Empaveli is a prescription medicine used to treat adults with a disease called paroxysmal nocturnal hemoglobinuria (PNH).

It is not known if Empaveli is safe and effective in children.

Empaveli is a medicine that can affect your immune system. Empaveli can lower the ability of your immune system to fight infections.

• Empaveli may increase your chance of getting serious and life-threatening meningococcal infections.
• Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early.
• Empaveli may also increase the risk of getting serious infections. People who take Empaveli may have an increased risk of getting infections caused by Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. Serious infections may quickly become life threatening and cause death if not recognized and treated early.
• You must be vaccinated against these bacteria at least 2 weeks before your first dose if you have not already had these vaccines.
• If your healthcare provider decides that urgent treatment with Empaveli is needed, you should receive the required vaccinations as soon as possible.
• If you have not been vaccinated and Empaveli therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations.
• If you have been vaccinated against these bacteria in the past, you might need additional vaccinations before starting treatment. Your healthcare provider will decide if you need additional vaccinations.
• Vaccines reduce the risk of serious infections, but do not prevent all serious infections. 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 and a rash
  • shortness of breath
  • extreme pain or discomfort
  • headache with nausea or vomiting
  • high heart rate
  • headache and a fever
  • headache with a stiff neck or stiff back
  • confusion
  • muscle aches with flu-like symptoms
  • eyes sensitive to light
  • clammy skin

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. Your risk of serious infections may continue for several weeks after your last dose. 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 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.
• give you a Patient Safety Card about your risk of serious infections, as discussed above.
• make sure that you are vaccinated.

• See the detailed Instructions for Use that comes with your prescription for information about how to prepare and infuse your dose of Empaveli.
• Your healthcare provider should show you how to prepare and infuse Empaveli before you use it for the first time.
• Use this medicine exactly as your healthcare provider tells you. Your healthcare provider will tell you how much to infuse and how often. Do not infuse more or less than your healthcare provider tells you to.
• Empaveli is given by infusion under the skin (subcutaneously) into your stomach (abdomen), back of upper arms, hips, or thighs using an infusion pump.
• Empaveli is given by an infusion 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 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)

If you miss a dose, take the missed dose as soon as possible. Take your next dose at your regularly scheduled time.

Do not take Empaveli if you:

• are allergic to pegcetacoplan or any of the other ingredients. See the end of this Medication Guide for a complete list of ingredients.
• have not been vaccinated against Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B, unless your healthcare provider decides that urgent treatment with Empaveli is needed. See Important information.
• have a serious Streptococcus pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type B infection.

Before taking Empaveli

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.
  • Females who are able to become pregnant should use an effective method of birth control (contraception) during treatment, and for 40 days after the final dose.
• are breastfeeding or plan to breastfeed. It is not known if Empaveli passes into your breast milk. You should not breastfeed during treatment, and for 40 days after the final 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.

Empaveli can cause serious side effects including:

• See Important information
• Allergic reactions. Allergic reactions can happen during your Empaveli infusion. Stop your infusion and tell your healthcare provider or get emergency medical care right away if you get any of these symptoms during your infusion:
  • chest pain
  • trouble breathing or shortness of breath
  • swelling of your face, tongue, or throat
  • feel faint or pass out

The most common side effects in people with PNH treated with Empaveli include injection-site reactions, infections, diarrhea, pain in the stomach (abdomen), respiratory tract infection, viral infection, and tiredness.

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. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with pegcetacoplan, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.