Doxvex 50

Doxvex 50

doxorubicin

Manufacturer:

Vexxa Lifesciences

Distributor:

VE Pharma
Concise Prescribing Info
Contents
Doxorubicin HCl
Indications/Uses
Acute leukaemias eg, acute lymphoblastic leukaemia (ALL) & AML, lymphomas & a number of solid tumors. Metastatic adenocarcinoma of the breast, carcinoma of bladder, bronchogenic carcinoma & neuroblastoma. Metastatic thyroid carcinoma. Carcinoma of the endometrium, testes, prostate, cervix, head & neck, & plasma-cell myeloma. Wide range of sarcomas including osteogenic, Ewing's & soft-tissue sarcoma. In combination w/ cisplatin & cyclophosphamide for carcinoma of the ovary. In combination w/ other cytotoxic drugs for carcinoma of the breast & small (oat)-cell carcinoma of the lung. In ABVD combination for Hodgkin's disease. In combination w/ BACOP for non-Hodgkin's lymphomas.
Dosage/Direction for Use
Monotherapy 60-75 mg/m2 as a single IV inj administered at 21-day intervals. In combination w/ other chemotherapy drugs 40-60 mg/m2 as a single IV inj every 21-28 days.
Contraindications
Hypersensitivity to doxorubicin, other anthracyclines or anthracenediones. Persistent myelosuppression; myocardial insufficiency; recent MI; severe arrhythmias. Previous treatment w/ max cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, &/or other anthracyclines & anthracenediones. Severe hepatic impairment.
Special Precautions
Recovery from acute toxicities of prior cytotoxic treatment (eg, stomatitis, neutropenia, thrombocytopenia & generalised infections) before starting treatment. Risk of cardiotoxicity which may manifested by early or late events; thrombocytopenia & anaemia may occur; myelosuppression; dose-dependent, reversible leukaemia &/or granulocytopenia; amenorrhoea & premature menopause may occur; mucositis/stomatitis appears early after administration; secondary acute myeloid leukaemia w/ or w/out a pre-leukaemic phase. Patients w/ risk factors for increased cardiotoxicity. Assess cardiac function before undergoing treatment & monitor throughout therapy to minimise the risk of incurring severe cardiac impairment. Assess haematologic profiles before & during each cycle of therapy including differential WBC counts. Monitor total bilirubin serum before & during treatment. May cause infertility during therapy. Phlebosclerosis may occur if medication is injected into a small vessel or from repeated inj into the same vein. Stop infusion if signs or symptoms of extravasation occurs. Monitor various lab parameters & cardiac function. Blood counts & measurement of Hb conc should be carried out routinely. Incompatible w/ heparin; do not mix w/ other medicines. Hepatic impairment. Men & women undergoing therapy should use effective contraceptive methods. Pregnancy & lactation. Obese patients. Elderly.
Adverse Reactions
ECG abnormalities, sinus tachycardia, tachyarrhythmias, AV & bundle branch block, asymptomatic reductions in left ventricular ejection fraction, CHF; leukopenia, anaemia, thrombocytopenia, haemorrhage, neutropenia; nausea/vomiting, mucositis/stomatitis, oesophagitis, abdominal pain, diarrhea, anorexia, dehydration; amenorrhea, oligospermia, azoospermia; alopecia, local toxicity, rash/itch, skin changes; red colouration of urine for 1-2 days after administration; malaise/asthenia fever, infection, sepsis/septicemia, chills, shock.
Drug Interactions
Precipitate may form w/ heparin or fluorouracil. Contact w/ alkaline soln can lead to hydrolysis.
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.
Presentation/Packing
Form
Doxvex 50 powd for inj 50 mg
Packing/Price
1's
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