The FDA-listed label for Empaveli (pegcetacoplan) included a boxed warning effective August 21, 2026. The warning states that Empaveli, a complement inhibitor, increases the risk of serious infections, particularly infections caused by encapsulated bacteria.
The label warning identifies this risk as a major safety issue and names encapsulated bacteria as the focus of the concern. The supplied FDA label summary specifically includes Streptococcus pneumoniae and a reference to Neisseria meningiti.
Background
Pegcetacoplan is listed under the brand names Empaveli and Syfovre in the supplied data. The Empaveli label describes the drug as a complement inhibitor. The provided record does not state an indication, dosing schedule, mechanism beyond this classification, or patient population.
Label change
The event was an FDA label revision for Empaveli. The supplied headline states that a boxed warning was present on the label, with an effective date of August 21, 2026. The warning concerns serious infections caused by encapsulated bacteria and states that Empaveli increases this risk.
What this means
For clinicians and patients reviewing the Empaveli label, the central safety message is the elevated risk of serious infection associated with the drug, especially infections involving encapsulated bacteria. The boxed-warning designation places this information prominently in the product labeling.
The supplied data do not provide infection rates, a list of required preventive measures, vaccination instructions, treatment recommendations, contraindications, or details about how the warning affects prescribing. They also do not provide a separate label change for Syfovre or describe any clinical-trial results.
Source
Source: FDA, DailyMed drug-label document for Empaveli, effective August 21, 2026. The authoritative label is available through dailymed.nlm.nih.gov at the supplied URL.