Empaveli

What is EMPAVELI?

(EMPAVELI) Pegcetacoplan is used to treat a certain blood disorder (paroxysmal nocturnal hemoglobinuria). This disorder causes your body's immune system to destroy red blood cells, which results in anemia. It works by helping block your body's destruction of red blood cells. This effect helps lessen symptoms of anemia (such as tiredness, shortness of breath), and may reduce the need for blood transfusions.

How should I use EMPAVELI?

Read the Medication Guide and Instructions for Use provided by your pharmacist. Carry the Patient Safety Card with you at all times during treatment and for 2 months after your last dose of pegcetacoplan. If you have any questions, ask your doctor or pharmacist. If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Take the vial out of the refrigerator and let it warm to room temperature for about 30 minutes before injecting. Do not warm up this medication in any other way such as heating in the microwave or placing in hot water. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely. This medication is given by slow injection under the skin as directed by your doctor, usually twice a week using an infusion pump. The injection is given under the skin of your abdomen, thighs, hips, or upper arms. Do not infuse where the skin is tender, bruised, red, or hard. Avoid injecting into tattoos, scars, or stretch marks. Use a different site(s) from the last time you infused this medication. If more than one site is needed for your dose, make sure they are at least 3 inches apart. The dosage is based on your medical condition, lab tests, and response to treatment. Reactions may happen with your injection. Tell your health care professional right away if you have symptoms such as chest discomfort/pain, shortness of breath, feeling faint, or injection site itching, warmth, redness, swelling, rash, or pain. Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar to keep track of when to use the next dose. If you are changing to this medication treatment from another drug, carefully follow your doctor's directions for when to start or stop this and your other medication(s). Do not stop using this medication without consulting your doctor. Your condition may become worse when the drug is stopped. If you do stop using this medication, your doctor will monitor you for at least 8 weeks to make sure your condition does not get worse. Consult your doctor for more details. Tell your doctor if your condition does not get better or if it gets worse.

What should I tell my health care provider before I take EMPAVELI?

Before using pegcetacoplan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/recent infection, vaccinations. Pegcetacoplan can make you more likely to get certain infections (such as flu, colds, meningitis). Talk to your doctor for more details. Tell your doctor your vaccine history and ask if you need to get any vaccines before starting treatment with this medication. Tell your health care professional that you are using pegcetacoplan before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose). This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using pegcetacoplan. Pegcetacoplan may harm an unborn baby. Your doctor may order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for 40 days after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 40 days after the last dose. Consult your doctor before breastfeeding.

What may interact with EMPAVELI?

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

What should I watch for while using EMPAVELI?

Pegcetacoplan can lower your body's ability to fight infections. This increases your chance of getting very serious (possibly fatal) infections (especially meningitis or sepsis). Get medical help right away if you develop symptoms such as nausea/vomiting that doesn't stop, fever, chills, severe headache, stiff neck, mental/mood changes (such as confusion), muscle aches with flu-like symptoms, eye sensitivity to light. Your doctor may prescribe certain vaccines for you to get at least 2 weeks before receiving this medication. Vaccines may not fully protect everyone who receives them, so you should still watch for signs of infection after you get the vaccine. To receive this medication in the United States, you must understand, agree to, and carefully follow the requirements of the Empaveli REMS Program. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

What if I miss a dose of EMPAVELI?

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

What side effects may I notice from receiving EMPAVELI?

See also Warning and How to Use sections. Tiredness, headache, dizziness, diarrhea, abdominal pain, or muscle/joint pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Where should I keep EMPAVELI?

Store in the original container in a refrigerator away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.