Pegcetacoplan

What it is used for

SYFOVRE is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). SYFOVRE is a complement inhibitor indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

The most important thing to know

EMPAVELI is a medicine that affects your immune system. EMPAVELI may lower the ability of your immune system to fight infections. EMPAVELI increases your chance of getting serious infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. These serious infections may quickly become life-threatening or cause death if not recognized and treated early.

You must complete or be up to date with the vaccines against Streptococcus pneumoniae and Neisseria meningitidis at least 2 weeks before your first dose of EMPAVELI. If you have not completed your vaccines and EMPAVELI must be started right away, you should receive the required vaccines as soon as possible. If you have not been vaccinated and EMPAVELI must be started right away, you should also receive antibiotics to take for as long as your healthcare provider tells you.

If you have been vaccinated against these bacteria in the past, you might need additional vaccines before starting EMPAVELI. Your healthcare provider will decide if you need additional vaccines. Vaccines do not prevent all infections caused by encapsulated bacteria. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a serious infection: fever with or without shivers or the chills fever with chest pain and cough fever with high heart rate headache and fever confusion clammy skin fever and a rash fever with breathlessness or fast breathing headache with nausea or vomiting headache with a stiff neck or stiff back body aches with flu-like symptoms eyes sensitive to light Your healthcare provider will give you a Patient Safety Card about the risk of serious infections.

Carry it with you at all times during treatment and for 2 months after your last dose of EMPAVELI. Your risk of serious infections may continue for several weeks after your last dose of EMPAVELI. It is important to show this card to any healthcare provider who treats you. This will help them diagnose and treat you quickly.

EMPAVELI is only available through a program called the EMPAVELI Risk Evaluation and Mitigation Strategy (REMS). Before you can take EMPAVELI, your healthcare provider must: enroll in the EMPAVELI REMS program counsel you about the risk of serious infections caused by certain bacteria give you information about the symptoms of serious infections make sure that you are vaccinated against serious infections caused by encapsulated bacteria and that you receive antibiotics if you need to start EMPAVELI right away and you are not up to date on your vaccines give you a Patient Safety Card about your risk of serious infections, as discussed above For more information about side effects, see "

How to take it

See the detailed Instructions for Use that comes with your EMPAVELI for information about how to prepare and infuse your dose of EMPAVELI with your infusion pump. See the detailed Instructions for Use that comes with your EMPAVELI Injector for information about how to prepare and inject your dose of EMPAVELI with your EMPAVELI Injector.

Your healthcare provider should show you how to prepare and administer EMPAVELI before you use it for the first time. Use EMPAVELI exactly as your healthcare provider tells you. Do not use more or less than your healthcare provider tells you to. If you miss a dose of EMPAVELI, take the missed dose as soon as possible. Take your next dose at your regularly scheduled time.

For adults with PNH: EMPAVELI is given under the skin (subcutaneously) 2 times each week. If there is an increase in your LDH, an enzyme in your blood, your healthcare provider may tell you to take EMPAVELI every 3 days. If you are changing treatment from eculizumab to EMPAVELI, you should continue eculizumab for 4 weeks after your first dose of EMPAVELI.

After 4 weeks, you should stop treatment with eculizumab. If you are changing treatment from ravulizumab to EMPAVELI, you should take your starting dose of EMPAVELI no more than 4 weeks after your last dose of ravulizumab. If you have PNH and you stop taking EMPAVELI, your healthcare provider will need to monitor you closely for at least 8 weeks after stopping EMPAVELI.

Stopping treatment with EMPAVELI may cause a breakdown of red blood cells due to PNH. Symptoms or problems that can happen due to red blood cell breakdown include: decreased hemoglobin level in your blood blood in your urine shortness of breath trouble swallowing tiredness pain in the stomach (abdomen) blood clots erectile dysfunction (ED) For adults and children 12 years of age and older with C3G or primary IC-MPGN: EMPAVELI is given under the skin (subcutaneously) 2 times each week.

What are the possible side effects of EMPAVELI? EMPAVELI can cause serious side effects including: Allergic reactions. Allergic reactions can happen during your EMPAVELI infusion and can be life-threatening. Stop your EMPAVELI infusion and get emergency medical care right away if you get any of these symptoms during your EMPAVELI infusion: chest pain trouble breathing or shortness of breath wheezing swelling of your face, tongue, or throat feel dizzy or faint or pass out fast heart rate nausea or vomiting feel confused or anxious skin reactions, including rash, hives, and itching The most common side effects in adults with PNH treated with EMPAVELI include: injection-site reactions infections diarrhea pain in the stomach (abdomen) respiratory tract infection pain in the arms, hands, legs or feet low potassium in blood tiredness viral infection cough joint pain dizziness headache rash The most common side effects in adults and children 12 years of age and older with C3G or primary IC-MPGN treated with EMPAVELI include: injection-site reactions fever common cold flu cough nausea Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all of the possible side effects of EMPAVELI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects, and when to stop

" What is EMPAVELI? EMPAVELI is a prescription medicine used to: treat adults with a disease called paroxysmal nocturnal hemoglobinuria (PNH). treat adults and children 12 years of age and older with a kidney disease called complement 3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), to reduce levels of protein in the urine (proteinuria).

It is not known if EMPAVELI is safe and effective in children with PNH. It is not known if EMPAVELI is safe and effective in children under 12 years of age with C3G or primary IC-MPGN.

Who should not take it

Do not take EMPAVELI if you: are allergic to pegcetacoplan or any of the ingredients in EMPAVELI. See the end of this Medication Guide for a complete list of ingredients in EMPAVELI. have a serious infection caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type B when you are starting EMPAVELI treatment.

Before you take EMPAVELI, tell your healthcare provider about all of your medical conditions, including if you: have an infection or fever. are pregnant or plan to become pregnant. EMPAVELI may harm your unborn baby. Females who are able to become pregnant: should have a pregnancy test before starting treatment with EMPAVELI.

use an effective method of birth control (contraception) during treatment with EMPAVELI and for 40 days after the last dose. are breastfeeding or plan to breastfeed. It is not known if EMPAVELI passes into your breast milk. You should not breastfeed during treatment with EMPAVELI and for 40 days after the last dose. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

EMPAVELI and other medicines can affect each other, causing side effects. Know the medicines you take and the vaccines you receive. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Storing it

Store vials of EMPAVELI in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. Do not use EMPAVELI past the expiration date stamped on the carton. Keep EMPAVELI and all medicines out of the reach of children.