Pegcetacoplan (peg-set-a-KOE-plan)

Treats paroxysmal nocturnal hemoglobinuria (PNH).

Brand Name(s):

Empaveli

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot in the stomach, or through an IV catheter placed under your skin, usually in the stomach, thigh, hip or upper arm. It must be given slowly, so the IV will have to stay in place using an infusion pump for at least 30 minutes (for 2 infusion sites) or at least 60 minutes (for 1 infusion site).
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where the infusion can be given. Use a different body area each time you give yourself an injection. Keep track of where you give each injection to make sure you rotate body areas. Do not inject into areas where the skin is tender, red, bruised, or hard or in areas with tattoos, scars, or stretch marks.
• Use a new needle and syringe each time you inject your medicine.
• Allow this medicine to warm to room temperature for 30 minutes before you use it. Do not warm it in any other way.
• Check the liquid in the vial. It should be clear and colorless to slightly yellow solution. Do not use the medicine if the liquid is cloudy, discolored, or has particles in it.
• Tell your doctor if you are changing treatment from eculizumab or ravulizumab to pegcetacoplan.
• Missed dose: Call your doctor or pharmacist for instructions. If you miss a dose of this medicine, use it as soon as possible. Do not double doses.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Keep the medicine in its original carton, away from direct light, until you are ready to use it. Throw away any unused medicine.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment with this medicine and for at least 40 days after the last dose.
• Do not breastfeed during treatment at for at least 40 days after the last dose.
• Tell your doctor if you have a weak immune system or any kind of infection.
• This medicine can increase your risk of serious infections, including pneumonia, meningitis, and flu-like infection. You will need to be vaccinated against these infections at least 2 weeks before you start treatment with this medicine. You may also be given antibiotic medicine to prevent infection if you are to use this medicine right away. You will also be given a patient safety card that lists the symptoms of infection and what to do if you have them. Carry the card with you at all times. Show the card to any doctor who treats you.
• This medicine can also cause an infusion reaction that can be life-threatening.
• When you stop receiving this medicine, you could develop hemolysis (breakdown of red blood cells). Your doctor will monitor you for at least 8 weeks.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, headache, fast, slow, pounding, or uneven heartbeat, lightheadedness, dizziness
• Change in how much or how often you urinate, lower back or side pain, painful or difficult urination
• Chest pain, trouble breathing
• Dry mouth, increased thirst, muscle cramps, nausea or vomiting
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Arm, leg, back, or joint pain
• Diarrhea, stomach pain
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088