Daunorubicin: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

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

Generic Medicine Info

Indications and Dosage

Intravenous
Acute leukaemia

Adult: 30-45 mg/m² BSA daily on days 1-3 of the induction course and days 1 and 2 for the subsequent courses. Admin as a solution in 0.9% sodium chloride into a fast-running infusion of sodium chloride or glucose. May repeat course 3-6 wk later. Max (total cumulative dose): 550 mg/m² in patients without risk factors for cardiotoxicity and 400 mg/m² in patients who have received chest radiotherapy.
Child: For acute lymphoblastic leukaemia: 25 mg/m² BSA once wkly in combination with other regimens. <2 yr old or BSA <0.5 m²: 1 mg/kg once wkly. Max (total cumulative dose): 300 mg/m² and in children <2 yr: 10 mg/kg.

Intravenous
AIDS-related Kaposi's sarcoma

Adult: As the liposomal formulation: Initially, 40 mg/m² once every 2 wk, diluted in glucose 5% to a concentration of 0.2-1 mg/ml and given over 30-60 minutes. May continue for as long as disease control can be maintained.

Renal Impairment

Based on serum-creatinine concentrations: 105-265 micromoles/l: 75% of the usual dose; >265 micromoles/l: 50% of the usual dose.

Hepatic Impairment

Based on serum bilirubin concentrations of 12-30 mcg/ml: 75% of the usual dose; >30 mcg/ml: 50% of the usual dose.

Incompatibility

Incompatible with heparin sodium and dexamethasone sodium phosphate solution.

Contraindications

Heart failure. Pregnancy, lactation.

Special Precautions

Regular blood count and ECG monitoring; elderly, children. Hepatic or renal impairment may increase risk of toxicity. Pre-existing cardiac disease and previous treatment with doxorubicin. Myocardial toxicity leading to potentially fatal congestive heart failure may occur during therapy or mth to yr after therapy cessation. Incidence of myocardial toxicity increases after total cumulative dose exceeds 400-550 mg/m² in adults, 300 mg/m² in children >2 yr, or 10 mg/kg in children <2 yr. Risk of severe myelosuppression leading to infection or haemorrhage.

Adverse Reactions

GI disturbances; stomatitis; alopoecia and dermatological reactions. Extravasation of daunorubicin may cause severe local tissue necrosis damaging surrounding muscles, tendons and nerves. IV infusion, back pain, flushing and chest tightness.
Potentially Fatal: Bone marrow suppression, cardiac toxicity, cardiomyopathy and congestive heart failure.

Pregnancy Category (US FDA)

IV/Parenteral: D

Overdosage

Severe myelosupression, cardiotoxicity with or without transient reversible ECG changes leading to CHF. Treatment is supportive and symptomatic.

Drug Interactions

Increased risk of cardiotoxicity when used with cyclophosphamide. Increased risk of hepatic toxicity when used with hepatotoxic drugs e.g. high-dose methotrexate.
Potentially Fatal: Immunisation with live vaccines is not recommended. Concurrent radiation may lead to increased radiation reaction.

Action

Description:
Mechanism of Action: Daunorubicin forms a stable complex with DNA and interferes with the nucleic acid synthesis. It is a cell-cycle nonspecific agent, but its cytotoxic effects are mostly marked in the S-phase. It also has immunosuppressant and antibacterial effects.
Pharmacokinetics:
Distribution: Body tissues; crosses the placenta; enters breast milk.
Metabolism: Hepatic; converted to daunorubicinol.
Excretion: Urine (as active form). Elimination half-life: 18.5 hr (daunorubicin), 26.7 hr (active metabolite).

Storage

Powder for inj: Store at 15-25°C. Solution for inj & liposomal inj: Refrigerate at 2-8°C. Do not freeze.

MIMS Class

Cytotoxic Chemotherapy

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