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Long-Term Data from a Landmark Phase III Trial Show Survival Benefit at Three- and Four-Years in Patients with Glioblastoma multiforme
Date:10/30/2007

ore frequent in the TEMODAR plus radiotherapy arm. The most common side effects across the cumulative TEMODAR experience were alopecia, nausea, vomiting, anorexia, headache and constipation. Forty-nine percent of patients treated with TEMODAR reported one or more severe or life-threatening events, most commonly fatigue, convulsions, headache and thrombocytopenia. Patients treated with TEMODAR Capsules may experience myelosuppression. Geriatric patients and women have been shown in clinical trials to have a higher risk of developing myelosuppression. Grade 3/4 neutropenia (lab and AE combined) occurred in eight percent and Grade 3/4 thrombocytopenia in 14 percent of patients treated with temozolomide. In refractory anaplastic astrocytoma, Grade 3/4 neutropenia occurred in 14 percent and Grade 3/4 thrombocytopenia occurred in 19 percent of patients treated with temozolomide. TEMODAR Capsules are contraindicated in patients who have a history of hypersensitivity to any of its components, or to DTIC. Caution should be exercised when administered to those with severe hepatic or renal impairment.

TEMODAR may cause fetal harm when administered to a pregnant woman. Nursing should be discontinued in women receiving TEMODAR. The effectiveness of TEMODAR in children has not been established. 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. Prophylaxis against Pneumocystis carinii pneumonia (PCP) 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.

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SOURCE Schering-Plough Corp.
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