Pegcetacoplan

Is Pegcetacoplan safe?

Boxed infection warning from trials

Blocking C3 disables a major defense against encapsulated bacteria, such as meningococcus, pneumococcus and Haemophilus influenzae. Empaveli carries a boxed warning for serious infections. It is sold only through a risk-management program. Patients get vaccinated against these germs first. In PEGASUS, the common adverse events were injection-site reactions, diarrhea, headache and fatigue. A few patients in each arm had breakthrough hemolysis. ¹²

The eye form has its own risks tied to injection into the eye. The American Academy of Ophthalmology's IRIS Registry covered injections from 2016 to 2024. Endophthalmitis (infection inside the eye) within 30 days followed 6.6 per 10,000 pegcetacoplan injections. For anti-VEGF drugs the rate was 3.3 per 10,000. The gap was significant. Sixty-six reports of retinal vasculitis with pegcetacoplan reached the FDA's adverse event reporting system between 2020 and 2025. But spontaneous reports cannot establish how often it happens or what caused it. ⁴⁵

Read the full Pegcetacoplan page

Reference information only, not medical advice. Drawn from the Pegcetacoplan article, fact-checked against the cited sources. No dosing anywhere on this site.