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Idamycin-PFS

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Idamycin PFS

Idamycin PFS

INDICATIONS

IDAMYCIN PFS (idarubicin hydrochloride injection) 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 through M7.

DOSAGE AND ADMINISTRATION

(See WARNINGS)

For induction therapy in adult patients with AML the following dose schedule is recommended:

IDAMYCIN PFS (idarubicin hydrochloride injection) 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 (idarubicin hydrochloride injection) should be considered. IDAMYCIN PFS (idarubicin hydrochloride injection) 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 and Administration Precautions

Caution in handling the solution must be exercised as skin reactions associated with IDAMYCIN PFS (idarubicin hydrochloride injection) may occur. Skin accidentally exposed to IDAMYCIN PFS (idarubicin hydrochloride injection) 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 (idarubicin hydrochloride injection) 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 (idarubicin hydrochloride injection) 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 PFS (idarubicin hydrochloride injection) 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.

Incompatibility

Unless specific compatibility data are available, IDAMYCIN PFS (idarubicin hydrochloride injection) 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.

HOW SUPPLIED

IDAMYCIN PFS Injection (idarubicin hydrochloride injection)

Single Dose Glass Vials: Sterile single use only, contains no preservative.

NDC 0013-2200-01 5 mg/5 mL vial (1 mg/mL), single vials.
NDC 0013-2201-01 10 mg/10 mL vial (1 mg/mL), single vials.
NDC 0013-2202-01 20 mg/20 mL vial (1 mg/mL), single vials.

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 vials.
NDC 0013-2596-91 20 mg/20 mL vial (1 mg/mL), single vials.

Store under refrigeration 2° to 8°C (36° to 46°F), and protect from light. Retain in carton until time of use.

REFERENCES

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 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 Co., A Division of Pfizer Inc., NY, NY 10017. Revised January 2006. FDA revision date: 5/1/2003

Last reviewed on RxList: 10/9/2008
This monograph has been modified to include the generic and brand name in many instances.

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