Dosage & Administration
The recommended dose of EMPAVELI is 1,080 mg administered subcutaneously twice weekly
To reduce the risk of hemolysis with abrupt treatment discontinuation:
Recommended dosage is 1,080 mg administered subcutaneously twice weekly.
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) |
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Empaveli Prescribing Information
EMPAVELI, a complement inhibitor, increases a patient's susceptibility to serious, life-threatening, or fatal infections caused by encapsulated bacteria including
Complete or update vaccination against encapsulated bacteria at least 2 weeks prior to administration of the first dose of EMPAVELI, according to the most current ACIP recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations considering the duration of therapy with EMPAVELI. Note that, ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. If urgent EMPAVELI therapy is indicated in a patient who is not up to date with vaccines against encapsulated bacteria according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible. Various durations and regimens of antibacterial drug prophylaxis have been considered, but the optimal durations and drug regimens for prophylaxis and their efficacy have not been studied in unvaccinated or vaccinated patients receiving complement inhibitors, including EMPAVELI. The benefits and risks of treatment with EMPAVELI, as well as the benefits and risks of antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by encapsulated bacteria.
Vaccination does not eliminate the risk of serious encapsulated bacterial infections, despite development of antibodies following vaccination. Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected. Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if these signs and symptoms occur. Promptly treat known infections. Serious infection may become rapidly life-threatening or fatal if not recognized and treated early. Consider interruption of EMPAVELI in patients who are undergoing treatment for serious infections.
EMPAVELI is available only through a restricted program under a REMS
- Complete or update vaccination for encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, unless the risks of delaying therapy with EMPAVELI outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor.Seefor additional guidance on the management of the risk of serious infections caused by encapsulated bacteria.
5.1 Serious Infections Caused by Encapsulated BacteriaEMPAVELI, a complement inhibitor, increases a patient's susceptibility to serious, life-threatening, or fatal infections caused by encapsulated bacteria including
Streptococcus pneumoniae,Neisseria meningitidis(caused by any serogroup, including non-groupable strains), andHaemophilus influenzaetype B. Life-threatening and fatal infections with encapsulated bacteria have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. The initation of EMPAVELI treatment is contraindicated in patients with unresolved serious infection caused by encapsulated bacteria.Complete or update vaccination against encapsulated bacteria at least 2 weeks prior to administration of the first dose of EMPAVELI, according to the most current ACIP recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations considering the duration of therapy with EMPAVELI. Note that, ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. If urgent EMPAVELI therapy is indicated in a patient who is not up to date with vaccines against encapsulated bacteria according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible. Various durations and regimens of antibacterial drug prophylaxis have been considered, but the optimal durations and drug regimens for prophylaxis and their efficacy have not been studied in unvaccinated or vaccinated patients receiving complement inhibitors, including EMPAVELI. The benefits and risks of treatment with EMPAVELI, as well as the benefits and risks of antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by encapsulated bacteria.
Vaccination does not eliminate the risk of serious encapsulated bacterial infections, despite development of antibodies following vaccination. Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected. Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if these signs and symptoms occur. Promptly treat known infections. Serious infection may become rapidly life-threatening or fatal if not recognized and treated early. Consider interruption of EMPAVELI in patients who are undergoing treatment for serious infections.
EMPAVELI is available only through a restricted program under a REMS
[see Warnings and Precautions (5.2)]. - Patients receiving EMPAVELI are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected.
EMPAVELI is available only through a restricted program under a REMS called EMPAVELI REMS, because of the risk of serious infections caused by encapsulated bacteria
Notable requirements of the EMPAVELI REMS include the following:
- Prescribers must enroll in the REMS.
- Prescribers must counsel patients about the risk of serious infections caused by encapsulated bacteria.
- Prescribers must provide the patients with the REMS educational materials.
- Prescribers must assess patient vaccination status for encapsulated bacteria and vaccinate if needed according to current ACIP recommendations two weeks prior to the first dose of EMPAVELI.
- Prescribers must provide a prescription for antibacterial drug prophylaxis if treatment must be started urgently, and the patient is not up to date with vaccinations against encapsulated bacteria according to current ACIP recommendations at least two weeks prior to the first dose of EMPAVELI.
- Pharmacies that dispense EMPAVELI must be certified in the EMPAVELI REMS and must verify prescribers are certified.
- Patients must receive counseling from the prescriber about the need to receive vaccinations against encapsulated bacteria per ACIP recommendations, the need to take antibiotics as directed by the prescriber, and the signs and symptoms of serious infections.
- Patients must be instructed to carry the Patient Safety Card with them at all times during and for 2 months following treatment discontinuation with EMPAVELI.
Further information is available at www.empavelirems.com or 1-888-343-7073
Indication (EMPAVELI®is indicated for the treatment of adult and pediatric patients aged 12 years and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), to reduce proteinuria. | 7/2025 | ||||||||||||||||
Dosage and Administration (For adults (18 years and older) The recommended dose of EMPAVELI is 1,080 mg (20 mL) administered subcutaneously twice weekly [see Dosage and Administration (2.4)] .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 [see Dosage and Administration (2.4)] .
