Financial assistance
(for those who are eligible)
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adult who's taken
EMPAVELI.
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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 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.
- 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.
- If you have not completed your vaccines and EMPAVELI must be started right away, you should receive the required vaccines as soon as possible.
- 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.
- 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.
- 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
- 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.
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:
Self-administration training from an Apellis Care Educator (ACE)
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
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)
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.
“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 is an adult with PNH who's taken 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.
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 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.
‡Additional terms and conditions apply. 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
- Be under the care of a US-licensed, practicing healthcare provider
- Meet financial eligibility criteria
Additional terms and conditions apply. Program terms are subject to change.
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. Program terms are subject to change.
