As with other drugs, Empaveli (pegcetacoplan) can cause side effects, such as injection site reaction and diarrhea. If you are not able to tolerate side effects of Empaveli, talk with your doctor or pharmacist.

Empaveli (pegcetacoplan) is a brand-name injection that’s prescribed for a rare blood disorder called paroxysmal nocturnal hemoglobinuria (PNH) in adults.

If you have problems with side effects from Empaveli, talk with your doctor or pharmacist. They can discuss ways to manage side effects or other available treatment options. Do not stop taking Empaveli without consulting your doctor first.

For additional information about Empaveli, including details about its uses, see this Empaveli overview article.

Empaveli has a boxed warning. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Boxed warning for Empaveli” section.

Empaveli can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects persist, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who took Empaveli in clinical trials:

  • injection site reaction, such as pain or swelling
  • infection
  • diarrhea
  • fatigue
  • abdominal pain

For more information about some of these side effects, see the “Side effect specifics” section.

Mild side effects can occur with Empaveli use. This list does not include all possible mild side effects of the drug. For more information, you can refer to Empaveli’s prescribing information.

Mild side effects that have been reported with Empaveli include:

These side effects may be temporary, lasting a few days to weeks. However, if the side effects continue, worsen, or become too difficult to tolerate, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while taking Empaveli and want to tell the FDA about it, visit MedWatch.

For more information about some of these side effects, see the “Side effect specifics” section.

Empaveli may cause serious side effects. The following list may not include all possible serious side effects of the drug. For more information, you can refer to Empaveli’s prescribing information.

If you develop serious side effects while taking Empaveli, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported include serious infection, such as pneumonia. (Empaveli has a boxed warning for this side effect. See the “Side effect specifics” section for more details.)

Allergic reaction

For some people, Empaveli can cause an allergic reaction.

In general, symptoms of an allergic reaction can be mild or serious.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or difficulty breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Empaveli, your doctor may recommend taking a different medication instead.

Empaveli has a boxed warning. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

Risk of serious infections caused by encapsulated bacteria

Empaveli may increase your risk of serious infections caused by certain bacteria called encapsulated bacteria. The infections can include meningitis, sepsis (blood infection), and pneumonia. Symptoms can vary depending on the type of infection, but they may include:

  • difficulty breathing
  • fever
  • confusion
  • rash
  • sensitivity to light
  • clammy skin
  • tachycardia (fast heart rate)
  • cough

In rare cases, these infections can lead to death if not treated quickly.

What you can do

To reduce your risk of these infections, you should be up to date on your vaccinations. If not, you’ll likely need to receive the vaccine against the bacteria before you start treatment with Empaveli.

If you develop any symptoms of serious infections while taking Empaveli, talk with your doctor right away. They’ll likely prescribe antibiotics to treat it. You also may also need to stop taking Empaveli until the infection gets better. If your symptoms feel life threatening, call 911 or a local emergency number.

Due to the risk of serious infections, only doctors who are enrolled in a certain drug safety program can prescribe Empaveli. The name of the program is the Risk Evaluation and Mitigation Strategy (REMS) program.

Learn more about some of the side effects that Empaveli may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Empaveli.

Injection site reaction

Injection site reaction was a common side effect reported in studies of Empaveli. Injection site reaction may cause symptoms such as:

  • pain
  • redness or other color changes, darkness, or discoloration
  • warmth or swelling
  • hardening
  • itching

What you can do

If you experience an injection site reaction during Empaveli treatment, talk with your doctor. They can recommend ways to help manage this side effect based on your symptoms. For example, if you have pain or swelling with using Empaveli, applying a cold pack may help.

Diarrhea

Diarrhea was a common side effect reported in studies of Empaveli. This side effect was usually mild.

What you can do

Talk with your doctor or pharmacist if you have diarrhea while taking Empaveli. They’ll likely recommend taking an over-the-counter medication such as loperamide (Imodium). It’s also important to drink plenty of fluids when you have diarrhea to help prevent dehydration.

Empaveli may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

How do side effects of Empaveli compare with those seen with Soliris?

They have some similarities. Empaveli is approved to treat PNH. Soliris is also approved for this indication, and a few other indications. Empaveli is given as a subcutaneous injection (under the skin), while Soliris is given as an intravenous (IV) infusion.

More common side effects with Soliris include headache, common cold, back pain, and nausea. Empaveli can also cause headache, back pain, and certain infections. Digestive side effects may differ between the two drugs. Soliris can cause nausea and constipation, while Empaveli can cause diarrhea and abdominal pain.

If you have questions about Empaveli and Soliris, talk with your doctor or pharmacist.

Do side effects of Empaveli go away?

Yes, side effects of Empaveli go away. Most side effects of the drug are mild and temporary.

If you experience side effects that are bothersome or do not go away while using Empaveli, talk with your doctor or pharmacist.

Empaveli has a boxed warning. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Boxed warning for Empaveli” section.

Other precautions

Before taking Empaveli, discuss your health history with your doctor. Empaveli may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

  • previous allergic reaction to this or a similar drug
  • pregnancy
  • breastfeeding

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.