Zavedos CS

Acute non-lymphocytic leukemia (ANLL) in adults for remission induction in untreated, relapsed or refractory patients. Acute lymphocytic leukemia (ALL) as 2nd-line treatment in adults & childn.

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 IV dose daily for 3 days. Childn 10 mg/m² single IV dose 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.

Early/delayed cardiotoxicity; active or dormant CV disease; severe myelosuppression; secondary leukemia w/ or w/o pre-leukemic phase; 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. Prior or concomitant RT to mediastinal/pericardial area, previous therapy w/ other anthracyclines or anthracenediones. Not to be used in combination w/ other cardiotoxic agents. 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. Male partners should use effective contraception during & at least 3.5 mth after last dose. Pregnancy. Not to be used during lactation & at least 14 days after last dose. Infants & childn.

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 left ventricular ejection fraction reductions, ECG abnormalities, liver enzymes & bilirubin elevation.

Monitor cardiac function w/ other potentially cardiotoxic drugs & cardioactive compd eg, Ca-channel blockers. Additive myelosuppressant effect w/ RT. Precipitation w/ heparin. Avoid contact w/ alkaline pH soln.

Cytotoxic Chemotherapy

L01DB06 - idarubicin ; Belongs to the class of cytotoxic antibiotics, anthracyclines and related substances. Used in the treatment of cancer.

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