Idarubicin PhaRes

Idarubicin PhaRes PhaRes in combination with other approved antileukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults. This includes French-American- British (FAB) classifications M1 through M7.

Dosage & Administration

For induction therapy in adult patients with AML the following dose schedule is recommended
: Idarubicin hydrochloride 12 mg/m2 daily for 3 days by slow (10 to 15 min) intravenous injection in combination with cytarabine. The cytarabine may be given as 100 mg/m2 daily by continuous infusion for 7 days or as cytarabine 25 mg/m2 intravenous bolus followed by cytarabine 200 mg/m2 daily for 5 days continuous infusion. In patients with unequivocal evidence of leukemia after the first induction course, a second course may be administered. 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. In patients with hepatic and/or renal impairment, a dose reduction of Idarubicin should be considered. Idarubicin should not be administered if the bilirubin level exceeds 5 mg%. The benefit of consolidation in prolonging the duration of remissions and survival is not proven. There is no consensus regarding optional regimens to be used for consolidation.
Pediatric Use
: Safety and effectiveness in children have not been established.

Idarubicin PhaRes PhaRes is intended for administration under the supervision of a physician who is experienced in leukemia chemotherapy. Idarubicin PhaRes is a potent bone marrow suppressant. Idarubicin PhaRes should not be given to patients with pre-existing bone marrow suppression induced by previous drug therapy or radiotherapy unless the benefit warrants the risk. 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. Pre-existing heart disease and previous therapy with anthracyclines at high cumulative doses or other potentially cardiotoxic agents are co-factors 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 PhaRes. Myocardial toxicity as manifested by potentially fatal congestive heart failure, acute life- threatening arrhythmias or other cardiomyopathies may occur following therapy with Idarubicin PhaRes. Appropriate therapeutic measures for the management of congestive heart failure and/or arrhythmias are indicated.

Idarubicin hydrochloride is a DNA-intercalating analog of daunorubicin which has an inhibitory effect on nucleic acid synthesis and interacts with the enzyme topoisomerase II. The absence of a methoxy group at position 4 of the anthracycline structure gives the compound a high lipophilicity which results in an increased rate of cellular uptake compared with other anthracyclines.