Empaveli - Pegcetacoplan Injection

What is this medication?

PEGCETACOPLAN (peg set a KOE plan) treats paroxysmal nocturnal hemoglobinuria (PNH), a condition that causes low levels of red blood cells (anemia) and blood clots. It works by slowing down an overactive immune system, which reduces the breakdown of red blood cells. It may also be used to treat kidney disease. It works by decreasing levels of protein in the urine. This helps protect the kidneys.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): EMPAVELI

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Infection
• An unusual or allergic reaction to pegcetacoplan, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is injected under the skin. You will be taught how to prepare and give it. Take it as directed on the prescription. Keep taking it unless your care team tells you to stop.

It is important that you put your used needles, syringes, tubing, and infusion set or on-body injector in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. While it may be given to children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Talk to your care team about your vaccination history. To lower your risk of infection, you may need certain vaccines before you start this medication.

Carry the Patient Wallet Card with you at all times. Show it to all members of your care team. It describes the signs and symptoms of severe side effects you may have while taking this medication.

Talk to your care team if you may be pregnant. This medication can cause serious fetal side effects if taken during pregnancy. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 40 days after the last dose. Your care team can help you find the option that works for you.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
• Low potassium level—muscle pain or cramps, unusual weakness or fatigue, fast or irregular heartbeat, constipation

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Diarrhea
• Dizziness
• Headache
• Joint pain
• Pain in the hands, arms, legs, or feet
• Pain, redness, or irritation at injection site
• Stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store this medication in the refrigerator. Keep it in the original carton until you are ready to take it. Remove the dose from the carton about 30 minutes before it is time for you to take it. Protect from light. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.