Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Vabysmo

Vabysmo 120 mg/mL solution for injection Vabysmo 120 mg/mL solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 10

HOS-148374 · Präparat HOS-099888

There is a potential for an immune response in patients treated with faricimab (see section 4.4). After dosing with faricimab for up to 112 (nAMD), 100 (DME), and 72 (RVO) weeks, treatment-emergent anti-faricimab antibodies were detected in approximately 13.8%, 9.6%, and 14.4% of patients with nAMD, DME, and RVO randomised to faricimab, respectively. The clinical significance of anti- faricimab antibodies on safety is unclear at this time. The incidence of intraocular inflammation in anti-faricimab antibody positive patients was 12/98 (12.2%; nAMD), 15/128 (11.7%; DME), and 9/95 (9.5%; RVO), and in anti-faricimab antibody negative patients was 8/562 (1.4%; nAMD), 5/1124 (0.4%; DME), and 10/543 (1.8%; RVO). The incidence of serious ocular adverse reactions in anti- faricimab antibody positive patients was 6/98 (6.1%; nAMD), 14/128 (10.9%; DME), and 7/95 (7.4%; RVO), and in anti-faricimab antibody negative patients was 23/562 (4.1%; nAMD), 45/1124 (4.0%; DME), and 34/543 (6.3%; RVO). Anti-faricimab antibodies were not associated with an impact on clinical efficacy or systemic pharmacokinetics.

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