d. Antiemetic therapy may be administered prior to and/or following administration of TEMODAR Capsules.
TEMODAR (temozolomide) Capsules should not be opened or chewed. They should be swallowed whole with a glass of water.
Handling and Disposal: TEMODAR causes the rapid appearance of malignant tumors in rats. Capsules should not be opened. If capsules are accidentally opened or damaged, rigorous precautions should be taken with the capsule contents to avoid inhalation or contact with the skin or mucous membranes. Procedures for proper handling and disposal of anticancer drugs should be considered. 1-7 Several guidelines on this subject have been published. There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
HOW SUPPLIED
TEMODAR (temozolomide) Capsules are supplied in amber glass bottles with child-resistant polypropylene caps containing the following capsule strengths:
TEMODAR (temozolomide) Capsules 5 mg: 5 and 20 capsule bottles.
5 count - NDC 0085-1248-01
20 count - NDC 0085-1248-02
TEMODAR (temozolomide) Capsules 20 mg: 5 and 20 capsule bottles.
5 count - NDC 0085-1244-01
20 count - NDC 0085-1244-02
TEMODAR (temozolomide) Capsules 100 mg: 5 and 20 capsule bottles.
5 count - NDC 0085-1259-01
20 count - NDC 0085-1259-02
TEMODAR (temozolomide) Capsules 250 mg: 5 and 20 capsule bottles.
5 count - NDC 0085-1252-01
20 count - NDC 0085-1252-02
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
[see USP Controlled Room Temperature]
REFERENCES
Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs, NIH Publication No. 83-2621. For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402.
AMA Council Report, Guidelines for Handling Parenteral Antineoplastics. JAMA . 1985;2.53(11):1590-1592.
National Study Commission on Cytotoxic Exposure--Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, ScD., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.
Clinical Oncological Society of Australia, Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia . 1983;1:426-428.
Jones RB, et al. Safe Handling Of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA - A Cancer Journal for Clinicians . 1983;(Sept/Oct):258-263.
American Society of Hospital Pharmacists 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.
Schering®
Schering Corporation
Kenilworth, NJ 07033 USA
Rev. 11/04 22487876
U.S. Patent No. 5,260,291.
Copyright © 2005, Schering Corpora
