Not an
actual patient.

Resources
and FAQs

Videos, guides, and answers to help you no matter where you are in your VOYXACT journey.

FAQs

Q:
What does VOYXACT do?
A:

VOYXACT is a prescription medicine used to reduce protein in the urine (proteinuria) in adults with primary IgA nephropathy who are at risk for their disease getting worse.

Q:
How does VOYXACT work?
A:

VOYXACT was designed to precisely block APRIL (A PRoliferation-Inducing Ligand). Blocking APRIL is one way to target the immune system activity of IgA nephropathy—as stated by the KDIGO guidelines.

Q:
What makes VOYXACT unique?
A:

VOYXACT is unique in multiple ways. First, VOYXACT is the only subcutaneous (under the skin) self-administered injection that is indicated for adults with primary IgA nephropathy at risk for disease progression. Second, it is the only medicine for IgA nephropathy that comes in a prefilled syringe. Third, it's self-injected once every 4 weeks. And lastly, it is the first and only FDA-approved treatment that selectively blocks APRIL.

Q:
Is VOYXACT safe?
A:

The safety of VOYXACT was evaluated in 510 patients with IgA nephropathy. Side effects for people taking VOYXACT were similar to those on placebo (no active medicine). The most common side effects were upper respiratory infections and injection-site reactions. Most infections and injection-site reactions were mild to moderate and resolved without pausing or stopping treatment.

Q:
How can I get on VOYXACT?
A:

VOYXACT is available by prescription only. Together, you and your nephrologist can decide if VOYXACT is right for you.

If you’d like help starting the conversation, download our Doctor discussion guide.

Q:
What happens after my nephrologist prescribes VOYXACT?
A:

After your nephrologist prescribes VOYXACT, the specialty pharmacy that dispenses VOYXACT will contact you.

Q:
Can I get VOYXACT at my local pharmacy?
A:

VOYXACT is only available from a specialty pharmacy. Specialty pharmacies work differently from traditional pharmacies. They ship your medicine directly to the address you provide. The specialty pharmacy for VOYXACT is called PANTHERx® Rare. PANTHERx Rare focuses solely on rare and orphan conditions like IgA nephropathy. They will call you to set up your shipments of VOYXACT.

Q:
What is a “dose” of VOYXACT?
A:

A single dose of VOYXACT is 400 mg/2 mL in 1 self-administered prefilled syringe. 

Q:
How do I store VOYXACT?
A:

Once you receive your VOYXACT prefilled syringe, be sure to keep it in the refrigerator (36 °F to 46 °F/2 °C to 8 °C) in its original box to protect it from light. Do not freeze, heat, or expose it to direct sunlight. Always keep VOYXACT—and all medicines—out of the reach of children.

Q:
How warm should the medicine be before injecting?
A:

Before injecting, let the prefilled syringe warm naturally to room temperature (up to 77 °F/25 °C). To get it to room temperature, let it sit out for 15–30 minutes before injecting. You can set a timer so you know when enough time has passed.
Once the VOYXACT prefilled syringe has reached room temperature, do not return it to the refrigerator.

Q:
There are bubbles in the liquid—is that normal?
A:

Yes, it’s normal to see air bubbles. Do not try to remove them.

Q:
What if the liquid looks cloudy or the prefilled syringe looks damaged?
A:

Do not use the VOYXACT prefilled syringe before injecting if:

  • The liquid looks cloudy or discolored (it should look clear to opalescent, colorless to yellow)
  • It has particles in it (it should look clear)
  • The expiration date has passed
  • It has been at room temperature for 7 days or longer
  • Any part of the prefilled syringe is damaged
  • The needle guard has been activated

If you can’t use the prefilled syringe because of any of these reasons, contact PANTHERx® Rare by phone at 833-VOYXACT (869-9228), or use the PANTHERx Rare app. They will send you another VOYXACT prefilled syringe.

Q:
What if I miss a dose?
A:

If you miss a dose, take the next dose as soon as possible, and then resume every 4 weeks after that.

Q:
What kind of support does Otsuka Patient Services provide?
A:

When you are enrolled in Otsuka Patient Services, you will be paired with an Otsuka Care Navigator. Otsuka Care Navigators can provide education about IgA nephropathy, VOYXACT, and support those getting started on treatment. They can also provide more information about using the prefilled syringe.
 
The Otsuka Care Navigator is not a replacement for your nephrologist. Talk to your doctor about any medical questions. You should continue to keep your lab and nephrologist appointments and follow their medical advice while on VOYXACT.
 
If you have questions about the Otsuka Patient Services program or need assistance, you can call 833-VOYXACT (869-9228), Monday through Friday, 8 AM-8 PM ET (except holidays).

Q:
Can I contact specialty pharmacy PANTHERx® Rare directly?
A:

Yes. Be sure to download the PANTHERx Rare app using one of these links:

Once you’ve been prescribed VOYXACT, you can use the PANTHERx Rare app for delivery coordination and refill requests. You can also contact PANTHERx Rare by phone at 833-VOYXACT (869-9228) Monday through Friday, 8 AM-8 PM ET
(except holidays).

IgA=immunoglobulin A.

More IgA nephropathy education and support

Living with IgA nephropathy can feel overwhelming at times, but you are not alone.
Here are a few trusted websites where you can learn more about the disease and
connect with others who understand what you’re going through.*

American Kidney Fund Logo

AKF provides education, support services, and financial assistance programs for people living with kidney disease. They also offer tools to help you track your kidney health.
www.kidneyfund.org

IgA Nephropathy Foundation Logo

The IgA Nephropathy Foundation provides education, research updates, and ways for you to connect with others living with the disease.www.igan.org

National Kidney Foundation Logo

NKF provides information about kidney health, testing, and ways to manage kidney disease. They also offer free support programs and events for patients and families.
www.kidney.org

NephCure Logo

NephCure is uniquely focused on protein-spilling kidney diseases like IgA nephropathy. They help patients find the best care, resources, and community support available.
www.nephcure.org

*The organizations and resources listed are not affiliated with nor are they controlled or influenced by Otsuka America Pharmaceutical, Inc. (OAPI). OAPI may have entered into limited fee-for-service or sponsorship arrangements with some of the listed organizations and resources from time to time. OAPI are providing information to you about these organizations and resources merely as a convenience, and OAPI shall not be liable for any use of this information, or for any information obtained from or provided by these organizations or resources. OAPI are not responsible for the consequences of your
use of any information provided by these organizations and resources.

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.