Doxvex 50

Doxvex 50



Vexxa Lifesciences


VE Pharma
Concise Prescribing Info
Doxorubicin HCl
As monotherapy for patients w/ metastatic breast cancer, where there is an increased cardiac risk. Treatment of 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 eg, vinca alkaloid, bleomycin & standard doxorubicin (or other anthracycline).
Dosage/Direction for Use
Breast & ovarian cancer 50 mg/m2 IV once every 4 wk. Multiple myeloma 30 mg/m2 on day 4 of the bortezomib 3 wk regimen as 1 hr infusion administered immediately after bortezomib infusion. Bortezomib regimen 1.3 mg/m2 on days 1, 4, 8 & 11 every 3 wk. Day 4 dosing of both drugs may be delayed up to 48 hr as medically necessary. Doses of bortezomib should be at least 72 hr apart. AIDS-related KS 20 mg/m2 IV every 2-3 wk. Treatment of patients for 2-3 mth is recommended to achieve a therapeutic response.
Hypersensitivity to doxorubicin, peanut or soya. Not for treatment of AIDS-KS that may be treated effectively w/ local therapy or systemic α-interferon.
Special Precautions
Routinely undergo frequent ECG monitoring. Risk of myocardial injury; patients w/ cardiac disease; impaired cardiac function; cardiomyopathy; CHF; those who have received other anthracyclines; prior mediastinal irradiation or in those receiving concurrent cyclophosphamide therapy. Cardiac safety profile for the dosing schedule. Myelosuppression; perform periodic blood counts during the course of therapy. Persistent severe myelosuppression may result in superinfection or haemorrhage. Secondary acute myeloid leukamias & myelodysplasias. Secondary oral neoplasms in long-term (>1 yr) exposure or those receiving a cumulative dose >720 mg/m2. Serious & sometimes life-threatening infusion reactions. Initial dose should be at a rate no greater than 1 mg/min to minimise the risk of infusion reactions. Diabetic patients. May affect ability to drive & use machines. Do not use in pregnancy & lactation. Women of child-bearing potential. Childn <18 yr.
Adverse Reactions
Breast cancer program: Anorexia; nausea, stomatitis, vomiting, palmar-plantar erythrodysesthesia (PPE), alopecia, rash; asthenia, fatigue, mucositis NOS. Ovarian cancer program: Leukopenia, anemia, neutropenia, thrombocytopenia; anorexia; constipation, diarrhea, nausea, stomatitis, vomiting; PPE, alopecia, rash; asthenia, mucous membrane disorder. Multiple myeloma program: Anemia, neutropenia, thrombocytopenia; anorexia, peripheral sensory neuropathy, neuralgia, headache; nausea, diarrhea, vomiting, constipation, stomatitis; PPE, rash; asthenia, fatigue, pyrexia. AIDS-related KS program: Neutropenia, anemia, leukopenia; nausea.
Drug Interactions
May potentiate the toxicity of other anti-cancer therapies. Exacerbation of cyclophosphamide-induced haemorrhagic cystitis. Enhancement of the hepatotoxicity of 6-mercaptopurine. Caution when in concomitant w/ 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.
Doxvex 50 powd for inj 50 mg
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