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CHMP Recommends Approval in the European Union (EU) for New Options for Patients With Certain Primary Brain Tumors
Date:12/8/2008

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.

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.

In newly diagnosed patients with GBM, the adverse event profile was similar in patients <65 years of age and those greater than or equal to 65 years.

In newly diagnosed GBM, the most common adverse events in clinical

studies in the Concomitant Phase (Radiotherapy + TEMODAR) and the Maintenance Phase (TEMODAR alone), respectively, were alopecia 69%, 55%; fatigue 54%, 61%; nausea 36%, 49%; vomiting 20%, 29%; anorexia 19%, 27%; headache 19%, 23%; constipation 18%, 22%; with the following important adverse events also reported: convulsions 6%, 11% and thrombocytopenia 4%; 8%.

Of these adverse events, those grade greater than or equal to 3 in clinical studies in the Concomitant Phase (Radiotherapy + TEMODAR) and the Maintenance Phase (TEMODAR alone), respectively, were fatigue 7%, 9% nausea; 1%, 1%; vomiting <1%, 2%; anorexia 1%, 1%; headache 2%, 4%; constipation 1%, 0%; convulsions 3%, 3%; thrombocytopenia 3%, 4%.

In the newly diagnosed GBM population, when laboratory abnormalities and adverse events were combined, Grade 3 or 4 neutropenia occurred in 8% and Grade 3 or 4 platelet abnormalities i
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SOURCE Schering-Plough Corporation
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