Voyxact

Voyxact injection is used to reduce protein in the urine (proteinuria) in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for their disease getting worse. Voyxact is a subcutaneous injection that is administered once every 4 weeks.

It is not known if Voyxact is safe and effective in children.

Voyxact injection (sibeprenlimab-szsi) gained FDA approval on November 25, 2025, under the accelerated approval designation, and is the first "anti-APRIL" antibody to be approved.

• Approval was based on interim results from the VISIONARY Phase 3 clinical trial (NCT05248646) that showed Voyxact reduced proteinuria by 51% more than placebo after nine months of treatment (P<0.0001).
• Among 320 participants, 50% taking Voyxact showed improvement compared to just 2% taking a placebo.
• Continued approval may be contingent upon a clinical benefit being shown in a confirmatory clinical trial.

Voyxact (sibeprenlimab-szsi) works by blocking a protein called APRIL that causes harmful antibodies to build up and damage the kidneys of people with IgAN.

Voyxact belongs to the drug class called Proliferation-Inducing Ligand (APRIL) blockers, also known as anti-APRIL antibodies.

Do not take Voyxact if you are allergic to any of the ingredients in Voyxact. See the end of this guide for a complete list of 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 feeling 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 infection from live vaccines
• Are pregnant or planning to become pregnant. It is not known if Voyxact will harm your unborn baby.
• Are breastfeeding or planning 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.

Voyxact is given as an injection under the skin (subcutaneous injection).

• Read the detailed “Instructions for Use” that comes with the Voyxact Package Insert 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.

Inject Voyxact under the skin (subcutaneous injection) in the front of your upper legs (thighs) or stomach area (abdomen), avoiding the area 2 inches around the belly button. The back of the upper arms may also be used if a caregiver gives the injection.

Most Common

The most common side effects of Voyxact are:

• Upper respiratory tract infections
• Skin redness at the injection site.

Serious Side Effects and Warnings

Voyxact can cause the following serious side effects.

Immunosuppression and an 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.

These are not all of the possible side effects of Voyxact. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Recommended dose of Voyxact for IgAN in adults: 400 mg subcutaneously once every 4 weeks

If you miss a dose of Voyxact, inject the missed dose as soon as possible. Then take your next dose in 4 weeks.

Active ingredient: sibeprenlimab-szsi

Inactive ingredients: arginine, glutamic acid, histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sorbitol, and Water for Injection.

Voyxact prefilled syringe is not made with natural rubber latex.

Voyxact is available as a 400 mg/2 mL (200 mg/mL) single-dose, prefilled syringe.

Otsuka Pharmaceutical Company, Ltd., Tokyo, 101-8535 Japan.