starch glycolate, tartaric acid, stearic acid.
The body of the capsules are made of gelatin and are opaque white. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia, potassium hydroxide, and ferric oxide.
TEMODAR 5 mg: The green cap contains gelatin, titanium dioxide, iron oxide yellow, sodium lauryl sulfate, and FD&C Blue #2.
TEMODAR 20 mg: The yellow cap contains gelatin, sodium lauryl sulfate, and iron oxide yellow.
TEMODAR 100 mg: The pink cap contains gelatin, titanium dioxide, sodium lauryl sulfate, and iron oxide red.
TEMODAR 140 mg: The blue cap contains gelatin, sodium lauryl sulfate, and FD&C Blue #2.
TEMODAR 180 mg: The orange cap contains gelatin, iron oxide red, iron oxide yellow, titanium dioxide, and sodium lauryl sulfate.
TEMODAR 250mg: The white cap contains gelatin, titanium dioxide, and sodium lauryl sulfate.
TEMODAR for Injection:
Active ingredient: temozolomide.
Inactive ingredients: mannitol, L-threonine, polysorbate 80, sodium citrate dihydrate, and hydrochloric acid.
Issued: February 2009
TEMODAR Capsules
Manufactured by: Schering Corporation, a subsidiary of {corporate logo}MERCK & CO. INC., Whitehouse Station, NJ 08889, USA
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©1999, 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
31851114T
The trademarks depicted in this piece are owned by their respective companies.
PHARMACIST INFORMATION SHEET
What is TEMODAR? [See Full Prescribing Information, Indications and Usage (1)].
TEMODAR® (temozolomide) is an alkylating drug for the treatment of adult patients with newly diagnosed glioblastoma multiforme and refractory anaplastic astrocytoma.
How is TEMODAR dosed? [See Full Prescribing Information, Recommended Dosing and Dose Modification Guidelines (2.1)].
The daily dose of TEMODAR for a given patient is calculated by the physician, based on the patient's body surface area (BSA) [see Table 5 in the Full Prescribing Information, Recommended Dosing and Dose Modification Guidelines (2.1)]. The recommended dose for TEMODAR as an intravenous infusion over 90 minutes is the same as the dose for the oral capsule formulation. Bioequivalence has been established only when TEMODAR for Injection was given over 90 minutes. 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.
Dosing for Patients with Refractory Anaplastic Astrocytoma [See Full Prescribing Information, Recommended Dosing and Dose Modification Guidelines, Patients with Refractory Anaplastic Astrocytoma (2.1)].
Dosage of TEMODAR must be adjusted according to nadir neutrophil and platelet counts in the previous cycle and neutrophil and platelet counts at the time of initiating the next cycle. The initial dose is 150 mg/m2 orally once daily for 5 consecutive days per 28-day treatment cycle. If both the nadir and |
