Empaveli Side Effects

Generic name: pegcetacoplan

Medically reviewed by Philip Thornton, DipPharm. Last updated on Aug 7, 2024.

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.

Important warnings This medicine can cause some serious health issues

Subcutaneous route (solution)

Warning: Serious Infections Caused by Encapsulated Bacteria. Meningococcal 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 side effects

• black, tarry stools
• 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
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the urine or stools
• 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
• decreased urine
• diarrhea
• difficulty in breathing
• dizziness
• dry mouth
• ear congestion
• fainting
• fever
• flu-like symptoms
• general feeling of discomfort or illness
• headache
• increased thirst
• irregular heartbeat
• lightheadedness
• loss of appetite
• loss of voice
• mood changes
• muscle aches, pain, or cramps
• nausea
• numbness or tingling in the hands, feet, or lips
• pinpoint red spots on the skin
• pounding in the ears
• rapid, shallow breathing
• rapid weight gain
• seizures
• slow or fast heartbeat
• sneezing
• sore throat
• severe stomach pain
• sleepiness
• stuffy or runny nose
• thickening of bronchial secretions
• tingling of the hands or feet
• trouble breathing
• tooth or gum pain
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss

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 side effects

• arm or leg pain
• bloody nose
• diarrhea
• difficulty in moving
• heartburn
• joint pain
• lack or loss of strength
• large, flat, blue or purplish patches in the skin
• 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.

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]

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