PNH

For questions about financial assistance, call 1-866-MY-APL-ASSIST

Take charge with
twice-weekly dosing and
the EMPAVELI Injector

Laura is an adult with PNH who’s taken EMPAVELI

The EMPAVELI Injector is a compact, on-body device that gives you freedom to self-administer

The EMPAVELI injector works for your schedule




>97% compliance* reported with at-home administration

Nearly 100% of patients reported they were confident self-administering EMPAVELI after receiving training from an Apellis Care Educator†

*Compliance calculated by medical possession ratio of >350 US patients on EMPAVELI. Data as of 03/31/2025.

†Based on feedback from >300 people with PNH after receiving self-administration training with an Apellis Care Educator. They rated their confidence with self-infusion on a scale from 1-7. A score of ≥5 was considered “confident.” Data as of 05/21/2025.

See how to use EMPAVELI

Jesus is an adult with PNH who’s taken EMPAVELI

“Being able to self-administer EMPAVELI is a huge improvement over going to the infusion center. It’s more convenient, and it’s also easier not being in a clinical setting. And the in-home training from the ACE was incredibly helpful!”

Individual experiences may vary.

Keep in mind while taking EMPAVELI:

Avoid intense physical activity and do not bump or knock the EMPAVELI Injector or button during the injection. Keep the skin on your abdomen completely dry.

EMPAVELI is designed to stay in your system but if you miss a dose, take your missed dose as soon as possible and resume the regular dosing schedule.

You will be trained before using the EMPAVELI Injector for the first time. See the EMPAVELI Injector Instructions for Use or, if using an infusion pump, see those specific Instructions for Use.

Jesus is an adult with PNH who’s taken EMPAVELI

Actor portrayal.

EMPAVELI puts treatment in your hands with a compact device.

What else should I know before starting EMPAVELI?

EMPAVELI REMS program ensures your safety is a top priority

Because of the risk of serious infections caused by encapsulated bacteria, EMPAVELI is only available through a program called the EMPAVELI Risk Evaluation and Mitigation Strategy (REMS).

REMS is a safety program run by the FDA. Before you can take EMPAVELI, your doctor must enroll in the program and will provide you with the following:

  • Counseling on the risk of serious infections caused by certain bacteria
  • Information about the symptoms of serious infections
  • Appropriate vaccinations against serious infections caused by encapsulated bacteria
    • You will receive antibiotics if you need to start EMPAVELI right away and are not up to date on your vaccines.
      Find vaccine support >
  • A Patient Safety Card
    • Carry this card with you at all times during treatment and for 2 months after your last EMPAVELI dose
    • Show this card to any healthcare professional to help diagnose and treat you quickly
    • Your risk of serious infection may continue for several weeks after your last dose of EMPAVELI

Certain vaccines are required before starting EMPAVELI

At least 2 weeks before your first dose of EMPAVELI, complete or update your vaccinations against Streptococcus pneumoniae and Neisseria meningitidis.

You may need the following vaccines:

  • Pneumococcal vaccination(s)
  • Meningococcal vaccinations
    • MenACWY series
    • MenB series

To see where you can get vaccinated, start by talking to your doctor to see if they offer the vaccines.

Vaccines may also be available at:

  • Retail pharmacies
  • Health clinics
  • Your local health department

As part of the ApellisAssist program, a Vaccine Coordinator can help you with this process.
Reach out to your doctor if you have any additional questions about starting EMPAVELI.

If you are switching from a C5 inhibitorC5 inhibitorA treatment that targets the C5 protein in the complement system (part of the immune system). C5 is a protein located in the blood that plays an important role contributing to inflammation and intravascular hemolysis caused by the complement system.

Your doctor will provide guidance on how to switch from your previous treatment to EMPAVELI in order to provide a smooth transition and reduce the risk of hemolysis from treatment discontinuation. That guidance may include the following:

  • If you are switching from eculizumab, you should start EMPAVELI while on your current dose of eculizumab. After 4 weeks, you may discontinue eculizumab and continue to take EMPAVELI on its own
  • If you are switching from ravulizumab, you should start EMPAVELI no more than 4 weeks after your last dose of ravulizumab
ACEs are here for 1-on-1 self-administration training

With the ApellisAssist patient support program, you will have the help of an Apellis Care Educator (ACE). ACEs have nursing backgrounds and will provide you with self-administration training.

They will continue to be by your side throughout your journey with ongoing support, education, and answers to your questions.

ACEs do not give medical advice. Talk to your doctor for treatment-related questions.

Emma is an adult with PNH who’s taken EMPAVELI

“My ACE is amazing. Her training helped give me confidence in self-administering EMPAVELI. She continues to be there for me and is always a phone call away.”

Individual experiences may vary.

Discover tools to support

your treatment journey

Find helpful resources

Hear from people like you
who are taking EMPAVELI

Watch real patient stories

ACE=Apellis Care Educator; PNH=paroxysmal nocturnal hemoglobinuria.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about EMPAVELI?

