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.
RECENT MAJOR CHANGES
Indications and Usage, Metastatic Gastric Cancer (1.3) 10/2010
Dosage and Administration (2.1) 10/2010
Warnings and Precautions, Embryo-Fetal Toxicity (5.3) 10/2010
Warnings and Precautions, HER2 Testing (5.6) 10/2010
INDICATIONS AND USAGE
Herceptin is a HER2/neu receptor antagonist indicated for:
the treatment of HER2 overexpressing breast cancer (1.1,1.2).
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).
Adjuvant Treatment of HER2‑Overexpressing Breast Cancer (2.1)

Administer at either:
Initial dose of 4mg/kg over 90minute IV infusion, then 2mg/kg over 30minute IV infusion weekly for 52weeks, or
Initial dose of 8mg/kg over 90minutes IV infusion, then 6mg/kg over 30–90minutes IV infusion every three weeks for 52weeks.
Metastatic HER2‑Overexpressing Breast Cancer (2.1)
Initial dose of 4mg/kg as a 90minute IV infusion followed by subsequent weekly doses of 2mg/kg as 30minute IV infusions.
Metastatic HER2-overexpressing Gastric Cancer (2.1)
Initial dose of 8mg/kg over 90minutes IV infusion, followed by 6mg/kg over 30 to 90minutes IV infusion every 3weeks.
DOSAGE FORMS AND STRENGTHS
Multidose vial nominally containing 440mg Herceptin as a lyophilized, sterile powder. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Cardiomyopathy (5.1, 6.1)
Infusion Reactions (5.2, 6.1)
Embryo-fetal Toxicity. Pregnancy registry available (1-800-690-6720) (5.3, 8.1)
Pulmonary Toxicity (5.4, 6.1)
Exacerbation of Chemotherapy‑Induced Neutropenia (5.5, 6.1)
HER2 testing should be performed using FDA-approved tests by laboratories with demonstrated proficiency. (5.6)
ADVERSE REACTIONS
Adjuvant Breast Cancer
Most common adverse reactions (≥ 5%) are headache, diarrhea, nausea, and chills. (6.1)
Metastatic Breast Cancer
Most common adverse reactions (≥ 10%) are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash. (6.1)
Metastatic Gastric Cancer
Most common adverse reactions (≥ 10%) are neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, u