Nebenwirkungen · Elfabrio
Elfabrio 2 mg/mL concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 8–9
HOS-148151 · Präparat HOS-099842
8 serious. Four of these events were confirmed type I hypersensitivity reactions and 3 led to the discontinuation from the study. Another patient was later withdrawn from the study, after the occurrence of another moderate IRR. All 5 patients however recovered within the day after of occurrence with appropriate treatment. IRRs predominantly occurred within the first year of treatment with pegunigalsidase alfa and no serious IRR was observed during the second year and beyond.
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Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-03-17T10:45:43Z · SHA-256 f8d185f0fac5af8f43cde534b380457316d3428beb7acd8edb36cc2adde1ddb6 · Passage e41ef1b081d7ec33fb365fcf709d9d9e4b06bda198017d91dd792d791cf4bc25 · Zeichen 6582–7062 im Abschnitt