Molecule
Pegcetacoplan is a complement inhibitor indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), among other approved uses. It is available as injection for intravitreal and subcutaneous use. MedsAcross supplies Pegcetacoplan for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
EMPAVELI is a complement inhibitor indicated: for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). 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 and the loss of kidney function.
Source: US FDA prescribing information
Pegcetacoplan binds to complement protein C3 and its activation fragment C3b, thereby regulating the cleavage of C3 and the generation of downstream effectors of complement activation. In PNH, extravascular hemolysis (EVH) is facilitated by C3b opsonization while intravascular hemolysis (IVH) is mediated by the downstream membrane attack complex (MAC). Pegcetacoplan acts proximally in the complement cascade controlling both C3b-mediated EVH and terminal complement-mediated IVH. In C3G and primary IC-MPGN, complement dysregulation and overactivation causes deposition of C3 fragments in glomeruli, which contributes to the pathogenesis of C3G and is thought to contribute to the pathogenesis of primary IC-MPGN.
Source: US FDA prescribing information
PNH. Recommended dosage is 1,080 mg administered subcutaneously twice weekly. C3G or Primary IC-MPGN. Recommended dosage for adults is 1,080 mg administered subcutaneously twice weekly. Recommended dosage for pediatric patients is dependent upon patient weight. See full prescribing information for the recommended dosage in patients with C3G or primary IC-MPGN. EMPAVELI can be administered via a commercially available pump or with EMPAVELI Injector. See Full Prescribing Information for instructions on preparation and administration.
Source: US FDA prescribing information
EMPAVELI is contraindicated: in patients with hypersensitivity to pegcetacoplan or to any of the excipients. for initiation in patients with unresolved serious infection caused by encapsulated bacteria including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. EMPAVELI is contraindicated: in patients with hypersensitivity to pegcetacoplan or any of the excipients. for initiation in patients with unresolved serious infection caused by encapsulated bacteria.
Source: US FDA prescribing information
Boxed warning (serious infections caused by encapsulated bacteria empaveli): a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in patients treated with complement inhibitors. Serious infections caused by encapsulated bacteria. Infusion-Related Reactions: Monitor patients for infusion-related reactions and institute appropriate medical management as needed. Interference with Laboratory Tests: Use of silica reagents in coagulation panels may result in artificially prolonged activated partial thromboplastin time (aPTT).
Source: US FDA prescribing information
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Serious Infections Caused by Encapsulated Bacteria Infusion-Related Reactions The most common adverse reactions in patients with PNH (incidence ≥10%) were injection site reactions, infections, diarrhea, abdominal pain, respiratory tract infection, pain in extremity, hypokalemia, fatigue, viral infection, cough, arthralgia, dizziness, headache, and rash. The most common adverse reactions in patients with C3G or primary IC-MPGN (incidence ≥10%) were infusion site reactions, pyrexia, nasopharyngitis, influenza, cough, and nausea.
Source: US FDA prescribing information
Store vials of EMPAVELI refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Pegcetacoplan, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Syfovre 450 mg/3 mL injectionIntravitreal | Apellis Pharmaceuticals | US FDA | Available on request |
| Empaveli 1080 mg/20 mL injectionSubcutaneous Cold chain | Apellis Pharmaceuticals | US FDA | Available on request |
2 brand names across 1 markets.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 2 presentations of Pegcetacoplan and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 2 brand names for Pegcetacoplan, including Empaveli, Syfovre.
Yes. The US FDA first approved Pegcetacoplan on 14 May 2021, according to Drugs@FDA.
Yes. Pegcetacoplan has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Pegcetacoplan must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Pegcetacoplan is classified under ATC code L04AJ03 (Pegcetacoplan).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.