IDAMYCIN (idarubicin hydrochloride for injection, USP) in
combination with other approved antileukemic drugs is indicated for the
treatment of acute myeloid leukemia (AML) in adults. This includes
French-American-British (FAB) classifications M1 through M7.
DOSAGE AND ADMINISTRATION
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 (½
hour immediately, then ½ 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.
Handling And Disposal
Procedures for handling and disposal of anticancer drugs
should be considered. Several guidelines on this subject have been published.1-8
There is no general agreement that all of the procedures recommended in the
guidelines are necessary or appropriate.
Store at controlled room temperature, 15° to 30°C (59° to
86°F), and protect from light.
IDAMYCIN (idarubicin hydrochloride for injection, USP)
NDC 0013-2526-86 20 mg single dose vial. Available in
1. ONS Clinical Practice Committee. Cancer Chemotherapy
Guidelines and Recommendations for Practice. Pittsburgh, Pa: Oncology Nursing
2. Recommendations for the Safe Handling of Parenteral
Antineoplastic Drugs. Washington, DC; Division of Safety, Clinical Center
Pharmacy Department and Cancer Nursing Services, National Institutes of Health;
1992. US Department of Health and Human Services, Public Health Service
Publication NIH 92-2621.
3. AMA Council on Scientific Affairs. Guidelines for
Handling Parenteral Antineoplastics. JAMA. 1985;253:1590–1591.
4. National Study Commission on Cytotoxic Exposure
-Recommendations for Handling Cytotoxic Agents. 1987. Available from Louis P.
Jeffrey, Sc.D., Chairman, National Study Commission on Cytotoxic Exposure,
Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood
Avenue, Boston, MA 02115.
5. Clinical Oncological Society of Australia: Guidelines
and Recommendations for Safe Handling of Antineoplastic Agents. Med J
Australia. 1983; 1:426–428.
6. Jones RB, Frank R, Mass T. Safe Handling of
Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA
Cancer J Clin. 1983;33:258– 263.
7. American Society of Hospital Pharmacists. ASHP
Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J
Hosp Pharm. 1990; 47:1033– 1049.
8. Controlling Occupational Exposure to Hazardous Drugs
(OSHA Work-Practice Guidelines). Am J Health-Syst Pharm. 1996;53:1669–1685.
Distributed by: Pharmacia & Upjohn Company, Division
of Pfizer Inc., NY, NY 10017. Revised: December 2014