PNH

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Take charge of PNH
with powerful results

Jonathan is an adult with PNH who’s taken EMPAVELI

EMPAVELI was studied in two Phase 3 clinical trials to find out how effective and safe EMPAVELI is in treating PNH:

In people with previous C5 inhibitor treatment
In people without previous complement
inhibitor treatment
Long-term results

How EMPAVELI was studied (PEGASUS)

PEGASUS was a study of 80 adults with PNH who had previously taken a C5 inhibitorC5 inhibitorA 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 contributing to inflammation and intravascular hemolysis caused by the complement system. treatment (eculizumab). The study explored whether EMPAVELI was better at improving hemoglobin than a C5 inhibitor (eculizumab) at Week 16. After that time, patients taking eculizumab were switched to EMPAVELI, and all patients were observed for an additional 32 weeks.

The study consisted of 3 parts:

Part 1 of PEGASUS clinical trial of EMPAVELI icon

Part 1

All participants received both eculizumab and EMPAVELI

Part 2 of PEGASUS clinical trial of EMPAVELI icon

Part 2

They were then split into 2 groups:

  • Group 1 received only EMPAVELI for 16 weeks (n=41)
  • Group 2 received only eculizumab for 16 weeks (n=39)
Part 3 of PEGASUS clinical trial of EMPAVELI icon

Part 3

  • Group 1 continued EMPAVELI for 32 more weeks
  • Group 2 transitioned to EMPAVELI for 32 weeks*

*Group 2 took both eculizumab and EMPAVELI for 4 weeks, then switched to EMPAVELI only.

Who was studied?
  • People who had been on a steady dose of eculizumab for at least 3 months
  • People who had anemiaanemiaA condition due to the body not having enough healthy red blood cells, which carry oxygen throughout the body. (hemoglobin [Hb]hemoglobin (Hb)The critical protein found inside red blood cells that enables other cells throughout the body to get the oxygen they need.Hemoglobin acts like drops of glue that can “stick” to oxygen and carry it from the lungs to other tissues. It can also “stick” to waste like carbon dioxide to help remove it from the body. levels less than 10.5 g/dL in their blood)
What was studied?

The primary goal was:

  • Change in hemoglobin (Hb)hemoglobin (Hb)The critical protein found inside red blood cells that enables other cells throughout the body to get the oxygen they need.Hemoglobin acts like drops of glue that can “stick” to oxygen and carry it from the lungs to other tissues. It can also “stick” to waste like carbon dioxide to help remove it from the body. levels in the blood, which indicate the number of red blood cells, from their starting values to Week 16

Some of the secondary goals were:

  • The number of people who could become transfusion freetransfusion freeA term indicating that people did not need transfusions during the time period of the study.†
  • Absolute reticulocyte count (ARC)†
  • Lactate dehydrogenase (LDH)†
  • Explore changes in fatigue

†Noninferiority tests were used for these secondary goals. These statistical tests determined if EMPAVELI was no worse than a C5 inhibitor (eculizumab).

Among people with PNH who had previously received a C5i (eculizumab), EMPAVELI was proven superior at raising hemoglobin (Hb)hemoglobin (Hb)The critical protein found inside red blood cells that enables other cells throughout the body to get the oxygen they need.Hemoglobin acts like drops of glue that can “stick” to oxygen and carry it from the lungs to other tissues. It can also “stick” to waste like carbon dioxide to help remove it from the body. levels vs those who remained on eculizumab

At Week 16

A superior difference of

3.84 g/dL

with EMPAVELI vs a C5 inhibitor (eculizumab) (P<0.0001)

Average change in Hb levels from beginning to Week 16

Average change in Hb levels from beginning to Week 16

See full study results Go back

Higher hemoglobin is a key goal in managing PNH, as it helps your red blood cells carry more oxygen throughout your body.

Laura is an adult with PNH who’s taken EMPAVELI

“After being on EMPAVELI for a few months, my hemoglobin went up to 12, which was a great improvement for me. That number has remained steady since I’ve been on the treatment.”

Individual experiences may vary.

