Pegcetacoplan
Pegcetacoplan is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand names including Syfovre, Empaveli. Available dosage forms: injection, solution, powder.
Drug Details
- Generic Name
- Pegcetacoplan
- Brand Names
- Syfovre, Empaveli
- Application Number
- NDA217171
- Sponsor
- Apellis Pharmaceuticals, Inc.
- NDC Codes
- 3
- Dosage Forms
- INJECTION, SOLUTION, POWDER
- Routes
- INTRAVITREAL, SUBCUTANEOUS
- Active Ingredients
- PEGCETACOPLAN
Indications and Usage
1 INDICATIONS AND USAGE EMPAVELI is a complement inhibitor indicated: for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). ( 1.1 ) for the treatment of adult and pediatric patients aged 12 years and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), to reduce proteinuria. ( 1.2 ) 1.1 Paroxysmal Nocturnal Hemoglobinuria EMPAVELI ® is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). 1.2 C3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritis EMPAVELI ® is indicated for the treatment of adult and pediatric patients aged 12 years and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), to reduce proteinuria.