Doxorubicin: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the local prescribing information.

Generic Medicine Info

Indications and Dosage

Intravenous
Metastatic breast cancer

Adult: 60-75 mg/m² BSA once every 3 wk in combination with cyclophosphamide given as an infusion over 1 hr diluted in 0.9% sodium chloride or 5% glucose.

Intravenous
AIDS-related Kaposi's sarcoma

Adult: As pegylated liposome: 20 mg/m² BSA infused over 30 min once every 2-3 wk.

Intravenous
Ovarian carcinoma

Adult: As pegylated liposome: 50 mg/m² BSA infused over 1 hr once every 4 wk.

Irrigation
Local malignant neoplasms in the bladder

Adult: 50 ml of a 1 mg/ml solution instilled into the bladder for 1 hr once a mth.

Hepatic Impairment

Moderate impairment (serum-bilirubin: 12-30 mcg/mL): Half the normal dose; severe impairment (serum-bilirubin >30 mcg/mL): Quarter of the usual dose.

Contraindications

Cardiac disease, neonates, pregnancy and lactation, prior irradiation to mediastinum. IM/SC admin. Severe myelosuppression due to previous treatment with antitumour agents or radiotherapy.

Special Precautions

Elderly, children, hepatic impairment. Monitor blood counts and ECG.

Adverse Reactions

Leucopenia, thrombocytopenia, nausea, vomiting, diarrhoea. Rarely facial flushing, rash, alopecia. Blurred vision, headache, seizures, paraesthesia, confusion, malaise, lethargy, skin pigmentation.
Potentially Fatal: Bone marrow suppression, cardiotoxicity.

Pregnancy Category (US FDA)

Intra-arterial/Intravesical/IV/Parenteral: D

Overdosage

Acute overdosage may increase the toxic effects of mucositis, leukopenia and thrombocytopenia. Treatment includes hospitalisation of the severely myelosuppressed patient, antimicrobials, platelet transfusions and symptomatic treatment of mucositis. Use of haemopoietic growth factor (G-CSF, GM-CSF) may be considered. Cumulative dosage increases risk of cardiomyopathy and resultant congestive heart failure which may be managed with digitalis preparations, diuretics, and after load reducers such as ACE inhibitors.

Drug Interactions

Doxorubicin interacts with a number of other drugs e.g. antibiotics (aminoglycosides), steroids, aminophylline and propranolol.
Potentially Fatal: Cholestasis induced by mercaptopurine may be potentiated by concurrent administration of the drug. Toxicity may be increased if streptozocin is given concurrently.

Action

Description: Doxorubicin is a cytotoxic anthracycline antibiotic. The cytotoxic action results from its binding to DNA and inhibition of nucleic acid synthesis. Doxorubicin has been shown to produce regression in a variety of disseminated malignancies.
Pharmacokinetics:
Absorption: Rapidly cleared from the blood after IV admin.
Distribution: Distributed into tissues including lungs, liver, heart, spleen and kidneys (IV); crosses the placenta; enters breast milk.
Metabolism: Hepatic; rapidly converted to doxorubicinol.
Excretion: Bile (as unchanged drug); 12 min, 3.3 hr, 30 hr (mean elimination half-lives).

Storage

Powder for inj: Store at 15-30°C. Solution for inj & liposomal formulations: Refrigerate at 2-8°C. Do not freeze.

MIMS Class

Cytotoxic Chemotherapy

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