Idarubicin Hydrochloride is used in combination with other approved anti-leukemia medicines for the treatment of acute myeloid leukemia (AML) in adult patients. It is effective for AML cases classified under the French–American–British (FAB) system from M1 to M7.

Idarubicin Hydrochloride is an anthracycline chemotherapy drug and a DNA-intercalating analog of daunorubicin. It works by inhibiting nucleic acid synthesis and interacting with the enzyme topoisomerase II, which interferes with cancer cell growth and division. The absence of a methoxy group at position 4 in its anthracycline structure increases its lipophilicity, allowing the drug to enter cells more rapidly than many other anthracycline medicines.

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: The safety and effectiveness of Idarubicin Hydrochloride in children have not yet been clearly established. Therefore, its use in pediatric patients should be carefully considered and only administered under the supervision of a qualified physician.

No formal studies have been conducted to evaluate the drug interactions of Idarubicin Hydrochloride with other medications. Therefore, caution should be exercised when it is used together with other drugs.

Pregnancy Category D. Studies in animals have shown that Idarubicin may cause harm to the developing fetus. In rats, it caused embryotoxic and teratogenic effects at doses much lower than the human dose. In rabbits, embryotoxic effects were observed but without clear evidence of birth defects. There is limited information about its effects on human fertility or birth defects. One case of fetal death has been reported when the mother was exposed to idarubicin during the second trimester of pregnancy. There are no well-controlled studies in pregnant women. If Idarubicin Hydrochloride is used during pregnancy, or if a patient becomes pregnant while receiving this treatment, she should be informed about the possible risks to the unborn baby. Women who can become pregnant are advised to avoid pregnancy during treatment.

Nursing Mothers: It is not known whether Idarubicin Hydrochloride passes into human breast milk. Because many medicines are excreted in breast milk and may cause serious side effects in nursing infants, mothers should stop breastfeeding before starting this medication.

Idarubicin Hydrochloride should be administered only under the supervision of a physician experienced in leukemia chemotherapy. This medicine strongly suppresses bone marrow function. It should not be used in patients who already have bone marrow suppression caused by previous chemotherapy or radiotherapy unless the potential benefit outweighs the risk. Severe suppression of bone marrow (myelosuppression) is expected in most patients receiving therapeutic doses during induction, consolidation, or maintenance therapy. Therefore, careful monitoring of blood counts is essential. Infections and bleeding, which can be life-threatening, have been reported during periods of severe myelosuppression. Healthcare facilities using this medicine should have proper laboratory support and resources to monitor the patient and manage possible toxic effects. Immediate treatment for severe bleeding or infections must be available. Patients with existing heart disease, previous high cumulative doses of anthracyclines, or treatment with other cardiotoxic drugs have a higher risk of heart toxicity from Idarubicin. In such cases, the potential benefits and risks should be carefully evaluated before starting treatment. Heart-related toxicity may occur after treatment, including congestive heart failure, serious arrhythmias, or other cardiomyopathies. Appropriate treatment should be provided if these complications occur.

Cytotoxic Chemotherapy

Store Idarubicin Hydrochloride at a controlled room temperature between 15°C and 30°C, and keep it protected from light.