Zavedos Dosage/Direction for Use

Idarubicin hydrochloride, either as the reconstituted solution or the ready to use solution must be administered only by the intravenous (IV) route (see Special precautions for disposal and other handling under Cautions for Usage). A slow administration over 5 to 10 minutes via the tubing of a freely running intravenous infusion of 0.9% sodium chloride or 5% dextrose, must be followed. A direct push injection is not recommended due to the risk of extravasation, which may occur even in the presence of adequate blood return upon needle aspiration (see Precautions).
Acute non-lymphocytic leukemia (ANLL): In adult ANLL, the recommended intravenous dose schedule suggested is 12 mg/m² IV daily for 3 days in combination with cytarabine.
Idarubicin hydrochloride may also be administered as a single agent and in combination, at a dose of 8 mg/m² IV daily for 5 days.
Acute lymphocytic leukemia (ALL): In adult ALL, the recommended single-agent intravenous dose is 12 mg/m² daily for 3 days. In children with ALL, the recommended single-agent intravenous dose is 10 mg/m² daily for 3 days.
All of these dosage schedules should, however, take into account the haematological status of the patient and the dosages of other cytotoxic drugs when used in combination.
Dose Modifications: Hepatic or Renal Dysfunction. While no specific dose recommendation can be made based on the limited available data in patients with hepatic and/or renal impairment, dose reductions should be considered in patients with bilirubin and/or creatinine serum levels greater than 2.0 mg% (see Precautions).
Idarubicin hydrochloride should not be administered to patients with severe hepatic and/or renal impairment (see Contraindications).