Idarubicin Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Leukocytoclastic Vasculitis

For the treatment of acute myeloid leukemia (AML) in combination with other approved antileukemic drugs: (This includes French-American-British (FAB) classifications M1 through M7.)

idarubicin 12 mg/m2 daily for 3 days by slow (10 to 15 min) intravenous injection in combination with cytarabine.

In patients with unequivocal evidence of leukemia after the first induction course, a second course may be administered.

Usual Pediatric Dose for Leukemia

10 to 12 mg/m2 once daily for 3 days.

Usual Pediatric Dose for Solid Tumors

5 mg/m2 once daily for 3 days.

Renal Dose Adjustments

Because renal function impairment can affect the disposition of idarubicin, kidney function should be evaluated with conventional clinical laboratory tests (using serum creatinine as an indicator) prior to and during treatment.

In a number of Phase III clinical trials, treatment was not given if creatinine serum levels exceeded 2 mg%. Dose reduction of idarubicin should be considered if the creatinine levels are above the normal range. Some clinicians have reduced the dose by 25% if the serum creatinine is >=2 mg/dL. However, others feel dosing reductions may not be necessary in those with renal impairment.

Liver Dose Adjustments

Because hepatic function impairment can affect the disposition of idarubicin, liver function should be evaluated with conventional clinical laboratory tests (using serum bilirubin as an indicator) prior to and during treatment.

In a number of Phase III clinical trials, treatment was not given if bilirubin serum levels exceeded 2 mg%. However, in one Phase III trial, patients with bilirubin levels between 2.6 mg% and 5 mg% received the anthracycline with a 50% reduction in dose. Dose reduction of idarubicin should be considered if the bilirubin levels are above the normal range.

Monitoring of hepatic function tests are recommended.

Dose Adjustments

Administration of the second course should be delayed in patients who experience severe mucositis, until recovery from this toxicity has occurred, and a dose reduction of 25% is recommended.

Precautions

Idarubicin should not be administered if the bilirubin level exceeds 5 mg%.

Preexisting heart disease and previous therapy with anthracyclines at high cumulative doses or other potentially cardiotoxic agents are cofactors for increased risk of idarubicin-induced cardiac toxicity and the benefit to risk ratio of idarubicin therapy in such patients should be weighed before starting treatment with idarubicin.

Myocardial toxicity as manifested by potentially fatal congestive heart failure, acute life-threatening arrhythmias or other cardiomyopathies may occur following therapy with idarubicin. Appropriate therapeutic measures for the management of congestive heart failure and/or arrhythmias are indicated.

Cardiac function should be carefully monitored during treatment in order to minimize the risk of cardiac toxicity of the type described for other anthracycline compounds. The risk of such 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. While there are no reliable means for predicting congestive heart failure, cardiomyopathy induced by anthracyclines is usually associated with a decrease of the left ventricular ejection fraction (LVEF) from pretreatment baseline values.

Patients over 60 years of age who were undergoing induction therapy experienced congestive heart failure, serious arrhythmias, chest pain, myocardial infarction, and asymptomatic declines in LVEF more frequently than younger patients.

Severe myelosuppression will occur in all patients given a therapeutic dose of this agent for induction, consolidation or maintenance. Careful hematologic monitoring is required. Deaths due to infection and/or bleeding have been reported during the period of severe myelosuppression. Facilities with laboratory and supportive resources adequate to monitor drug tolerability and protect and maintain a patient compromised by drug toxicity should be available. It must be possible to treat rapidly and completely a severe hemorrhagic condition and/or a severe infection.

Therapy with idarubicin requires close observation of the patient and careful laboratory monitoring. Hyperuricemia secondary to rapid lysis of leukemic cells may be induced. Appropriate measures must be taken to prevent hyperuricemia and to control any systemic infection before beginning therapy.

Extravasation of idarubicin can cause severe local tissue necrosis. Extravasation may occur with or without an accompanying stinging or burning sensation even if blood returns well on aspiration of the infusion needle. If signs or symptoms of extravasation occur the injection or infusion should be terminated immediately and restarted in another vein.

Other Comments

Idarubicin is a potent bone marrow suppressant. Idarubicin should not be given to patients with preexisting bone marrow suppression induced by previous drug therapy or radiotherapy unless the benefit warrants the risk.

Frequent complete blood counts are recommended.

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