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HERCEPTIN (trastuzumab)Intravenous Infusion
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Herceptin safely and effectively. See full prescribing information for Herceptin.
HERCEPTIN ® (trastuzumab)
Intravenous Infusion
Initial U.S. Approval: 1998
WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY
See full prescribing information for complete boxed warning
Cardiomyopathy: Herceptin can result in sub-clinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. eva luate cardiac function prior to and during treatment. Discontinue Herceptin for cardiomyopathy. (5.1, 2.2)
Infusion reactions, Pulmonary toxicity: Discontinue Herceptin for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. (5.2, 5.4)
Embryo-Fetal Toxicity: Exposure to Herceptin during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. (5.3, 8.1, 8.6)
RECENT MAJOR CHANGES
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Dosage and Administration (2) |
04/2015 |
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Warnings and Precautions (5) |
04/2015 |
INDICATIONS AND USAGE
Herceptin is a HER2/neu receptor antagonist indicated for:
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the treatment of HER2 overexpressing breast cancer (1.1,1.2).
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the treatment of HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma (1.3)
DOSAGE AND ADMINISTRATION
For intravenous (IV) infusion only. Do not administer as an IV push or bolus (5.2).
Do not substitute Herceptin (trastuzumab) for or with ado-trastuzumab emtansine. (2.1)
Adjuvant Treatment of HER2-Overexpressing Breast Cancer (2.1)
Administer at either:
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Initial dose of 4 mg/kg over 90 minute IV infusion, then 2 mg/kg over 30 minute IV infusion weekly for 52 weeks, or
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Initial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30–90 minutes IV infusion every three weeks for 52 weeks.
Metastatic HER2-Overexpressing Breast Cancer (2.1)
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Initial dose of 4 mg/kg as a 90 minute IV infusion followed by subsequent weekly doses of 2 mg/kg as 30 minute IV infusions.
Metastatic HER2-overexpressing Gastric Cancer (2.1)
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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.
DOSAGE FORMS AND STRENGTHS
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Multidose vial nominally containing 440 mg Herceptin as a lyophilized, sterile powder. (3)
CONTRAINDICATIONS
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Exacerbation of Chemotherapy-Induced Neutropenia (5.5, 6.1)
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HER2 testing should be performed using FDA-approved tests by laboratories with demonstrated proficiency. (5.6)
ADVERSE REACTIONS
Adjuvant Breast Cancer
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Most common adverse reactions (≥ 5%) are headache, diarrhea, nausea, and chills. (6.1)
Metastatic Breast Cancer
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Most common adverse reactions (≥ 10%) are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash. (6.1)
Metastatic Gastric Cancer
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Most common adverse reactions (≥ 10%) are neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Nursing Mothers: Discontinue nursing or discontinue Herceptin. (8.3)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 4/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
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