Talk to someone with EMPAVELI 
Sign up to get the latest on EMPAVELI. EMPAVELI is a medicine that affects your immune system and may lower the ability of your immune system to fight infections.
EMPAVELI increases your chance of getting serious infections caused by encapsulated bacteria such as 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.
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. 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, and give you a Patient Safety Card about your risk of serious infections.
Do not take EMPAVELI if you:
Before you take EMPAVELI, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the vaccines you receive and medicines you take, including prescription 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:
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:
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; pain in the arms, hands, legs, or feet; low potassium in blood; tiredness; viral infection; cough; joint pain; dizziness; headache; and rash.
These are not all of the possible side effects of EMPAVELI. Tell your healthcare provider about any side effect 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.
EMPAVELI is a prescription medicine used to treat adults with a disease called paroxysmal nocturnal hemoglobinuria (PNH).
Please see full Prescribing Information, including Boxed WARNING regarding risk of serious infections, and Medication Guide for additional information.
According to a US survey of 122 people with PNH taking a C5iC5iA treatment that targets the C5 protein in the complement system (part of the immune system). C5 is a protein located in the blood that plays an important role in inflammation and intravascular hemolysis caused by the complement system. treatment (35 received eculizumab and 87 received ravulizumab), some of them continued to have low Hb levels, ongoing fatigue, and the need for transfusions. Most people surveyed (97%) received C5i treatment for ≥3 months.
Possible limitations of the survey included:
While C5i treatments have been shown to be effective in addressing some aspects of hemolysis, below normal Hb, impaired functioning, and the need for transfusions remain common and could mean hemolysis is not under control.
Not achieving Hb levels ≥10.5 g/dL*
on eculizumab
(20/32)
on ravulizumab
(47/82)
Ongoing fatigue†
on eculizumab
(31/35)
on ravulizumab
(65/87)
Ongoing need for transfusions‡
on eculizumab
(12/23)
on ravulizumab
(7/31)
*Based on responses from 114 of the 122 survey participants who reported their Hb levels.
†Fatigue was measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale, which is a type of survey that collects information about the impact of fatigue on different parts of daily life. The scale ranges from 0 to 52. Higher scores mean less fatigue.
‡In patients who had a lifetime history of a transfusion and were on C5i treatment for at least 1 year. The need for transfusions was defined as 1 or more transfusions in the past 12 months.
Talk to your healthcare provider about your ongoing PNH
symptoms and available treatment options.
EMPAVELI is a medicine that affects your immune system and may lower the ability of your immune system to fight infections.
EMPAVELI increases your chance of getting serious infections caused by encapsulated bacteria such as 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.
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. 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, and give you a Patient Safety Card about your risk of serious infections.
Do not take EMPAVELI if you:
Before you take EMPAVELI, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the vaccines you receive and medicines you take, including prescription 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:
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:
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; pain in the arms, hands, legs, or feet; low potassium in blood; tiredness; viral infection; cough; joint pain; dizziness; headache; and rash.
These are not all of the possible side effects of EMPAVELI. Tell your healthcare provider about any side effect 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.
EMPAVELI is a prescription medicine used to treat adults with a disease called paroxysmal nocturnal hemoglobinuria (PNH).
Please see full Prescribing Information, including Boxed WARNING regarding risk of serious infections, and Medication Guide for additional information.
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