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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.
- 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.
- If your healthcare provider decides that urgent treatment with EMPAVELI is needed, you should receive the required vaccinations as soon as possible.
- If you have not been vaccinated and EMPAVELI therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations.
- 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.
- 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
- 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 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
- 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.
EMPAVELI is a paroxysmal nocturnal hemoglobinuria (PNH) treatment that you give yourself at home or wherever works for you (after receiving proper training). Each EMPAVELI infusion should take about 30 to 60 minutes.
EMPAVELI is self-administered subcutaneously (just under the skin) with a commercially available infusion pump with a reservoir of at least 20 mL. With EMPAVELI self-administration, there’s no need to plan days or vacations around infusion center visits.
- No intravenous (IV) infusions
- No infusion center visits
- No need to plan around
How do I take EMPAVELI?
EMPAVELI is self-administered just under the skin using a small, thin needle.
For illustration purposes only.
- Subcutaneous needles reach just under the skin into the fatty layer
- EMPAVELI is not an IV infusion (into the vein) that requires a healthcare provider to administer it for you
Not actual size, for illustration purposes only.
- Exact needle size may vary for some people with PNH
What else should I know before starting EMPAVELI?
1-on-1 self-administration training
Your healthcare provider will first show you how to self-administer your EMPAVELI.
At Apellis, we understand each person’s journey with PNH and EMPAVELI is different. With that in mind, we have designed our support services and self-administration training to fit comprehensive patient needs.
With the ApellisAssist® patient support program, you will have the help of an Apellis Care Educator (ACE). ACEs have nursing backgrounds and will provide you with self-administration training. Your ACE can train you in your home or virtually—multiple times, if necessary—to make sure you’re comfortable with the process.
They will continue to be by your side throughout your journey with ongoing support, education, and answers to your questions.
ACEs do not give medical advice. Talk to your doctor for treatment-related questions.
Transitioning to EMPAVELI from a C5i treatment
Your healthcare provider will work with you to transition you to EMPAVELI.
- For the first 4 weeks, you will receive EMPAVELI and your current dose of eculizumab
- After 4 weeks, STOP eculizumab and only take EMPAVELI
- You should start taking EMPAVELI no more than 4 weeks after your last dose of ravulizumab
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 before taking your first dose of EMPAVELI.
As part of the ApellisAssist program, a Vaccine Coordinator through our specialty pharmacy, PANTHERx® Rare, can help you with this process
Your Vaccine Coordinator can help make sure you get the required vaccines by:
- Researching local pharmacies based on your location and insurance coverage
- Creating a list of local options that have all required vaccines in stock along with information on hours of operations and how to make an appointment
- Contacting your pharmacy of choice to transfer any required prescription orders and make sure the pharmacy has all the appropriate information on file for billing the vaccines
When visiting your healthcare provider:
- Bring your vaccination records
- Ask your healthcare provider which vaccines you will need before starting EMPAVELI
Reach out to your healthcare provider if you have any additional questions about starting EMPAVELI.
How often do I take EMPAVELI?
- EMPAVELI is taken 2 times a week*
- The infusion takes about 30 minutes (if using 2 infusion sites) or 60 minutes (if using 1)
*If there is an increase in your LDH, an enzyme in your blood, your healthcare provider may tell you to take EMPAVELI every 3 days.
Watch the EMPAVELI self-administration video
“I love to travel. With EMPAVELI self-administration, I can bring my supplies with me and travel without interrupting my treatment schedule.”
Emma is an adult with PNH taking EMPAVELI.
Individual experiences may vary.
When traveling, ensure that EMPAVELI stays at 36°F to 46°F (2°C-8°C).