n reported. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Schering Corporation, a subsidiary of Merck & Co., Inc. at 1-800-526-4099 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
Valproic acid: decreases oral clearance of temozolomide. (7.1)
USE IN SPECIFIC POPULATIONS
Nursing mothers: Not recommended. (8.3)
Pediatric use: No established use. (8.4)
Hepatic/Renal Impairment: Caution should be exercised when TEMODAR is administered to patients with severe renal or hepatic impairment. (8.6, 8.7)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling
Revised: 11/2010
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FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
1 INDICATIONS AND USAGE
1.1 Newly Diagnosed Glioblastoma Multiforme
1.2 Refractory Anaplastic Astrocytoma
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing and Dose Modification Guidelines
2.2 Preparation and Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Hypersensitivity
5 WARNINGS AND PRECAUTIONS
5.1 Myelosuppression
5.2 Myelodysplastic Syndrome
5.3 Pneumocystis carinii Pneumonia
5.4 Laboratory Tests
5.5 Use in Pregnancy
5.6 Infusion Time
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Valproic Acid
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Newly Diagnosed Glioblastoma Multiforme
14.2 Refractory Anaplastic Astrocytoma
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 Safe Handling and Disposal
16.2 How Supplied
16.3 Storage
17 PATIENT COUNSELING INFORMATION
17.1 Information for the Patient
17.2 FDA-approved Patient Labeling
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
1.1 Newly Diagnosed Glioblastoma Multiforme
TEMODAR® (temozolomide) is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.
1.2 Refractory Anaplastic Astrocytoma
TEMODAR is indicated for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing and Dose Modification Guidelines
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 [see Clinical Pharmacology (12.3)]. Dosage of TEMODAR must be adjusted according to nadir neutrophil and platelet counts in the previous cycle and the neu |
