) and cyclophosphamide.→Paclitaxel+Trastuzumab | 3.2% (64/2000)Includes 1 patient with fatal cardiomyopathy and 1 patient with sudden death without documented etiology. | 1.3% (21/1655) |
| HERAIncludes NYHA II-IV and cardiac death at 12.6 months median duration of follow-up in the one-year trastuzumab arm. | Chemotherapy→Trastuzumab | 2% (30/1678) | 0.3% (5/1708) |
| BCIRG006 | AC→Docetaxel+Trastuzumab | 2% (20/1068) | 0.3% (3/1050) |
| BCIRG006 | Docetaxel+Carboplatin+Trastuzumab | 0.4% (4/1056) | 0.3% (3/1050) |
In HERA (one-year trastuzumab treatment), at a median follow-up duration of 8 years, the incidence of severe CHF (NYHA III & IV) was 0.8%, and the rate of mild symptomatic and asymptomatic left ventricular dysfunction was 4.6%.
| Incidence | |||||
|---|---|---|---|---|---|
| NYHA I-IV | NYHA III-IV | ||||
| Study | Event | Trastuzumab | Control | Trastuzumab | Control |
| H0648g (AC)Anthracycline (doxorubicin or epirubicin) and cyclophosphamide | Cardiac Dysfunction | 28% | 7% | 19% | 3% |
| H0648g (paclitaxel) | Cardiac Dysfunction | 11% | 1% | 4% | 1% |
| H0649g | Cardiac DysfunctionIncludes 1 patient with fatal cardiomyopathy. | 7% | N/A | 5% | N/A |
In BCIRG006, the incidence of NCI-CTC Grade 3/4 cardiac ischemia/infarction was higher in the trastuzumab containing regimens (AC-TH: 0.3% (3/1068) and TCH: 0.2% (2/1056)) as compared to none in AC-T.
Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion included nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia
In post-marketing reports, serious and fatal infusion reactions have been reported. Severe reactions, which include bronchospasm, anaphylaxis, angioedema, hypoxia, and severe hypotension, were usually reported during or immediately following the initial infusion. However, the onset and clinical course were variable, including progressive worsening, initial improvement followed by clinical deterioration, or delayed post-infusion events with rapid clinical deterioration. For fatal events, death occurred within hours to days following a serious infusion reaction.
Interrupt HERZUMA infusion in all patients experiencing dyspnea, clinically significant hypotension, and intervention of medical therapy administered (which may include epinephrine, corticosteroids, diphenhydramine, bronchodilators, and oxygen). Patients should be evaluated and carefully monitored until complete resolution of signs and symptoms. Permanent discontinuation should be strongly considered in all patients with severe infusion reactions.
There are no data regarding the most appropriate method of identification of patients who may safely be retreated with trastuzumab products after experiencing a severe infusion reaction. Prior to resumption of trastuzumab infusion, the majority of patients who experienced a severe infusion reaction were pre-medicated with antihistamines and/or corticosteroids. While some patients tolerated trastuzumab infusions, others had recurrent severe infusion reactions despite pre-medications.
Trastuzumab product use can result in serious and fatal pulmonary toxicity. Pulmonary toxicity includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events can occur as sequelae of infusion reactions
Trastuzumab products can cause fetal harm when administered to a pregnant woman. In post marketing reports, use of trastuzumab during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.
Verify the pregnancy status of females of reproductive potential prior to the initiation of HERZUMA. Advise pregnant women and females of reproductive potential that exposure to HERZUMA during pregnancy or within 7 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of HERZUMA
Trastuzumab products can cause fetal harm when administered to a pregnant woman. In post-marketing reports and published literature, use of trastuzumab products during pregnancy resulted in cases of oligohydramnios and of oligohydramnios sequence, manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death
The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Monitor women who
In post-m
In studies where trastuzumab was administered to pregnant Cynomolgus monkeys during the period of organogenesis at doses up to 25 mg/kg given twice weekly (up to 25 times the recommended weekly human dose of 2 mg/kg), trastuzumab crossed the placental barrier during the early (Gestation Days 20 to 50) and late (Gestation Days 120 to 150) phases of gestation. The resulting concentrations of trastuzumab in fetal serum and amniotic fluid were approximately 33% and 25%, respectively, of those present in the maternal serum but were not associated with adverse developmental effects.
