How EMPAVELI can help

Peg is an
adult who's taken
EMPAVELI.

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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
  • 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; 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.

The effectiveness of EMPAVELI in clinical trials

EMPAVELI was studied in two Phase 3 clinical trials for PNH:

  • The PEGASUS study, which included adults with previous C5i treatment (eculizumab)
  • The PRINCE study, which included adults without any previous complement inhibitor treatment
Previous C5i treatment (PEGASUS)
No previous complement
inhibitor treatment (PRINCE)

Superior improvements in hemoglobin (Hb) in people who previously received a C5i: results at Week 16

Primary goal: to explore whether EMPAVELI was better at improving Hb levels than a C5i (eculizumab) in people living with PNH



People taking EMPAVELI had a2.37 g/dL Hb INCREASE

People taking eculizumab had a1.47 g/dL Hb DECREASE

SUPERIOR
Hb DIFFERENCE
of 3.84 g/dL
with EMPAVELI
compared to eculizumab
(P<0.0001)

Average change in Hb levels from beginning to Week 16

Average change in hemoglobin levels with EMPAVELI across 16 weeks  in PEGASUS clinical trial chartAverage change in hemoglobin levels with EMPAVELI across 16 weeks  in PEGASUS clinical trial chart


Hb improvement was maintained through the 48-week study

Average change in Hb levels from beginning to Week 48

Average change in hemoglobin levels with EMPAVELI across 48 weeks in PEGASUS clinical trial chartAverage change in hemoglobin levels with EMPAVELI across 48 weeks in PEGASUS clinical trial chart


How EMPAVELI was studied in PEGASUS

In the PEGASUS clinical trial, EMPAVELI was compared to the C5i treatment eculizumab.

Study participants with paroxysmal nocturnal hemoglobinuria (PNH) icon

80 adults
with PNH

Steady dose of C5i treatment study icon

On a steady dose of
eculizumab for
at least 3 months

Low hemoglobin levels study icon

With low Hb levels
(less than 10.5 g/dL)

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

The transition time for Group 2 was 4 weeks and involved taking both eculizumab and EMPAVELI, before receiving EMPAVELI only.


Main goals of PEGASUS

  • Primary goal: explore changes in Hb levels from the beginning of the study
  • Safety: monitor the occurrence of side effects

Selected secondary goals and analyses

  • See how many people could become transfusion-free
  • Explore changes in absolute reticulocyte count (ARC)absolute reticulocyte count (ARC)A test that measures the number of immature red blood cells in your blood. High reticulocyte counts may be a sign of ongoing hemolysis with PNH, as the body is making more new red blood cells to replace the ones being destroyed by the immune system. from the beginning of the study
  • Explore changes in lactate dehydrogenase (LDH)lactate dehydrogenase (LDH)An enzyme found in the blood and tissues of the body, including 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. from the beginning of the study
  • Explore changes in fatigue from the beginning of the study
  • Measure the proportion of people achieving normalizationnormalizationLab values improving to levels like those of adults who don’t have PNH. of Hb or LDH

Noninferiority testsNoninferiority testsA test done to show that a treatment is not worse than another treatment. were used for these secondary goals. These tests determined if EMPAVELI was no worse than a C5i (eculizumab) compared to the beginning of the study.

Emma adult patient with paroxysmal nocturnal hemoglobinuria (PNH) drawing

“After 2 weeks into treatment, my Hb began to rise, and it has stayed consistently around 13. This is the type of response my doctor and I were hoping for.”

—Emma

Emma is an adult with PNH who's taken EMPAVELI.
Individual experiences may vary.

Avoiding the need for transfusions

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

0%

of people taking EMPAVELI
were transfusion-free

Avoiding the need for transfusions icon
0%

of people taking a C5i (eculizumab)
were transfusion-free


Reduced ARC

At Week 16, EMPAVELI was no worse than a C5i (eculizumab) in helping people with PNH reduce their absolute reticulocyte count (ARC).

  • People taking EMPAVELI saw their ARC reduced by 136 x 109 cells/L
  • People taking a C5i (eculizumab) saw an increase in ARC of 28 x 109 cells/L

Changes in LDH

At Week 16, it could not be determined if EMPAVELI was any worse than C5i (eculizumab) in reducing LDH.

  • People taking EMPAVELI had reduced LDH by 15 U/L compared to their LDH values at the beginning of the study
  • People taking a C5i (eculizumab) had reduced LDH by 10 U/L compared to their values at the beginning of the study

This information is for observation only and no conclusions can be made on the effect of EMPAVELI on LDH levels.


