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Voyxact (ibeprenlimab-szsi-szsi Injection): Side Effects, Uses, Dosage, Interactions, Warnings

Voyxact

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 12/8/2025

Drug Summary

What Is Voyxact?

Voyxact (sibeprenlimab-szsi) is an A Proliferation Inducing Ligand (APRIL) blocker, indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.

What Are Side Effects of Voyxact?

Side effects of Voyxact include:

  • upper respiratory tract infection and
  • injection site redness.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Voyxact

The recommended dosage of Voyxact is 400 mg injected subcutaneously once every 4 weeks.

Voyxact In Children

Safety and effectiveness of VOYXACT in pediatric patients have not been established.

What Drugs, Substances, or Supplements Interact with Voyxact?

Voyxact may interact with other medicines such as:

  • live vaccines.

Tell your doctor all medications and supplements you use and all vaccines you recently received or plan to get.

Voyxact During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Voyxact; it is unknown if it would affect a fetus. It is unknown if Voyxact passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Voyxact (sibeprenlimab-szsi) Injection, for Subcutaneous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Description for Voyxact

VOYXACT contains sibeprenlimab-szsi, an A Proliferation Inducing Ligand (APRIL) blocker and humanized immunoglobulin G2 (IgG2) monoclonal antibody produced by Chinese Hamster Ovary (CHO) cells.

The approximate molecular weight of sibeprenlimab-szsi is 146 kDa.

VOYXACT (sibeprenlimab-szsi) injection is a sterile, preservative-free, clear to opalescent, colorless to yellow solution in a single-dose prefilled syringe for subcutaneous use.

Each 2 mL prefilled syringe delivers 400 mg sibeprenlimab-szsi and the inactive ingredients: arginine (17.6 mg), glutamic acid (14.8 mg), histidine (4.34 mg), L-histidine hydrochloride monohydrate (4.62 mg), polysorbate 80 (0.40 mg), sorbitol (36.4 mg), and Water for Injection, USP. The pH is 6.2.

ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Immunosuppression and Increased Risk of Infections [see Warnings and Precautions (5.1)]
  • Immunosuppression and Immunization Risks [see Warnings and Precautions (5.2)]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of VOYXACT was evaluated in a randomized, double-blind, placebo- controlled, clinical study in patients with IgAN (VISIONARY). The median duration of exposure was 44 weeks in the 259 patients treated with VOYXACT and 48 weeks in the 251 patients administered placebo. The most common adverse reactions (reported in ≥10% of patients treated with VOYXACT and at a higher incidence than placebo) in patients treated with VOYXACT and placebo, respectively, were infections (49% versus 45%) and injection site reactions (24% versus 23%). The most common infection was upper respiratory infection (15% versus 14%), and the most common injection site reaction was injection site erythema (13% versus 12%). Most adverse reactions were reported as mild or moderate in severity and resolved without treatment interruption or discontinuation.

Drug Interactions for Voyxact

No information provided.

Warnings for Voyxact

Included as part of the PRECAUTIONS section.

Precautions for Voyxact

Immunosuppression and Increased Risk of Infections

VOYXACT suppresses the immune system by reducing antibody production, which may increase the risk of infections. Patients with chronic or recurring infections may have an increased risk of serious infection. In clinical trials, infections occurred in 49% of patients treated with VOYXACT compared with 45% of patients treated with placebo.

Before initiating VOYXACT, assess patients for active infections. During treatment, monitor patients for signs and symptoms of infection. If a serious infection develops, consider interrupting VOYXACT until the infection is controlled.

There are limited clinical study data with concomitant use of VOYXACT and systemic immuno-suppressants. Consider the potential for increased immunosuppression when coadministering VOYXACT and immuno-suppressants or when initiating VOYXACT before or after immuno-suppressive therapy.

Immunosuppression and Immunization Risks

Because of its mechanism of action, VOYXACT may interfere with the immune responses to vaccines and increase the risk of infection from live vaccines. Live vaccines are not recommended within 30 days prior to initiation of VOYXACT or during treatment with VOYXACT as safety has not been established. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving VOYXACT or on the efficacy of immunizations administered while receiving VOYXACT.

NONCLINICAL TOXICOLOGY

Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenicity or mutagenicity studies have been conducted with sibeprenlimab- szsi.

Impairment of Fertility

In cynomolgus monkeys intravenously administered sibeprenlimab-szsi at doses of 25, 50, or 100 mg/kg once every two weeks for 26 weeks, no sibeprenlimab-related adverse effects on female menstrual cycle frequency and lengths, male sperm analysis of motility, concentration and count, or male and female reproductive organs were observed at doses up to 100 mg/kg, which provides an approximately 13-fold exposure margin to the clinical exposure at the MRHD based on AUC.

Patient Information for Voyxact

Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Infections

Inform patients that they may be more likely to develop infections when taking VOYXACT. Instruct patients to tell their healthcare provider if they develop signs or symptoms of an infection [see Warnings and Precautions (5.1)].