Verify the pregnancy status of females of reproductive potential prior to the initiation of HERZUMA.
Trastuzumab products can cause embryo-fetal harm when administered during pregnancy. Advise females of reproductive potential to use effective contraception during treatment with HERZUMA and for 7 months following the last dose of HERZUMA
Dosage and Administration, Evaluation and Testing Before Initiating HERZUMA (For intravenous (IV) infusion only. Do not administer as an IV push or bolus. HERZUMA has different dosage and administration instructions than subcutaneous trastuzumab products. Do not substitute HERZUMA (trastuzumab-pkrb) for or with ado-trastuzumab emtansine or fam-trastuzumab deruxtecan. Perform HER2 testing using FDA-approved tests by laboratories with demonstrated proficiency. Adjuvant Treatment of HER2-Overexpressing Breast Cancer Administer at either:
Metastatic HER2-Overexpressing Breast Cancer
Metastatic HER2-Overexpressing Gastric Cancer
Evaluation and Testing Before Initiating HERZUMA Assess left ventricular ejection fraction (LVEF) prior to initiation of HERZUMA and at regular intervals during treatment. [see Boxed Warning, Dosage and Administration (2.5), Warnings and Precautions (5.1)] .Verify the pregnancy status of females of reproductive potential prior to the initiation of HERZUMA [see Warnings and Precautions (5.3), Use in Specific Populations]. Select patients based on HER2 protein overexpression or HER2 gene amplification in tumor specimens [see Indications and Usage (1)and Clinical Studies (14)] . Assessment of HER2 protein overexpression and HER2 gene amplification should be performed using FDA-approved tests specific for breast or gastric cancers by laboratories with demonstrated proficiency. Information on the FDA-approved tests for the detection of HER2 protein overexpression and HER2 gene amplification is available at: http://www.fda.gov/CompanionDiagnostics.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.
Adjuvant Treatment of Breast Cancer Administer according to one of the following doses and schedules for a total of 52 weeks of HERZUMA therapy: During and following paclitaxel, docetaxel, or docetaxel and carboplatin:
As a single agent within three weeks following completion of multi-modality, anthracycline-based chemotherapy regimens:
Metastatic Breast Cancer
Metastatic Gastric Cancer
Missed Dose If the patient has missed a dose of HERZUMA by one week or less, then the usual maintenance dose (weekly schedule: 2 mg/kg; once every three week schedule: 6 mg/kg) should be administered as soon as possible. Do not wait until the next planned cycle. Subsequent HERZUMA maintenance doses should be administered 7 days or 21 days later according to the weekly or once every three week schedules, respectively. If the patient has missed a dose of HERZUMA by more than one week, a re-loading dose of HERZUMA should be administered over approximately 90 minutes (weekly schedule: 4 mg/kg; once every three week schedule: 8 mg/kg) as soon as possible. Subsequent HERZUMA maintenance doses (weekly schedule: 2 mg/kg; once every three week schedule 6 mg/kg) should be administered 7 days or 21 days later according to the weekly or once every three week schedules, respectively. Infusion Reactions [see Boxed Warning, Warnings and Precautions (5.2)]
Cardiomyopathy [see Boxed Warning, Warnings and Precautions (5.1)] Assess left ventricular ejection fraction (LVEF) prior to initiation of HERZUMA and at regular intervals during treatment. Withhold HERZUMA dosing for at least 4 weeks for either of the following:
HERZUMA may be resumed if, within 4 to 8 weeks, the LVEF returns to normal limits and the absolute decrease from baseline is ≤ 15%. Permanently discontinue HERZUMA for a persistent (> 8 weeks) LVEF decline or for suspension of HERZUMA dosing on more than 3 occasions for cardiomyopathy. To prevent medication errors, it is important to check the vial labels to ensure that the drug being prepared and administered is HERZUMA (trastuzumab-pkrb) and not ado-trastuzumab emtansine or fam-trastuzumab deruxtecan. 420 mg Multiple-dose vial Reconstitution Reconstitute each 420 mg vial of HERZUMA with 20 mL of Bacteriostatic Water for Injection (BWFI), USP, containing 1.1% benzyl alcohol as a preservative to yield a multiple-dose solution containing 21 mg/mL trastuzumab-pkrb that delivers 20 mL (420 mg trastuzumab-pkrb). In patients with known hypersensitivity to benzyl alcohol, reconstitute with 20 mL of Sterile Water for Injection (SWFI) without preservative to yield a one-time use solution. Use appropriate aseptic technique when performing the following reconstitution steps:
Dilution
150 mg Single-dose vial Reconstitution Reconstitute each 150 mg vial of HERZUMA with 7.4 mL of Sterile Water for Injection (SWFI) (not supplied) to yield a single-dose solution containing 21 mg/mL trastuzumab-pkrb that delivers 7.15 mL (150 mg trastuzumab-pkrb). Use appropriate aseptic technique when performing the following reconstitution steps:
Dilution
| 11/2024 |
HERZUMA is a HER2/neu receptor antagonist indicated in adults for:
- the treatment of HER2-overexpressing breast cancer. (,
1.1 Adjuvant Breast CancerHERZUMA 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 CancerHERZUMA 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 CancerHERZUMA 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. (
HERZUMA 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.