Changes in fatigue

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

Measuring fatigue improvement

Participants measured their fatigue using the
FACIT-Fatigue scale, a type of survey

Fatigue was measured using the FACIT-Fatigue scale, a 13-question survey. In the survey, participants rated the level of impact they felt that their fatigue had on daily activities and function.


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.

People taking EMPAVELI
showed an improvement of

0points

compared to their fatigue scores
at the beginning of the study

Experiencing changes in fatigue icon

People taking a C5i (eculizumab)
showed a decrease of

0points

compared to their fatigue scores
at the beginning of the study

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

Average FACIT-Fatigue scores with EMPAVELI across 16 weeks in PEGASUS clinical trial chartAverage FACIT-Fatigue scores with EMPAVELI across 16 weeks in PEGASUS clinical trial chart

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

An increase of 5 or more points
is seen as a clinically meaningful improvement.

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


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

FACIT=Functional Assessment of Chronic Illness Therapy.

In a post hoc analysispost hoc analysisAn analysis that is done after a study has ended. It gathers additional findings based on what happened in the study. It is not considered as scientifically strong as an analysis that was planned before the study began. of PEGASUS data, most people taking EMPAVELI reported fatigue levels consistent with adults who don’t have PNH

  • FACIT-Fatigue normalization was achieved when scores reached those of adults without PNH (≥43.6)
  • FACIT-Fatigue normalization was achieved by 72% (23/32) of those taking EMPAVELI and 21% (6/29) of those taking a C5i (eculizumab)
  • A post hoc analysis gathers additional findings after a study has ended. It is not considered as scientifically strong as an analysis that was planned before the study began

A post hoc analysispost hoc analysisAn analysis that is done after a study has ended. It gathers additional findings based on what happened in the study. It is not considered as scientifically strong as an analysis that was planned before the study began. of PEGASUS data found a link between Hb and fatigue

Post hoc analysis of PEGASUS clinical trial data on hemoglobin and fatigue chartPost hoc analysis of PEGASUS clinical trial data on hemoglobin and fatigue chart

People with greater
improvements in Hb
showed larger
reductions in fatigue

People with PNH who had an Hb improvement of 1 g/dL or more
had an average fatigue improvement of ~10 points.

  • This analysis included people receiving EMPAVELI and people receiving eculizumab

“I love leisurely walks and vacations with my family. With my increase in Hb levels and energy, I don't have to miss out.”

—Andrea

Andrea is an adult with PNH who's taken EMPAVELI.
Individual experiences may vary.

Getting to normalization of lab values

What is normalization? How is it different than stabilization?

NormalizationNormalizationLab values improving to levels like those of adults who don’t have PNH. means lab values improved to levels like those of adults who don’t have PNH. This is different than stabilizationstabilizationLab values remaining at a stable level and not getting worse., which generally means that lab values did not get worse.


Hb normalization

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

At Week 16 in PEGASUS

Hemoglobin normalization at Week 16 in PEGASUS clinical trial of EMPAVELI chartHemoglobin normalization at Week 16 in PEGASUS clinical trial of EMPAVELI chart

34%

of people taking
EMPAVELI achieved
Hb normalization

These data include only people who did not require a transfusion during the study.

Hb normalization means their Hb got to within the normal range (12-16 g/dL for females, 13.6-18 g/dL for males).


LDH normalization

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

The majority of people taking EMPAVELI reduced their LDH levels to within the normal range (113-226 U/L).

At Week 16 in PEGASUS

LDH normalization at Week 16 in PEGASUS clinical trial of EMPAVELI chartLDH normalization at Week 16 in PEGASUS clinical trial of EMPAVELI chart

71%

of people taking
EMPAVELI achieved
LDH normalization

These data include only people who did not require a transfusion during the study.

Stabilized hemoglobin (Hb)*

Hemoglobin stabilization at Week 26 in PRINCE clinical trial of EMPAVELI chart

86%

of people taking
EMPAVELI achieved
Hb stabilization
over 26 weeks

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


Hb normalization

This information is for observation only and no conclusions can be made on the effect of EMPAVELI on Hb normalization. No comparisons can be made between those taking EMPAVELI and those in the control arm (excluding complement inhibitors).

At Week 26 in PRINCE

Hemoglobin normalization at Week 26 in PRINCE clinical trial of EMPAVELI chart

46%

of people taking
EMPAVELI achieved
Hb normalization

These data include only people who did not require a transfusion during the study.

Hb normalization means their Hb got to within the normal range (12-16 g/dL for females, 13.6-18 g/dL for males).



