Pegcetacoplan: Dosing Protocols
Dosing guidelines, reconstitution, and administration information
๐TL;DR
- โข2 dosing protocols documented
- โขReconstitution instructions included
- โขStorage: Empaveli: Store refrigerated at 2-8 degrees C. May be stored at room temperature up to 25 degrees C for up to 14 days. Syfovre: Store refrigerated at 2-8 degrees C. Keep in original carton to protect from light. Do not freeze either formulation.
Protocol Quick-Reference
Paroxysmal nocturnal hemoglobinuria and geographic atrophy
Dosing
Amount
1,080 mg SC (PNH) or 15 mg IVT (GA)
Frequency
Twice weekly (PNH) or monthly/EOM (GA)
Duration
Ongoing
Step-wise Titration
Administration
Route
subcutaneous (PNH) or intravitreal (GA)Schedule
Twice weekly (PNH) or monthly/EOM (GA)
Timing
PNH: Self-administered via infusion pump over 20-30 minutes. GA: Administered by retinal specialist in clinic.
โ Rotate injection sites
Cycle
Duration
Ongoing
Repeatable
Yes
Preparation & Storage
โ Ready-to-use โ no reconstitution required
Storage: Refrigerate at 2-8 degrees C. Protect from light. Do not freeze.
โ๏ธ Suggested Bloodwork (4 tests)
When:
Why:
When:
Why:
When:
Why:
When:
Why:
๐ก Key Considerations
- โFDA-approved prescription medication
- โVaccination against encapsulated bacteria required before treatment (PNH)
- โSC formulation self-administered via infusion pump; IVT by specialist
- โTransition from eculizumab requires 4-week overlap period (PNH)
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| Purpose | Dose | Frequency | Duration | Notes |
|---|---|---|---|---|
| Paroxysmal Nocturnal Hemoglobinuria (Empaveli) | 1,080 mg subcutaneously twice weekly. Self-administered via infusion pump over approximately 20-30 minutes per infusion. | Twice weekly (every 3-4 days) subcutaneous infusion | Ongoing (chronic treatment for PNH management) | FDA-approved dose. When transitioning from eculizumab, administer pegcetacoplan concomitantly with eculizumab for the first 4 weeks. Vaccination against encapsulated bacteria required before treatment. |
| Geographic Atrophy Secondary to AMD (Syfovre) | 15 mg (0.1 mL of 150 mg/mL solution) by intravitreal injection. Monthly or every other month dosing schedules approved. | Monthly or every other month intravitreal injection | Ongoing (chronic treatment for GA progression) | FDA-approved dose. Administered by an ophthalmologist or retinal specialist in a clinical setting. Monthly dosing showed numerically greater effect size than every-other-month dosing in trials. |
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๐Reconstitution Instructions
Empaveli (SC): Supplied as a 1,080 mg/20 mL (54 mg/mL) ready-to-use solution in a single-dose vial. No reconstitution required. Administered via infusion pump. Syfovre (intravitreal): Supplied as 15 mg/0.1 mL (150 mg/mL) ready-to-use solution in a single-dose vial.
Recommended Injection Sites
- โAbdomen
- โThigh
- โUpper arm (outer area)
- โIntravitreal (Syfovre only, by specialist)
๐งStorage Requirements
Empaveli: Store refrigerated at 2-8 degrees C. May be stored at room temperature up to 25 degrees C for up to 14 days. Syfovre: Store refrigerated at 2-8 degrees C. Keep in original carton to protect from light. Do not freeze either formulation.
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Before You Begin
Review safety warnings and contraindications before starting any protocol.
Approved Dosing Information#
Pegcetacoplan is FDA-approved for two indications with different formulations, routes, and dosing schedules. All dosing information reflects the approved prescribing information for Empaveli (PNH) and Syfovre (GA).
Empaveli Dosing (PNH)#
Standard Dose#
The approved dose is 1,080 mg subcutaneously twice weekly (every 3-4 days), self-administered via an infusion pump.
Administration Details:
- Supplied as a 1,080 mg/20 mL (54 mg/mL) ready-to-use solution
- Self-administered via subcutaneous infusion pump over approximately 20-30 minutes
- Injection sites: abdomen, thigh, or outer upper arm; rotate sites between infusions
- No dose adjustment for body weight
Transition from Eculizumab#
For patients switching from eculizumab to pegcetacoplan:
- Continue eculizumab at the current dose and schedule
- Add pegcetacoplan 1,080 mg SC twice weekly
- Maintain overlap for 4 weeks
- After 4 weeks, discontinue eculizumab
- Continue pegcetacoplan monotherapy
This overlap period prevents breakthrough hemolysis during the transition from C5 to C3 inhibition.
Pre-Treatment Requirements (PNH)#
- Vaccinate against Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae type B at least 2 weeks before the first dose
- Ensure adequate training on infusion pump use and self-injection technique
Syfovre Dosing (Geographic Atrophy)#
Standard Dose#
The approved dose is 15 mg (0.1 mL of 150 mg/mL solution) administered as an intravitreal injection monthly or every other month.
Administration Details:
- Administered by a retinal specialist in a clinical setting under sterile conditions
- Standard intravitreal injection technique
- Monthly dosing showed numerically greater effect sizes in OAKS and DERBY trials
- No reconstitution required
Dosing Schedule Selection#
| Schedule | Efficacy (24-month GA growth reduction) | Convenience |
|---|---|---|
| Monthly | 19-22% vs sham | 12 injections/year |
| Every other month | 16-18% vs sham | 6 injections/year |
The choice between monthly and every-other-month dosing involves a trade-off between potential efficacy and treatment burden.
Monitoring Requirements#
PNH (Empaveli)#
| Parameter | Timing | Purpose |
|---|---|---|
| Vaccination status | Before treatment | Infection risk mitigation |
| CBC with reticulocytes | Regular monitoring | Hemolysis assessment |
| LDH, bilirubin, haptoglobin | Regular monitoring | Hemolysis markers |
| Signs of infection | Ongoing | Early detection of encapsulated bacterial infection |
Geographic Atrophy (Syfovre)#
| Parameter | Timing | Purpose |
|---|---|---|
| Fundus examination | Before each injection | Assess for endophthalmitis, nAMD conversion |
| OCT imaging | Regular monitoring | GA lesion area measurement |
| IOP measurement | Before/after injection | Transient IOP elevation |
| Visual acuity | Regular monitoring | Functional outcome tracking |
Treatment Interruption#
PNH#
Interrupting pegcetacoplan in PNH may lead to breakthrough hemolysis. If treatment is discontinued, patients should be monitored for at least 8 weeks for signs of hemolysis (elevated LDH, reticulocytosis, decreased hemoglobin, hemoglobinuria).
Geographic Atrophy#
Treatment interruption in GA does not carry acute safety risks but may result in resumption of complement-mediated lesion progression.
Related Reading#
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Medical Disclaimer
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.