Prescription medicine
Pegcetacoplan Brand names: Empaveli, Syfovre
Pegcetacoplan (Syfovre) is a prescription medicine with an FDA approval on record since 2021. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the pegcetacoplan FDA label on DailyMed (effective August 21, 2026, Apellis Pharmaceuticals, Inc.); the NDA 215014 record on Drugs@FDA; every pegcetacoplan label on DailyMed.
Highlights of the record
FDA label of August 21, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 [see Warnings and Precautions (5.1) ]. Life-threatening and fatal infections with encapsulated bacteria have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early. Complete or update vaccination for encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, unless the risks of delaying therapy with EMPAVELI outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor. See Warnings and Precautions (5.1) for additional guidance on the management of the risk of serious infections caused by encapsulated bacteria. Patients receiving EMPAVELI are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected. […]
Used for
From the label: indications and usageEMPAVELI is a complement inhibitor indicated: for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
Forms and strengths
- 15 mg/.1ml
- 1080 mg/20ml
Injection (solution).
On the market
- Earliest approval on file
- May 14, 2021 Empaveli, Apellis Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 14, 2038 Syfovre injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,779 through July 30, 2026
What is pegcetacoplan used for?
From the label: indications and usageEMPAVELI 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 and the loss of kidney function. […]
FDA pharmacologic class: Complement Inhibitor.
Source: FDA drug label (Empaveli), Apellis Pharmaceuticals, Inc., effective August 21, 2026 (SPL set c23d89e9-b00b-4520-e053-2995a90a95af), via openFDA; the full label on DailyMed
What does the patient leaflet for pegcetacoplan say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about EMPAVELI?EMPAVELI is a medicine that affects your immune system. EMPAVELI may lower the ability of your immune system to fight infections. EMPAVELI increases your chance of getting serious infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. These serious infections may quickly become life-threatening or cause death if not recognized and treated early. You must complete or be up to date with the vaccines against Streptococcus pneumoniae and Neisseria meningitidis at least 2 weeks before your first dose of EMPAVELI. If you have not completed your vaccines and EMPAVELI must be started right away, you should receive the required vaccines as soon as possible. If you have not been vaccinated and EMPAVELI must be started right away, you should also receive antibiotics to take for as long as your healthcare provider tells you. If you have been vaccinated against these bacteria in the past, you might need additional vaccines before starting EMPAVELI. Your healthcare provider will decide if you need additional vaccines. Vaccines do not prevent all infections caused by encapsulated bacteria. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a serious infection: fever with or without shivers or the chills fever with chest pain and cough fever with high heart rate headache and fever confusion clammy skin fever and a rash fever with breathlessness or fast breathing headache with nausea or vomiting headache with a stiff neck or stiff back body aches with flu-like symptoms eyes sensitive to light Your healthcare provider will give you a Patient Safety Card about the risk of serious infections. […]
From the patient leaflet: How should I store EMPAVELI?Store vials of EMPAVELI in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. Do not use EMPAVELI past the expiration date stamped on the carton. Keep EMPAVELI and all medicines out of the reach of children.
Source: FDA drug label (Empaveli), Apellis Pharmaceuticals, Inc., effective August 21, 2026 (SPL set c23d89e9-b00b-4520-e053-2995a90a95af), via openFDA; the full label on DailyMed
Is there a generic for pegcetacoplan (Syfovre)?
No generic pegcetacoplan is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 13 patents for Syfovre injection: the compound patent runs to November 15, 2033, and the last listed entry to December 14, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2021 earliest approval on file
- 2038 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for pegcetacoplan?
The FDA Adverse Event Reporting System holds 1,779 reports that list pegcetacoplan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 103 are coded as a death and 324 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other complement inhibitors
- the pharmacologic class, with prices and generics
- Pegcetacoplan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other