Nebenwirkungen · Entyvio
Entyvio 300 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 9
HOS-129654 · Präparat HOS-096773
In EARNEST controlled study (pouchitis) with intravenous vedolizumab, hypersensitivity reactions, including IRRs, were reported in 3 out of 51 subjects (5.9%) in the vedolizumab group and 2 out of 51 subjects (3.9%) in the placebo group. The individual Preferred Terms included mouth ulceration, swelling, oedema peripheral, chest discomfort, asthenia, acute kidney injury, obstructive airway disorder and flushing. All events were reported as mild to moderate in intensity, none were considered serious and none resulted in study discontinuation.
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Version 2026-03-03T09:14:00Z · SHA-256 3d6ba3681a1d0775f0244dea2efe5bbcd88dbb2a6c736f41490947f42cd86c3e · Passage 767b8305571fb95b37be753f1533f56a7f52acae58d0031261298d749e2ec2f2 · Zeichen 6954–7501 im Abschnitt