HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ENHERTU safely and effectively. See full prescribing information for ENHERTU. ENHERTU� (fam-trastuzumab deruxtecan-nxki) for injection, for intravenous use Initial U.S. Approval: 2019 ________________________ INDICATIONS AND USAGE ________________________ ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. (1) This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. (1, 14.1) _________________________ DOSAGE AND ADMINISTRATION_____________________� Do not substitute ENHERTU for or with trastuzumab or ado-trastuzumab emtansine.(2.1, 2.3) � For intravenous infusion only. Do not administer as an intravenous push or bolus. Do not use Sodium Chloride Injection, USP. (2.3) � The recommended dosage of ENHERTU is 5.4 mg/kg given as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. (2.1, 2.2) � Management of adverse reactions (ILD, neutropenia, or left ventricular dysfunction) may require temporary interruption, dose reduction, or discontinuation of ENHERTU. (2.2) ______________________ DOSAGE FORMS AND STRENGTHS____________________For injection: 100 mg lyophilized powder in a single-dose vial (3) __________________________ CONTRAINDICATIONS_________________________None. (4) _____________________ WARNINGS AND PRECAUTIONS_____________________� Neutropenia: Monitor complete blood counts prior to initiation of ENHERTU and prior to each dose, and as clinically indicated. Manage through treatment interruption or dose reduction. (2.2, 5.2) � Left Ventricular Dysfunction: Assess LVEF prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated. Manage through treatment interruption or discontinuation. Permanently discontinue ENHERTU in patients with symptomatic congestive heart failure (CHF). (2.2, 5.3) __________________________ ADVERSE REACTIONS__________________________The most common adverse reactions (?20%) were nausea, fatigue, vomiting, alopecia, constipation, decreased appetite, anemia, neutropenia, diarrhea, leukopenia, cough, and thrombocytopenia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch._________________________ USE IN SPECIFIC POPULATIONS_____________________ � Lactation: Advise not to breastfeed. (8.2) � Females and Males of Reproductive Potential: Verify pregnancy status of females prior to initiation of ENHERTU. (8.3) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 12/2019