Hypersensitivity

Inform patients about the signs and symptoms of hypersensitivity reactions. Advise patients to discontinue VOYXACT and seek immediate medical attention for signs or symptoms of hypersensitivity reactions [see Contraindications (4)].

Pregnancy

Advise patients who are exposed to VOYXACT during pregnancy to contact Otsuka Pharmaceutical Development and Commercialization, Inc. at 1-833-869-9228 or www.VOYXACT.com.

Manufactured by:
Otsuka Pharmaceutical Company, Ltd.,
Tokyo, 101-8535 Japan
U.S. License No XXXX 

Distributed by:
Otsuka America Pharmaceutical, Inc.
Rockville, MD 20850, USA

©2025, Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan

OVERDOSES

No information provided.

Contraindications for Voyxact

VOYXACT is contraindicated in patients with serious hypersensitivity to sibeprenlimab- szsi or any of the excipients of VOYXACT.

Clinical Pharmacology for Voyxact

Mechanism Of Action

VOYXACT binds to APRIL with a dissociation constant (KD) of 0.95 pM, which blocks signaling at the B cell maturation antigen (BCMA) and transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptors. Inhibition of APRIL results in reduced levels of serum galactose-deficient immunoglobulin A1 (Gd-IgA1), which is implicated in the pathogenesis of IgAN.

Pharmacodynamics

In healthy subjects administered a single 400 mg subcutaneous VOYXACT dose, serum levels of APRIL were reduced by >90% by Day 3 and the reduction was maintained until Day 42.

In IgAN patients treated with VOYXACT every four weeks in the VISIONARY Study, APRIL suppression > 90% was observed by Week 4 and was sustained throughout treatment. Serum Gd-IgA1, IgA, IgG, and IgM levels decreased within 4 weeks, reached a plateau by Week 24, and by Week 48 mean serum levels were reduced from baseline by 67% for Gd-IgA1, 69% for IgA, 35% for IgG, and 75% for IgM.

Pharmacokinetics

Following 400 mg doses of VOYXACT administered subcutaneously every 4 weeks to patients with IgAN, steady-state is reached by 20 weeks of dosing.

Absorption

Following a single subcutaneous dose of 400 mg VOYXACT in healthy subjects, the median time to reach peak concentration is 8 days.

The absolute bioavailability of sibeprenlimab-szsi is approximately 92% and there is no difference in relative bioavailability following administration to the abdomen, thigh, or arm.

Distribution

The volume of distribution is 4 L.

Elimination

Following a single 400 mg VOYXACT dose, the mean terminal half-life is 9.3 days. The mean apparent clearance of sibeprenlimab-szsi following 400 mg doses every 4 weeks is 206 mL/day.

Metabolism

As an IgG2 monoclonal antibody, sibeprenlimab-szsi is expected to be degraded by proteolytic enzymes via catabolic pathways in the same manner as endogenous IgG.

Specific Populations

No dedicated studies were conducted to evaluate the effects of renal impairment and hepatic impairment on the pharmacokinetics of sibeprenlimab-szsi.

Population pharmacokinetic analysis did not identify any clinically relevant differences in the pharmacokinetics of sibeprenlimab-szsi based on sex, age, weight, race, and mild to moderate renal impairment (eGFR: 30 to 89 mL/min).

Immunogenicity

The observed incidence of anti-drug antibodies (ADA) is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of ADA in the study described below with the incidence of ADA in other studies, including those of sibeprenlimab-szsi.

During the treatment period in the VISIONARY Study, 88 of 256 (34%) evaluable patients treated with VOYXACT developed ADA. Among the 88 patients who tested positive for ADA, 21 patients (23.9%) developed ADA that had neutralizing activity. Sibeprenlimab-szsi exposure in patients with IgAN who developed ADA was ~ 40% lower than in patients with undetectable ADA over the treatment period. The reduction in urine protein/creatinine ratio based on 24-hour urine collections (uPCR-24h) from baseline to Month 9 was numerically lower in patients who developed ADA (41.6%) compared to those who did not (52.7%). The clinical significance of the differences in uPCR reduction according to the presence or absence of ADA is not clear. The presence of ADA did not have a clinically significant effect on the incidence or severity of adverse reactions.

INSTRUCTIONS FOR USE

INSTRUCTIONS FOR USE
VOYXACT® (VOY-ZAKT) (sibeprenlimab-szsi) injection,
for subcutaneous use Single-Dose Prefilled Syringe

This Instructions for Use contains information on how to inject VOYXACT. Read and follow this Instructions for Use before you inject VOYXACT prefilled syringe for the first time and each time you get a refill. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Your healthcare provider should show you or your caregiver how to prepare and inject VOYXACT the right way before you use or give it for the first time.

