Pegcetacoplan Injection

Why is this medicine prescribed?

Pegcetacoplan injection is used to treat paroxysmal nocturnal hemoglobinuria (PNH: a type of anemia in which too many red blood cells are broken down in the body, so there are not enough healthy cells to bring oxygen to all parts of the body) and a certain type of kidney disease called complement 3 glomerulopathy (C3G) orprimary immune-complex membranoproliferative glomerulonephritis (IC-MPGN). Pegcetacoplan is in a class of medications called monoclonal antibodies. It works by blocking the activity of the part of the immune system that may damage blood cells.

Are there other uses for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

Pegcetacoplan injection comes as a solution (liquid) to be injected subcutaneously (just under the skin) with an infusion pump or an on-body injector. It is injected over 30 to 60 minutes twice a week.

Use pegcetacoplan injection exactly as directed. Do not use more or less of it or take it more often than prescribed byyour doctor.

You will be shown how to use the infusion pump or the on-body injector by your doctor or nurse. Youwill be given instructions for use with the medicine. This will tell you how to inject it. Read itcarefully. Ask your doctor or pharmacist if you have any questions on how to inject themedicine.

Pegcetacoplan injection may cause serious or life-threatening reactions during and after the infusion of the medication. Stop your infusion and tell your doctor or get emergency medical treatment if you experience any of the following symptoms during or after the infusion: difficulty 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; itching; or fever. Your doctor may need to stop your treatment if you experience any of these side effects.

Remove the medication from the refrigerator 30 minutes before you are ready to inject it. Place it on a flat surface and allow it to reach room temperature. Do not try to warm the medication.

Be sure that the skin in the area where you plan to use pegcetacoplan injection is clean, dry, and healthy. Choose a different site for each injection. Do not inject into an area where the skin is tender, bruised, red, hard, or where there are tattoos, scars or stretch marks.

You can inject pegcetacoplan injection using an infusion pump anywhere on the front of your thighs (upper leg), hips, or stomach, and the back of the upper arm. If you are using more than 1 infusion site, give each infusion at least 3 inches (7.5 centimeters) away from other infusion sites.

You can apply the on-body injector anywhere on the stomach except the area 1 inch (2.5 centimeters) around your belly button. Choose a different spot each time you apply the on-body injector. Do not apply the on-body injector in an area directly under a belt or waistband.

Dispose of used needles, syringes, and devices in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Pegcetacoplan injection controls your condition but does not cure it. Continue to use pegcetacoplan injection even if you feel well. Do not stop using pegcetacoplan injection without talking to your doctor.

What special precautions should I follow?

Before using pegcetacoplan injection,

• tell your doctor and pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had low blood levels of potassium or any other medical condition(s).

• tell your doctor if you are pregnant or plan to become pregnant. You may need to take a pregnancy test before you start treatment. You should not become pregnant while you are receiving pegcetacoplan injection. Use birth control to prevent pregnancy during your treatment and for at least 40 days after your final dose. If you become pregnant while using pegcetacoplan injection, call your doctor immediately. Pegcetacoplan may harm the fetus.

• tell your doctor if you are breastfeeding. You should not breastfeed while you are using pegcetacoplan injection and for 40 days after the final dose.

• you should know that your condition may cause too many red blood cells to break down after your treatment stops. This could result in blood clots. Your doctor may monitor you carefully and may order laboratory tests for at least 8 weeks after you finish your treatment. Call your doctor right away if you develop any of the following symptoms: extreme tiredness, blood in urine, stomach pain, difficulty swallowing, shortness of breath, or an inability to get or keep an erection.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget to take a dose?

Use the missed dose as soon as you remember it and continue your regular dosing schedule.

What side effects can this medicine cause?

Pegcetacoplan injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• stomach pain
• nausea
• joint, muscle, arm, leg, or back pain
• headache
• redness, pain, itching, or swelling at the injection site
• cough
• nasal congestion, runny nose or sore throat
• dizziness
• sleepiness
• bruising
• swelling of the arms, hands, feet, ankles, or lower legs
• nose bleeds

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING, HOW, or SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment.

Pegcetacoplan injection may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store pegcetacoplan injection in the refrigerator.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reachhttps://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of overdose?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to pegcetacoplan injection.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using pegcetacoplan injection.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

Brand name(s)

• Empaveli^®