Is Zilucoplan safe?
Boxed meningococcal warning from trials
In RAISE, the most common adverse event was bruising at the injection site. It affected 16 percent on zilucoplan versus 9 percent on placebo. Headache and diarrhea came next. Serious adverse events and serious infections were similar in the two groups. One patient died in each group (COVID-19 on zilucoplan, cerebral haemorrhage on placebo). Neither death was judged related to the drug. No meningococcal infections occurred in the trial. 1
The boxed warning reflects the mechanism. Blocking complement C5 leaves patients open to meningococcal infection. It can be life-threatening. Patients must finish or update meningococcal vaccines at least two weeks before the first dose. If not, they take antibiotics until they have. The drug is dispensed only through the Zilbrysq REMS. Pancreatitis and raised pancreatic enzymes were seen in the development program. They are listed warnings. 2
More on Zilucoplan
Citations
- Howard 2023, Lancet Neurol: Safety and efficacy of zilucoplan in generalized myasthenia gravis (RAISE), phase 3 trial doi.org
- FDA 2024: Zilbrysq (zilucoplan) prescribing information accessdata.fda.gov
- Tammam 2026, J Neuromuscul Dis: Real-world effectiveness and safety of zilucoplan in anti-AChR myasthenia gravis, French early-access cohort pubmed.ncbi.nlm.nih.gov
Reference information only, not medical advice. Drawn from the Zilucoplan article, fact-checked against the cited sources. No dosing anywhere on this site.