Concise Prescribing Info
Idarubicin HCl
In adults & childn w/ acute non-lymphoblastic leukaemia (ANLL), also referred as acute myeloid leukemia (AML); 2nd-line treatment of relapsed acute lymphoblastic leukemia (ALL).
Dosage/Direction for Use
IV ANLL/AML Adult 12 mg/m2 daily for 3 days in combination w/ cytarabine or 8 mg/m2 daily as a single agent & in combination for 5 days. Childn 10-12 mg/m2 daily for 3 days in combination w/ cytarabine. ALL Adult 12 mg/m2 daily as a single agent for 3 days. Childn 10 mg/m2 daily as a single agent for 3 days.
Hypersensitivity to idarubicin HCl, other anthracyclines or anthracenediones. Previous treatment w/ max cumulative dose of idarubicin HCL, &/or other anthracyclines & anthracendiones. Severe hepatic & renal impairment; cardiomyopathy; arrhythmias. Recent MI. Persistent myelosuppression. Uncontrolled infections. Lactation.
Special Precautions
Patient should recover from acute toxicities of prior cytotoxic treatment before beginning the therapy. Secondary leukaemia w/ or w/o a preleukemic phase. Mucositis. Phlebosclerosis. Stop immediately if signs or symptoms of extravasation occur. Avoid vaccination w/ live vaccine. Sperm preservation in men. Thrombophlebitis & thromboembolic phenomena. Galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption. Assess cardiac function before patient undergo treatment & monitor throughout therapy to minimize the risk of incurring severe cardiac impairment; haematologic profiles before & during each cycle of therapy including differential WBC counts. Evaluate blood uric acid levels, K, Ca phosphate & creatinine after initial treatment. Hydration, urine alkalinization & prophylaxis w/ allopurinol.
Adverse Reactions
Infections; anaemia, severe leukopenia & neutropenia, thrombocytopenia; anorexia; nausea, vomiting, mucositis/stomatitis, diarrhoea, abdominal pain or burning sensation; alopecia; red coloration of the urine for 1-2 days after treatment; fever, headache, chills. Bradycardia, sinus tachycardia, tachyarrhythmia, asymptomatic reduction of left ventricular ejection fraction, CHF, cardiomyopathies; local phlebitis, thrombophlebitis, haemorrhages; GI tract bleeding, bellyache; elevation of the liver enzymes & bilirubin; rash, itch, hypersensitivity of irradiated skin ('radiation recall reaction').
Drug Interactions
Induced additive myelosuppressant effects w/ other agents w/ similar action or radiotherapy. Cardiotoxic drugs or other cardioactive compd (eg, Ca channel blockers). Fatal systemic disease w/ live attenuated vaccines (eg, yellow fever). Increased AUC w/ cyclosporin A.
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 powd for inj 5 mg
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