Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · MabThera

MabThera 100 mg concentrate for solution for infusion MabThera 500 mg concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 23

HOS-087585 · Präparat HOS-083527

Infusion-related reactions The most frequent adverse reactions following receipt of MabThera in clinical studies were IRRs (refer to Table 4). Among the 3 189 patients treated with MabThera, 1 135 (36%) experienced at least one IRR with 733/3 189 (23%) of patients experiencing an IRR following first infusion of the first exposure to MabThera. The incidence of IRRs declined with subsequent infusions. In clinical trials fewer than 1% (17/3 189) of patients experienced a serious IRR. There were no CTC Grade 4 IRRs and no deaths due to IRRs in the clinical trials. The proportion of CTC Grade 3 events and of IRRs leading to withdrawaldecreased by course and were rare from course 3 onwards. Premedication with intravenous glucocorticoid significantly reduced the incidence and severity of IRRs (see sections 4.2 and 4.4). Severe IRRs with fatal outcome have been reported in the post-marketing setting.

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