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Theresa is an
adult taking
EMPAVELI.

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INDICATION AND IMPORTANT SAFETY INFORMATION

What is EMPAVELI® (pegcetacoplan)?

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

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

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

EMPAVELI may increase your chance of getting serious and life-threatening meningococcal infections that may quickly become life-threatening and cause death if not recognized and treated early.

EMPAVELI may also increase the risk of getting serious infections caused by certain bacteria such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. Serious infections may quickly become life-threatening and cause death if not recognized and treated early.

  1. You must be vaccinated against these bacteria at least 2 weeks before your first dose of EMPAVELI if you have not already had these vaccines.
  2. If your healthcare provider decides that urgent treatment with EMPAVELI is needed, you should receive the required vaccinations as soon as possible.
  3. If you have not been vaccinated and EMPAVELI therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations.
  4. If you have been vaccinated against these bacteria in the past, you might need additional vaccinations before starting EMPAVELI. Your healthcare provider will decide if you need additional vaccinations.
  5. Vaccines reduce the risk of serious infections, but do not prevent all serious infections. 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 and a rash
    • shortness of breath
    • extreme pain or discomfort
    • headache with nausea or vomiting
    • high heart rate
    • headache and a fever
    • headache with a stiff neck or stiff back
    • confusion
    • muscle aches with flu-like symptoms
    • clammy skin
    • 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. It is important to show this card to any healthcare provider to 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, give you a Patient Safety Card about your risk of serious infections, and make sure that you are vaccinated.

Who should NOT take EMPAVELI?

Do not take EMPAVELI if you:

  • are allergic to pegcetacoplan or any of the ingredients in EMPAVELI.
  • have not been vaccinated against Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B, unless your healthcare provider decides that urgent treatment with EMPAVELI is needed.
  • have a serious infection caused by the bacteria above.

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
  • swelling of your face, tongue, or throat
  • feel faint or pass out

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.

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

ApellisAssist logo with tagline

The ApellisAssist® program is here for you

It takes teamwork to help manage paroxysmal nocturnal hemoglobinuria (PNH). The ApellisAssist patient support program provides comprehensive support, with helpful resources and experienced people dedicated to making a difference for you.

With the program, you have access to:

ApellisAssist financial assistance icon

Financial assistance
(for those who are eligible)

ApellisAssist self-administration training icon

Self-administration training from an Apellis Care Educator (ACE)

ApellisAssist insurance support icon

Insurance support

Call the ApellisAssist team at
1-866-MY-APL-ASSIST (1-866-692-7527) from 8 AM-8 PM ET, MONDAY-FRIDAY

Your ApellisAssist support partners

With EMPAVELI, you don’t have to go it alone. Learn about your dedicated partners from the ApellisAssist program.

Care Coordinator

ApellisAssist Care Educator icon

Through our specialty pharmacy, PANTHERx Rare, a Care Coordinator will:

  • Help schedule your deliveries for medication and supplies
  • Explain your insurance benefits or available financial assistance options, if eligible
Apellis Care Educator (ACE)

Apellis Care Educator (ACE) icon

Your ACE is there for you from the start. They will provide you:

  • 1-on-1 training on how to self-administer EMPAVELI—in your home or virtually
  • Ongoing support every step of the way
  • A wide variety of educational resources
  • Answers to questions that may pop up

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

Emma adult patient with paroxysmal nocturnal hemoglobinuria (PNH) at coffee shop

“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.”

—Emma

Emma is an adult with PNH taking EMPAVELI.
Individual experiences may vary.

See the Instructions for Use for information about how to prepare, infuse, and store your EMPAVELI. Your doctor should show you how to prepare and infuse EMPAVELI before you use it for the first time. Use EMPAVELI exactly as your doctor tells you. Your doctor will tell you how much and how often to infuse EMPAVELI. Do not infuse more or less than your doctor tells you to.

EMPAVELI Trial Offer logo

8 weeks of EMPAVELI treatment at no cost to eligible adults with PNH*

If you haven’t tried EMPAVELI yet, you may be eligible for the EMPAVELI Trial Offer regardless of insurance coverage or current C5i treatment.

