Not actual
patients.

Understanding IgAN

IgA nephropathy begins outside the kidneys.

It's important to know that when it comes to proteinuria—
the lower the better.

Proteinuria, or protein in your urine, is a symptom most people associate with IgA nephropathy. Sometimes proteinuria causes foamy urine, but often there are no signs that a person has it.

Proteinuria icon Proteinuria icon

New KDIGO® Clinical Practice Guideline for the management of IgAN calls for a different way of treating IgA nephropathy and for lower proteinuria goals.

Because of the risks associated with proteinuria, kidney experts updated treatment guidelines for IgA nephropathy. 

The new approach recommends treating patients if proteinuria levels are 0.5g/day or higher.

Click here to read the updated guidelines.

IgA=immunoglobulin A.

IgAN=IgA nephropathy.

KDIGO=Kidney Disease: Improving Global Outcomes.

The KDIGO guidelines suggest treating to:

KDIGO Guidelines Graphic KDIGO Guidelines Graphic

Updated treatment goals are to keep proteinuria below 0.5g/day, with an ideal target of less than 0.3g/day.

IgA nephropathy and immune system activity.

The exact cause of IgA nephropathy is unknown. However, it is believed to start outside your kidneys in your immune system. IgA nephropathy is considered to be an immune-driven disease that can affect the kidneys.

*Antibodies are part of your immune system that usually help fight infections.
Gd-IgA1=galactose-deficient IgA1.

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INDICATION and IMPORTANT SAFETY INFORMATION for VOYXACT® (sibeprenlimab‑szsi)

INDICATION

VOYXACT is a prescription medicine used to reduce protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN) who are at risk for their disease getting worse. It is not known if VOYXACT is safe and effective in children.

This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether VOYXACT slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about VOYXACT?

  • Do not take VOYXACT if you are allergic to any of the ingredients in VOYXACT. Stop using VOYXACT and get emergency help if you develop signs and symptoms of an allergic reaction, including:
    • breathing problems
    • swelling of the face, lips, mouth, tongue or throat
    • dizziness or feel lightheaded
    • itching
    • hives
    • skin rash

Before taking VOYXACT, tell your healthcare provider about all of your medical conditions, including if you:

  • have an infection.
  • have received or plan to receive therapy that can lower the ability of your immune system to fight infections (immunosuppressive therapy).
  • have recently received or are scheduled to receive an immunization (vaccine). VOYXACT may affect your immune system response to vaccines and increase your risk of infections from live vaccines.
  • are pregnant or plan to become pregnant. It is not known if VOYXACT will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if VOYXACT passes into your breast milk or if it will affect your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with VOYXACT.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take VOYXACT?

  • Read the detailed “Instructions for Use” that come with VOYXACT for information about how to prepare and inject VOYXACT, and how to properly store and throw away (dispose of) used VOYXACT prefilled syringes.
  • Use VOYXACT exactly as your healthcare provider tells you to.
  • If you miss a dose of VOYXACT, inject the missed dose as soon as possible. Then take your next dose in 4 weeks.

What are the possible side effects of VOYXACT?

VOYXACT can cause serious side effects, including: 

  • immunosuppression and increased risk of infections. VOYXACT weakens your immune system, which may increase your risk of infections. Your healthcare provider will check you for signs and symptoms of infections before you start and during treatment with VOYXACT. Tell your healthcare provider right away if you develop any signs and symptoms of infection during treatment with VOYXACT, including:
    • fever
    • chills
    • feeling tired
    • cough
    • flu-like symptoms
    • aches and pain
    • warm, red, or painful skin

The most common side effects of VOYXACT include: upper respiratory tract infection and skin redness at your injection site.

These are not all of the possible side effects of VOYXACT. 

Call your doctor for medical advice about side effects.
You are encouraged to report side effects to FDA. 
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see FULL PRESCRIBING INFORMATION 
and PATIENT INFORMATION.

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