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Empaveli (Generic Pegcetacoplan Injection)

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A meningococcal infection, which can harm the covering of the brain and spinal cord and can spread via the bloodstream, as well as other hazardous infections during treatment or for a while after, may increase as a result of receiving a pegcetacoplan injection. Meningococcal infections have the potential to result in mortality quickly. To lower your risk of contracting this type of infection, you must receive a specific vaccine at least two weeks before starting your pegcetacoplan injectable treatment. Before starting your therapy, you might need to have a booster shot if you’ve already had this vaccination. You will have your vaccinations as quickly as possible, but you will need to take an antibiotic for two weeks if your doctor determines that you need to start treatment with a pegcetacoplan injection immediately away.

Even if you receive the meningococcal vaccine, there is still a chance that you could contract the disease while receiving the pegcetacoplan injection or afterward. Get emergency medical assistance or call your doctor right away if you develop any of the following symptoms: If you have a headache that is accompanied by nausea, vomiting, a fever, a stiff neck, or a stiff back, as well as a rash, muscular aches, other flu-like symptoms, or light sensitivity.

Before starting your pegcetacoplan injectable therapy, let your doctor know if you develop a fever or any other symptoms of infection. If you already have a certain infection, your doctor might not be able to administer the pegcetacoplan injection.

A patient safety card that details the possibility of contracting meningococcal illness or another dangerous infection while receiving treatment or for some time after will be given to you by your doctor. Throughout your treatment and for two months after it, keep this card on you at all times. All of your medical professionals who treat you should see the card so they are aware of your risk.

The chance of receiving a pegcetacoplan injection has been reduced with the implementation of a program called Empaveli REMS. Only a doctor who has signed up for this program, who has discussed the dangers of meningococcal illness and other serious diseases with you, who has given you a patient safety card, and who has made sure you’ve had the necessary vaccines can administer pegcetacoplan injection.

Every time you receive an injection of pegcetacoplan, your doctor or pharmacist will give you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

The risks of obtaining a pegcetacoplan injection should be discussed with your doctor.

Why is this medication prescribed?

Injections of pegcetacoplan are used to treat paroxysmal nocturnal hemoglobinuria (PNH), a kind of anemia in which the body breaks down too many red blood cells, leaving insufficient numbers of healthy cells to carry oxygen throughout the body. Monoclonal antibodies are a class of drugs that includes pegcetacoplan. It functions by preventing the immune system’s component from acting in a way that could harm blood cells.

How should this medicine be used?

Pegcetacoplan injection is available as a solution (liquid) that must be administered subcutaneously (just under the skin) by a healthcare professional using a pump. You may also be given the drug to use at home. When using two infusion sites, it is often administered twice a week for over 30 minutes or over 60 minutes.

During and after the medication’s infusion, pegcetacoplan injection may result in serious or fatal side effects. If you experience any of the following symptoms during or after the infusion: trouble breathing, shortness of breath and wheezing, chest pain, swelling of your face, tongue, or throat, feeling faint, dizziness, nausea, vomiting, confusion, anxiety, facial swelling, hives, or itching, stop the infusion and inform your doctor, or seek emergency medical attention. If you encounter any of these side effects, your doctor might decide to terminate your therapy.

Your healthcare practitioner will show you or your caregiver how to store, administer, and discard the drug and supplies if you will be using pegcetacoplan injection at home. Make sure you comprehend these instructions, and if you have any issues, consult your healthcare professional. If you experience any difficulties while using pegcetacoplan injection, consult your doctor for advice.

30 minutes before you are prepared to administer the drug via injection, take it out of the refrigerator. It should be placed on a flat surface and given time to warm up. Never attempt to warm the medicine.

Anywhere on the front of your thighs (upper leg), hips, belly (stomach), and back of your upper arm are suitable injection sites for pegcetacoplan injection. A minimum of 3 inches (7.5 centimeters) should separate each infusion site from other infusion sites. Use a different place for each injection to lessen the possibility of discomfort or redness. Injecting shouldn’t be done in areas with sensitive, bruised, red, or hard skin, tattoos, scars, or stretch marks.

For a copy of the manufacturer’s information for the patient, ask your pharmacist or doctor.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before receiving pegcetacoplan injection,

  • If you have any allergies, including to pegcetacoplan injection, other medicines, or any of the substances in pegcetacoplan injection, notify your doctor right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Inform your doctor of any additional medical conditions you now have or have ever had.
  • If you are pregnant or plan to become pregnant, let your doctor know. Before beginning therapy, you must perform a pregnancy test, and you must use birth control to avoid getting pregnant while receiving treatment and for at least 40 days after your last dose. The fetus might suffer from pegcetacoplan.
  • If you are breastfeeding, let your doctor know. During and for 40 days after the last dosage of pegcetacoplan, breastfeeding should be avoided.
  • You should be aware that after stopping the pegcetacoplan injection, your condition could lead to an excessive number of red blood cells rupturing. For at least 8 weeks after you stop your therapy, your doctor will closely follow you and perhaps request laboratory testing. If you experience any of the following symptoms, contact your doctor right away: extreme exhaustion, urinating blood, experiencing stomach pain, having trouble swallowing, or being unable to achieve or maintain an erection.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

Continue your regular dosing regimen while using the missed dose as soon as you remember it.

What side effects can this medication cause?

Side effects from pegcetacoplan injection are possible. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Diarrhea
  • Abdominal pain
  • Back ache
  • Headache
  • Swelling, itchiness, discomfort, or redness at the injection site

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you experience any of these symptoms or any of the ones detailed in the IMPORTANT WARNING or HOW sections.

Other negative effects of pegcetacoplan injection are possible. If you have any strange side effects while taking this medicine, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online at or by phone at 1-800-332-1088 if you have a serious side event.

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. It should be kept in the fridge.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilizing a medicine take-back program is the easiest approach to get rid of your medication. To find out about take-back programs in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back program, see the FDA’s Safe Disposal of Medicines website at for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to the pegcetacoplan injection, your doctor will request a few lab tests.

Inform the lab staff and your doctor that you are receiving a pegcetacoplan injection prior to any laboratory test.

Do not share your medication with anybody else. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every drug you take, including prescription and nonprescription (over-the-counter) medications, vitamins, minerals, and other dietary supplements. Every time you see a doctor or are admitted to the hospital, you should carry this list with you. Additionally, it is crucial to have this knowledge on hand in case of emergency.

Brand names

  • Empaveli®
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