Generic name: idarubicin hydrochloride
Dosage form: for injection, USP
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For induction therapy in adult patients with AML the following dose schedule is recommended:
IDAMYCIN (idarubicin hydrochloride for injection, USP) 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 IDAMYCIN should be considered. IDAMYCIN should not be administered if the bilirubin level exceeds 5 mg%. (See WARNINGS.)
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. (See CLINICAL STUDIES for doses used in U.S. clinical studies.)
Preparation of Solution
Caution in handling of the powder and preparation of the solution must be exercised as skin reactions associated with IDAMYCIN may occur. Skin accidently exposed to IDAMYCIN should be washed thoroughly with soap and water and if the eyes are involved, standard irrigation techniques should be used immediately. The use of goggles, gloves, and protective gowns is recommended during preparation and administration of the drug.
IDAMYCIN 20 mg vials should be reconstituted with 20 mL of Water for Injection, USP, to give a final concentration of 1 mg/mL of idarubicin hydrochloride. Bacteriostatic diluents are not recommended. The reconstituted solution is hypotonic, and the recommended administration procedure via a freely flowing intravenous infusion must be followed.
The vial contents are under a negative pressure to minimize aerosol formation during reconstitution; therefore, particular care should be taken when the needle is inserted. Inhalation of any aerosol produced during reconstitution must be avoided.
Reconstituted solutions are physically and chemically stable for 72 hours (3 days) under refrigeration (2° to 8°C, 36° to 46°F) and at controlled room temperature, (15° to 30°C, 59° to 86°F). Discard unused solutions in an appropriate manner (see Handling and Disposal).
Care in the administration of IDAMYCIN will reduce the chance of perivenous infiltration. It may also decrease the chance of local reactions such as urticaria and erythematous streaking. During intravenous administration of IDAMYCIN extravasation may occur with or without an accompanying stinging or burning sensation even if blood returns well on aspiration of the infusion needle. If any signs or symptoms of extravasation have occurred, the injection or infusion should be immediately terminated and restarted in another vein. If it is known or suspected that subcutaneous extravasation has occurred, it is recommended that intermittent ice packs (1/2 hour immediately, then 1/2 hour 4 times per day for 3 days) be placed over the area of extravasation and that the affected extremity be elevated. Because of the progressive nature of extravasation reactions, the area of injection should be frequently examined and plastic surgery consultation obtained early if there is any sign of a local reaction such as pain, erythema, edema or vesication. If ulceration begins or there is severe persistent pain at the site of extravasation, early wide excision of the involved area should be considered.
IDAMYCIN should be administered slowly (over 10 to 15 minutes) into the tubing of a freely running intravenous infusion of Sodium Chloride Injection USP (0.9%) or 5% Dextrose Injection USP. The tubing should be attached to a Butterfly needle or other suitable device and inserted preferably into a large vein.
Unless specific compatibility data are available, IDAMYCIN should not be mixed with other drugs. Precipitation occurs with heparin. Prolonged contact with any solution of an alkaline pH will result in degradation of the drug.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and containers permit.