r handling and disposal of anticancer drugs should be used. 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
Leukeran is supplied as brown, film-coated, round, biconvex tablets containing 2mg chlorambucil in amber glass bottles with child-resistant closures. One side is engraved with “GX EG3” and the other side is engraved with an “L.”
Bottle of 50 (NDC 0173-0635-35).
Store in a refrigerator, 2° to 8°C (36° to 46°F).
REFERENCES
ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburgh, PA: Oncology Nursing Society; 1999:32-41.
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 and Human Services, 1992, US Dept of Health and Human Services, Public Health Service publication NIH 92-2621.
AMA Council on Scientific Affairs. Guidelines for handling parenteral antineoplastics. JAMA. 1985;253:1590-1591.
National Study Commission on Cytotoxic Exposure. Recommendations for handling cytotoxic agents. 1987. Available from Louis P. Jeffrey, Chairman, National Study Commission on Cytotoxic Exposure. Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115.
Clinical Oncological Society of Australia. Guidelines and recommendations for safe handling of antineoplastic agents. Med J Australia. 1983;1:426-428.
Jones RB, Frank R, Mass T. Safe handling of chemotherapeutic agents: a report from the Mount Sinai Medical Center. CA-A Cancer J for Clin. 1983;33:258-263.
American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm. 1990;47:1033-1049.
Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines.) Am J Health-Syst Pharm. 1996;53:1669-1685.
GlaxoSmithKline
Research Triangle Park, NC 27709
©2006, GlaxoSmithKline. All rights reserved.
November 2006 RL-2328
Principal Display Panel
NDC 0173-0635-35
LEUKERAN®
(chlorambucil) Tablets
2 mg
50 Tablets
Each tablet contains 2 mg chlorambucil.
Rx only
WARNING: This drug is only to be taken under close medical supervision. Do not take in larger doses or more frequently or for a longer time than specifically directed by the physician. Periodic blood counts are necessary to determine proper dose and to avoid ill effects.
See prescribing information for Dosage and Administration.
Store in a refrigerator, 2o to 8oC (36o to 46oF). Dispense in tight container as defined in the USP.
Mfd by Heumann Pharma GmbH
90537 Feucht, Germany for
GlaxoSmithKline
RTP, NC 27709
Made in Germany
7000049 Rev. 3/04
LEUKERAN
chlorambucil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0635
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORAMBUCIL (CHLORAMBUCIL) CHLORAMBUCIL 2mg
Inactive Ingredients
Ingredient Nam