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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.
Curious about EMPAVELI
What are some of the benefits of EMPAVELI?
There are a number of benefits that EMPAVELI may provide:
- Improvement in hemoglobin (Hb) levels: compared to the beginning of the PEGASUS study, people taking EMPAVELI had a 2.37 g/dL increase in Hb and people taking eculizumab had a 1.47 g/dL decrease in Hb at Week 16. EMPAVELI showed a superior 3.84 g/dL difference in Hb levels vs eculizumab (P<0.0001)
- Stabilized Hb: in the PRINCE study, 86% of people taking EMPAVELI achieved Hb stabilization* over 26 weeks. 0% of those in the control arm (excluding complement inhibitors) achieved Hb stabilization (P<0.0001)
- Reduced lactate dehydrogenase (LDH): in the PRINCE study, at Week 26, average reductions in LDH levels were -1870 U/L in the EMPAVELI group and -400 U/L in the control arm (excluding complement inhibitors) from the start of the study (P<0.0001)
*Hb stabilization means avoiding a >1 g/dL decrease in Hb levels throughout the study.
What are some of the possible risks of EMPAVELI?
EMPAVELI can cause serious side effects. Partner with your healthcare team to help manage these side effects.
EMPAVELI is a medicine that affects your immune system. EMPAVELI may lower the ability of your immune system to fight infections.
- EMPAVELI increases your chance of getting serious infections caused by encapsulated bacteria, including 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
See all Important Safety Information
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.
How does EMPAVELI work?
The complement cascade is a part of your immune system that protects your body from threats like viruses or bacteria. It is responsible for both kinds of hemolysis: intravascular and extravascular.
In the complement cascade, the C3 protein binds to your red blood cells and tags them for destruction, activating C5 and causing intravascular hemolysis (IVH). Red blood cells that are not destroyed through IVH continue to be covered with C3 proteins, causing extravascular hemolysis (EVH).
EMPAVELI works higher in the complement system than other treatments, like eculizumab. It prevents C3 from splitting into C3a and C3b, helping to stop IVH and EVH. C5 treatments, like eculizumab, work on C5.
What if I’m not taking EMPAVELI but have questions?
You should direct all questions to your doctor. Your doctor will be able to help answer questions, share information, and connect you to additional resources.
Your doctor will be your primary contact before and after you’re prescribed EMPAVELI. After you have been prescribed EMPAVELI in your doctor’s office, you will have the opportunity to opt in to the ApellisAssist® patient support program. Once enrolled, you will have access to a dedicated Care Coordinator and Apellis Care Educator (ACE).
There are other ways to learn more about EMPAVELI, including:
- Connect 1-on-1 with someone already taking EMPAVELI with our PNH Peer 2 Peer program
- Attend an upcoming community event
How can I talk to my doctor to find out if EMPAVELI is right for me?
Every appointment with your doctor is an opportunity to take steps toward better health. When you schedule your appointment, it’s helpful to:
- Start by letting the office staff know that you would like to discuss EMPAVELI as a potential treatment option for paroxysmal nocturnal hemoglobinuria (PNH). That way, your doctor can be prepared to discuss this with you and make sure there is enough time scheduled for your appointment
- Bring a list of your symptoms, any current medications, and any other concerns you want to discuss
- Bring someone with you who can take notes about your conversation with your doctor
Getting started on EMPAVELI
I’ve heard certain vaccines are required before starting EMPAVELI. Is that true?
Yes, before starting EMPAVELI, you will need to get certain vaccines that help reduce the risk of certain serious infections.
You will be required to receive these vaccinations at least 2 weeks prior to taking your first dose of EMPAVELI. Check in with your doctor to determine which vaccines you may need.
The ApellisAssist program is here to help! Our Vaccine Coordinator can assist you with this process.
Who will be contacting my insurance provider?
A Care Coordinator from PANTHERx® Rare, our specialty pharmacy, will work with your doctor and insurance company on the approval process.
