INDICATION AND IMPORTANT SAFETY INFORMATION
What is EMPAVELI® (pegcetacoplan)?
EMPAVELI is a prescription medicine used to treat adults with a disease called paroxysmal nocturnal
What is the most important information I should know about EMPAVELI?
EMPAVELI is a medicine that can affect your immune system
and can lower the ability of your immune system to fight infections.
EMPAVELI may increase your chance of getting serious and life-threatening meningococcal infections
that may quickly become life-threatening and cause death if not recognized and treated early.
EMPAVELI may also increase the risk of getting serious infections caused by certain bacteria such as
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 of EMPAVELI 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
starting EMPAVELI. 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
provider or get emergency medical care right away if you get any of these signs and symptoms of a
- 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
- muscle aches with flu-like symptoms
- clammy skin
- 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 EMPAVELI dose. It is important to
this card to any healthcare provider to help them diagnose and treat you quickly.
EMPAVELI is only available through a program called the EMPAVELI Risk Evaluation
Strategy (REMS). Before you can take EMPAVELI, your healthcare provider must enroll in the
program, counsel you about the risk of serious infections caused by certain bacteria, give you information
the symptoms of serious infections, give you a Patient Safety Card about your risk of serious infections,
make sure that you are vaccinated.
Who should NOT take EMPAVELI?
Do not take EMPAVELI if you:
- are allergic to pegcetacoplan or any of the ingredients in EMPAVELI.
- 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.
- have a serious infection caused by the bacteria above.
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 and use an
method of birth control during treatment with EMPAVELI 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.
not breastfeed during treatment with EMPAVELI and for 40 days after the final dose.
Tell your healthcare provider about all the vaccines you receive and medicines you take, including
and over-the-counter medicines, vitamins, and herbal supplements which could affect your treatment.
If 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
- pain in the stomach (abdomen)
- blood clots
- erectile dysfunction (ED)
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. Stop your EMPAVELI infusion and tell your healthcare provider or 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
- 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
These are not all of the possible side effects of EMPAVELI. Tell your healthcare provider about any side
that bothers you or that does not go away.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.