Concise Prescribing Info
Idarubicin HCl
Acute non-lymphocytic leukemia (ANLL) in adult for remission induction in untreated, relapsed or refractory patients; acute lymphocytic leukemia (ALL) as 2nd-line treatment in adult & childn.
Dosage/Direction for Use
Adult ANLL 12 mg/m2 IV daily for 3 days in combination w/ cytarabine or 8 mg/m2 IV daily for 5 days as single agent or in combination. ALL Adult 12 mg/m2 single dose IV daily for 3 days. Childn 10 mg/m2 single dose IV daily for 3 days.
Hypersensitivity to idarubicin, other anthracyclines or anthracenediones. Severe myocardial insufficiency & arrhythmias; recent MI; persistent myelosuppression. Previous treatment w/ max cumulative doses of idarubicin &/or other anthracyclines & anthracenediones. Severe hepatic & renal impairment.
Special Precautions
Early/delayed cardiotoxicity; active or dormant CV disease, prior or concomitant RT to mediastinal/pericardial area, previous therapy w/ other anthracyclines or anthracenediones; severe myelosuppression; secondary leukemia; mucositis, stomatitis; tumor lysis syndrome, thrombophlebitis & thromboembolic phenomena. Inj site effects, extravasation. Assess cardiac function, hematologic profile before & during treatment. Evaluate blood uric acid, K, Ca phosphate & creatinine levels after initial treatment. Avoid use w/ live vaccine. Concomitant use of drugs w/ ability to suppress cardiac contractility or cardiotoxic drugs eg, trastuzumab. Hepatic &/or renal impairment. May affect fertility. Women of childbearing potential should use effective contraception during & at least 6.5 mth after last dose. Pregnancy. Not to be used during lactation. Infants & childn.
Adverse Reactions
Infection, sepsis/septicemia; secondary leukemias; anemia, leukopenia, neutropenia, thrombocytopenia; anaphylaxis; anorexia, dehydration, hyperuricemia; cardiac, vascular, GI & skin & subcutaneous tissue disorders; red color urine 1-2 days after administration; fever; asymptomatic reductions in left ventricular ejection fraction, ECG abnormalities, elevation of liver enzymes & bilirubin.
Drug Interactions
Monitor cardiac function w/ other potentially cardiotoxic drugs & cardioactive compd eg, Ca-channel blockers. Additive myelosuppressant effect w/ RT.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01DB06 - idarubicin ; Belongs to the class of cytotoxic antibiotics, anthracyclines and related substances. Used in the treatment of cancer.
Zavedos soln for inj 1 mg/mL
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