Empaveli Side Effects

Generic name: pegcetacoplan

Medically reviewed by Philip Thornton, DipPharm. Last updated on May 1, 2025.

Note: This document provides detailed information about Empaveli Side Effects associated with pegcetacoplan. Some dosage forms listed on this page may not apply specifically to the brand name Empaveli.

Applies to pegcetacoplan: subcutaneous solution.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine could harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this treatment. Use an effective form of birth control during treatment with this medicine and for 40 days after the last dose to keep from getting pregnant. Tell your doctor right away if you think you have become pregnant.

Pegcetacoplan may increase your chance of having serious infections, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae. Avoid people who are sick or have infections. Tell your doctor right away if you develop headaches, nausea, vomiting, fever, a stiff neck or back, a rash, confusion, muscle aches, or if your eyes have become sensitive to light. Make sure you have received a vaccine to prevent encapsulated bacterial infections at least 2 weeks before you receive this medicine. You may also be given antibiotic medicines for 2 weeks to prevent infections if you are to use this medicine right away. If you have already received the vaccine in the past, your doctor will decide if you need another dose.

Ask your doctor for a patient safety card. This card will list the symptoms of encapsulated bacterial infections and what to do if you have them. Carry the card with you at all times during treatment and for 2 months after your last dose. You will need to show the card to any doctor who treats you.

This medicine may cause infusion-related reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, chest pain, trouble breathing, itching or rash, lightheadedness, fainting, or swelling of the face, tongue, or throat after receiving this medicine.

When this medicine is stopped you could have red blood cell destruction or breakdown (hemolysis). Your doctor will need to monitor you closely for at least 8 weeks after you stop using this medicine. Be sure to keep all appointments.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Serious side effects of Empaveli

Along with its needed effects, pegcetacoplan (the active ingredient contained in Empaveli) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking pegcetacoplan:

Other side effects of Empaveli

Some side effects of pegcetacoplan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to pegcetacoplan: subcutaneous solution.

General adverse events

The most common adverse reactions with a frequency of 10% and greater were injection-site reactions, infections, diarrhea, abdominal pain, respiratory tract infection, viral infection, pain in extremity, hypokalemia, arthralgia, dizziness, rash, headache, hemolysis, pyrexia, cough, urinary tract infection, vaccination complication, back pain, nausea, and fatigue. The most common serious adverse reactions were hemolysis, sepsis, and infections.^[Ref]

Cardiovascular

• Common (1% to 10%): Systemic hypertension, septic shock
• Common (1% to 10%): Hypertension^[Ref]

Dermatologic

• Very common (10% or more): Rash (11%)
• Common (1% to 10%): Ecchymosis, erythema, skin infection^[Ref]

Rash includes maculo-papular rash and dermatitis.^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (22%), abdominal pain (up to 20%)
• Common (1% to 10%): Abdominal distension, gastrointestinal infection, oral infection
• Frequency not reported: Intestinal ischemia^[Ref]

Abdominal pain includes abdominal pain upper, abdominal discomfort, abdominal pain, abdominal pain lower, abdominal tenderness, and epigastric discomfort.^[Ref]

Genitourinary

• Uncommon (0.1% to 1%): Vulvovaginal mycotic infection^[Ref]

Hematologic

• Common (1% to 10%): Thrombocytopenia, hemolysis, neutropenia^[Ref]

Hepatic

• Frequency not reported: Biliary sepsis^[Ref]

Local

• Very common (10% or more): Injection site reaction (39%)^[Ref]

Injection-site reaction includes injection-site erythema, injection-site reaction, injection-site swelling, injection-site induration, injection-site bruising, injection-site pain, injection-site pruritus, vaccination-site reaction, administration-site swelling, injection-site hemorrhage, injection-site edema, injection-site warmth, administration-site pain, application-site pain, injection-site mass, injection-site rash, vaccination-site pain, application site reaction, and puncture site reaction.^[Ref]

Metabolic

• Common (1% to 10%): Hypokalemia (13%)^[Ref]

Musculoskeletal

• Very common (10% or more): Pain in extremity (up to 13%), arthralgia (up to 11%)
• Common (1% to 10%): Back pain, musculoskeletal pain, myalgia, muscle spasms
• Uncommon (0.1% to 1%): Groin infection^[Ref]

Back pain includes sciatica.^[Ref]

Nervous system

• Very common (10% or more): Dizziness (11%), headache (11%)
• Common (1% to 10%): Somnolence^[Ref]

Headache includes migraine.^[Ref]

Ocular

• Uncommon (0.1% to 1%): Ophthalmic herpes zoster^[Ref]

Other

• Very common (10% or more): Infections (up to 29%), viral infection (up to 13%), fatigue (12%)
• Common (1% to 10%): Chest pain, pyrexia, peripheral edema, increased blood creatinine, contusion, increased ALT, increased bilirubin
• Uncommon (0.1% to 1%): Cervicitis^[Ref]

Viral infection includes oral herpes, viral gastrointestinal infection, viral upper respiratory tract infection, rhinovirus infection, COVID-19, COVID-19 pneumonia, coronavirus test positive, herpes virus, and influenza.

Infections includes oral herpes, bacterial infection, fungal infection, gastrointestinal infection, viral gastrointestinal infection, influenza-like illness, nasopharyngitis, pulpitis dental, rhinitis, tonsillitis, bacterial tonsillitis, vulvovaginal mycotic infection, hordeolum, sepsis, furuncle, otitis externa, viral respiratory tract infection, gastroenteritis, upper respiratory tract infection, bronchitis, ear infection, respiratory tract infection, rhinovirus infection, sinusitis, urinary tract infection, acne pustular, anal abscess, cellulitis, helicobacter gastritis, esophageal candidiasis, pharyngitis, septic shock, tuberculosis, vaginal infection, pneumocystitis Jirovecii pneumonia, and pulmonary tuberculosis.

Peripheral edema includes peripheral swelling.

Fatigue includes asthenia and lethargy.

Chest pain includes chest discomfort, non-cardiac chest pain, and musculoskeletal chest pain.^[Ref]

Psychiatric

• Common (1% to 10%): Anxiety^[Ref]

Respiratory

• Very common (10% or more): Respiratory tract infection (15%), cough (12%)
• Common (1% to 10%): Oropharyngeal pain, COVID-19 infection, epistaxis
• Frequency not reported: Hypersensitivity pneumonitis
• Uncommon (0.1% to 1%): Pneumonia, nasal abscess^[Ref]

Respiratory tract infection includes influenza-like illness, nasopharyngitis, rhinitis, tonsillitis, viral upper respiratory tract infection, upper respiratory tract infection, respiratory tract infection, and sinusitis.

Cough includes allergic cough.

One patient died due to the COVID-19 infection.^[Ref]

Renal

• Common (1% to 10%): Acute kidney injury, chromaturia^[Ref]

See also:

Frequently asked questions

• How does Empaveli compare to Soliris?
• How is Empaveli administered?
• How does Empaveli work?
• How do Izervay and Syfovre compare?

Further information

Empaveli side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer