البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
DOXORUBICIN HYDROCHLORIDE (UNII: 82F2G7BL4E) (DOXORUBICIN - UNII:80168379AG)
Sun Pharmaceutical Industries, Inc.
DOXORUBICIN HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE 2 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Doxorubicin hydrochloride liposome injection is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. Doxorubicin hydrochloride liposome injection is indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy. Doxorubicin hydrochloride liposome injection, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy. Doxorubicin hydrochloride liposome injection is contraindicated in patients who have a history of severe hypersensitivity reactions, including anaphylaxis, to doxorubicin hydrochloride [see Warnings and Precautions (5.2)]. Risk Summary Based on findings in animals and its mechanism of action, doxorubicin hydrochloride liposome injection can cause fetal harm when administered to a pregnant woman; avoid the
Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion in 10 mL or 25 mL glass, single-dose vials. The following individually cartoned vials are available: Refrigerate unopened vials of doxorubicin hydrochloride liposome injection at 2° to 8°C (36° to 46°F). Do not freeze. Discard unused portion. Doxorubicin hydrochloride liposome injection is a cytotoxic drug. Follow applicable special handling and disposal procedures1 .
Abbreviated New Drug Application
DOXORUBICIN HYDROCHLORIDE - DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL SUN PHARMACEUTICAL INDUSTRIES, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION. DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1995 WARNING: CARDIOMYOPATHY AND INFUSION-RELATED REACTIONS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION CAN CAUSE MYOCARDIAL DAMAGE, INCLUDING ACUTE LEFT VENTRICULAR FAILURE. THE RISK OF CARDIOMYOPATHY WAS 11% WHEN THE CUMULATIVE ANTHRACYCLINE DOSE WAS BETWEEN 450 MG/M TO 550 MG/M . ASSESS LEFT VENTRICULAR CARDIAC FUNCTION PRIOR TO INITIATION OF DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION, DURING TREATMENT, AND AFTER TREATMENT (5.1). SERIOUS, LIFE-THREATENING, AND FATAL INFUSION-RELATED REACTIONS CAN OCCUR. ACUTE INFUSION-RELATED REACTIONS OCCURRED IN 11% OF PATIENTS WITH SOLID TUMORS. WITHHOLD DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION FOR INFUSION-RELATED REACTIONS AND RESUME AT A REDUCED RATE. DISCONTINUE DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION INFUSION FOR SERIOUS OR LIFE-THREATENING INFUSION-RELATED REACTIONS (5.2). INDICATIONS AND USAGE Doxorubicin hydrochloride is an anthracycline topoisomerase inhibitor indicated for: (1) OVARIAN CANCER: After failure of platinum-based chemotherapy (1.1). AIDS-RELATED KAPOSI’S SARCOMA: After failure of prior systemic chemotherapy or intolerance to such therapy (1.2). MULTIPLE MYELOMA: In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy (1.3). DOSAGE AND ADMINISTRATION Administer doxorubicin hydrochloride liposome injection at an initial rate of 1 mg/min to minimize the risk of infusion reactions. If no infusion related reactions occur, increase rate of infusion اقرأ الوثيقة كاملة