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Empaveli is a prescription complement inhibitor containing pegcetacoplan. It treats paroxysmal nocturnal hemoglobinuria in adults and C3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritis in adults and patients age 12 and older. The kidney indications are intended to reduce proteinuria and loss of kidney function.
read more about empaveli ...Pegcetacoplan binds complement protein C3 and its activation fragment C3b. This regulates cleavage of C3 and generation of downstream complement effectors. By acting at C3, Empaveli reduces uncontrolled complement activity involved in red blood cell destruction in PNH and complement-mediated kidney injury in C3G and primary IC-MPGN.
Empaveli treats adults with paroxysmal nocturnal hemoglobinuria. Current labeling also includes adults and patients age 12 and older with C3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritis. Pediatric dosing for the kidney indications depends on body weight.
Adults with PNH receive 1080 mg subcutaneously twice weekly. Adults with C3G or primary IC-MPGN use the same 1080 mg twice-weekly dose. Patients age 12 to under 18 with these kidney diseases use weight-based twice-weekly dosing. Administration uses an infusion pump or the Empaveli Injector after appropriate training.
Empaveli carries a boxed warning for serious and life-threatening infections caused by encapsulated bacteria. Vaccination against pneumococcal and meningococcal disease is completed or updated at least two weeks before treatment when possible. Other concerns include anaphylaxis, infusion reactions, and hemolysis after stopping treatment in patients with PNH.
Empaveli treats adult PNH and C3G or primary IC-MPGN in adults and patients age 12 and older.
The recommended adult dose is 1080 mg subcutaneously twice weekly for PNH and the kidney indications.
Complement inhibition raises the risk of severe infections from encapsulated bacteria, including pneumococcal and meningococcal infections.
Yes. Hemolysis can occur after discontinuation, so current labeling calls for monitoring for at least eight weeks.
EMPAVELI (Pegcetacoplan) Prescribing Information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c23d89e9-b00b-4520-e053-2995a90a95af. Date Accessed September 29, 2026.
Empaveli (Pegcetacoplan) Orphan Drug Designation and Approval for C3 Glomerulopathy. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=633418. Date Accessed September 29, 2026.
Empaveli (Pegcetacoplan) Orphan Drug Designation and Approval for Primary Immune-Complex Membranoproliferative Glomerulonephritis. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=799620. Date Accessed September 29, 2026.
Empaveli (Pegcetacoplan) Orphan Drug Designation and Approval for Paroxysmal Nocturnal Hemoglobinuria. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=427614. Date Accessed September 29, 2026.
Pegcetacoplan Injection: MedlinePlus Drug Information. https://medlineplus.gov/druginfo/meds/a621045.html. Date Accessed September 29, 2026.