TEMODAR® (temozolomide) Capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.
TEMODAR® (temozolomide) Capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma, ie, patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.

Important Safety Information

TEMODAR® Capsules are contraindicated in patients who have a history of hypersensitivity to any of its components, or to DTIC.

Patients treated with TEMODAR® Capsules may experience myelosuppression including prolonged pancytopenia, which may result in aplastic anemia, which in some cases has resulted in a fatal outcome. In some cases, exposure to concomitant medications associated with aplastic anemia including carbamazepine, phenytoin, and sulfamethoxazole/trimethoprim complicates assessment. Geriatric patients and women have been shown in clinical trials to have a higher risk of developing myelosuppression. Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukemia, have also been observed.

TEMODAR® may cause fetal harm when administered to a pregnant woman. Nursing should be discontinued in women receiving TEMODAR®.

Prophylaxis against Pneumocystis carinii pneumonia is required for all patients receiving concomitant TEMODAR® and radiotherapy for the 42-day regimen. There may be a higher occurrence of PCP when temozolomide is administered during a longer dosing regimen. However, all patients receiving temozolomide, particularly patients receiving steroids, should be observed closely for the development of PCP regardless of the regimen.

In newly diagnosed patients with glioblastoma multiforme, the adverse event profile was similar in patients <65 years of age and those ≥65 years. Caution should be exercised when administered to those with severe hepatic or renal impairment.

TEMODAR® Capsules should not be opened or chewed. If capsules are accidentally opened or damaged, rigorous precautions should be taken with the capsule contents to avoid inhalation or contact with the skin or mucous membranes.

The effectiveness of TEMODAR® in children has not been established.

Grade 3/4 neutropenia occurred in 8% and Grade 3/4 thrombocytopenia in 14% of patients treated with temozolomide. The most common side effects associated with TEMODAR® therapy are nausea, vomiting, anorexia, alopecia, headache, fatigue, constipation, convulsions, weakness, and thrombocytopenia.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information for details about TEMODAR®