Pegcetacoplan (Systemic

This information from Lexicomp^® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.

Brand Names: US

Empaveli

Brand Names: Canada

Empaveli

What is this drug used for?

• It is used to treat a blood disease called paroxysmal nocturnal hemoglobinuria (PNH).

What do I need to tell my doctor BEFORE I take this drug?

• If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have not had a vaccine against meningococcal or Streptococcus pneumoniae infection.
• If you have a meningococcal, Haemophilus influenzae, or Streptococcus pneumoniae infection.
• If you are breast-feeding. Do not breast-feed while you take this drug and for 40 days after your last dose.

This is not a list of all drugs or health problems that interact with this drug.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take this drug?

• Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• Have your patient safety card with you at all times for at least 2 months after this drug is stopped.
• Have your blood work and other lab tests checked as you have been told by your doctor.
• This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
• Some people have had side effects during the infusion. Tell your doctor if you have any side effects during the infusion.
• Some health problems may happen after this drug is stopped. You will need to be watched closely for at least 2 months after stopping this drug. Call your doctor right away if you have dark urine; swelling, warmth, or pain in the leg or arm; chest pain or pressure; coughing up blood; trouble breathing or swallowing; or stomach pain. Call your doctor right away if you feel confused, very tired or weak, or have weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on 1 side of the face, or change in eyesight. Call your doctor right away if you are not able to get or keep an erection.
• This drug may cause harm to an unborn baby. A pregnancy test will be done before you start this drug to show that you are NOT pregnant.
• If you may become pregnant, you must use birth control while taking this drug and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.

On-body Injector:

• If you are allergic to acrylics, talk with your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Chest pain or pressure or a fast heartbeat.
• Dizziness or passing out.
• Upset stomach or throwing up.
• Swollen belly.
• Feeling confused.
• Anxiety.
• Signs of a common cold.
• Any unexplained bruising or bleeding.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where this drug was used.
• Stomach pain or diarrhea.
• Feeling tired or weak.
• Headache.
• Back, muscle, joint, arm, or leg pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to your national health agency.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

How is this drug best taken?

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion under the skin over a period of time.
• It may be given using a pump or an on-body injector.
• If you will be giving yourself the infusion, your doctor or nurse will teach you how to prepare and give your infusion.
• Wash your hands before and after use.
• Before using this drug, take it out of the refrigerator and leave it at room temperature for 30 minutes.
• Do not heat or microwave.
• Do not use if the solution is cloudy, leaking, or has particles.
• This drug is colorless to a faint yellow. Do not use if the solution changes color.
• Move the site where you give this drug as you were told by the doctor.
• Do not give into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
• Do not give into skin that is tattooed.
• Throw away any part left over after the dose is given.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

Infusion pump:

• If your dose needs more than 1 infusion site, make sure the infusion sites are at least 3 inches apart.

On-body Injector:

• Do not use the injector if it has been dropped or if it is broken.
• Do not give into skin within 1 inch of the belly button.
• Do not let your clothes touch the clean skin before you put the injector on your stomach.
• Do not put the on-body injector where a belt, waistband, or other type of clothing may rub against it or push it off your skin.
• Do not touch the white sticky part on the bottom of the injector before you put this drug on the stomach. Do not use anything to hold the injector in place.
• Do not bathe, shower, or swim after you put on the injector. Do not get your stomach wet. Water or sweat may cause the injector to come loose.
• Do not sleep while wearing the injector. Avoid intense physical activity and exercise while wearing it. Do not bump or knock the injector.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

How do I store and/or throw out this drug?

• Store in a refrigerator. Do not freeze.
• Store in the outer carton to protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

General drug facts

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else’s drugs.
• Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
• This drug comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this drug is refilled. If you have any questions about this drug, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This generalized information is a limited summary of diagnosis, treatment, and/or medication information. It is not meant to be comprehensive and should be used as a tool to help the user understand and/or assess potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a specific patient. It is not intended to be medical advice or a substitute for the medical advice, diagnosis, or treatment of a health care provider based on the health care provider’s examination and assessment of a patient’s specific and unique circumstances. Patients must speak with a health care provider for complete information about their health, medical questions, and treatment options, including any risks or benefits regarding use of medications. This information does not endorse any treatments or medications as safe, effective, or approved for treating a specific patient. UpToDate, Inc. and its affiliates disclaim any warranty or liability relating to this information or the use thereof. The use of this information is governed by the Terms of Use, available at https://www.wolterskluwer.com/en/know/clinical-effectiveness-terms.

Last Reviewed Date

2024-02-28

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