How will I know if I am approved by my insurance provider?
Based on your stated communication preferences, your Care Coordinator will provide updates related to insurance approval.
What will my out-of-pocket costs be while taking EMPAVELI?
Out-of-pocket costs vary based on individual insurance coverage. Your Care Coordinator will help explain your insurance benefits and coverage options. Your Care Coordinator will also review available financial assistance programs for which you may be eligible.
Is there a trial offer available for EMPAVELI?
Yes. You may be eligible for 8 weeks of EMPAVELI treatment at no cost.*
The EMPAVELI Trial Offer is available to eligible adults with PNH regardless of insurance coverage or current C5i treatment.
- Enrollment is straightforward for you and your doctor
- Self-administration training and support are available
- There’s no obligation to continue with EMPAVELI after the trial ends
If you and your doctor are ready to try EMPAVELI, you may be eligible to enroll in the Trial Offer program.
*Terms, conditions, and eligibility requirements apply. Ask your doctor for more information.
What is a specialty pharmacy?
You will most likely receive EMPAVELI from our specialty pharmacy, PANTHERx Rare. A specialty pharmacy provides medications used to treat rare diseases or more complex health problems. Many of these medications are not stocked by regular pharmacies.
The staff at specialty pharmacies are trained to help you understand your medication better. They will also communicate with your healthcare team and insurance company when needed.
How do I get my medication and everything I need to self-administer EMPAVELI?
Medication and supplies will typically be shipped by PANTHERx Rare on a monthly basis to a location of your choice. If you choose to enroll in the ApellisAssist program, you’ll receive a CareKit containing everything you need to become familiar with self-administration.
How will I know if my medication will be delivered securely?
Your Care Coordinator will work with you to schedule shipments on the delivery date and at the location of your choice. Someone will need to be available to sign for delivery upon arrival.
EMPAVELI must be stored in the refrigerator in the original cartons, between 36°F and 46°F (2°C-8°C), once delivered.
Self-administration training and the ApellisAssist® program
How do I get trained to administer my own medication?
A qualified healthcare professional can show you or your caregiver how to administer EMPAVELI correctly before you use it for the first time. Also, after enrolling in the ApellisAssist program, an Apellis Care Educator (ACE) can provide you with 1-on-1 training in your home or virtually. They can come back multiple times, if necessary, and can provide tips and tools to help you feel comfortable with taking EMPAVELI.
Your ACE is a compassionate care partner with a nursing background who is there for you throughout your journey with ongoing education and support.
Hear from some of our ACEs!
How do I enroll in the ApellisAssist program?
If you are unsure whether you are enrolled in the ApellisAssist program, or if you would like to enroll, call 1-866-MY-APL-ASSIST (1-866-692-7527) and your Care Coordinator will confirm or assist you with enrollment.
How does my Apellis Care Educator (ACE) contact me and how do we communicate?
As you prepare to start on EMPAVELI, you will collaborate with your Apellis Care Team, composed of a dedicated Care Coordinator through our specialty pharmacy, PANTHERx Rare, and an ACE. Together, you’ll decide how you’d like to receive training. Also, you’ll decide on your communication preferences:
- In-home or virtual self-administration training
- Via phone call, text, or email
- Frequency of communications
Who can I call for additional help regarding my treatment?
Your doctor will be your primary contact before and after you’re prescribed EMPAVELI.
Once you are enrolled in the ApellisAssist program, you will have access to a dedicated Care Coordinator through our specialty pharmacy, PANTHERx Rare, and an Apellis Care Educator (ACE). Your ACE will provide self-administration training, disease education, and ongoing support.
Taking EMPAVELI
How long can I store EMPAVELI in my refrigerator?
EMPAVELI can be used until the expiration date printed on the carton. Do not use EMPAVELI if the expiration date has passed.
At what temperature does it need to be stored?
EMPAVELI should be stored in the refrigerator between 36ºF to 46ºF (2°C-8°C) in the original carton to protect from light.
