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THIS SITE IS INTENDED FOR US RESIDENTS 18 YEARS AND OLDER.
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This site is intended for US residents 18 years and older

“With EMPAVELI self-infusions, I'm able to travel without interrupting my infusion schedule. I can bring my supplies with me wherever I go.”

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. When traveling, ensure that EMPAVELI stays at 36°F to 46°F (2°C-8°C). 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.

PNH=paroxysmal nocturnal hemoglobinuria.

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

How to take EMPAVELI

Take your treatment wherever is most convenient for you

EMPAVELI does not require visits to an infusion center

EMPAVELI is a treatment you infuse yourself

You can take EMPAVELI when you are away from home

No need to plan days or vacations around infusion visits

Your healthcare provider should show you how to prepare and infuse EMPAVELI before you use it for the first time. Use EMPAVELI exactly as your healthcare provider tells you.

EMPAVELI is a 1080-mg subcutaneous self-infusion

EMPAVELI is administered using a small, thin needle that goes just under the skin.
EMPAVELI can be self-infused in either 1 or 2 sites—in the abdomen, thighs, hips, or upper arms—based on your preference. See the Instructions for Use for more information.

*If there is an increase in your lactate dehydrogenase (LDH), an enzyme in your blood, your healthcare provider may tell you to take EMPAVELI every 3 days.

Not actual size, for illustration purposes only. Exact needle size may vary for some people with PNH.

What is a subcutaneous infusion?

  • Subcutaneous needles reach just under the skin into the fatty layer
  • The needle does NOT go into the muscle or vein like intravenous (IV) therapies in an infusion center

For illustration purposes only.

How should I take EMPAVELI?

Before you begin treatment, a healthcare provider should show you how to prepare and infuse EMPAVELI

See the Instructions for Use

If you miss a dose of EMPAVELI, take the missed dose as soon as possible. Take your next dose as regularly planned

Your healthcare provider will tell you how much EMPAVELI to infuse and how often to infuse. Do not infuse more or less than your healthcare provider tells you to

If your healthcare provider decides to stop your treatment with EMPAVELI, follow their instructions for how to stop. Your healthcare provider will monitor you closely for at least 8 weeks after stopping treatment with EMPAVELI for any signs of hemolysis due to PNH

Will I need vaccines before starting EMPAVELI?

Before starting your treatment journey with EMPAVELI, you will need to get certain vaccines. They help reduce the risk of certain serious infections.

You will be required to receive vaccinations against certain types of bacteria at least 2 weeks prior to taking your first dose of EMPAVELI. You may not need all the vaccines if you have already received them in the past.

When visiting your doctor:

  • Bring your vaccination records
  • Ask your doctor which vaccines you will need before starting EMPAVELI

Reach out to your doctor if you have any additional questions about starting EMPAVELI.

How will I transition to EMPAVELI from a C5i treatment?
  • For the first 4 weeks, you will receive EMPAVELI and your current dose of eculizumab
  • After 4 weeks, STOP eculizumab and only take EMPAVELI
  • If you are changing treatment from ravulizumab, you should start taking EMPAVELI no more than 4 weeks after your last dose of ravulizumab

This process helps reduce the risk of hemolysis during your treatment transition.

How will I learn how to self-infuse?

You will receive support from your healthcare team. Also, Apellis can provide you with support from an Apellis Care Educator (ACE) who is trained to help you learn how to infuse. We're here to help.

1-866-MY-APL-ASSIST (1-866-692-7527)
FROM 8 AM-8 PM ET, MONDAY-FRIDAY

They can also connect you to a PANTHERx® Rare
pharmacist who is on call 24 hours a day.

Learn how to infuse EMPAVELI

Watch the video to learn how to
self-infuse EMPAVELI

play
Image is an actor portrayal.

Additional tools for your treatment journey

Download the
self-infusion brochure
download
Ask your Care Coordinator
to register you for
the My Infusion Tracker™ app
Get support from the ApellisAssist patient support program
learn more
Peg is an adult with PNH taking EMPAVELI.
INDICATION AND IMPORTANT SAFETY INFORMATION

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 final 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 final 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, viral infection, and tiredness.

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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