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Empaveli Dosage

Generic name: Pegcetacoplan 1080mg in 20mL
Dosage form: injection, solution
Drug class: Selective immunosuppressants

Medically reviewed by Drugs.com. Last updated on Jul 30, 2025.

Recommended Vaccination and Prophylaxis

Vaccinate patients against encapsulated bacteria, including Streptococcus pneumoniae and Neisseria meningitidis (serogroups A, C, W, Y and B), according to current ACIP recommendations at least 2 weeks prior to initiation of EMPAVELI therapy.

If urgent EMPAVELI therapy is indicated in a patient who is not up to date with vaccines for Streptococcus pneumoniae and Neisseria meningitidis, according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible.

Healthcare professionals who prescribe EMPAVELI must enroll in the REMS for EMPAVELI.

Recommended Dosage - PNH

The recommended dose of EMPAVELI is 1,080 mg administered subcutaneously twice weekly.

Dosage for patients switching to EMPAVELI from C5 inhibitors

To reduce the risk of hemolysis with abrupt treatment discontinuation:

  • For patients switching from eculizumab, initiate EMPAVELI while continuing eculizumab at its current dose. After 4 weeks, discontinue eculizumab before continuing on monotherapy with EMPAVELI.
  • For patients switching from ravulizumab, initiate EMPAVELI no more than 4 weeks after the last dose of ravulizumab.

Dose Adjustment

  • For lactate dehydrogenase (LDH) levels greater than 2 × the upper limit of normal (ULN), adjust the dosing regimen to 1,080 mg every three days.
  • In the event of a dose increase, monitor LDH twice weekly for at least 4 weeks.

Missed Dose

  • Administer EMPAVELI as soon as possible after a missed dose. Resume the regular dosing schedule following administration of the missed dose.

Recommended Dosage - C3G or Primary IC-MPGN

For adults (18 years and older)

The recommended dose of EMPAVELI is 1,080 mg (20 mL) administered subcutaneously twice weekly.

For pediatric patients (12 years to less than 18 years of age)

For pediatric patients 12 years of age and older, administer EMPAVELI dose and volume based upon body weight, according to the schedule in Table 1. Administer the recommended dose of EMPAVELI subcutaneously twice weekly .

Table 1: Dosing recommendation in C3G or primary IC-MPGN
Patient Body Weight First dose
(infusion volume)
Second dose
(infusion volume)
Maintenance dose
(infusion volume)
50 kg or higher 1,080 mg (20 mL) 1,080 mg (20 mL) 1,080 mg twice weekly (20 mL)
35 kg to less than 50 kg 648 mg (12 mL) 810 mg (15 mL) 810 mg twice weekly (15 mL)
Less than 35 kg 540 mg (10 mL) 540 mg (10 mL) 648 mg twice weekly (12 mL)

Missed Dose

Administer EMPAVELI as soon as possible after a missed dose. Resume the regular dosing schedule following administration of the missed dose.

Administration

EMPAVELI is for subcutaneous administration using:

  • A commercially available infusion pump with a reservoir of at least 20 mL OR
  • EMPAVELI Injector, a single-use, disposable on body injector

EMPAVELI is intended for use under the guidance of a healthcare professional. Patients may self-administer or caregivers may administer EMPAVELI after proper training by a healthcare professional on how to prepare and administer EMPAVELI.

Follow the steps below and use aseptic technique to prepare and administer EMPAVELI, either by an infusion pump or EMPAVELI Injector:

  • Prior to use‚ allow EMPAVELI to reach room temperature 20°C to 25°C (68°F to 77°F) for approximately 30 minutes. Keep the vial in the carton until ready for use to protect from light.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. EMPAVELI is a clear, colorless to slightly yellowish solution. Do not use if the liquid looks cloudy, contains particles, or is dark yellow.
  • Discard any unused portion of EMPAVELI.

Preparation with Infusion Pump

  • Refer to the EMPAVELI Instructions for Use and the infusion pump manufacturer's instructions for full preparation and administration information.
  • Use a needleless transfer device (such as a vial adapter) or a transfer needle to fill the syringe.
  • Rotate infusion sites (i.e., abdomen, thighs, hips, upper arms) from one infusion to the next. Do not infuse where the skin is tender, bruised, red, or hard. Avoid infusing into tattoos, scars, or stretch marks.
  • If multi-infusion sets are needed, ensure the infusion sites are at least 3 inches apart.
  • The typical infusion time is approximately 30 minutes (if using two infusion sites) or approximately 60 minutes (if using one infusion site).

Preparation with EMPAVELI Injector

  • Refer to the EMPAVELI Injector Instructions for Use, which comes with the device.
  • Use a needleless transfer device (such as a vial adapter).
  • EMPAVELI Injector is for abdominal subcutaneous use only. Rotate the site of each subcutaneous administration. Do not inject where the skin is tender, bruised, red, or hard. Avoid injecting into tattoos, scars, or stretch marks.
  • Injection time is approximately 30 to 60 minutes.

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Frequently asked questions

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.