Not an
actual patient.

How VOYXACT® Works

VOYXACT was designed to precisely block APRIL.

VOYXACT is the first and only FDA approved treatment that selectively blocks APRIL.

APRIL (A PRoliferation-Inducing Ligand) is an immune messenger that helps your body make certain types of antibodies to protect you from infections.

However, in IgA nephropathy, APRIL has been linked to the production of abnormal antibodies, including Gd-IgA1.

Over time, these abnormal IgA antibodies can build up in your kidneys, and lead to symptoms like proteinuria.

Blocking APRIL is one way to target the immune system activity of IgA nephropathy—as stated by the KDIGO guidelines.

Kidney graphic
Kidney graphic

Blocking APRIL is one way to target the immune system activity of IgA nephropathy—as stated by the KDIGO guidelines.

FDA=U.S. Food and Drug Administration. 
IgA=immunoglobulin A.

IgAN=IgA nephropathy.

Gd-IgA1=galactose-deficient IgA1. 
KDIGO=Kidney Disease: Improving Global Outcomes.

VOYXACT binds to APRIL.

Blocking APRIL has been shown to reduce the production of abnormal IgA antibodies (Gd-IgA1). These abnormal antibodies play a role in driving IgA nephropathy.

How VOYXACT can fit into your care plan.

Your care plan is unique to you. It’s important to know how VOYXACT can fit into it.

Be sure to continue working with your nephrologist while on VOYXACT. Always reach out to your care team if you have any questions.

Not a steriod icon

VOYXACT is not a steroid;
it is a monoclonal
antibody (biologic).

Can be taken with other meds icon

VOYXACT can be taken
with ACE inhibitors, ARBs,
and/or SGLT2 inhibitors.

No REMS icon

VOYXACT does not require

enrollment in an FDA REMS

monitoring program.

ACE inhibitors=angiotensin-converting enzyme inhibitors.
ARBs=angiotensin receptor blockers.
SGLT2 inhibitors=sodium-glucose cotransporter 2 inhibitors.
FDA=U.S. Food and Drug Administration.
REMS=Risk Evaluation and Mitigation Strategies.

Packaging for VOYXACT® (sibeprenlimab-szsi) Injection 400 mg/2 ml
Packaging for VOYXACT® (sibeprenlimab-szsi) Injection 400 mg/2 ml

A convenient treatment.
VOYXACT is a self-administered injection, dosed once every
4 weeks, delivered right to you in a prefilled syringe.

How to take VOYXACT
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.