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Empaveli Side Effects

Generic name: pegcetacoplan

Medically reviewed by Philip Thornton, DipPharm. Last updated on Sep 13, 2022.

Note: This document contains side effect information about pegcetacoplan. Some dosage forms listed on this page may not apply to the brand name Empaveli.

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 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:

More common

  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • bloody vomit
  • blurred vision
  • body aches or pain
  • change in the color, amount, or odor of the vaginal discharge
  • chest pain, discomfort, or tightness
  • chills
  • confusion
  • cough or hoarseness
  • cough producing mucus
  • diarrhea
  • difficulty in breathing
  • dizziness
  • ear congestion
  • fainting
  • fever
  • flu-like symptoms
  • general feeling of discomfort or illness
  • headache
  • lightheadedness
  • loss of appetite
  • loss of voice
  • muscle aches
  • nausea
  • pounding in the ears
  • rapid, shallow breathing
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • severe stomach pain
  • stuffy or runny nose
  • thickening of bronchial secretions
  • tooth or gum pain
  • unusual tiredness or weakness

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:

More common

  • Diarrhea
  • heartburn
  • lack or loss of strength
  • pain in the lower back, bottom, hips, or upper legs
  • unusual drowsiness, dullness, or feeling of sluggishness

For Healthcare Professionals

Applies to pegcetacoplan: subcutaneous solution.

Hypersensitivity

Common (1% to 10%): Chest pain,[Ref]

Musculoskeletal

Common (1% to 10%): Back pain[Ref]

Respiratory

Very common (10% or more): Respiratory tract infection (15%)

Frequency not reported: Hypersensitivity pneumonitis[Ref]

Other

Very common (10% or more): Viral Infection (12%), infections (29%)

Nervous system

Very common (10% or more): Fatigue (12%)

Common (1% to 10%): Headache[Ref]

Cardiovascular

Common (1% to 10%): Systemic hypertension, chest pain[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (22%), abdominal pain (20%)[Ref]

Local

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

Hepatic

Frequency not reported: Biliary sepsis[Ref]

Frequently asked questions

References

1. "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.