Nebenwirkungen · Ituxredi
Ituxredi 100 mg concentrate for solution for infusion Ituxredi 500 mg concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 21–22
HOS-152151 · Präparat HOS-100701
The adverse reactions identified only during post marketing surveillance, and for which a frequency could not be estimated, are listed under “not known”, see footnotes. The most frequent adverse reactions considered due to receipt of rituximab were IRRs. The overall incidence of IRRs in clinical trials was 23% with the first infusion and decreased with subsequent infusions. Serious IRRs were uncommon (0.5% of patients) and were predominantly seen during the initial course. In addition to adverse reactions seen in RA clinical trials for rituximab, progressive multifocal leukoencephalopathy (PML) (see section 4.4) and serum sickness-like reaction have been reported during post marketing experience.
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