g 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 250 mg: 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.
TEMODAR Capsules
Manufactured by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
TEMODAR for Injection
Manufactured by: 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
The trademarks depicted herein are owned by their respective companies.
Copyright © 1999, 2008 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.
Revised: 06/2013
ppi-mk7365-mtl-1306r007
TEMODAR® (temozolomide) for Injection
PHARMACIST:
Dispense enclosed Patient Package Insert to each patient.
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 day of dosing (Day 29, Day 1 of next cycle) absolute neutrophil counts (ANC) are greater than or equal to 1.5 × 109 /L (1500/µL) and both the nadir and Day 29, Day 1 of next cycle platelet counts are greater than or equal to 100 × 109 /L (10 |
