Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Aimovig

Aimovig 70 mg solution for injection in pre-filled syringe Aimovig 140 mg solution for injection in pre-filled syringe Aimovig 70 mg solution for injection in pre-filled pen Aimovig 140 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 6

HOS-139260 · Präparat HOS-098306

Immunogenicity During the double-blind treatment phase of the clinical studies, the incidence of anti-erenumab antibody development was 6.3% (56/884) among subjects receiving a 70 mg dose of erenumab (3 of whom had in vitro neutralising activity) and 2.6% (13/504) among subjects receiving the 140 mg dose of erenumab (none of whom had in vitro neutralising activity). In an open-label study with up to 256 weeks of treatment, the incidence of anti-erenumab antibody development was 11.0% (25/225) among patients who only received 70 mg or 140 mg of Aimovig throughout the entire study (2 of whom had in vitro neutralising activity). There was no impact of anti-erenumab antibody development on the efficacy or safety of erenumab.

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