Pegcetacoplan: Side Effects
Known side effects, contraindications, and interactions
📌TL;DR
- •4 known side effects documented
- •1 mild, 2 moderate, 1 severe
- •4 contraindications listed
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Side Effects Severity Chart
Most common adverse event for subcutaneous Empaveli, reported in approximately 39% of patients. Includes erythema, swelling, induration, pruritus, and pain at the infusion site. Generally mild to moderate.
Infections reported in clinical trials, with serious infections (primarily encapsulated bacteria) in approximately 5% of patients. Includes respiratory tract infections, urinary tract infections, and diarrhea.
Serious ocular infection risk associated with intravitreal injection. Rare but potentially vision-threatening. Standard intravitreal injection precautions are required.
A signal for increased conversion from dry to neovascular (wet) AMD was observed in OAKS and DERBY trials. Patients should be monitored for signs of nAMD and treated promptly if conversion occurs.
⛔Contraindications
- •Patients with unresolved serious infection caused by encapsulated bacteria
- •Patients not vaccinated against Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae type B (Empaveli) unless treatment urgency outweighs risk
- •Known hypersensitivity to pegcetacoplan or any excipient
- •Active ocular or periocular infection (Syfovre)
⚠️Drug Interactions
- •Empaveli: When transitioning from eculizumab, a 4-week overlap is required to prevent breakthrough hemolysis. No other significant drug interactions identified.
- •Syfovre: No systemic drug interactions expected due to local administration with minimal systemic absorption.
Community-Reported Side Effects
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Based on 75+ community reports
View community protocolsSafety Overview#
Pegcetacoplan safety profiles differ significantly between the two formulations, reflecting the distinct routes of administration and patient populations. Empaveli (SC for PNH) carries systemic complement inhibition-related risks, while Syfovre (IVT for GA) has primarily ocular safety considerations.
Empaveli (Subcutaneous, PNH) Safety#
Boxed Warning: Serious Infections#
Empaveli carries a boxed warning for serious infections caused by encapsulated bacteria:
- Organisms of concern: Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae type B
- Mechanism: C3 inhibition impairs opsonization, a key defense against encapsulated organisms
- Vaccination requirement: Patients must be vaccinated at least 2 weeks before the first dose
- Residual risk: Infections can occur in vaccinated patients
- Monitoring: Patients should be educated on infection signs and seek immediate medical care
Injection Site Reactions#
- Frequency: Approximately 39% of patients
- Manifestations: Erythema, swelling, induration, pruritus, and pain at the SC infusion site
- Severity: Generally mild to moderate
- Management: Site rotation; usually do not require treatment discontinuation
Other Common Adverse Events (Empaveli)#
| Adverse Event | Frequency | Notes |
|---|---|---|
| Injection site reactions | ~39% | Mild to moderate; site rotation helps |
| Infections | Common | Respiratory, urinary tract, viral |
| Diarrhea | Common | Usually mild and transient |
| Abdominal pain | Common | - |
| Fatigue | Common | - |
| Serious adverse events | 17% | Primarily infections (5%) |
Breakthrough Hemolysis#
When transitioning from eculizumab:
- A 4-week overlap period with both drugs is required
- Abrupt eculizumab discontinuation without adequate pegcetacoplan coverage may cause breakthrough hemolysis
- Patients should be monitored for signs of hemolysis during transition
Syfovre (Intravitreal, GA) Safety#
Ocular Adverse Events#
| Adverse Event | Notes |
|---|---|
| Endophthalmitis | Rare but serious; standard IVT precautions required |
| Retinal detachment | Rare; requires monitoring |
| nAMD conversion | Signal for increased conversion to wet AMD |
| Vitreous floaters | Common; usually transient |
| Ocular discomfort | Common post-injection |
| Subconjunctival hemorrhage | Common; related to injection procedure |
Neovascular AMD Conversion#
A notable safety signal in the OAKS and DERBY trials was an apparent increase in conversion from dry AMD to neovascular (wet) AMD in pegcetacoplan-treated eyes:
- The mechanism is not fully understood
- May be related to complement modulation affecting the balance of pro- and anti-angiogenic factors
- Patients should be monitored for signs of nAMD (fluid on OCT, new hemorrhage, vision changes)
- Prompt anti-VEGF treatment if conversion occurs
Systemic Safety (Syfovre)#
Intravitreal pegcetacoplan has minimal systemic absorption, and systemic complement inhibition-related adverse events are not expected with the ocular formulation.
Contraindications#
- Unresolved serious infection caused by encapsulated bacteria (Empaveli)
- Unvaccinated patients (Empaveli, unless urgency outweighs risk)
- Known hypersensitivity to pegcetacoplan or excipients
- Active ocular or periocular infection (Syfovre)
Drug Interactions#
- Empaveli + eculizumab: 4-week overlap required during transition to prevent breakthrough hemolysis
- No other significant drug-drug interactions identified for either formulation
- No interaction with anti-VEGF agents when used concurrently for nAMD conversion
Related Reading#
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This website is for educational and informational purposes only. The information provided is not intended to diagnose, treat, cure, or prevent any disease. Always consult with a qualified healthcare professional before using any peptide or supplement.