Hb improvement was maintained through Week 48

Average change in Hb levels from study start to Week 48











The main 16-week PEGASUS study results only looked at data from patients before they received a blood transfusion. Because transfusions could skew the results, data from a patient were not included in this 16-week analysis after they had one. Later parts of the study (called the open-label period) did look at data from all patients, even if they had received a transfusion.

Average change in Hb levels from study start to Week 48

Average change in Hb levels from study start to Week 48

See full study results Go back

In PEGASUS, a study of people previously treated with a C5 inhibitor:

Most people taking EMPAVELI were transfusion freetransfusion freeA term indicating that people did not need transfusions during the time period of the study.

At Week 16 in PEGASUS, EMPAVELI was no worse than a C5i (eculizumab) in helping people with PNH become transfusion free.

Most people on EMPAVELI did not need transfusions after 16 weeks, while most on a C5 inhibitor (eculizumab) did.

Jonathan is
an adult with PNH who’s taken EMPAVELI

“I have always used my personal time off for infusions or transfusions. I have never thought about what I can really do with
that time until now. ”

Individual experiences may vary.

Sign of reduced red blood cell destruction

The study looked at something called absolute reticulocyte count (ARC). Reticulocytes are new, immature red blood cells. A high ARC can be a sign that your body is working hard to replace red blood cells being destroyed by PNH. A lower ARC can be a sign that this destruction is better controlled.

At Week 16, EMPAVELI was no worse than a C5i (eculizumab) in helping people with PNH reduce their ARC. EMPAVELI was effective at lowering ARC.

  • On average, people taking EMPAVELI saw their ARC decrease by 136 billion cells per liter
  • In contrast, people taking eculizumab saw their ARC increase by 28 billion cells per liter

A look at LDH levels in the study

The study also observed changes in lactate dehydrogenase (LDH), another marker of red blood cell destruction. It is important to know that these findings are observational, and we cannot draw firm conclusions from them. At Week 16, it could not be determined if EMPAVELI was better or worse than a C5i (eculizumab) at reducing LDH.

  • The average change from the start of the study was a 15 U/L decrease for people taking EMPAVELI and a 10 U/L decrease for those taking eculizumab

In PEGASUS, people previously treated with a C5 inhibitor were asked to report how fatigue impacted their daily lives while taking EMPAVELI or eculizumab

Although it was not formally tested, people in the study were asked to report their changes in fatigue levels at Week 16.

This information is for observation only and no conclusions can be made on the effect of EMPAVELI on fatigue. No comparisons can be made between those taking EMPAVELI and those taking eculizumab.

In a survey called the FACIT-Fatigue scale, 13 questions measure the level of impact of fatigue on daily activities and function

Patients with PNH suffer from persistent anemia, which can cause ongoing symptoms of fatigue because there are not enough red blood cells to carry oxygen throughout the body. Fatigue is a common symptom in patients with PNH.

Average FACIT-Fatigue scores from

beginning of study through Week 16

These data include people who did and did not get a transfusion during the study.

Average FACIT-Fatigue scores from beginning of study through Week 16

These data include people who did and did not get a transfusion during the study.

These data include people who did and did not get a transfusion during the study.

These data include people who did and did not get a transfusion during the study.

The scale ranges from 0 to 52. Higher scores mean less fatigue.

Compared to fatigue scores at the beginning of the study:

People taking EMPAVELI demonstrated

an average improvement of 9.2 points

People taking a C5i (eculizumab) demonstrated

an average decrease of -2.7 points

Report of fatigue may be an under- or overestimation since participants were aware of the treatment they were being given.

Bob is an
adult with PNH who’s taken EMPAVELI

“I have had more energy and have been able to get back to the things I enjoy doing without feeling as much intense fatigue as I felt before.”

Individual experiences may vary.

“I’ve been on EMPAVELI for a couple of years now, and my labs have been pretty steady, remaining in a good range. I feel much better now than I did before EMPAVELI.”

Individual experiences may vary.
Ask your doctor about EMPAVELI

Cathy is an
adult with PNH who’s taken EMPAVELI

How EMPAVELI was studied (PRINCE)

PRINCE was a study of 53 adults with PNH that looked at the effectiveness of EMPAVELI in people who had not been previously treated with a complement inhibitor. The study, which lasted 26 weeks, is explained in more detail in the pop ups below.

