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Pegcetacoplan Reference
Educational, not medical advice reference for Pegcetacoplan: Immune; regulatory status, evidence posture, source review, and schedule notes. Also known as Em…
Reference summary
Pegcetacoplan is a label-verified complement C3 inhibitor with FDA Phase 3 evidence in PNH (Empaveli) and GA (Syfovre). pepSmart surfaces label-reference content only.
- Categories
- Immune
- Aliases
- Empaveli, Syfovre, APL-2, Pegylated cyclic peptide complement C3 inhibitor
- Evidence posture
- human - Empaveli carries label warnings for serious infections caused by encapsulated bacteria (Streptococcus pneumoniae, Neisseria meningitidis, Haemophilus influenzae) and requires meningococcal, pneumococcal, and Hib vaccination per label before initiation. Syfovre labeling notes intraocular inflammation (including retinal vasculitis) and increased risk of neovascular age-related macular degeneration.
- Regulatory status
- FDA-approved prescription medication shipping as two distinct branded products. Empaveli (initial US approval 2021) is indicated for adults with paroxysmal nocturnal hemoglobinuria (PNH); subcutaneous infusion via on-body infusor. Syfovre (initial US approval 2023) is indicated for geographic atrophy (GA) secondary to age-related macular degeneration; intravitreal injection administered by an ophthalmologist. Pegylated cyclic peptide that binds complement C3. The two products are not interchangeable and must be used per their respective labels.
- Content review status
- label verified