HERZUMA 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
HERZUMA 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
HERZUMA 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
- HERZUMA is for intravenous infusion only. Do not administer as an intravenous push or bolus.
- HERZUMA has different dosage and administration instructions than subcutaneous trastuzumab products.
- Do not mix HERZUMA with other drugs.
- Do not substitute HERZUMA (trastuzumab-pkrb) 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 HERZUMA 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 HERZUMA, administer HERZUMA 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 HERZUMA, 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 HERZUMA 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 HERZUMA (trastuzumab-pkrb) for or with ado-trastuzumab emtansine or fam-trastuzumab deruxtecan. (
- HERZUMA is for intravenous infusion only. Do not administer as an intravenous push or bolus.
- HERZUMA has different dosage and administration instructions than subcutaneous trastuzumab products.
- Do not mix HERZUMA with other drugs.
- Do not substitute HERZUMA (trastuzumab-pkrb) 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 HERZUMA 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 HERZUMA, administer HERZUMA 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 HERZUMA, 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 HERZUMA 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. (
HERZUMA 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.
HERZUMA 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
HERZUMA 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
HERZUMA 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 IV infusion, then 2 mg/kg over 30 minutes IV infusion weekly for 12 weeks (with paclitaxel or docetaxel) or 18 weeks (with docetaxel and carboplatin). One week after the last weekly dose of HERZUMA, administer 6 mg/kg as an IV 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 IV infusion, then 6 mg/kg over 30 to 90 minutes IV infusion every three weeks for 52 weeks.
- HERZUMA is for intravenous infusion only. Do not administer as an intravenous push or bolus.
- HERZUMA has different dosage and administration instructions than subcutaneous trastuzumab products.
- Do not mix HERZUMA with other drugs.
- Do not substitute HERZUMA (trastuzumab-pkrb) 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 HERZUMA 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 HERZUMA, administer HERZUMA 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 HERZUMA, 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 HERZUMA 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 IV infusion followed by subsequent weekly doses of 2 mg/kg as 30 minutes IV infusions.
- HERZUMA is for intravenous infusion only. Do not administer as an intravenous push or bolus.
- HERZUMA has different dosage and administration instructions than subcutaneous trastuzumab products.
- Do not mix HERZUMA with other drugs.
- Do not substitute HERZUMA (trastuzumab-pkrb) 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 HERZUMA 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 HERZUMA, administer HERZUMA 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 HERZUMA, 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 HERZUMA 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 IV infusion, followed by 6 mg/kg over 30 to 90 minutes IV infusion every 3 weeks.
- For injection: 150 mg of HERZUMA as a white to pale yellow lyophilized powder in a single-dose vial
- For injection: 420 mg of HERZUMA as a white to pale yellow lyophilized powder in a multiple-dose vial.
Females and Males of Reproductive Potential: Verify the pregnancy status of females prior to initiation of HERZUMA. (
Verify the pregnancy status of females of reproductive potential prior to the initiation of HERZUMA.
Trastuzumab products can cause embryo-fetal harm when administered during pregnancy. Advise females of reproductive potential to use effective contraception during treatment with HERZUMA and for 7 months following the last dose of HERZUMA