Uses

What is Empaveli used for?

Empaveli (pegcetacoplan) is commonly used to treat a blood disorder called paroxysmal nocturnal hemoglobinuria (PNH). People with PNH have a problem with their immune system that causes their body to attack and break down red blood cells. If too many red blood cells are destroyed, it can cause anemia.

Empaveli for Paroxysmal Nocturnal Hemoglobinuria: What You Need to Know

Empaveli may also be used for other conditions as determined by your healthcare provider.

How does Empaveli work (mechanism of action)?

Empaveli works in a specific part of your immune system, called the complement system, to stop your body from breaking down red blood cells. When you use Empaveli, fewer red blood cells are destroyed by your body, which reduces symptoms of anemia. This effect may also help to lower the number of blood transfusions that you need.  

How is Empaveli supplied (dosage forms)?

Empaveli is available as a 1,080 mg/20 mL (54 mg/mL) solution for injection in a single-dose vial that is injected under the skin (subcutaneous).

How should I store Empaveli?

Store Empaveli in the refrigerator, between 36 F to 46 F (2 C to 8 C). Store Empaveli in the original carton to protect it from light. 

Side Effects

What are the most common side effects of Empaveli?

The most common side effects of Empaveli are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Pain, itching, swelling, or redness near the injection site
  • Infections (see below)
  • Diarrhea
  • Stomach pain
  • Pain in the arms, hands, legs, or feet
  • Low potassium level (hypokalemia)
  • Tiredness
  • Cough
  • Joint pain
  • Dizziness
  • Headache
  • Rash

There may be other side effects of Empaveli that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Empaveli?

While less common, the most serious side effects of Empaveli are described below, along with what to do if they happen.

Severe Allergic Reactions. Empaveli may cause allergic reactions, which can be serious. Stop using Empaveli and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Infection. Empaveli can increase the risk of infections, including serious infections from certain bacteria that can cause meningitis, pneumonia, or other conditions. These infections can be life-threatening and lead to death. Call your healthcare provider right away if you have an infection or any of the following symptoms.

  • Fever, clammy skin, or chills
  • Chest pain with cough
  • Shortness of breath
  • Fast heart rate
  • Headache
  • Confusion
  • Nausea or vomiting
  • Body aches and flu-like symptoms
  • Sensitivity to light
  • Stiff neck or back

Infusion Reactions. Empaveli can cause reactions that can be serious when it is given to you. Your infusion may need to be slowed or stopped if you have these reactions. Tell your healthcare provider right away if you have any of the following symptoms when you get your infusion.  

  • Swelling of your face, tongue, or throat
  • Trouble breathing
  • Nausea or vomiting
  • Feeling confused or anxious
  • Dizziness or fainting
  • Chest pain
  • Fast heart rate
  • Hives, itching, rash, or other skin problems

Warnings & Precautions

Who should not use Empaveli?

Allergies to Ingredients. People who are allergic to any of the following should not use Empaveli.

  • Empaveli
  • Pegcetacoplan
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Empaveli.

Serious Infections. People with certain serious infections should not start treatment with Empaveli.

What should I know about Empaveli before using it?

Do not use Empaveli unless it has been prescribed to you by a healthcare provider. Use it as prescribed.

Do not share Empaveli with other people, even if they have the same condition as you. It may harm them.

This medicine is injected under the skin. Make sure that you or a caregiver understands how to properly prepare and use Empaveli. If you have any questions, talk to your healthcare provider.

Keep Empaveli out of the reach of children. Since this medicine must be kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator.

If you stop using Empaveli, keep all appointments with your healthcare provider to make sure that your condition is not getting worse. Some people who stop Empaveli have a breakdown of red blood cells due to their PNH. This may cause you to have symptoms such as blood in your urine, trouble breathing or swallowing, or tiredness. You will need to be monitored for at least 8 weeks after stopping Empaveli. 

Empaveli can interact with certain laboratory tests. Make sure your healthcare provider knows that you are using Empaveli before you have any labs drawn.

You should be up to date with your vaccines at least 2 weeks before starting Empaveli. Even if you are current with your vaccines, you can still develop serious infections while using Empaveli. If you need to start Empaveli right away and have not received all of your recommended vaccines yet, you may need to take antibiotics to prevent infection until the vaccines have time to work. Ask your healthcare provider if you are not sure.

You can only get Empaveli at certain pharmacies that are enrolled in the Empaveli Risk Evaluation and Mitigation Strategy (REMS) program. To receive Empaveli, you must understand that the medicine can increase your risk of serious infections. This risk can last for several weeks after you stop using Empaveli. When you start Empaveli, you will receive a Patient Safety Card about this risk that you should keep with you at all times while using the medicine and for at least 2 months after stopping it. To learn more about how to get Empaveli, you can visit empaveli.com/apellisassist-program or call 866-692-7527.

What should I tell my healthcare provider before using Empaveli?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Empaveli is right for you.

In particular, make sure that you discuss any of the following.

Infection or Fever. Empaveli can increase your risk for serious, sometimes fatal, infections. Tell your healthcare provider right away if you have a fever or any other signs of infection. 

Pregnancy. Empaveli may cause harm to an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. If you can become pregnant, you should have a pregnancy test before starting Empaveli. You should also use effective birth control while you are receiving Empaveli and for 40 days after your last dose. Talk to your healthcare provider about your birth control options. 

Breastfeeding. It is not known if Empaveli passes into breast milk. You should not breastfeed while being treated with Empaveli and for 40 days after your last dose. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Empaveli?

For more information about Empaveli, you can visit the manufacturer’s website at empaveli.com or call them at 866-692-7527.

Interactions

Does Empaveli interact with foods or drinks?

There are no known interactions between Empaveli and foods or drinks.

There are no known interactions between Empaveli and alcohol.

Does Empaveli interact with other medicines (drug interactions)?

There are no known interactions between Empaveli and other medicines. Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does Empaveli (pegcetacoplan) interact with other drugs you are taking?
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Overdose/Missed Dose

What should I do if I accidentally use too much Empaveli?

If you or someone else has used too much Empaveli, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Empaveli?

If you miss a dose of Empaveli, use the missed dose as soon as possible. Then, use your next dose at the regular time.

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