For US audiences only

VOYXACT® is now
FDA approved

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.

VOYXACT works by
binding to APRIL

(A PRoliferation-Inducing Ligand)
and blocking its signaling.

Blocking APRIL reduces production
of abnormal IgA antibodies
(Gd-IgA1),
which play a role
in causing IgA nephropathy.

The effect of VOYXACT on proteinuria (protein in urine) was studied in the VISIONARY clinical trial of adults with IgA nephropathy.

  • 510 adults with IgA nephropathy participated
  • Adults were randomly assigned into 2 groups—about half received an injection of VOYXACT, and about half received a placebo injection (no active medicine)
  • At the start of the study, 98% were receiving the maximum tolerated dose of blood pressure medications (ACE inhibitors and ARBs)
  • 40% of patients were also on blood sugar-lowering medications (SGLT2 inhibitors)

ACE inhibitors=angiotensin-converting enzyme inhibitors.
ARBs=angiotensin receptor blockers.
SGLT2 inhibitors=sodium-glucose cotransporter 2 inhibitors.
uPCR-24h=24-hour urine protein-to-creatinine ratio.

Change in proteinuria at 9 months of treatment (n = 320)

Change in proteinuria at 9 months, Graph
Change in proteinuria at 9 months, Graph

After 9 months, people taking VOYXACT (n = 152) had about 50% less protein in their urine, while people taking placebo or no active medication (n = 168) had 2% more protein in their urine.

The results in this graph are based on an analysis of the first 320 adults in the trial at 9 months. This study is ongoing. These results were consistent across sex, age, race, ethnicity, and geographic region. At the beginning of the trial, participants had a mean uPCR-24h of 1.5 g/g.
uPCR-24h=24-hour urine protein-to-creatinine ratio.

The safety of VOYXACT was evaluated
in the VISIONARY clinical trial of adults
with IgA nephropathy.

Most common side effects of VOYXACT
Most common side effects of VOYXACT

Most adverse reactions were
reported as mild or moderate in
severity and resolved without
pausing or stopping treatment.

Ask your nephrologist if VOYXACT
may be right for you.

VOYXACT is a self-administered injection that
is given once every 4 weeks. It is delivered
right to you in a single-dose prefilled syringe.

VOYXACT is available through a specialty
pharmacy, who will call you to set up your
shipment(s) of VOYXACT.

See Instructions For Use
below for complete information
on administration, storage,
and safe use.

Instructions For Use

Support created with you in mind.

Otsuka Patient Services Logo

Enroll today for Otsuka Patient Services,
the patient support program for VOYXACT.*

A Care Navigator will be assigned to you after you enroll in Otsuka Patient Services.* You will be able to directly reach out to them when you have questions or need support.

If you have questions, need assistance, or would like to enroll in Otsuka Patient Services, call 833-VOYXACT (869-9228) Monday through Friday, 8 am–8 pm ET (except holidays).

*Available for patients who have been prescribed VOYXACT by their doctor.

Prescription savings and coverage support.

Eligible patients may pay as little as $0 for VOYXACT† or may qualify for temporary access options
if insurance coverage challenges arise.‡

†VOYXACT Copay Program:

The VOYXACT Copay Program can help cover copays and costs for eligible, commercially insured patients who are prescribed VOYXACT. Benefits may apply to copays, coinsurance, and pharmacy deductibles.
Maximum annual benefit and other restrictions apply. See full terms and
conditions below.

‡VOYXACT Bridge Program:

The VOYXACT Bridge Program may provide temporary access to VOYXACT when you encounter insurance coverage challenges. Eligible patients with commercial insurance may be able to start VOYXACT immediately while coverage is being determined. See full terms and conditions below.

Have a prescription but not insured, or need help paying for your VOYXACT? Learn about additional assistance here.

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

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.

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.

Please see FULL PRESCRIBING INFORMATION and PATIENT INFORMATION.