Doxorubicin is an anthracycline topoisomerase II inhibitor indicated for: Ovarian cancer: After failure of platinum-based chemotherapy. AIDS-related Kaposi$#$#$#$s Sarcoma: After failure of prior systemic chemotherapy or intolerance to such therapy. Multiple Myeloma: In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy.
Doxorubicin hydrochloride is a cytotoxic, anthracycline topoisomerase IIinhibitor. The cytotoxic effect of Doxorubicin HCl on malignant cells and its toxic effects on various organs are thought to be related to nucleotide base intercalation and cell membrane lipid binding activities of Doxorubicin. Intercalation inhibits nucleotide replication and action of DNA and RNA polymerases. The interaction of Doxorubicin with topoisomerase II to form DNA-cleavable complexes appears to be an important mechanism of Doxorubicin HCl cytocidal activity.
Administer Doxorubicin 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 to complete administration over 1 hour. Do not administer as bolus injection or undiluted solution. Ovarian cancer: 50 mg/m2 IV every 4 weeks AIDS-related Kaposi$#$#$#$s Sarcoma: 20 mg/m2 IV every 3 weeks Multiple Myeloma: 30 mg/m2 IV on day 4 following bortezomib
Doxorubicin is a major substrate of cytochrome P450 CYP3A4 and CYP2D6, and P-glycoprotein (P-gp). Avoid concurrent use of Doxorubicin HCl with inhibitors and inducers of CYP3A4, CYP2D6, or P-gp. Concurrent use of Trastuzumab and Doxorubicin HCl results in an increased risk of cardiac dysfunction. Avoid concurrent administration of Doxorubicin and Trastuzumab. Paclitaxel, when given prior to Doxorubicin HCl, increases the plasma-concentrations of Doxorubicin and its metabolites. Administer Doxorubicin HCl prior to Paclitaxel if used concomitantly.
Cardiac disease, neonates, pregnancy and lactation, prior irradiation to mediastinum. IM/SC admin. Severe myelosuppression due to previous treatment with antitumour agents or radiotherapy. Elderly, children, hepatic impairment. Monitor blood counts and ECG.
Leucopenia, thrombocytopenia, nausea, vomiting, diarrhoea. Rarely facial flushing, rash, alopecia. Blurred vision, headache, seizures, paraesthesia, confusion, malaise, lethargy, skin pigmentation.
Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
The symptoms of overdose are likely to be an extension of Doxorubicin's pharmacological action. Single doses of 250 mg and 500 mg of Doxorubicin have proven to be fatal. Such doses may cause acute myocardial degeneration within 24 hours and severe myelosuppression, the greatest effects of which are seen between 10 and 15 days after administration. Delayed cardiac failure may occur up to six months after the overdose. Patients should be observed carefully and treatment should aim to support the patient during this period.
Store in a dry place at 2°-8° C temperature. Protect from light and do not freeze. Keep out of the reach of children.
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