Reduced LDH

Rapid and sustained LDH reductions

By Week 2 in PRINCE, average LDH levels in the EMPAVELI group had dropped from baseline and remained there through 26 weeks.

Reduction of LDH through 26 weeks in PRINCE clinical trial of EMPAVELI chart

At Week 26, average reductions in LDH levels were:

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

LDH normalization

This information is for observation only and no conclusions can be made on the effect of EMPAVELI on LDH normalization. No comparisons can be made between those taking EMPAVELI and those in the control arm (excluding complement inhibitors).

Nearly 2/3 of people taking EMPAVELI reduced their LDH levels to within the normal range (113-226 U/L).

At Week 26 in PRINCE

LDH normalization at Week 26 in PRINCE clinical trial of EMPAVELI chart

66%

of people taking
EMPAVELI achieved
LDH normalization

These data include only people who did not require a transfusion during the study.



Avoiding the need for transfusions

At Week 26, most people taking EMPAVELI were transfusion-free.

0%

of people taking EMPAVELI
were transfusion-free

Avoiding the need for transfusions icon
0%

of people in the
control arm (excluding
complement inhibitors)
were transfusion-free


How EMPAVELI was studied in PRINCE

The PRINCE clinical trial compared people taking EMPAVELI to people in a control arm, which meant they were not taking EMPAVELI or any type of complement inhibitor treatment. People in the control arm continued their non–complement inhibitor medications, if they were taking any.

Study participants with paroxysmal nocturnal hemoglobinuria (PNH) icon

53 adults with PNH were randomly divided
into 2 groups and studied for 26 weeks

Group 1 of participants with paroxysmal nocturnal hemoglobinuria (PNH) in PIRNCE clinical trial icon

received EMPAVELI
(n=35)

Group 2 of participants with paroxysmal nocturnal hemoglobinuria (PNH) in PIRNCE clinical trial icon

(the control arm)
continued their PNH treatment
without EMPAVELI or any
other complement inhibitor
(n=18)

  • These people had never received complement inhibitor treatment for their PNH before entering the trial. People entering the trial had an Hb level below normal
  • Most people in the trial had been getting frequent blood transfusions to make up for low Hb levels. People entering the PRINCE trial had received an average of 4 transfusions in the preceding year



Main goals of PRINCE

  • Explore achieving stabilization of Hb levels
  • Explore changes in LDH from the beginning of the study
  • Safety: monitor the occurrence of side effects

Selected secondary goals and analyses

  • See how many people could become transfusion-free
  • Measure the proportion of people who achieved normalization of Hb
  • Measure the proportion of people who achieved normalization of LDH

Up to 3 years of results from an integrated analysis

An open-label extension study included adults with PNH (N=114) who enrolled and had previously completed the EMPAVELI Phase 3 studies (PEGASUS, PRINCE). Long-term data presented are from an integrated 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 (2.5 years, PRINCE; 3 years, PEGASUS).

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 post hoc, integrated analysisintegrated analysis An analysis of 2 sets of clinical trial data. are descriptive in nature, collected for observation only
  • The analysis included a mixed group of people with PNH—those with previous C5i treatment (PEGASUS) and those without complement inhibitor treatment (PRINCE). Findings may not represent all people with PNH
  • Baseline for those not originally assigned EMPAVELI in the trials was defined by when they started receiving EMPAVELI to evaluate the long-term effectiveness and safety of treatment with EMPAVELI

Long-term sustained Hb and LDH

Hb levels up to 3 years

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


LDH levels up to 3 years

Most common side effects

  • The most common adverse events (≥10%) were infections and infestations (75.8%), injection site reactions (36.4%), abdominal pain (18.2%), fatigue (18.2%), headache (16.7%), and cough (12.1%)—consistent with those reported in the original studies

Serious side effects

  • Two serious adverse events deemed related to EMPAVELI occurred: 1 case of biliary sepsis (severe infection of the gallbladder and associated structures) in PEGASUS and 1 case of sepsis (severe, potentially life-threatening infection throughout the body) in PRINCE

Overall, no new or unexpected side effects were identified.

Louis adult patient with paroxysmal nocturnal hemoglobinuria (PNH) with baseball bat and glove

“Before EMPAVELI, my Hb and LDH were not where my doctor and I wanted them to be. Now they’re at comfortably normal levels.”

—Louis

Louis is an adult with PNH who's taken EMPAVELI.
Individual experiences may vary.

Learn about the safety of EMPAVELI view possible side effects

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
  • 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; 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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