EMPAVELI is a medicine that affects your immune system and may lower the ability of your immune system to fight infections.

EMPAVELI increases your chance of getting serious infections caused by encapsulated bacteria such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. These serious infections may quickly become life-threatening or cause death if not recognized and treated early.

  1. You must complete or be up to date with the vaccines against Streptococcus pneumoniae and Neisseria meningitidis at least 2 weeks before your first dose of EMPAVELI.
  2. If you have not completed your vaccines and EMPAVELI must be started right away, you should receive the required vaccines as soon as possible.
  3. If you have not been vaccinated and EMPAVELI must be started right away, you should also receive antibiotics to take for as long as your healthcare provider tells you.
  4. If you have been vaccinated against these bacteria in the past, you might need additional vaccines before starting EMPAVELI. Your healthcare provider will decide if you need additional vaccines.
  5. Vaccines do not prevent all infections caused by encapsulated bacteria. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a serious infection:
    • fever with or without shivers or the chills
    • fever with chest pain and cough
    • fever with high heart rate
    • headache and a fever
    • confusion
    • clammy skin
    • fever and a rash
    • fever with breathlessness or fast breathing
    • headache with nausea or vomiting
    • headache with a stiff neck or stiff back
    • body aches with flu-like symptoms
    • eyes sensitive to light

Your healthcare provider will give you a Patient Safety Card about the risk of serious infections. Carry it with you at all times during treatment and for 2 months after your last EMPAVELI dose. Your risk of serious infections may continue for several weeks after your last dose of EMPAVELI. It is important to show this card to any healthcare provider who treats you. This will help them diagnose and treat you quickly.

EMPAVELI is only available through a program called the EMPAVELI Risk Evaluation and Mitigation Strategy (REMS). Before you can take EMPAVELI, your healthcare provider must enroll in the EMPAVELI REMS program, counsel you about the risk of serious infections caused by certain bacteria, give you information about the symptoms of serious infections, make sure that you are vaccinated against serious infections caused by encapsulated bacteria and that you receive antibiotics if you need to start EMPAVELI right away and you are not up to date on your vaccines, and give you a Patient Safety Card about your risk of serious infections.

Who should NOT take EMPAVELI?

Do not take EMPAVELI if you:

  • are allergic to pegcetacoplan or any of the ingredients in EMPAVELI.
  • have a serious infection caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B when you are starting EMPAVELI treatment.

Before you take EMPAVELI, tell your healthcare provider about all of your medical conditions, including if you:

  • have an infection or fever.
  • are pregnant or plan to become pregnant. EMPAVELI may harm your unborn baby. Females who are able to become pregnant should have a pregnancy test before starting treatment with EMPAVELI and use an effective method of birth control during treatment with EMPAVELI and for 40 days after the last dose.
  • are breastfeeding or plan to breastfeed. It is not known if EMPAVELI passes into your breast milk. You should not breastfeed during treatment with EMPAVELI and for 40 days after the last dose.

Tell your healthcare provider about all the vaccines you receive and medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements which could affect your treatment.

If you stop taking EMPAVELI, your healthcare provider will need to monitor you closely for at least 8 weeks after stopping EMPAVELI. Stopping treatment with EMPAVELI may cause a breakdown of red blood cells due to PNH.

Symptoms or problems that can happen due to red blood cell breakdown include:

  • decreased hemoglobin level in your blood
  • blood in your urine
  • shortness of breath
  • trouble swallowing
  • tiredness
  • pain in the stomach (abdomen)
  • blood clots
  • erectile dysfunction (ED)

What are the possible side effects of EMPAVELI?

EMPAVELI can cause serious side effects including allergic reactions. Allergic reactions can happen during your EMPAVELI infusion. Stop your EMPAVELI infusion and tell your healthcare provider or get emergency medical care right away if you get any of these symptoms during your EMPAVELI infusion:

  • chest pain
  • trouble breathing or shortness of breath
  • wheezing
  • swelling of your face, tongue, or throat
  • feel dizzy or faint or pass out
  • fast heart rate
  • nausea or vomiting
  • feel confused or anxious
  • skin reactions, including rash, hives, and itching

The most common side effects in people with PNH treated with EMPAVELI include injection-site reactions; infections; diarrhea; pain in the stomach (abdomen); respiratory tract infection; pain in the arms, hands, legs, or feet; low potassium in blood; tiredness; viral infection; cough; joint pain; dizziness; headache; and rash.

These are not all of the possible side effects of EMPAVELI. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What is EMPAVELI® (pegcetacoplan)?

EMPAVELI is a prescription medicine used to treat adults with a disease called paroxysmal nocturnal hemoglobinuria (PNH).

Please see full Prescribing Information, including Boxed WARNING regarding risk of serious infections, and Medication Guide for additional information.

