Daunorubicin


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Acute leukaemia 30-45 mg/m2/day on days 1-3 of the induction regimen and days 1 and 2 of subsequent courses. May repeat course 3-6 wk later. Max total cumulative dose: 550 mg/m2 in patients w/o risk factors for cardiotoxicity and 400 mg/m2 in patients who have received chest radiotherapy. AIDS-related Kaposi's sarcoma As liposomal formulation: Initial: 40 mg/m2 every 2 wk. Continue treatment for as long as disease control is maintained.
Dosage Details
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.
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: 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.
Disclaimer: This information is independently developed by MIMS based on Daunorubicin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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