Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Entyvio

Entyvio 300 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 9

HOS-129652 · Präparat HOS-096773

In GEMINI 1 and 2 controlled studies (ulcerative colitis and Crohn’s disease), 4% of intravenous vedolizumab-treated patients and 3% of placebo-treated patients experienced an adverse reaction defined by the investigator as infusion-related reaction (IRR) (see section 4.4). No individual Preferred Term reported as an IRR occurred at a rate above 1%. The majority of IRRs were mild or moderate in intensity and < 1% resulted in discontinuation of study treatment. Observed IRRs generally resolved with no or minimal intervention following the infusion. Most infusion related reactions occurred within the first 2 hours. Of those patients who had infusion related reactions, those dosed with intravenous vedolizumab had more infusion related reactions with in the first 2 hours as compared to placebo patients with infusion related reactions. Most infusion related reactions were not serious and occurred during the infusion or within the first hour after infusion is completed.

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