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IMPORTANT SAFETY INFORMATION

What is the most important information I should know about EMPAVELI?

EMPAVELI is a medicine that affects your immune system and may lower the ability of your immune system to fight infections.

EMPAVELI increases your chance of getting serious infections caused by encapsulated bacteria such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. These serious infections may quickly become life-threatening or cause death if not recognized and treated early.

  1. You must complete or be up to date with the vaccines against Streptococcus pneumoniae and Neisseria meningitidis at least 2 weeks before your first dose of EMPAVELI.
  2. If you have not completed your vaccines and EMPAVELI must be started right away, you should receive the required vaccines as soon as possible.
  3. If you have not been vaccinated and EMPAVELI must be started right away, you should also receive antibiotics to take for as long as your healthcare provider tells you.
  4. If you have been vaccinated against these bacteria in the past, you might need additional vaccines before starting EMPAVELI. Your healthcare provider will decide if you need additional vaccines.
  5. Vaccines do not prevent all infections caused by encapsulated bacteria. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a serious infection:
    • fever with or without shivers or the chills
    • fever with chest pain and cough
    • fever with high heart rate
    • headache and a fever
    • confusion
    • clammy skin
    • fever and a rash
    • fever with breathlessness or fast breathing
    • headache with nausea or vomiting
    • headache with a stiff neck or stiff back
    • body aches with flu-like symptoms
    • eyes sensitive to light

Your healthcare provider will give you a Patient Safety Card about the risk of serious infections. Carry it with you at all times during treatment and for 2 months after your last EMPAVELI dose. Your risk of serious infections may continue for several weeks after your last dose of EMPAVELI. It is important to show this card to any healthcare provider who treats you. This will help them diagnose and treat you quickly.

EMPAVELI is only available through a program called the EMPAVELI Risk Evaluation and Mitigation Strategy (REMS). Before you can take EMPAVELI, your healthcare provider must enroll in the EMPAVELI REMS program, counsel you about the risk of serious infections caused by certain bacteria, give you information about the symptoms of serious infections, make sure that you are vaccinated against serious infections caused by encapsulated bacteria and that you receive antibiotics if you need to start EMPAVELI right away and you are not up to date on your vaccines, and give you a Patient Safety Card about your risk of serious infections.

Who should NOT take EMPAVELI?

Do not take EMPAVELI if you:

  • are allergic to pegcetacoplan or any of the ingredients in EMPAVELI.
  • have a serious infection caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B when you are starting EMPAVELI treatment.

Before you take EMPAVELI, tell your healthcare provider about all of your medical conditions, including if you:

  • have an infection or fever.
  • are pregnant or plan to become pregnant. EMPAVELI may harm your unborn baby. Females who are able to become pregnant should have a pregnancy test before starting treatment with EMPAVELI and use an effective method of birth control during treatment with EMPAVELI and for 40 days after the last dose.
  • are breastfeeding or plan to breastfeed. It is not known if EMPAVELI passes into your breast milk. You should not breastfeed during treatment with EMPAVELI and for 40 days after the last dose.

Tell your healthcare provider about all the vaccines you receive and medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements which could affect your treatment.

If you stop taking EMPAVELI, your healthcare provider will need to monitor you closely for at least 8 weeks after stopping EMPAVELI. Stopping treatment with EMPAVELI may cause a breakdown of red blood cells due to PNH.

Symptoms or problems that can happen due to red blood cell breakdown include:

  • decreased hemoglobin level in your blood
  • blood in your urine
  • shortness of breath
  • trouble swallowing
  • tiredness
  • pain in the stomach (abdomen)
  • blood clots
  • erectile dysfunction (ED)

What are the possible side effects of EMPAVELI?

EMPAVELI can cause serious side effects including allergic reactions. Allergic reactions can happen during your EMPAVELI infusion. Stop your EMPAVELI infusion and tell your healthcare provider or get emergency medical care right away if you get any of these symptoms during your EMPAVELI infusion:

  • chest pain
  • trouble breathing or shortness of breath
  • wheezing
  • swelling of your face, tongue, or throat
  • feel dizzy or faint or pass out
  • fast heart rate
  • nausea or vomiting
  • feel confused or anxious
  • skin reactions, including rash, hives, and itching

The most common side effects in people with PNH treated with EMPAVELI include injection-site reactions; infections; diarrhea; pain in the stomach (abdomen); respiratory tract infection; pain in the arms, hands, legs, or feet; low potassium in blood; tiredness; viral infection; cough; joint pain; dizziness; headache; and rash.

These are not all of the possible side effects of EMPAVELI. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What is EMPAVELI® (pegcetacoplan)?

EMPAVELI is a prescription medicine used to treat adults with a disease called paroxysmal nocturnal hemoglobinuria (PNH).

Please see full Prescribing Information, including Boxed WARNING regarding risk of serious infections, and Medication Guide for additional information.