erse reactions in nursing infants 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 TEMODAR to the mother.
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.
1.OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999.
2.American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006; 63:1172–1193.
3.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]
4.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 for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
Manufactured by:
Baxter Oncology GmbH, Halle 33790, Germany
For patent information: www.merck.com/product/patent/home.html
Copyright © 2008 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved.
Revised: 06/2013
phi-mk7365-pwi-1306r013
TEMODAR® (temozolomide) Capsules
PHARMACIST:
Dispense enclosed Patient Package Insert to each patient.
PHARMACIST INFORMATION SHEET
IMPORTANT DISPENSING INFORMATION
For every patient, TEMODAR must be dispensed in a separate vial or in its original package making sure each container lists the strength per capsule and that patients take the appropriate number of capsules from each package 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 a |
