fants and tumorigenicity shown for temozolomide in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother from TEMODAR.
What are the side effects of TEMODAR? [See Full Prescribing Information, Adverse Reactions (6)].
Nausea and vomiting are the most common side effects associated with TEMODAR. Noncumulative myelosuppression is the dose-limiting toxicity. Patients should be eva luated periodically by their physician to monitor blood counts.
Other commonly reported side effects reported by patients taking TEMODAR are fatigue, constipation, alopecia, anorexia, headache, and bruising, as well as pain, irritation, itching, warmth, swelling, and redness at the site of infusion.
How is TEMODAR supplied? [See Full Prescribing Information, How Supplied/Storage and Handling (16)].
TEMODAR for Injection is supplied in single-use glass vials containing 100 mg temozolomide. TEMODAR is also available as capsules in 5-mg, 20-mg, 100-mg, 140-mg, 180-mg, and 250-mg strengths.
OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999.
American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006; 63:1172–1193.
NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.[3]
Polovich, M., White, J. M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology.
TEMODAR for Injection
Manufactured by: Baxter Oncology GmbH, Halle/Westfalen, Germany
Distributed by: Schering Corporation, a subsidiary of {corporate logo}MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
Copyright© 2008 Schering Corporation, a subsidiary of Merck & Co., Inc. All rights reserved.
U.S. Patent Nos. 5,260,291 and 6,987,108.
Rev. 04/10
30984439T
PHARMACIST:
Tear at perforation and give to patient.
PHARMACIST INFORMATION SHEET
IMPORTANT DISPENSING INFORMATION
For every patient, TEMODAR must be dispensed in a separate vial or in its original glass bottle making sure each container lists the strength per capsule and that patients take the appropriate number of capsules from each bottle or vial.
Please see the dispensing instructions below for more information.
What is TEMODAR?
TEMODAR® (temozolomide) is an oral alkylating agent for the treatment of newly diagnosed glioblastoma multiforme and refractory anaplastic astrocytoma.
How is TEMODAR dosed?
The daily dose of TEMODAR Capsules for a given patient is calculated by the physician, based on the patient's body surface area (BSA). The resulting dose is then rounded off to the nearest 5 mg. An example of the dosing may be as follows: the initial daily dose of TEMODAR in milligrams is the BSA multiplied by mg/m2/day, (a patient with a BSA of 1.84 is 1.84 × 75 mg = 138, or 140 mg/day). The dose for subsequent cycles may be adjusted according to nadir neutrophil and platelet counts in the previous cycle and at the time of initiating the next cycle.
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