pper 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: 10/2010
--------------------------------------------------------------------------------
Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
*Sections or subsections omitted from the full prescribing information are not listed
WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY
1 INDICATIONS AND USAGE
1.1 Adjuvant Breast Cancer
1.2 Metastatic Breast Cancer
1.3 Metastatic Gastric Cancer
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Doses and Schedules
2.2 Dose Modifications
2.3 Preparation for Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Cardiomyopathy
5.2 Infusion Reactions
5.3 Embryo-Fetal Toxicity
5.4 Pulmonary Toxicity
5.5 Exacerbation of Chemotherapy-Induced Neutropenia
5.6 HER2 Testing
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Immunogenicity
6.3 Post-Marketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Adjuvant Breast Cancer
14.2 Metastatic Breast Cancer
14.3 Metastatic Gastric Cancer
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Stability and Storage
17 PATIENT COUNSELING INFORMATION
----------------------------------------------------------------------------
FULL PRESCRIBING INFORMATION
WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY
Cardiomyopathy
Herceptin administration can result in sub‑clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving Herceptin with anthracycline‑containing chemotherapy regimens.
eva luate left ventricular function in all patients prior to and during treatment with Herceptin. Discontinue Herceptin treatment in patients receiving adjuvant therapy and withhold Herceptin in patients with metastatic disease for clinically significant decrease in left ventricular function. [see Warnings and Precautions (5.1) and Dosage and Administration (2.2)]
Infusion Reactions; Pulmonary Toxicity
Herceptin administration can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of Herceptin administration. Interrupt Herceptin infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue Herceptin for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. [see Warnings and Precautio
