1 DOXIL (doxorubicin hydrochloride liposome injection), for intravenous use Item info. These highlights do not include all the info. needed to use DOXIL safely and effectively. See full prescribing info. for DOXIL. DOXIL (doxorubicin hydrochloride liposome injection), for intravenous use Initial U.S. Approval: 1995 WARNING: CARDIOMYOPATHY and INFUSION-RELATED REACTIONS See full prescribing info. for complete boxed warning. Myocardial damage may lead to congestive heart failure and may occur as the total cumulative dose of doxorubicin HCl approaches 550 mg/m . The risk of cardiomyopathy may be increased at lower cumulative doses with mediastinal irradiation . Acute infusion-related reactions occurred in 11% of patients with solid tumors. Serious, life-threatening, and fatal infusion reactions have been reported. Medications/emergency equipment to treat such reactions should be available for immediate use . -INDICATIONS AND USAGE DOXIL is an anthracycline topoisomerase II inhibitor indicated for: Ovarian cancer After failure of platinum-based chemotherapy. AIDS-related Kaposi?s Sarcoma After failure of prior systemic chemotherapy or intolerance to such therapy. Multiple Myeloma In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy. DOSAGE AND ADMINISTRATION - Administer DOXIL at an initial rate of mg/min to minimize the risk of infusion reactions. If no infusion related reactions occur, increase rate of infusion to complete administration over hour. Do not administer as bolus injection or undiluted solution . Ovarian cancer: 50 mg/m IV every weeks AIDS-related Kaposi?s Sarcoma: 20 mg/m IV every weeks Multiple Myeloma: 30 mg/m IV on day following bortezomib -DOSAGE FORMS AND STRENGTHS - Doxorubicin hydrochloride (HCl) liposomal injection: Single use vials: 20 mg/10 mL and 50 mg/25 mL CONTRAINDICATIONS ? Hypersensitivity reactions to doxorubicin HCl or the components of DOXIL (4, 5.2) WARNINGS AND PRECAUTIONS Hand-Foot Syndrome may occur. Dose modification or discontinuation may be required Embryofetal Toxicity: Can cause fetal harm. Advise of potential risk to fetus. Use effective contraception (5.5, 8.1, 8.3) ADVERSE REACTIONS Most common adverse reactions (>20%) are asthenia, fatigue, fever, anorexia, nausea, vomiting, stomatitis, diarrhea, constipation, hand-foot syndrome, rash, neutropenia, thrombocytopenia, and anemia . To report SUSPECTED ADVERSE REACTIONS contact Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch USE IN SPECIFIC POPULATIONS Lactation: Discontinue breastfeeding . See 17 for PATIENT COUNSELING info.. Revised: 06/2016
