Full Prescribing Information
Herceptin Dear Healthcare Provider Letter (198K/PDF)

Herceptin is the first humanized antibody approved for the treatment of HER2-positive metastatic breast cancer. Herceptin is designed to target and block the function of HER2 protein overexpression.

Research has shown that HER2-positive breast cancer is a more aggressive disease with a greater likelihood of recurrence, a poorer prognosis, and a decreased chance of survival compared with HER2-negative breast cancer.

Status
Herceptin in combination with paclitaxel is indicated for treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have not received chemotherapy for their metastatic disease. Herceptin as a single agent is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease. The U.S. Food and Drug Administration (FDA) approved Herceptin in September 1998. In November 2006, the FDA approved Herceptin as part of a treatment regimen containing doxorubicin, cyclophosphamide and paclitaxel, for the adjuvant treatment of patients with HER2-positive, node-positive breast cancer.

WARNINGS:

Cardiomyopathy
Herceptin administration can result in left ventricular dysfunction and congestive heart failure (CHF). Left ventricular function should be evaluated in all patients prior to and during treatment with Herceptin.

The incidence and severity of left ventricular cardiac dysfunction/CHF was highest in patients who received Herceptin concurrently with anthracycline‑containing chemotherapy regimens. Discontinue Herceptin treatment in patients receiving adjuvant therapy for breast cancer and strongly consider discontinuation of Herceptin in patients with metastatic breast cancer who develop a clinically significant decrease in left ventricular function. (See WARNINGS: Cardiomyopathy, See DOSAGE AND ADMINISTRATION: Dose Modifications in Full Prescribing Information.)

Infusion Reactions
Pulmonary Toxicity
Herceptin administration can result in serious infusion reactions and pulmonary toxicity. Rarely, these have been fatal. In most cases, symptoms occurred during or within 24 hours of administration of Herceptin. Herceptin infusion should be interrupted for patients experiencing dyspnea or clinically significant hypotension. Patients should be monitored until signs and symptoms completely resolve. Discontinuation of Herceptin should be strongly considered for infusion reactions manifesting as anaphylaxis, angioedema, pneumonitis, or acute respiratory distress syndrome. (See WARNINGS in Full Prescribing Information