Doxorubicin Hydrochloride Liposome

FDA Drug Profile — Doxorubicin Hydrochloride Liposome

Drug Details

Generic Name
Doxorubicin Hydrochloride Liposome
Brand Names
Doxorubicin Hydrochloride Liposome
Application Number
NDA050718
Sponsor
Baxter Healthcare Company
NDC Codes
2
Dosage Forms
INJECTION, SUSPENSION, LIPOSOMAL
Routes
INTRAVENOUS
Active Ingredients
DOXORUBICIN HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Doxorubicin hydrochloride liposome injection is an anthracycline topoisomerase inhibitor indicated for: • 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 ) 1.1 Ovarian Cancer Doxorubicin hydrochloride liposome injection is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. 1.2 AIDS-Related Kaposi’s Sarcoma 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. 1.3 Multiple Myeloma 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.