Missed Dose Administer EMPAVELI as soon as possible after a missed dose. Resume the regular dosing schedule following administration of the missed dose. | 7/2025 | ||||||||||||||||
Warnings and Precautions (Systemic hypersensitivity reactions (e.g., facial swelling, rash, urticaria, pyrexia) have occurred in patients treated with EMPAVELI, which may resolve after treatment with antihistamines. Cases of anaphylaxis leading to treatment discontinuation have been reported. If a severe hypersensitivity reaction (including anaphylaxis) occurs, discontinue EMPAVELI infusion immediately, institute appropriate treatment, per standard of care, and monitor until signs and symptoms are resolved. | 7/2025 |
EMPAVELI is a complement inhibitor indicated:
- for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). ()
1.1 Paroxysmal Nocturnal HemoglobinuriaEMPAVELI®is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
- for the treatment of adult and pediatric patients aged 12 years and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), to reduce proteinuria. ()
1.2 C3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritisEMPAVELI®is indicated for the treatment of adult and pediatric patients aged 12 years and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), to reduce proteinuria.
The recommended dose of EMPAVELI is 1,080 mg administered subcutaneously twice weekly
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.
- 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.
- Administer EMPAVELI as soon as possible after a missed dose. Resume the regular dosing schedule following administration of the missed dose.
Recommended dosage is 1,080 mg administered subcutaneously twice weekly.
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) |
- Recommended dosage for adults is 1,080 mg administered subcutaneously twice weekly.
- Recommended dosage for pediatric patients is dependent upon patient weight. See full prescribing information for the recommended dosage in patients with C3G or IC-MPGN. ()
2.2 Recommended Dosage - PNHThe recommended dose of EMPAVELI is 1,080 mg administered subcutaneously twice weekly
[see Dosage and Administration (2.4)].Dosage for patients switching to EMPAVELI from C5 inhibitorsTo 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.
- EMPAVELI can be administered via a commercially available pump or with EMPAVELI Injector. ()
2.4 AdministrationEMPAVELI 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.
- See Full Prescribing Information for instructions on preparation and administration. (,
2.2 Recommended Dosage - PNHThe recommended dose of EMPAVELI is 1,080 mg administered subcutaneously twice weekly
[see Dosage and Administration (2.4)].Dosage for patients switching to EMPAVELI from C5 inhibitorsTo 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.
,2.3 Recommended Dosage - C3G or Primary IC-MPGNFor adults (18 years and older)The recommended dose of EMPAVELI is 1,080 mg (20 mL) administered subcutaneously twice weekly[see Dosage and Administration (2.4)].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[see Dosage and Administration (2.4)].Table 1: Dosing recommendation in C3G or primary IC-MPGN Patient Body WeightFirst dose
(infusion volume)Second dose
(infusion volume)Maintenance dose
(infusion volume)50 kg or higher1,080 mg (20 mL) 1,080 mg (20 mL) 1,080 mg twice weekly (20 mL) 35 kg to less than 50 kg648 mg (12 mL) 810 mg (15 mL) 810 mg twice weekly (15 mL) Less than 35 kg540 mg (10 mL) 540 mg (10 mL) 648 mg twice weekly (12 mL) Missed DoseAdminister EMPAVELI as soon as possible after a missed dose. Resume the regular dosing schedule following administration of the missed dose.)2.4 AdministrationEMPAVELI 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.
Injection: 1,080 mg/20 mL (54 mg/mL) clear, colorless to slightly yellowish solution in a single-dose vial.
There are insufficient data on EMPAVELI use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with untreated PNH in pregnancy
PNH in pregnancy is associated with adverse maternal outcomes, including worsening cytopenias, thrombotic events, infections, bleeding, miscarriages and increased maternal mortality, and adverse fetal outcomes, including fetal death and premature delivery.
Treatment of pregnant cynomolgus monkeys with pegcetacoplan at a subcutaneous dose of 28 mg/kg/day (2.9 times human exposure based on AUC) from the gestation period through parturition resulted in a statistically significant increase in abortions or stillbirths compared to controls
Animal reproduction studies with pegcetacoplan were conducted in cynomolgus monkeys. Pegcetacoplan treatment of pregnant cynomolgus monkeys at a subcutaneous dose of 28 mg/kg/day (2.9 times human exposure based on AUC) from the gestation period through parturition resulted in a statistically significant increase in abortions and stillbirths compared to controls. No increase in abortions or stillbirths occurred at a dose of 7 mg/kg/day (1.3 times human exposure based on AUC). No maternal toxicity or teratogenic effects were observed in offspring delivered at term. No developmental effects were observed in infants up to 6 months postpartum. Systemic exposure to pegcetacoplan of less than 1% of maternal levels was detected in fetuses from monkeys treated with 28 mg/kg/day from the period of organogenesis through the second trimester.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.