Who was studied?
  • People who had hemoglobin (Hb)hemoglobin (Hb)The critical protein found inside red blood cells that enables other cells throughout the body to get the oxygen they need.Hemoglobin acts like drops of glue that can “stick” to oxygen and carry it from the lungs to other tissues. It can also “stick” to waste like carbon dioxide to help remove it from the body. levels below normal
  • Most people had received frequent blood transfusions
What was studied?

The primary goals were:

  • Achieving stabilizationstabilizationLab values remaining at a stable level and not getting worse. of hemoglobin (Hb)hemoglobin (Hb)The critical protein found inside red blood cells that enables other cells throughout the body to get the oxygen they need.Hemoglobin acts like drops of glue that can “stick” to oxygen and carry it from the lungs to other tissues. It can also “stick” to waste like carbon dioxide to help remove it from the body. levels in the blood at
Week 26, which indicates the number of red blood cells that are not being destroyed and are staying healthy
  • Changes at Week 26 in LDHlactate dehydrogenase (LDH)An enzyme found in the blood and tissues of the body, including in the heart, kidneys, brain, and lungs. Red blood cell destruction results in the release of LDH into the blood. People with PNH often have higher levels of LDH due to ongoing hemolysis., a type of protein (or enzyme) released during red blood cell damage, which is a measure of intravascular hemolysisintravascular hemolysis (IVH)The destruction of red blood cells inside a blood vessel. from the beginning of the study

Selected secondary goal was:

  • The number of people who could become transfusion freetransfusion freeA term indicating that people did not need transfusions during the time period of the study. at Week 26

In people who had never received a complement inhibitor

People treated with EMPAVELI achieved Hb stabilizationstabilizationLab values remaining at a stable level and not getting worse.* and rapid and sustained reductions in LDHlactate dehydrogenase (LDH)An enzyme found in the blood and tissues of the body, including in the heart, kidneys, brain, and lungs. Red blood cell destruction results in the release of LDH into the blood. People with PNH often have higher levels of LDH due to ongoing hemolysis.

Hb stabilization*

*Hb stabilization means avoiding a >1 g/dL decrease in Hb levels throughout the study.

LDH reduction

For people taking EMPAVELI, average LDH levels in the EMPAVELI group had dropped
from baseline (starting values) at Week 2 and remained there through 26 weeks

At Week 26, patients saw average reductions in their LDH levels compared with their levels before treatment began (their baseline [starting values])

  • -1870 U/L in the EMPAVELI group
  • -400 U/L in the control arm (excluding complement inhibitors)

†Control arm (excluding complement inhibitors) only includes data on or before escape (switching to EMPAVELI).

LDH reduction

For people taking EMPAVELI, average LDH levels in the EMPAVELI group had dropped from baseline (starting values) at Week 2 and remained there through 26 weeks

At Week 26, patients saw average reductions in their LDH levels compared with their levels before treatment began (their baseline [starting values])

  • -1870 U/L in the EMPAVELI group
  • -400 U/L in the control arm (excluding complement inhibitors)

†Control arm (excluding complement inhibitors) only includes data on or before escape (switching to EMPAVELI).

In people who had never received a complement inhibitor

Most people taking EMPAVELI were transfusion freetransfusion freeA term indicating that people did not need transfusions during the time period of the study.

Most people taking EMPAVELI did not need transfusions through 26 weeks


Up to 3 years of long-term data from a clinical trial analysis

In an integrated analysis of both the PEGASUS and PRINCE trials, an open-label extension study included adults with PNH who enrolled and had previously completed the PEGASUS study (n=64). Long-term data presented are from an analysis of data in the subset of people who received 1080 mg of EMPAVELI by subcutaneous infusion twice weekly, or every 3 days, for up to 3 years.

The goal of this analysis was to evaluate the long-term effectiveness and safety of EMPAVELI in adults with PNH.