How long do I need to warm up the vial before starting my infusion?
Once you remove a single-vial carton from the refrigerator, keep the vial in its carton and let it warm up to room temperature, which should take approximately 30 minutes. Do not try to speed up the warming process.
What do I do if the vial is unusable?
You should not use the vial of medication if:
- Liquid looks cloudy
- Liquid contains particles
- Liquid is dark yellow
- Protective flip cap is missing or damaged
- Expiration date on the label has passed
If any of the above is true, set the vial aside and take another vial carton from the refrigerator. You should repeat the vial warming process and let it warm up to room temperature for approximately 30 minutes. Email the Apellis Product Compliance Team at medinfo@apellis.com to report the issue with your vial.
What happens if my vial is broken or unusable or it is my last vial?
The liquid in the vial should be clear, colorless, or slightly yellowish. If a vial is broken, the liquid looks cloudy, has particles, or is dark yellow, you should throw it out. Also, you should not use any vial with a missing or damaged flip cap, or if the expiration date has passed.
You should take out a new vial carton from the refrigerator and repeat the warming process to inject.
To order more EMPAVELI or schedule a delivery, reach out to your Care Coordinator through our specialty pharmacy, PANTHERx Rare.
If your vial breaks, set it aside and do not use it. Do not try to use any of the liquid from the broken vial. Email the Apellis Product Compliance Team at medinfo@apellis.com to report the issue with your vial.
When it comes time to refill your medication, PANTHERx Rare will reach out to you about 10 days prior to needing your refill. Be sure to accept their refill call and schedule your next shipment of medication. If you have any questions regarding refills, or if you break a vial, contact an ApellisAssist representative at 1-866-MY-APL-ASSIST (1-866-692-7527).
What happens if I miss a dose?
If you miss a dose of EMPAVELI, take the missed dose as soon as possible. Then take the next dose at your regularly scheduled time. Talk to your doctor and email the Apellis Product Compliance Team at medinfo@apellis.com to report if you missed a dose and the reason the dose was missed.
It is recommended that you keep a record of the doses you take in the My Infusion Tracker™ app, CareKit Treatment Journal, or other type of journal or log. Be sure to take the record with you each time you visit your doctor because they may ask to see it.
What happens if the button on the EMPAVELI Injector won’t push in and lock?
Make sure that you have taken off the Red Safety Tab. If the Safety Tab is removed, make sure you have tried to push the button all the way in. If you still cannot push the button all the way in, then the EMPAVELI Injector is damaged.
Remove your EMPAVELI Injector and set aside. Open a new EMPAVELI Injector and start over. Call the ApellisAssist team at 1-866-MY-APL-ASSIST (1-866-692-7527).
What if the EMPAVELI Injector falls off of my body?
If the EMPAVELI Injector falls off of your body, pick it up carefully. Do not touch the needle or any medicine that may be on the EMPAVELI Injector. Set the EMPAVELI Injector aside and out of the reach of children.
Call the ApellisAssist team at 1-866-MY-APL-ASSIST (1-866-692-7527).
Can I travel with EMPAVELI?
EMPAVELI can be self-administered when you are traveling. Please talk to your doctor before you travel and refer to the Travel Guide for specific details on travel storage, preparation, packing, and tips for traveling.
Once enrolled in the ApellisAssist program, you’ll have access to our Home Suite Home resources, including the Travel Bag. The Travel Bag will keep your medication cool and at the right temperature for up to 19 hours.
Additional resources
What other resources are available to me while on treatment?
After you’re enrolled in the ApellisAssist program, there will be several resources and dedicated care partners available to you.
The My Infusion Tracker™ app offers administration reminders, self-administration timers, guides, and much more. Ask your Care Coordinator for a link to download the app.
HOME SUITE HOME is a program that empowers you with tools to help you comfortably integrate EMPAVELI self-administration into your home. HOME SUITE HOME offers tools to stay organized and store EMPAVELI, and videos to help optimize your home space for your infusions.
