CAUTIONS
5.1 Cardiomyopathy
5.2 Embryo-Fetal Toxicity
5.3 Pulmonary Toxicity
5.4 Exacerbation of Chemotherapy-Induced Neutropenia
5.5 Hypersensitivity and Administration-Related Reactions
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
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Adjuvant Breast Cancer
14.2 Metastatic Breast Cancer
14.3 Patient Experience
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are notlisted
FULL PRESCRIBING INFORMATION
WARNING: CARDIOMYOPATHY, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITYCardiomyopathy
HERCEPTIN HYLECTA administration can result in sub-clinical and clinical cardiac failure. Theincidence and severity was highest in patients receiving HERCEPTIN HYLECTA withanthracycline-containing chemotherapy regimens.
eva luate left ventricular function in all patients prior to and during treatment with HERCEPTINHYLECTA. Discontinue HERCEPTIN HYLECTA treatment in patients receiving adjuvanttherapy and withhold HERCEPTIN HYLECTA in patients with metastatic disease for clinicallysignificant decrease in left ventricular function [see Dosage and Administration (2.3) and Warningsand Precautions (5.1)].
Pulmonary Toxicity
HERCEPTIN HYLECTA administration can result in serious and fatal pulmonary toxicity.
Symptoms usually occur during or within 24 hours of HERCEPTIN HYLECTA administration.
Discontinue HERCEPTIN HYLECTA for anaphylaxis, angioedema, interstitial pneumonitis, oracute respiratory distress syndrome [see Warnings and Precautions (5.3, 5.5)]. Monitor patients untilsymptoms completely resolve.
Embryo-Fetal Toxicity
Exposure to HERCEPTIN HYLECTA during pregnancy can result in oligohydramnios andoligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, andneonatal death. Advise patients of these risks and the need for effective contraception [see Warningsand Precautions (5.2) and Use in Specific Populations (8.1, 8.3)].
1 INDICATIONS AND USAGE
1.1 Adjuvant Breast Cancer
HERCEPTIN HYLECTA is indicated for adjuvant treatment of adults with HER2 overexpressing node positiveor 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 ordocetaxel
•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 trastuzumab [see Dosage andAdministration (2.1)].
1.2 Metastatic Breast Cancer
HERCEPTIN HYLECTA is indicated in adults:
•In combination with paclitaxel for first-line treatment of HER2-overexpressing |