LIMITATIONS

  • Data from this analysis, which was performed after the study data were collected, are descriptive in nature, collected for observation only, and may not represent all people with PNH
  • Baseline (starting values) for people not originally assigned EMPAVELI in the initial study was defined by when these people started taking EMPAVELI in this long-term study

*A run-in phase describes the time between patient recruitment and randomization in a clinical trial, when all of the patients receive the same treatment, which may be a medication, a placebo, or no treatment at all to screen out certain patients.

Long-term sustained Hb and LDH

Average Hb levels over 3 years

Patients who had a transfusion were not included in the Hb analysis for 60 days after the transfusion.
†12 g/dL to 16 g/dL for females, 13.6 g/dL to 18 g/dL for males.

Average LDH levels over 3 years

Long-term sustained Hb and LDH

Average Hb levels over 3 years

Patients who had a transfusion were not included in the Hb analysis for 60 days after the transfusion.
†12 g/dL to 16 g/dL for females, 13.6 g/dL to 18 g/dL for males.

Average LDH levels over 3 years

Up to 2.5 years of long-term data from a clinical trial analysis

In an integrated analysis of both the PEGASUS and PRINCE trials, an open-label extension study included adults with PNH who enrolled and had previously completed the PRINCE study (n=50). Long-term data presented are from an analysis of data in the subset of people who received 1080 mg of EMPAVELI by subcutaneous infusion twice weekly, or every 3 days, for up to 2.5 years. This long-term study included patients from another subset, which is not shown below.

The goal of this analysis was to evaluate the long-term effectiveness and safety of EMPAVELI in treating adults with PNH.

LIMITATIONS

  • Data from this analysis, which was performed after the study data were collected, are descriptive in nature, collected for observation only, and may not represent all people with PNH
  • Baseline (starting values) for people not originally assigned EMPAVELI in the initial study was defined by when these people started taking EMPAVELI in this long-term study

Long-term sustained Hb and LDH

Average Hb levels over 2.5 years

Patients who had a transfusion were not included in the Hb analysis for 60 days after the transfusion.
‡12 g/dL to 16 g/dL for females, 13.6 g/dL to 18 g/dL for males.

Average LDH levels over 2.5 years

Long-term sustained Hb and LDH

Average Hb levels over 2.5 years

Patients who had a transfusion were not included in the Hb analysis for 60 days after the transfusion.
‡12 g/dL to 16 g/dL for females, 13.6 g/dL to 18 g/dL for males.

Average LDH levels over 2.5 years

See EMPAVELI safety from the clinical studies

Learn about the safety data

FACIT=Functional Assessment of Chronic Illness Therapy; Hb=hemoglobin; PNH=paroxysmal nocturnal hemoglobinuria; SE=standard error.

Hb=hemoglobin; LDH=lactate dehydrogenase; PNH=paroxysmal nocturnal hemoglobinuria; SE=standard error.

Hb=hemoglobin; LDH=lactate dehydrogenase; PNH=paroxysmal nocturnal hemoglobinuria.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about 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.

  1. 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.
  2. If you have not completed your vaccines and EMPAVELI must be started right away, you should receive the required vaccines as soon as possible.
  3. 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.
  4. 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.
  5. 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 a 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 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.

Who should NOT take EMPAVELI?

Do not take EMPAVELI if you:

  • are allergic to pegcetacoplan or any of the ingredients in EMPAVELI.
  • have a serious infection caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and 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 and use an effective method of birth control 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 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:

  • 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)

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
  • 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 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.

What is EMPAVELI® (pegcetacoplan)?

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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IMPORTANT SAFETY INFORMATION

What is the most important information I should know about 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.

  1. 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.
  2. If you have not completed your vaccines and EMPAVELI must be started right away, you should receive the required vaccines as soon as possible.
  3. 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.
  4. 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.
  5. 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 a 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 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.

Who should NOT take EMPAVELI?

Do not take EMPAVELI if you:

  • are allergic to pegcetacoplan or any of the ingredients in EMPAVELI.
  • have a serious infection caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and 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 and use an effective method of birth control 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 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:

  • 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)

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
  • 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 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.

What is EMPAVELI® (pegcetacoplan)?

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.