C3G/primary IC-MPGN

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Understanding C3G and primary IC-MPGN

Actor portrayal.

How C3G and primary IC-MPGN impact the body

C3G (C3 glomerulopathy) and primary IC-MPGN (immune-complex membranoproliferative glomerulonephritis) are rare, serious kidney diseases that affect about 5000 people in the US. They happen when part of your immune system, called the complement systemComplement systemThe complement system is a part of your immune system that helps protect you from infections. When it’s working correctly, it attacks harmful bacteria. But when it becomes overactivated, it can lead to C3 fragment buildup., becomes overactivated.

Normally, the complement system helps defend against infections and gets rid of damaged cells. But in these diseases, it isn’t regulated properly, causing it to become overactivated.

The role of C3 in kidney damage

A protein called C3 plays a major role in complement overactivation.

Over time, ongoing complement system overactivation leads to:

Reduced kidney function

High levels of protein in your urine (proteinuriaProteinuriaProteinuria is the presence of too much protein in your urine. It means your kidneys’ filters aren’t working properly and are letting protein leak out. Proteinuria isn’t a disease itself, but it can be a sign of kidney damage or other health issues.)

C3 fragment buildupC3 fragment buildupC3 fragment buildup happens when pieces of a protein from your immune 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. in the kidneys that can cause kidney damage

A retrospective study of 149 patients with C3G or IC-MPGN found that at least 50% reduction in proteinuria at 12 months was associated with a lower risk of progression to kidney failureKidney failureKidney 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.*

*A retrospective study looks at existing patient records, this was not a new treatment trial. The results show a link between lower protein in the urine and better kidney outcomes. This does not prove that lowering protein will always prevent kidney failure.

*A retrospective study looks at existing patient records, this was not a new treatment trial. The results show a link between lower protein in the urine and better kidney outcomes. This does not prove that lowering protein will always prevent kidney failure.

If left unchecked, these effects can lead to a decline in kidney function and kidney failure.

Don’t delay!

Talk to your doctor about the role of complement system overactivation in C3G and primary IC-MPGN.

Testing: your path to diagnosis

As part of your diagnosis, many tests were likely performed, including:

  • Blood and urine tests to check
    • Protein levels or proteinuria (measured by urine protein-to-creatinine ratio, or uPCRuPCRuPCR is a test that measures the amount of protein in your urine compared to creatinine. It helps detect kidney problems without needing a full-day urine collection.)
    • Kidney function (measured by estimated glomerular filtration rate, or eGFReGFReGFR is a blood test that shows how well your kidneys are filtering waste. A higher number means better kidney function.)
    • C3 levels
  • A kidney biopsy to check for C3 staining
    • Your doctor used a special dye on kidney tissue obtained from a biopsy to look at the amount of C3 fragment buildup
    • This is the only way to confirm a C3G or primary IC-MPGN diagnosis

Actor portrayal.

Doctors use C3 staining from a kidney biopsy to assess how much C3 has built up in the kidneys

Examples of C3 staining from kidney biopsies:

Microscopic images: Courtesy of Patrick D. Walker, MD, Senior Renal Pathologist at Arkana Laboratories.

C3 levels are measured on a scale from 0 to 3, called “intensity levels.”

This image is for illustrative purposes only.
The intensity scale is a visual representation that does not reflect actual biopsy results.

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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C3G/Primary IC-MPGN

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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.