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Pegcetacoplan

Subcutaneous
Intravitreal
Class
Complement inhibitors
Subclass
Complement C3 inhibitors
Substance name
Pegcetacoplan
Brand names
Empaveli®, Syfovre®
Common formulations
Solution for injection
Dosage and administration
Adults patients
Treatment of paroxysmal nocturnal hemoglobinuria
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1,080 mg SC 2× per week
Adjust the dosing regimen to 1,080 mg every 3 days if LDH levels increase > 2× the ULN. Monitor LDH twice weekly for at least 4 weeks in case of a dose increase.
Indications for use
Labeled indications
Adults
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Treatment of paroxysmal nocturnal hemoglobinuria
Safety risks
Boxed warnings
Encapsulated bacterial infections
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Maintain a high level of suspicion, as pegcetacoplan increases the risk of serious infections, especially caused by encapsulated bacteria, such as S. pneumoniae, N. meningitidis, and H. influenzae type B. Complete or update vaccination against encapsulated bacteria at least 2 weeks before the first dose. Administer antibacterial prophylaxis in patients who are not up to date with vaccines. Do not administer pegcetacoplan in patients with untreated serious infections caused by encapsulated bacteria. Closely monitor patients for early signs and symptoms of serious infection.
Contraindications
Hypersensitivity to pegcetacoplan or its components
Warnings and precautions
Hemolysis
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Maintain a high level of suspicion, as hemolysis can occur after discontinuing pegcetacoplan or switching from C5 inhibitors. Initiate pegcetacoplan while continuing eculizumab at its current dose in patients switching from eculizumab. Discontinue eculizumab after 4 weeks before continuing on monotherapy with pegcetacoplan. Initiate pegcetacoplan ≤ 4 weeks after the last dose of ravulizumab in patients switching from ravulizumab.
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Closely monitor for signs and symptoms of hemolysis for at least 8 weeks after discontinuing pegcetacoplan, including elevated LDH levels, sudden decrease in PNH clone size or hemoglobin, or reappearance of symptoms such as fatigue, hemoglobinuria, abdominal pain, dyspnea, major adverse vascular events, dysphagia, or erectile dysfunction. Consider restarting treatment if hemolysis occurs.
Infusion-related reactions
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Maintain a high level of suspicion, as pegcetacoplan has been associated with an increased risk of infusion-related reactions.
Prolonged PTT
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Maintain a high level of suspicion, as pegcetacoplan may artificially prolong aPTT by interfering with silica reagents in coagulation panels.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
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Use acceptable. No dose adjustment required.
Renal replacement therapy
Any modality
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No guidance available.
Hepatic impairment
Any severity
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Use acceptable. No dose adjustment required.
Pregnancy and breastfeeding
Pregnancy
All trimesters
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Use only if benefits outweigh potential risks. Evidence of fetal harm in animals. Verify pregnancy status in females of reproductive potential before initiating treatment. Advise using effective contraception during treatment and for 40 days after the last dose.
Breastfeeding
Halt breastfeeding temporarily.
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Advise females not to breastfeed for 40 days after the last dose.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
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↓ serum potassium, infections, abdominal pain, cough, diarrhea, fatigue, injection site reactions, limb pain, pain in extremity, skin rash, dizziness, respiratory tract infections, viral infections
Common 1-10%
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Acute kidney injury, abdominal distension, anxiety, myalgia, intestinal ischemia, biliary sepsis, hypersensitivity pneumonitis, arthralgia, chest pain, musculoskeletal pain, somnolence, ecchymosis, peripheral edema, skin erythema, ↓ platelet count, nosebleed, ↑ serum creatinine, back pain, hypertension, fever, headache, throat pain
Unknown frequency
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Anaphylaxis, urticaria, facial edema
Interactions
Drug(s)
Check Interactions
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