IDAMYCIN PFS Injection 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
DOSAGE AND ADMINISTRATION
For induction therapy in adult patients with AML the
following dose schedule is recommended:
IDAMYCIN PFS Injection 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 PFS should be considered.
IDAMYCIN PFS should not be administered if the bilirubin level exceeds 5 mg%.
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 And Administration Precautions
Caution in handling the solution must be exercised as
skin reactions associated with IDAMYCIN PFS may occur. Skin accidentally
exposed to IDAMYCIN PFS 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.
Care in the administration of IDAMYCIN PFS 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 PFS 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 PFS 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 PFS 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.
IDAMYCIN PFS Injection (idarubicin hydrochloride
Single Dose Cytosafe™ Vials: Sterile single use only,
contains no preservative.
NDC 0013-2576-91 5 mg/5 mL vial (1 mg/mL), single vials.
NDC 0013-2586-91 10 mg/10 mL vial (1 mg/mL), single
NDC 0013-2596-91 20 mg/20 mL vial (1 mg/mL), single
Store under refrigeration 2° to 8°C (36° to 46°F), and
protect from light. Retain in carton until time of use.
1. ONS Clinical Practice Committee. Cancer Chemotherapy
Guidelines and Recommendations for Practice. Pittsburgh, PA: Oncology Nursing
Society. 1999: 32–41.
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
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 Co., Division of
Pfizer Inc., New York, NY 10017. Jan 2015