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Empaveli
Pronunciation: em-PAH-vee-li
Generic name: pegcetacoplan
Dosage form: injection, for subcutaneous use, via an infusion pump or Empaveli injector
Drug class: Selective immunosuppressants
Medically reviewed by Carmen Pope, BPharm. Last updated on Oct 12, 2023.
What is Empaveli?
Empaveli (pegcetacoplan) is an immunosuppressant that is given by subcutaneous (under the skin)
infusion, which may be used to treat adults with paroxysmal nocturnal hemoglobinuria (PNH). PNH is
a rare acquired, life-threatening disease of the blood that is characterized by the destruction of red
blood cells (hemolytic anemia), blood clots (thrombosis), and impaired bone marrow function.
Empaveli works by binding to specific proteins in the complement system, which is a part of the
immune system that enhances (or complements) the ability of antibodies and phagocytic cells to clear
microbes and damaged cells from an organism, promote inflammation, and attack the pathogen's cell
membrane. Empaveli binds to complement protein C3 and prevents it from splitting into C3a and C3b.
This helps to stop intravascular hemolysis (IVH or the destruction of red blood cells in the circulation)
and extravascular hemolysis (EVH or the breakdown of red blood cells in the spleen, bone marrow, or
liver by macrophages). Empaveli is the only treatment that targets C3 and may prevent both forms of
red blood cell destruction (IVH and EVH). It works higher in the complement system than other
treatments used for PNH.
Empaveli was FDA approved on May 14, 2021 and is only approved to treat PNH.
Warnings
Empaveli can lower the ability of your immune system to fight infections and increase your risk of
developing serious and life-threatening infections, including meningitis caused by encapsulated
bacteria such as Streptococcus pneumoniae; Neisseria meningitidis, types A, C, W, Y, and B; and
Haemophilus influenzae type B. You must be vaccinated against these bacteria at least 2 weeks
before your first dose 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. Meningococcal infections may quickly become life-threatening and cause death if not
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Empaveli: Uses, Dosage, Side Effects, Warnings - Drugs.com https://www.drugs.com/empaveli.html
May cause infusion-related reactions or anaphylaxis which may be life-threatening. Seek immediate
medical attention if you develop any of the following, difficulty breathing including shortness of breath
and wheezing, swollen tongue or throat, feeling faint, rapid heart rate, skin reactions, including hives
and itching, nausea or vomiting, confusion and anxiety, dizziness or fainting.
May interfere with laboratory tests, such as those that use silica reagents in coagulation panels (may
cause an artificially prolonged activated partial thromboplastin time [aPTT]).
Only available through a restricted program called the Empaveli REMS. Your healthcare provider
must be a member of this program to be able to prescribe Empaveli and provide you with the
necessary information and Patient Safety Card.
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 once you have started taking Empaveli:
• shortness of breath
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Empaveli: Uses, Dosage, Side Effects, Warnings - Drugs.com https://www.drugs.com/empaveli.html
• confusion
• clammy skin.
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 dose. Your risk of serious
infections may continue for several weeks after your last dose. It is important to show this card to any
healthcare provider who treats you. This will help them diagnose and treat you quickly.
It is not known if Empaveli passes into breast milk. You should not breastfeed during treatment, and
for 40 days after the final dose.
• have not been fully vaccinated against Streptococcus pneumoniae, Neisseria meningitidis, and
Haemophilus influenzae type B, unless your healthcare provider decides that urgent treatment
with Empaveli is needed
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Empaveli: Uses, Dosage, Side Effects, Warnings - Drugs.com https://www.drugs.com/empaveli.html
Your doctor or nurse will show you how to use the Injector or infusion pump so you can administer it
at home, or a caregiver can administer it to you.
It is usually given twice a week, although a healthcare provider may instruct some people to
administer it every three days.
If you are using the infusion pump, it usually takes around 30 minutes to infuse (if using two infusion
sites) or approximately 60 minutes (if using one infusion site). See the product information for
complete details about the administration process.
Do not stop taking Empaveli without your doctor's advice. After stopping it, your healthcare provider
will need to monitor you closely for at least 8 weeks, because stopping treatment may cause a
breakdown of red blood cells due to PNH, and symptoms such as:
• shortness of breath
• trouble swallowing
• tiredness
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Empaveli: Uses, Dosage, Side Effects, Warnings - Drugs.com https://www.drugs.com/empaveli.html
• blood clots
• chest pain
The most common side effects occurring in 10% or more people on Empaveli include:
• infections
• diarrhea
• tiredness
• cough
• joint pain
• dizziness
• headache
• a rash.
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Empaveli: Uses, Dosage, Side Effects, Warnings - Drugs.com https://www.drugs.com/empaveli.html
Tell your healthcare provider about any side effect that bothers you or that does not go away. These
are not all of the possible side effects. For more information, ask your healthcare provider or
pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA
at 1-800-FDA-1088 or to Apellis Pharmaceuticals, Inc at 1-833-866-3346.
Storage
Store vials in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton to protect from
light.
Ingredients
Active ingredient: pegcetacoplan
Inactive ingredients: sorbitol, glacial acetic acid, sodium acetate trihydrate, Water for Injection USP.
Empaveli may also contain sodium hydroxide and/or additional glacial acetic acid for pH adjustment.
Manufacturer
Apellis.
Popular FAQ
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Empaveli: Uses, Dosage, Side Effects, Warnings - Drugs.com https://www.drugs.com/empaveli.html
References
1. Product information
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to
your personal circumstances.
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