Pegcetacoplan: Dosing Protocols
Dosing guidelines, reconstitution, and administration information
📌TL;DR
- •2 dosing protocols documented
- •Reconstitution instructions included
- •Storage: 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.
✓ Rotate injection sites
Cycle
Duration
Ongoing
Repeatable
Yes
Preparation & Storage
✓ Ready-to-use — no reconstitution required
Storage: Refrigerate at 2-8 degrees C. Protect from light. Do not freeze.
⚗️ Suggested Bloodwork (4 tests)
When:
Why:
When:
Why:
When:
Why:
When:
Why:
💡 Key Considerations
- →FDA-approved prescription medication
- →Vaccination against encapsulated bacteria required before treatment (PNH)
- →SC formulation self-administered via infusion pump; IVT by specialist
- →Transition 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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💉Reconstitution 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
- ✓Abdomen
- ✓Thigh
- ✓Upper arm (outer area)
- ✓Intravitreal (Syfovre only, by specialist)
🧊Storage 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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Protocol updates
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Frequently Asked Questions About Pegcetacoplan
What is the recommended dose of pegcetacoplan for PNH?
The FDA-approved dose of pegcetacoplan for PNH (Empaveli) is 1,080 mg administered subcutaneously twice weekly via an infusion pump. Each infusion takes approximately 20-30 minutes. When transitioning from eculizumab, both drugs should be given concurrently for 4 weeks.
What is the recommended dose for geographic atrophy?
For geographic atrophy (Syfovre), the dose is 15 mg (0.1 mL) administered as an intravitreal injection either monthly or every other month. The injection is performed by an ophthalmologist in a clinical setting. Monthly dosing showed numerically greater lesion growth reduction in clinical trials.
How should pegcetacoplan be stored?
Both formulations should be stored refrigerated at 2-8 degrees C and protected from light. Empaveli may be stored at room temperature (up to 25 degrees C) for up to 14 days. Neither formulation should be frozen.
How is the transition from eculizumab to pegcetacoplan managed?
When switching from eculizumab to pegcetacoplan for PNH, both drugs are administered concurrently for 4 weeks to prevent breakthrough hemolysis. After 4 weeks, eculizumab is discontinued and pegcetacoplan continues as monotherapy.
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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.