Empaveli

Last updated on RxList: 5/20/2021
Empaveli Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Empaveli?

Empaveli (pegcetacoplan) is a complement inhibitor used to treat adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

What Are Side Effects of Empaveli?

Side effects of Empaveli include:

Dosage for Empaveli

The recommended dosage of Empaveli is 1,080 mg by subcutaneous infusion twice weekly via a commercially available pump.

Empaveli In Children

Safety and effectiveness of Empaveli in pediatric patients have not been established.

What Drugs, Substances, or Supplements Interact with Empaveli?

Empaveli may interact with other medicines.

Tell your doctor all medications and supplements you use.

Empaveli During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Empaveli; it may harm a fetus. There are risks to the mother and fetus associated with untreated PNH in pregnancy. Pregnancy testing is recommended for females of reproductive potential prior to treatment with Empaveli. Female patients of reproductive potential are advised to use effective contraception during treatment with Empaveli and for 40 days after the last dose. It is unknown if Empaveli passes into breast milk. Because of the potential for serious adverse reaction in a breastfeeding child, breastfeeding should be discontinued during treatment with Empaveli and for 40 days after the last dose.

Additional Information

Our Empaveli (pegcetacoplan) Injection, for Subcutaneous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Anemia Symptoms and Signs, Types, Treatment and Causes See Slideshow
Empaveli Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:

  • Serious Infections Caused by Encapsulated Bacteria [see WARNINGS AND PRECAUTIONS]
  • Infusion-Related Reactions [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Paroxysmal Nocturnal Hemoglobinuria

The data described below reflect the exposure of EMPAVELI in 80 adult patients with PNH who received EMPAVELI (n=41) or eculizumab (n=39) at the recommended dosing regimens for 16 weeks. Serious adverse events were reported in 7 (17%) patients with PNH receiving EMPAVELI. The most common serious adverse reaction in patients treated with EMPAVELI was infections (5%). The most common adverse reactions (≥10%) with EMPAVELI were injection-site reactions, infections, diarrhea, abdominal pain, respiratory tract infection, viral infection, and fatigue.

Table 1 describes the adverse reactions that occurred in ≥5% of patients treated with EMPAVELI in Study APL2-302.

Table 1: Adverse Reactions Reported in ≥5% of Patients Treated with EMPAVELI

Adverse Reaction EMPAVELI
(N=41) n (%)
Eculizumab
(N=39) n (%)
General disorders and administration site conditions
Injection-site reaction* 16 (39) 2 (5)
Fatigue* 5 (12) 9 (23)
Chest pain* 3 (7) 1 (3)
Infections and infestations
Infections* 12 (29) 10 (26)
Respiratory tract infection* 6 (15) 5 (13)
Viral Infection* 5 (12) 3 (8)
Gastrointestinal disorders
Diarrhea 9 (22) 1 (3)
Abdominal pain* 8 (20) 4 (10)
Musculoskeletal disorders
Back pain* 3 (7) 4 (10)
Nervous system disorders
Headache 3 (7) 9 (23)
Vascular disorders
Systemic hypertension* 3 (7) 1 (3)
*The following terms were combined:
Abdominal pain includes: abdominal pain upper, abdominal discomfort, abdominal pain, abdominal pain lower, abdominal tenderness, epigastric discomfort
Back pain includes: back pain, sciatica
Chest pain includes: chest discomfort, non-cardiac chest pain, musculoskeletal chest pain, chest pain
Fatigue includes: asthenia, lethargy, fatigue
Infections include: oral herpes, bacterial infection, fungal infection, gastrointestinal infection, gastrointestinal viral infection, influenza-like illness, nasopharyngitis, pulpitis dental, rhinitis, tonsillitis, tonsillitis bacterial, 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
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
Respiratory tract infection includes: influenza-like illness, nasopharyngitis, rhinitis, tonsillitis, viral upper respiratory tract infection, upper respiratory tract infection, respiratory tract infection, sinusitis
Systemic hypertension includes: hypertension
Viral infection includes: oral herpes, gastrointestinal viral infection, viral upper respiratory tract infection, rhinovirus infection

Clinically relevant adverse reactions in less than 5% of patients include:
  • Intestinal ischemia
  • Biliary sepsis
  • Hypersensitivity pneumonitis

Description Of Select Adverse Reactions

Injection-Site Reactions

Injection/infusion-site reactions (e.g., erythema, swelling, induration, pruritis, and pain) have been reported during Study APL2-302. These reactions were mild or moderate in severity.

Diarrhea

Nine cases of diarrhea have been reported during Study APL2-302. All cases were mild.

Immunogenicity

As with all therapeutic peptides, there is a potential for immunogenicity. Immunogenicity data are highly dependent on the sensitivity and specificity of the assay. The available methodology and data on anti-pegcetacoplan antibody formation were not adequate to fully assess the incidence of anti-drug antibodies or their effect on pharmacokinetics, pharmacodynamics, safety, or effectiveness of pegcetacoplan.

DRUG INTERACTIONS

No Information provided

Read the entire FDA prescribing information for Empaveli (Pegcetacoplan Injection, for Subcutaneous Use )

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© Empaveli Patient Information is supplied by Cerner Multum, Inc. and Empaveli Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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