Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Temozolomide Accord

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

HOS-212037 · Präparat HOS-154808

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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