should avoid becoming pregnant while receiving this drug. Women who are nursing prior to receiving TEMODAR should discontinue nursing. It is not known whether TEMODAR is excreted into breast milk.
What are the side effects of TEMODAR?
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, and headache.
How is TEMODAR supplied?
TEMODAR Capsules are available in 5-mg, 20-mg, 100-mg, 140-mg, 180-mg, and 250-mg strengths. The capsules contain a white capsule body with a color cap, and the colors vary based on the dosage strength.
TEMODAR Capsule Strength Color
5 mg Green Cap
20 mg Yellow Cap
100 mg Pink Cap
140 mg Blue Cap
180 mg Orange Cap
250 mg White Cap
The 5-mg, 20-mg, 100-mg, 140-mg, and 180-mg capsule strengths are available in 5-count and 14-count packages. The 250-mg capsule strength is available in a 5-count package.
How is TEMODAR dispensed?
Each strength of TEMODAR must be dispensed in a separate vial or in its original glass bottle (one strength per one container). Follow the instructions below:
Based on the dose prescribed, determine the number of each strength of TEMODAR capsules needed for the full 42- or 5-day cycle as prescribed by the physician. For example, in a 5-day cycle, 275 mg/day would be dispensed as five 250-mg capsules, five 20-mg capsules and five 5-mg capsules. Label each container with the appropriate number of capsules to be taken each day. Dispense to the patient, making sure each container lists the strength (mg) per capsule and that he or she understands to take the appropriate number of capsules of TEMODAR from each bottle or vial to equal the total daily dose prescribed by the physician.
How can TEMODAR be ordered?
TEMODAR can be ordered from your wholesaler. It is important to understand if TEMODAR is being used as part of a 42-day regimen or as part of a 5-day course. Remember to order enough TEMODAR for the appropriate cycle.
For example:
a 5-day course of 360-mg/day would require the following to be ordered: two 5-count packages of 180-mg capsules.
a 42-day course of 140-mg/day would require the following to be ordered: three 14-count packages of 140-mg capsules.
For examples of other dosing regimens, please refer to the full Prescribing Information (Table 10)
TEMODAR Product NDC Number
5-mg capsules (5 count) 0085-3004-02
5-mg capsules (14 count) 0085-3004-01
20-mg capsules (5 count) 0085-1519-02
20-mg capsules (14 count) 0085-1519-01
100-mg capsules (5 count) 0085-1366-02
100-mg capsules (14 count) 0085-1366-01
140-mg capsules (5 count) 0085-1425-01
140-mg capsules (14 count) 0085-1425-02
180-mg capsules (5 count) 0085-1430-01
180-mg capsules (14 count) 0085-1430-02
250-mg capsules (5 count) 0085-1417-01
Manufactured by: Schering Corporation, a subsidiary of {corporate logo}MERCK& CO., INC., Whitehouse Station, NJ 08889, USA
Copyright© 2005 Schering Corporation, a subsidiary of Merck & Co., Inc. All rights reserved.
U.S. Patent No. 5,260,291.
33276915T
Rev. 4/10
PRINCIPAL DISPLAY PANEL - 5 mg Capsule Bottle Carton
NDC 0085-3004-02
5 mg
per capsule
Temodar®
(temozolomide)
Caps |