  • Straightforward enrollment for you and your healthcare provider
  • You will receive the same comprehensive training and support as those currently taking EMPAVELI
  • No obligation to continue with EMPAVELI after trial ends

If you and your healthcare provider are ready to try EMPAVELI, you may be eligible to enroll in the Trial Offer program.

*Terms, conditions, and eligibility requirements apply. Ask your healthcare provider for more information.

Insurance questions? In need of financial assistance?

Your ApellisAssist team is here to help.

Call an ApellisAssist representative at 1-866-MY-APL-ASSIST
(1-866-692-7527) to speak with your Care Coordinator
about your insurance benefits or the financial assistance programs below.



Apellis Co-Pay Program

The Apellis Co-Pay Program for patients with commercial insurance may be able to help cover your co-pay and co-insurance costs. Enroll in ApellisAssist today to see if you’re eligible for this program.†,‡

The Apellis Co-Pay Program is for eligible patients who are enrolled in the ApellisAssist program, are commercially insured, and who are not covered under government insurance programs such as Medicaid, VA/DoD, or TRICARE.

Program terms are subject to change.

Apellis Patient Assistance Program

If you don’t have insurance or your insurance only provides limited coverage, the Apellis Patient Assistance Program may be able to help you obtain EMPAVELI at no cost.

To be eligible for the Apellis Patient Assistance Program, you must:

  • Have a diagnosis of paroxysmal nocturnal hemoglobinuria (PNH) that is appropriate for EMPAVELI treatment
  • Be enrolled in the ApellisAssist program
  • Have no insurance or be underinsured
  • Have a prescription for EMPAVELI treatment
  • Currently live in the US or a US territory
  • Meet financial eligibility criteria

Apellis Bridge Program

The Apellis Bridge Program can help with interruptions or changes in insurance. If your insurance provider has changed or your plan has changed, you may experience an interruption in coverage. If this occurs, you could be eligible for a temporary supply of EMPAVELI through the Apellis Bridge Program.§

§Terms and conditions apply.

Explore a range of helpful resources for your EMPAVELI journey view tools and resources

INDICATION AND IMPORTANT SAFETY INFORMATION

What is EMPAVELI® (pegcetacoplan)?

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

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

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

EMPAVELI may increase your chance of getting serious and life-threatening meningococcal infections that may quickly become life-threatening and cause death if not recognized and treated early.

EMPAVELI may also increase the risk of getting serious infections caused by certain bacteria such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. Serious infections may quickly become life-threatening and cause death if not recognized and treated early.

  1. You must be vaccinated against these bacteria at least 2 weeks before your first dose of EMPAVELI if you have not already had these vaccines.
  2. If your healthcare provider decides that urgent treatment with EMPAVELI is needed, you should receive the required vaccinations as soon as possible.
  3. If you have not been vaccinated and EMPAVELI therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations.
  4. If you have been vaccinated against these bacteria in the past, you might need additional vaccinations before starting EMPAVELI. Your healthcare provider will decide if you need additional vaccinations.
  5. Vaccines reduce the risk of serious infections, but do not prevent all serious infections. 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 and a rash
    • shortness of breath
    • extreme pain or discomfort
    • headache with nausea or vomiting
    • high heart rate
    • headache and a fever
    • headache with a stiff neck or stiff back
    • confusion
    • muscle aches with flu-like symptoms
    • clammy skin
    • 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. It is important to show this card to any healthcare provider to 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, give you a Patient Safety Card about your risk of serious infections, and make sure that you are vaccinated.

Who should NOT take EMPAVELI?

Do not take EMPAVELI if you:

  • are allergic to pegcetacoplan or any of the ingredients in EMPAVELI.
  • have not been vaccinated against Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B, unless your healthcare provider decides that urgent treatment with EMPAVELI is needed.
  • have a serious infection caused by the bacteria above.

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
  • swelling of your face, tongue, or throat
  • feel faint or pass out

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.

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

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