Curious about 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)
- Stable Hb levels: in the PRINCE study (in people without previous complement inhibitor treatment), 86% of people taking EMPAVELI achieved Hb stabilization* over 26 weeks. None (0%) of those in the control arm (without complement inhibitors) achieved Hb stabilization (P<0.0001)
- Reduced lactate dehydrogenase (LDH): also in the PRINCE study, average reductions in LDH levels at Week 26 were -1870 U/L in people taking EMPAVELI and -400 U/L in the control arm (without 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.
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.
The complement cascade is a part of your immune system that, when dysregulated or not working correctly, can cause overactivation. This can lead to extravascular hemolysis (EVH) or intravascular hemolysis (IVH). EMPAVELI addresses the dysregulation and thereby controls both kinds of hemolysis, not just one or the other.
When the complement cascade is activated, one action leads to another, like dominoes tipping over. In PNH, the complement cascade is dysregulated, like dominoes that keep tipping over again and again. This uncontrolled process needs to be corrected. EMPAVELI works at a critical point further up in this cascade, at a protein called C3, to do just that. C3 plays a central role in complement dysregulation.
Before you're prescribed EMPAVELI, you should direct all questions to your doctor. Your doctor will be able to answer questions, share information, and connect you to additional resources.
Your doctor will be your primary contact for questions regarding your treatment and care 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:
- Engaging with someone already taking EMPAVELI with our Meet a Peer program
- Ask a question and an Apellis Patient Engagement Team member will guide you to the answer
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 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. The Doctor Discussion Guide is a great resource for this conversation. You can download it here
- Bring someone with you who can take notes about your conversation with your doctor
Getting started on EMPAVELI
EMPAVELI may lower the ability of your immune system to fight infections and increases your chance of getting serious infections caused by encapsulated bacteria such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophulis influenzae type B.
Serious infections may quickly become life-threatening or cause death if not recognized and treated early. Therefore, your doctor will ensure you have been vaccinated against these bacteria. You must complete or be up to date with these vaccines at least 2 weeks before your first dose of EMPAVELI.
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.
Even if you have had these vaccines in the past, you might need additional vaccines before starting EMPAVELI. Your doctor will decide if you need additional vaccines.
The ApellisAssist program is here to help! Our Vaccine Coordinator can assist you with this process.
First, your doctor submits the EMPAVELI Start Form with your prescription.
Then, your dedicated Care Coordinator, through ApellisAssist, will work with your doctor on the approval process.
Your Care Coordinator from our specialty pharmacy partner will communicate insurance updates to you based on your communication preferences.
Out-of-pocket costs vary based on individual insurance coverage. Your Care Coordinator will help explain your insurance benefits and coverage options and review available financial assistance programs for which you may be eligible.
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 C5 inhibitor 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.
You will most likely receive EMPAVELI from a specialty pharmacy. 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 whenever necessary.
Medication and supplies will typically be shipped 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.
Your Care Coordinator will work with you to schedule shipments on the delivery date and at the location of your choice. If you'd like, a signature can be required upon arrival of the shipment.
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
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!
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.
As you prepare to start on EMPAVELI, you will collaborate with your Apellis Care Team, composed of a dedicated Care Coordinator through ApellisAssist 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
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 and an ACE.
Your ACE will provide self-administration training, disease education, and ongoing support.
Taking EMPAVELI
EMPAVELI can be used until the expiration date printed on the carton. Do not use EMPAVELI if the expiration date has passed.
EMPAVELI should be stored in the refrigerator between 36ºF to 46ºF (2°C-8°C) in the original carton to protect from light.
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.
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.
To order more EMPAVELI or schedule a delivery, reach out to your Care Coordinator through our specialty pharmacy partner.
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 partner.
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, the specialty pharmacy will reach out to you about 10 days prior to needing your refill. During this call you can 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).
The recommended dose of EMPAVELI is 1080 mg administered subcutaneously twice weekly. If you miss 1 or both doses within a week, talk to your doctor and notify the Apellis Product Compliance Team at medinfo@apellis.com or notify your ACE if enrolled in the ApellisAssist program.
It is recommended that you keep a record of the doses you take in a journal or log like the CareKit Treatment Journal. Be sure to take the record with you each time you visit your doctor because they may ask to see it.
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 preparing with a vial of EMPAVELI and syringe. Call the ApellisAssist team at 1-866-MY-APL-ASSIST (1-866-692-7527).
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).
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.
A Travel Bag is available for patients enrolled in ApellisAssist to be able to travel with their EMPAVELI medication. The Travel Bag will keep your medication cool and at the right temperature for up to 19 hours. To request a Travel Bag, please speak with your Care Coordinator or call the ApellisAssist team at 1-866-MY-APL-ASSIST (1-866-692-7527).
Additional resources
After you’re enrolled in the ApellisAssist program, there will be several resources and dedicated care partners available to you.
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.