Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Temozolomide Teva

Temozolomide Teva 5 mg hard capsules Temozolomide Teva 20 mg hard capsules Temozolomide Teva 100 mg hard capsules Temozolomide Teva 140 mg hard capsules Temozolomide Teva 180 mg hard capsules Temozolomide Teva 250 mg hard capsules · Abschnitt 4.8 · PDF-Seite 12

HOS-212066 · Präparat HOS-154816

In a population pharmacokinetics analysis of clinical trial experience there were 101 female and 169 male subjects for whom nadir neutrophil counts were available and 110 female and 174 male subjects for whom nadir platelet counts were available. There were higher rates of Grade 4 neutropenia (ANC < 0.5 x 109/l), 12% vs 5%, and thrombocytopenia (< 20 x 109/l), 9% vs 3%, in women vs men in the first cycle of therapy. In a 400 subject recurrent glioma data set, Grade 4 neutropenia occurred in 8% of female vs 4% of male subjects and Grade 4 thrombocytopenia in 8% of female vs 3% of male subjects in the first cycle of therapy. In a study of 288 subjects with newly-diagnosed glioblastoma multiforme, Grade 4 neutropenia occurred in 3% of female vs 0% of male subjects and Grade 4 thrombocytopenia in 1% of female vs 0% of male subjects in the first cycle of therapy.

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