Adult Dosing
Acute myeloid leukemia (AML)
- 12 mg/m2 by slow IV injection (10 to 15 min) qd X 3 days in combination with cytarabine
- Cytarabine dose: 100 mg/m2 IV by continuous infusion qd X 7 days; alt: 25 mg/m2 IV bolus followed by 200 mg/m2 continuous infusion qd x 5 days
Note:
- May administer a second course in patients with unequivocal evidence of leukemia
- Administration of the second course should be delayed in patients who develop severe mucositis, until this subsides; consider dose reduction of 25%
Acute promyelocytic leukemia [Non-FDA Approved]
- < 60 years: 12 mg/m2/d IV IV on days 2, 4, 6, and 8
- 61-70 years: 9 mg/m2/d IV
- >70 years: 6 mg/m2/d IV
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
Acute promyelocytic leukemia [Non-FDA Approved]
- Limited studies. Recent use IN APML4 protocol used 12 mg/m²/d IV (ages 1-60), days 2, 4, 6 and 8
[Outline]
- Administer idarubicin only under the supervision of a physician who is experienced in leukemia chemotherapy [US Black Box Warning]
- Should not be administered to patients with preexisting bone marrow suppression induced by previous drug therapy or radiotherapy unless the benefit warrants the risk. Severe myelosuppression occurs in all patients given a therapeutic dose for induction, consolidation or maintenance; consider close hematologic monitoring
- Death may occur due to infection or bleeding during severe myelosuppression
- Cardiac toxicity is more common in patients with preexisting cardiac disease or who have received prior anthracyclines [US Black Box Warning]
- Myocardial toxicity including potentially fatal CHF, acute life-threatening arrhythmias or other cardiomyopathies may occur with idarubicin therapy; institute appropriate therapeutic measures
- Carefully monitor cardiac function during treatment to minimize the risk of cardiac toxicity associated with use of anthracycline compounds. The risk of myocardial toxicity may be higher following concomitant or previous radiation to the mediastinal-pericardial area or in patients with anemia, bone marrow depression, infections, leukemic pericarditis and/or myocarditis
- Evaluate hepatic and renal function prior to and during therapy; consider dose reduction if the bilirubin and/or creatinine levels are above the normal range
- Women of childbearing potential should be advised to avoid becoming pregnant during treatment. If the patient becomes pregnant during therapy, the patient should be apprised of the potential hazard to the fetus
- Therapy may be associated with hyperuricemia secondary to rapid lysis of leukemic cells. Initiate proper measures to prevent hyperuricemia and to control any systemic infection prior to therapy
- Extravasation of the drug can cause severe local tissue necrosis, which may occur with or without accompanying stinging or burning sensation. If signs or symptoms of extravasation occur, therapy should be terminated immediately and restarted in another vein
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Concurrent use of cardiotoxic agents
- Elderly patients
Pregnancy Category:D
Breastfeeding: It is unknown whether this drug is excreted in human milk. Potential for serious adverse reactions in nursing infants exists from the drug. Manufacturer recommends discontinuing nursing prior to taking this drug.
