BDR Pharmaceutical




Concise Prescribing Info
Doxorubicin HCl (pegylated liposomal)
Monotherapy for patients w/ metastatic breast cancer, where there is an increased cardiac risk. Advanced ovarian cancer in women who have failed a 1st-line platinum-based chemotherapy regimen. In combination w/ bortezomib for the treatment of progressive multiple myeloma in patients who have received at least 1 prior therapy & who have already undergone or are unsuitable for bone marrow transplant. AIDS-related Kaposi's sarcoma (KS) in patients w/ low CD4 counts (<200 CD4 lymphocytes/mm3) & extensive mucocutaneous or visceral disease. 1st-line systemic chemotherapy or as 2nd line chemotherapy in AIDS-KS patients w/ disease that has progressed w/, or in patients intolerant to, prior combination systemic chemotherapy comprising at least 2 of the following agents: vinca alkaloid, bleomycin & standard doxorubicin (or other anthracycline).
Dosage/Direction for Use
IV 50 mg/m2 once every 4 wk. Administer 30 mg/m2 on day 4 of bortezomib 3 wk regimen as a 1-hr infusion administered immediately after bortezomib infusion. Bortezomib regimen: 1.3 mg/m2 on days 1, 4, 8 & 11 every 3 wk. May repeat dose as tolerated. Day 4 dosing may be delayed up to 48 hr. Doses of bortezumab should be at least 72 hr apart.
Hypersensitivity to doxorubicin HCl or to α-(2-[1,2-distearoyl-snglycero(3)phosphooxy]ethylcarbamoyl)-ω-methoxypoly(oxyethylen)-40 Na salt (MPEG-DSPE), fully hydrogenated soy phosphatidylcholine (HSPC), cholesterol, ammon sulphate, sucrose, histidine, water for inj, hydrochloric acid & Na hydroxide. Not to be used to treat AIDS-KS that may be treated effectively w/ local therapy or systemic α-interferon.
Special Precautions
Irreversible myocardial toxicity leading to heart failure; increased risk of cardiotoxicity; acute infusion-related reactions or serious/life-threatening/fatal allergic infusion reactions; severe bone marrow depression; impaired hepatic function. History of CV disease. Doxorubicin liposomal should not be substituted for conventional doxorubicin on per mg basis. Monitor liver function tests; cardaic function & CBC w/ differential frequently.
Adverse Reactions
Palmar-plantar erythrodysesthesia. Nausea, diarrhoea, neutropaenia, thrombocytopaenia, vomiting, fatigue, constipation.
Drug Interactions
May potentiate toxicity of other anticancer therapies. Exacerbation of cyclophosphamide-induced haemorrhagic cystitis & enhancement of hepatotoxicity of 6-mercaptopurine in patients w/ AIDS. Caution in concomitant use w/ medicinal products & when giving any other cytotoxic agents especially myelotoxic agents.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01DB01 - doxorubicin ; Belongs to the class of cytotoxic antibiotics, anthracyclines and related substances. Used in the treatment of cancer.
BDLYPO soln for infusion (conc) 2 mg/mL
10 mL x 1's
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