ulmonary Toxicity: Discontinue HERCEPTIN HYLECTA foranaphylaxis, angioedema, interstitial pneumonitis or acute respiratorydistress syndrome. (5.3)
Embryo-Fetal Toxicity: Exposure to HERCEPTIN HYLECTA duringpregnancy can result in oligohydramnios, in some cases complicatedby pulmonary hypoplasia and neonatal death. Advise patients of theserisks and the need for effective contraception. (5.2, 8.1, 8.3)
INDICATIONS AND USAGE
HERCEPTIN HYLECTA is a combination of trastuzumab, a HER2/neureceptor antagonist, and hyaluronidase, an endoglycosidase, indicated inadults for:
• The treatment of HER2-overexpressing breast cancer. (1.1, 1.2)
Select patients for therapy based on an FDA-approved companion diagnosticfor trastuzumab. (1, 2.1)
DOSAGE AND ADMINISTRATION
For subcutaneous use only. HERCEPTIN HYLECTA has differentdosage and administration instructions than intravenous trastuzumabproducts.
Do not administer intravenously. (2.2)
Do not substitute HERCEPTIN HYLECTA for or with ado-trastuzumabemtansine. (2.2)
Perform HER2 testing using FDA-approved tests by laboratories withdemonstrated proficiency. (1, 2.1)
The recommended dose of HERCEPTIN HYLECTA is 600 mg/10,000 units(600 mg trastuzumab and 10,000 units hyaluronidase) administeredsubcutaneously over approximately 2-5 minutes once every three weeks. (2.2)
DOSAGE FORMS AND STRENGTHS
•Injection: 600 mg trastuzumab and 10,000 units hyaluronidase per 5 mL (120mg/2,000 units per mL) solution in a single-dose vial. (3)
CONTRAINDICATIONS
•None. (4)
WARNINGS AND PRECAUTIONS
•Exacerbation of Chemotherapy-Induced Neutropenia. (5.4, 6.1)
•Hypersensitivity and Administration-Related Reactions (ARRs): SevereARRs, including anaphylaxis, have been reported with HERCEPTINHYLECTA. Monitor patients for systemic hypersensitivity reactions.
Permanently discontinue HERCEPTIN HYLECTA in patients whoexperience anaphylaxis or severe hypersensitivity reactions. (5.5)
ADVERSE REACTIONS
Adjuvant Breast Cancer
• Most common adverse reactions (≥10%) for HERCEPTIN HYLECTA arefatigue, arthralgia, diarrhea, injection site reaction, upper respiratory tractinfection, rash, myalgia, nausea, headache, edema, flushing, pyrexia, cough,and pain in extremity. (6.1)
Metastatic Breast Cancer (based on intravenous trastuzumab)
•Most common adverse reactions (≥10%) are fever, chills, headache,infection, congestive heart failure, insomnia, cough, and rash. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Genentech at1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Females and Males of Reproductive Potential: Verify the pregnancy status offemales prior to initiation of HERCEPTIN HYLECTA. (8.3)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 2/2019
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FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: CARDIOMYOPATHY, EMBRYO-FETAL TOXICITY,and PULMONARY TOXICITY
1 INDICATIONS AND USAGE
1.1 Adjuvant Breast Cancer
1.2 Metastatic Breast Cancer
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
2.2 Recommended Doses and Schedules
2.3 Important Dosing Considerations
2.4 Administration and Storage
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRE |
