Empaveli (Pegcetacoplan) for Kidney Disease

Empaveli (pegcetacoplan) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat adults and children ages 12 and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN). These are kidney diseases.

How Empaveli Works and How It’s Taken

Empaveli is a complement inhibitor. It works by binding to proteins called C3 and C3b. These proteins are part of the immune system.

In C3G and primary IC-MPGN, Empaveli may help reduce complement activity linked to kidney damage. It may also help lower C3 buildup in the kidneys and reduce protein in the urine.

Doctors prescribe Empaveli for adults and children ages 12 and older with C3G or primary IC-MPGN to reduce proteinuria. Proteinuria means there is too much protein in the urine.

Empaveli is given under the skin twice weekly. After training from a healthcare professional, an individual or caregiver may give Empaveli using an infusion pump or the Empaveli Injector.

Typical Dosing for C3G and Primary IC-MPGN

The recommended dose of Empaveli depends on body weight. For adults ages 18 and older, the recommended dose is 1,080 milligrams twice weekly.

For children ages 12 to younger than 18, the recommended dose of Empaveli depends on body weight.

For children over 12 who weigh 50 kilograms or more, the recommendation is:

First dose — 1,080 milligrams
Second dose — 1,080 milligrams
Maintenance dose — 1,080 milligrams twice weekly

For children over 12 who weigh 35 kilograms to less than 50 kilograms, the recommendation is:

First dose — 648 milligrams
Second dose — 810 milligrams
Maintenance dose — 810 milligrams twice weekly

For children over 12 who weigh less than 35 kilograms, the recommendation is:

First dose — 540 milligrams
Second dose — 540 milligrams
Maintenance dose — 648 milligrams twice weekly

Empaveli is given under the skin twice weekly using an infusion pump or the Empaveli Injector after training from a healthcare professional.

This information is based on the prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.

Empaveli Side Effects

In clinical studies of Empaveli for adults and children ages 12 and older with C3G or primary IC-MPGN, the listed side effects occurred in about 6 percent to 25 percent of people. These include:

Infusion-site reactions (reactions where the medicine is given)
Fever
Nasopharyngitis (common cold symptoms)
Influenza (flu)
Nausea
Cough
Fatigue

Serious Side Effects and Warnings

Empaveli can cause serious side effects that may require immediate medical attention. These include:

Serious infections caused by encapsulated bacteria — Severe, sometimes life-threatening infections can occur, including those caused by Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B.
Infusion-related reactions, including anaphylaxis — A severe allergic reaction can cause trouble breathing, swelling of the face or throat, hives, or feeling faint.

Get medical help right away if you think you are having a serious reaction.

Apellis Pharmaceuticals, the manufacturer of Empaveli, offers the Apellis Copay Program. Eligible people with commercial insurance may pay as little as $0. The Apellis Copay Program is not for people covered by government insurance programs such as Medicaid, Medicare, CHIP, VA/DoD, or TRICARE.

The Apellis Copay Program is part of ApellisAssist, which offers benefits investigation support, a Bridge Program for interruptions or changes in insurance, and the Apellis Patient Assistance Program for people who do not have insurance or whose insurance provides limited coverage. To learn more, visit the Empaveli savings and support website, or call 866-MY-APL-ASSIST (866-692-7527).

What To Know Before Taking Empaveli

Before starting Empaveli, your doctor should check to make sure your vaccines are up to date for certain bacteria.

Before starting Empaveli, you should receive vaccines against certain bacteria, including Streptococcus pneumoniae and Neisseria meningitidis (serogroups A, C, W, Y, and B), based on current ACIP recommendations, at least two weeks before your first dose. If you need to start Empaveli right away and are not up to date on these vaccines, your doctor may give you antibiotics and give the vaccines as soon as possible.

Tell your doctor if you have any allergies to pegcetacoplan or any ingredients in Empaveli. Do not take Empaveli if you have had a serious allergic reaction to pegcetacoplan or any of its ingredients.

Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.

Also let your doctor know if you have or recently had infections.

Do not start Empaveli if you have a serious infection caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type B.

Empaveli is also FDA-approved to treat paroxysmal nocturnal hemoglobinuria (PNH) in adults.

If you miss a dose of Empaveli, take it as soon as possible. Then return to your regular dosing schedule.

If you are pregnant, planning to become pregnant, or breastfeeding while taking Empaveli, talk with your doctor about the risks and benefits. Pregnancy testing is recommended before treatment for females who can become pregnant. Effective birth control should be used during treatment and for 40 days after the last dose.

Breastfeeding should be stopped during treatment and for 40 days after the last dose.

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Empaveli?

In a 26-week study of people ages 12 and older with C3G or primary IC-MPGN, Empaveli lowered the amount of protein in the urine by 68 percent compared with placebo (an inactive treatment).

By week 26:

49 percent of people taking Empaveli reached a kidney goal of at least a 50 percent drop in protein in the urine while keeping kidney function stable, compared with 3 percent of people taking placebo
60 percent of people taking Empaveli had at least a 50 percent reduction in protein in the urine, compared with 5 percent of people taking placebo

How long does Empaveli take to work for chronic kidney disease?

In clinical studies, kidney results were measured at week 26. In people with C3G or IC-MPGN, Empaveli levels in the body reached steady state in about four to eight weeks. The study’s main results for reducing protein in the urine were reported at the 26-week time point.

Should I take Empaveli for C3G or primary IC-MPGN (kidney disease) if I have an infection?

Empaveli should not be started if you have an unresolved serious infection caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type B. This medicine can increase the risk of serious, life-threatening, or fatal infections, even in people who have been vaccinated. People taking Empaveli should be monitored for early signs of infection and checked right away if an infection is suspected.