Quote from a real EMPAVELI patient.

Quote from a real EMPAVELI patient.
Image is an actor portrayal.

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.

Before, I could not make travel plans

Quote from a real EMPAVELI patient.
Image is an actor portrayal.

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.

Resources and tools for your treatment needs

Whether you're going to be starting EMPAVELI or you're finding your stride on treatment,
we hope these resources will help support you along the way.

Support When Starting
EMPAVELI Guide
Support When Starting EMPAVELI Guide

A guide that takes you from prescription to your first infusion with information about the support you can expect as you begin treatment with EMPAVELI, and who to contact if you have questions.

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EMPAVELI Treatment Brochure
EMPAVELI Treatment Brochure

A complete guide to understanding EMPAVELI including information on benefits, how it works, and side effects.

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Self-Infusion Guide
Self-Infusion Guide

Step-by-step instructions for preparing and infusing EMPAVELI in a convenient brochure format.

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Travel Guide
Travel Guide

A brochure with helpful information for travel and preparation so that taking trips can be easier.

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Travel Letter
Travel Letter

The EMPAVELI Travel Letter explains the supplies you need to travel with in order to self-infuse EMPAVELI. Presenting this letter to customs and security officials, along with your prescription, will help ensure you move through security easily.

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Frequently Asked Questions (FAQs)
Frequently Asked Questions (FAQs)

Whether you have just started EMPAVELI or if you're considering treatment, you can answer any questions you might have with this document.

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HOME SUITE HOME has tools to help you stay organized, store your medication, and get comfortable in your own space

You will have access to these tools once you enroll in ApellisAssist™, but they are not a requirement. We hope that you will find them to be a helpful addition to your treatment journey.

download information card

HOME SUITE HOME has tools to help you stay organized, store your medication, and get comfortable in your own space

You will have access to these tools once you enroll in ApellisAssist™, but they are not a requirement. We hope that you will find them to be a helpful addition to your treatment journey.

download information card

Watch helpful videos on HSH TV to help integrate treatment into your life

We talked to Genevieve Gorder to get her unique tips, advice, and how-to guide to help make your home setup as comfortable as possible. She goes over storage solutions for your supplies, how to build a routine, and how you can set up your space to be more comfortable when you are self-infusing at home. To stay up to date on the latest videos, be sure to subscribe to the YouTube channel.

infusion-studio

My Infusion Studio

A case to simply stow away all of your non-refrigerated treatment supplies.

refrigirator

Refrigerator Storage

A secure storage solution for your medication cartons.

Apellis-HSH

HSH TV

Expert advice from interior desinger Genevieve Gorder on how to set up your at-home treatment area.

My Infusion TrackerTM

An app designed to help keep track of your treatment so you never miss a dose. Once enrolled in ApellisAssist, your Care Coordinator will provide you with a link to download.

Join the community
Connect with us to learn more about PNH and
find support while going through treatment

Connect with us on Facebook to join the community and hear about upcoming events

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Subscribe to our YouTube channel so you can be notified whenever a new video is posted

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Connect with Apellis to stay up to date

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Attend EMPAVELI community events
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Image is an actor portrayal.
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.