C3G/primary IC-MPGN

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Meredith, a real adult who's taken EMPAVELI

EMPAVELI safety profile

Meredith, a real adult who's taken EMPAVELI

Most common side effects (≥5%) in adults and children (aged 12 years and older) treated with EMPAVELI and greater than placebo include:

Injection site reactions*

25% with EMPAVELI
(n=16)

vs 23% with placebo
(n=14)

Fever

19% with EMPAVELI
(n=12)

vs 10% with placebo
(n=6)

Fatigue

6% with EMPAVELI
(n=4)

vs 2% with placebo
(n=1)

Nasal swelling

18% with EMPAVELI
(n=11)

vs 12% with placebo
(n=7)

Influenza

11% with EMPAVELI
(n=7)

vs 5% with placebo
(n=3)

Nausea

10% with EMPAVELI
(n=6)

vs 7% with placebo
(n=4)

Cough

10% with EMPAVELI
(n=6)

vs 2% with placebo
(n=1)

Observed safety in children (12 to <18 years old)
  • Side effects in children 12-17 were similar to those seen in adults
  • Frequency and severity of treatment-emergent adverse eventsTreatment-emergent adverse eventsA treatment-emergent adverse event (TEAE) means any new or worsening health problem that happens after someone starts a treatment during a clinical trial. (TEAEs) were similar between patients treated with EMPAVELI and placebo
    • Frequency: 82.1% (n=23) with EMPAVELI, 96.3% (n=26) with placebo
    • Severity: serious treatment-related side effect in 10.7% (n=3) with EMPAVELI, 11.1% (n=3) with placebo
  • In the EMPAVELI arm, 1 serious TEAE (fever) was considered related to treatment
  • No transplant rejection or allograft lossAllograft lossAllograft loss occurs when a transplanted organ (like a kidney) stops working and can no longer support the body. This may mean the person needs another transplant or needs to return to treatments like dialysis. was observed in post-transplant C3G pediatric patients
  • There were no deaths in pediatric patients
  • Safety and effectiveness of EMPAVELI in patients with recurrent IC-MPGN following kidney transplant have not been established


Observed safety in post-transplant adults whose C3G returned

  • No treatment-emergent adverse eventsTreatment-emergent adverse eventsA treatment-emergent adverse event (TEAE) means any new or worsening health problem that happens after someone starts a treatment during a clinical trial. led to treatment discontinuation at Week 26 in the RCP in post-transplant patients with recurrent C3G
    • In the open-label period, 1 patient with recurrent C3G following kidney transplant developed herpes zoster meningoencephalitis (a rare brain infection that impacts the layer of thin tissue that covers your brain) while on concomitant immunosuppression, leading to treatment discontinuation
  • No deaths, transplant rejection, or allograft lossAllograft lossAllograft loss occurs when a transplanted organ (like a kidney) stops working and can no longer support the body. This may mean the person needs another transplant or needs to return to treatments like dialysis. were reported in post-transplant recurrent C3G patients
  • Safety and effectiveness of EMPAVELI in patients with recurrent IC-MPGN following kidney transplant have not been established

RCP=randomized controlled period; TEAE=treatment-emergent adverse event.

*Influenza (moderate), nasopharyngitis (mild), and viral infection (moderate); 1 each.

†Nasopharyngitis (mild).

‡Proteinuria and tubulointerstitial nephritis; 1 each.

  • Serious side effects due to viral infections resulting in hospitalizations occurred in 2 patients (3%) with C3G or primary IC-MPGN receiving EMPAVELI and 1 patient (2%) on placebo
  • One patient (2%) on EMPAVELI with native kidney C3G died because of respiratory failure due to COVID-19 pneumonia (a serious lung infection); there were no deaths in the placebo arm
  • The placebo-controlled period of VALIANT was followed by a 26-week open-label periodOpen-label periodA part of a clinical study when both the patient and the researchers know which treatment the patient is receiving. (OLP). During the OLP, 1 patient with native kidney C3G had a serious side effect of pneumonia caused by a type of bacteria called Streptococcus pneumoniae. One patient with recurrent C3G following kidney transplant developed herpes zoster meningoencephalitis (a rare brain infection that impacts the layers of thin tissue that covers your brain) while they were also taking immunosuppression medications, leading to treatment discontinuation
  • In a separate trial in 13 adults with recurrent C3G or primary IC-MPGN after kidney transplant, 1 patient with primary IC-MPGN experienced a serious side effect of lung fungal infection known as Pneumocystis jirovecii pneumonia (which can occur in individuals with suppressed immune systems) while on EMPAVELI and while on immunosuppressive medications

*Term includes the following reactions at the infusion site: erythema, pruritus, swelling, bruising, induration, pain, hemorrhage, discomfort, edema, rash, and hypoesthesia.

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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.

EMPAVELI REMS program ensures your safety is a top priority

EMPAVELI is only available through a program called the EMPAVELI Risk Evaluation and Mitigation Strategy (REMS).

REMS is a safety program run by the FDA. Before you can take EMPAVELI, your healthcare provider must enroll in the program and will provide you with the following:

  • Counseling on the risk of serious infections caused by certain bacteria
  • Information about the symptoms of serious infections
  • Appropriate vaccinations against serious infections caused by encapsulated bacteria
    • You will receive antibiotics if you need to start EMPAVELI right away and are not up to date on your vaccines

      Find vaccine support

  • A Patient Safety Card
    • Carry this card with you at all times during treatment and for 2 months after your last EMPAVELI dose
    • Show this card to any healthcare professional to help diagnose and treat you quickly
    • Your risk of serious infection may continue for several weeks after your last dose of EMPAVELI
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C3G=C3 glomerulopathy; IC-MPGN=immune-complex membranoproliferative glomerulonephritis.

INDICATION AND 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.

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 and can be life-threatening. Stop your EMPAVELI infusion and 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 adults and children 12 years of age and older with C3G or primary IC-MPGN treated with EMPAVELI include injection-site reactions, fever, common cold, flu, cough, and nausea.

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 and children 12 years of age and older with a kidney disease called complement 3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), to reduce levels of protein in the urine (proteinuria).

Please see full Prescribing Information, including Boxed WARNING regarding risk of serious infections, and Medication Guide for additional information.

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INDICATION AND 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.

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 and can be life-threatening. Stop your EMPAVELI infusion and 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 adults and children 12 years of age and older with C3G or primary IC-MPGN treated with EMPAVELI include injection-site reactions, fever, common cold, flu, cough, and nausea.

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 and children 12 years of age and older with a kidney disease called complement 3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), to reduce levels of protein in the urine (proteinuria).

Please see full Prescribing Information, including Boxed WARNING regarding risk of serious infections, and Medication Guide for additional information.