Idarubicin


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Refractory breast cancer 45 mg/m2 as a single dose or divided over 3 consecutive days. May repeat 3-4 wkly. Acute myeloid leukaemia Single agent: 30 mg/m2/day for 3 days; Combination: 15-30 mg/m2/day for 3 days. IV Acute lymphoblastic leukaemia 12 mg/m2/day for 3 days. Acute myeloid leukaemia Induction: 12 mg/m2/day for 3 days w/ cytarabine. A 2nd course may be used in patients with evidence of leukaemia after the 1st induction course.
Dosage Details
Intravenous
Acute myeloid leukaemia
Adult: Induction: 12 mg/m2 daily for 3 days, in combination with cytarabine. Dose to be given as slow inj (over 10-15 minutes). Cytarabine may be given as 100 mg/m2 daily for 7 days via continuous infusion or 25 mg/m2 via bolus inj followed by cytarabine 200 mg/m2 daily for 5 days via continuous infusion. A 2nd course may be used in patients with evidence of leukaemia after the 1st induction course; delay admin of the 2nd course if patient develops severe mucositis, until recovery has occurred, dose reduction of 25% is recommended.

Intravenous
Acute lymphoblastic leukaemia
Adult: 12 mg/m2 by inj daily for 3 days as single agent.
Child: 10 mg/m2 daily for 3 days as single agent.

Oral
Acute myeloid leukaemia
Adult: 30 mg/m2 daily for 3 days as single agent or 15-30 mg/m2 daily for 3 days in combination with other drugs.

Oral
Refractory breast cancer
Adult: 45 mg/m2 as a single dose or divided over 3 consecutive days; may be repeated every 3-4 wk depending on haematological recovery.
Special Patient Group
Patients who developed severe mucositis during the 1st course: Reduce 2nd course dose by 25%.
Renal Impairment
Reduce dose.
Hepatic Impairment
Intravenous:
Bilirubin 12-20 mcg/ml: Administer 50% of normal dose.
Oral:
Acute myeloid leukaemia: Bilirubin 12-20 mcg/ml: Administer 50% of normal dose.
Refractory breast cancer: Reduce dose.
Administration
May be taken with or without food. May be taken w/ a light meal.
Incompatibility
Intravenous:
Heparin. Solutions with alkaline pH.
Contraindications
Severe myelosuppression, uncontrolled infection. Pregnancy and lactation. Hypersensitivity.
Special Precautions
Elderly. Prevent hyperuricaemia. Systemic infections. Previous anthracyclines therapy. Preexisting cardiac disease. Monitor bilirubin levels and withhold if bilirubin >20 mcg/ml. Monitor CBC regularly. Monitor cardiac function. Renal and hepatic impairment.
Adverse Reactions
Severe myelosuppression, leucopenia, thrombocytopenia, cardiotoxicity, hyperuricaemia, reversible alopecia; nausea and vomiting, mucositis, diarrhoea; fever, rash; local tissue necrosis upon extravasation; increased bilirubin and transaminases; headache, peripheral neuropathy, mental status changes.
IV/Parenteral/PO: D
Overdosage
Symptoms: Severe myelosuppression, acute cardiac toxicity, increased GI toxicity. Management: Supportive e.g. platelet tranfusions, anti-infectives. No known antidote; unlikely to be removed by peritoneal dialysis or haemodialysis.
Drug Interactions
May impair immune response to vaccines; possible infection with live vaccines.
Action
Description: Idarubicin works by intercalating between DNA base pairs, thus inhibiting nucleic acid (DNA and RNA) synthesis.
Pharmacokinetics:
Absorption: Oral admin: Variable (4-77%).
Distribution: Volume of distribution: 64 L/kg. Extensive tissue binding. Protein binding: 94-97%.
Metabolism: Hepatically to idarubicinol which is active.
Excretion: Urine and hepatic. Elimination half-life: 14-35 hr (oral); 12-27 hr (IV).
Storage
Intravenous:
Store intact vials under refrigeration (2-8°C/36-46°F).
Disclaimer: This information is independently developed by MIMS based on Idarubicin 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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