C3G/primary IC-MPGN

For questions about financial assistance, call 1-866-MY-APL-ASSIST

Glossary

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real teen who's taken EMPAVELI

Allograft

A transplanted organ, such as a kidney, that comes from another person.

Allograft loss

Allograft loss occurs when a transplanted organ, like a kidney, stops working and can no longer support the body. In the case of transplanted kidneys, this may mean the person needs another transplant or needs to return to treatments like dialysis.

BUN-to-creatinine ratio test

A test that compares the levels of 2 waste products in your blood: blood urea nitrogen (BUN) and creatinine. The results can help your healthcare team understand how well your kidneys are working and identify possible causes of kidney problems.

C3 fragment buildup

C3 fragment buildup happens when fragments of a protein from the complement system, called C3, collect in your kidneys. This buildup can damage your kidneys in C3G and is thought to do the same in primary IC-MPGN.

C3 glomerulopathy (C3G)

A rare kidney disease that happens when part of the immune system, called the complement system, does not work properly. This can lead to inflammation and damage in the kidneys.

Complement overactivation

Complement overactivation happens when the complement system becomes too active. This can cause inflammation and damage to healthy tissues, including the kidneys.

Complement system

The complement system is a part of your immune system that helps to protect you from infections. When it’s working correctly, it helps the body recognize and remove harmful bacteria. But when it becomes overactivated, it can lead to C3 fragment buildup in the kidneys.

Dialysis

Dialysis is a treatment that helps remove waste and extra fluid from the blood when the kidneys are not working properly. Dialysis is generally used for patients with kidney failure or advanced kidney disease.

Disease progression

Disease progression refers to how a disease changes over time. As a disease progresses, symptoms may worsen or more damage may occur in the body.

Edema

Edema is swelling caused by extra fluid trapped in the body’s tissues.

eGFR

Estimated glomerular filtration rate, or eGFR, is a measure that shows how well your kidneys are filtering waste. A higher number means better kidney function.

Erythema

Erythema is redness of the skin that can happen when blood flow increases in response to irritation or inflammation.

Exploratory endpoint

An outcome researchers look at in a clinical study to learn more about how a treatment may work or affect patients. These results can provide helpful early insights, but more research is needed to confirm the findings.

Hematuria

Hematuria means there is blood in the urine. The blood may be visible, or it may only be found during a urine test.

Hemorrhage

Hemorrhage means bleeding, either inside or outside the body.

Hypoesthesia

Hypoesthesia means reduced feeling or numbness in part of the body.

Kidney failure

Kidney failure happens when your kidneys lose most or all of their ability to filter waste and fluids from your blood. This can lead to serious health problems and may require dialysis or a kidney transplant.

Inflammation

Inflammation is the body's response to injury, infection, or illness. Although it can help protect the body, too much inflammation can damage healthy tissues, including the kidneys.

Open-label period

A part of a clinical study when both the patient and the researchers know which treatment the patient is receiving.

Persistent proteinuria

Persistent proteinuria means there is an ongoing amount of protein in the urine. This can be a sign that the kidneys are damaged or not working properly.

Primary IC-MPGN

Primary IC-MPGN is a rare kidney disease that can happen when the immune system damages the kidneys. Over time, this damage can make it harder for the kidneys to work properly.

Proteinuria

Proteinuria is the presence of protein in your urine. It means your kidneys’ filters aren’t working properly and are letting protein leak out. Proteinuria can be a sign of kidney damage or other health issues.

Pruritus

Pruritus is another word for itching.

Pyrexia

Pyrexia is another word for fever.

uPCR

Urine protein-to-creatinine ratio, or uPCR, is a measure of the amount of protein in your urine compared to creatinine. It helps detect kidney problems without needing a full-day urine collection.

Treatment-emergent adverse event

A treatment-emergent adverse event (TEAE) is any new or worsening health problem that happens after someone starts a treatment or joins a clinical trial.

IC-MPGN=immune-complex membranoproliferative glomerulonephritis; uPCR=urine protein-to-creatinine ratio.

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) and the loss of kidney function.

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

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C3G/Primary IC-MPGN

For questions about financial assistance, call 1-866-MY-APL-ASSIST

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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) and the loss of kidney function.

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