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Pegcetacoplan Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 14, 2023.

Applies to pegcetacoplan: subcutaneous solution.

Warning

Subcutaneous route (Solution)

Warning: Serious Infections Caused by Encapsulated BacteriaMeningococcal infections may occur in patients treated with pegcetacoplan and may become rapidly life-threatening or fatal if not recognized and treated early. Use of pegcetacoplan may predispose individuals to serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis types A, C, W, Y, and B and Haemophilus influenzae type B.Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients with altered immunocompetence associated with complement deficiencies.Vaccinate patients against encapsulated bacteria as recommended at least 2 weeks prior to administering the first dose of pegcetacoplan unless the risks of delaying therapy with pegcetacoplan outweigh the risk of developing a serious infection.Vaccination reduces, but does not eliminate, the risk of serious infections. Monitor patients for early signs of infections and evaluate immediately if infection is suspected.Pegcetacoplan is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the EMPAVELI REMS, prescribers must enroll in the program. Enrollment in the EMPAVELI REMS program and additional information are available by telephone: 1-888-343-7073 or at www.empavelirems.com.

Serious side effects of Pegcetacoplan

Along with its needed effects, pegcetacoplan 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:

More common

Other side effects of Pegcetacoplan

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:

More common

For Healthcare Professionals

Applies to pegcetacoplan: subcutaneous solution.

General

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

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

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]

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

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]

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

Frequently asked questions

References

1. Cerner Multum, Inc. Australian Product Information.

2. Product Information. Aspaveli (pegcetacoplan). Swedish Orphan Biovitrum Ltd. 2022.

3. Product Information. Empaveli (pegcetacoplan). Apellis Pharmaceuticals, Inc. 2021.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.