Important Information You Need to Know Before Injecting VOYXACT Prefilled Syringe

  • VOYXACT prefilled syringe is for injection under the skin (subcutaneous injection) use only.
  • Do not remove the grey needle cap from the prefilled syringe until you are ready to inject.
  • Each prefilled syringe has a needle It will automatically cover the needle after the injection is completed.
  • Do not pull back on the plunger at any time.
  • Do not use if the VOYXACT prefilled syringe has been damaged.
  • Do not use if the VOYXACT prefilled syringe has been dropped after removing the needle cap.

 Storing VOYXACT Prefilled Syringe

  • Store your VOYXACT prefilled syringe in a refrigerator between 36°F to 46°F (2°C to 8°C). Keep the prefilled syringe in its original box to protect it from light.
  • Let the VOYXACT prefilled syringe come to room temperature up to 77°F (25°C) for 15 to 30 minutes before giving an injection.
  • When the VOYXACT prefilled syringe has reached room temperature, do not put it back in the refrigerator.
  • Do not use the VOYXACT prefilled syringe if it has been at room temperature for 7 days or longer.
  • Do not freeze the VOYXACT prefilled syringe.
  • Do not shake the VOYXACT prefilled syringe.
  • Keep the VOYXACT prefilled syringe away from heat and direct sunlight.
  • Throw away (dispose of) any VOYXACT prefilled syringe if it is See Step 11 for instructions on how to throw away (dispose of) the VOYXACT prefilled syringe.
  • Keep VOYXACT prefilled syringe and all medicines out of the reach of children.

Your VOYXACT Single-Dose Prefilled Syringe

Your VOYXACT Single-Dose Prefilled Syringe

Getting Your Supplies Ready

Step 1: Remove the VOYXACT prefilled syringe box from the refrigerator

Take the box containing VOYXACT prefilled syringe out of the refrigerator and check the expiration date (EXP) on the side of the box.

  • Do not use the prefilled syringe if the seals on the box have been broken.
  • Do not use the prefilled syringe if the expiration date (EXP) printed on the box has passed.

Step 2: Wait 15 to 30 minutes before use

Wait 15 to 30 minutes to let the prefilled syringe come to room temperature naturally (see Figure A).

  • Do not warm the prefilled syringe any other way.
  • Do not let the prefilled syringe sit in direct sunlight.
Wait 15 to 30 minutes to let the prefilled syringe come to room temperature naturally

Figure A

Step 3: Gather supplies

Gather supplies that are not included in the VOYXACT prefilled syringe box:

  • Alcohol swabs
  • Cotton balls or gauze
  • Adhesive bandages
  • Sharps disposal container (see Step 11)
Gather supplies that are not included in the VOYXACT prefilled syringe box

Preparing to Inject the VOYXACT Prefilled Syringe

Step 4: Take the VOYXACT prefilled syringe out of the box

Hold the middle of the prefilled syringe (near the viewing window) to carefully lift the prefilled syringe out of the box (see Figure B).

  • Do not lift the prefilled syringe by the plunger.
  • Do not shake or roll the prefilled syringe.
  • Do not remove the grey needle cap from the prefilled syringe until Step 8 and you are ready to inject.
carefully lift the prefilled syringe out of the box

Figure B

Step 5: Inspect the VOYXACT Prefilled Syringe

  • Make sure that VOYXACT appears on the labels.
  • Check the expiration date (EXP) printed on the prefilled syringe (see Figure C).
  • Check the medicine in the prefilled syringe through the viewing It is normal to see air bubbles. The medicine inside should be clear to slightly pearly and colorless to yellow (see Figure C).
  • Do not use VOYXACT prefilled syringe if:
    • the expiration date printed on the prefilled syringe label has passed.
    • the medicine is cloudy, discolored, or has particles floating in it.
    • any part of the prefilled syringe is damaged, broken, or the needle guard has been activated.
  • Do not try to remove air bubble(s) from the prefilled syringe.
The medicine inside should be clear to slightly pearly and colorless to yellow

Figure C

Step 6: Choose the injection site

Choose an injection site on your bare skin from 1 of the following areas (see Figure D):

  • front of upper thigh
  • stomach area (abdomen), avoiding the area 2 inches around the belly button.
    For caregiver only: back of the upper arm may also be used.
  • Do not inject into the same spot you used for your last injection.
  • Do not inject into moles, scars, or bruises or skin that is tender, damaged, hard or red.
Choose an injection site on your bare skin from 1 of the following areas

Figure D

Step 7: Clean the injection site

Wash your hands with soap and clean water (see Figure E).

  • Clean the injection site with an alcohol swab and let the skin dry (see Figure F).
  • Do not touch the area again before injecting.
  • Do not fan or blow on the injection site after you have cleaned it.
Wash your hands with soap and clean water

Figure E

Clean the injection site with an alcohol swab and let the skin dry

Figure F

Injecting VOYXACT

Step 8: Remove the needle cap

When you are ready to inject, hold the prefilled syringe with 1 hand, pull the needle cap straight off with the other hand (see Figure G).

  • You may see a drop of liquid at the end of the This is normal.
  • Do not touch or recap the needle or let it touch any surface.
  • Do not touch or pull back the plunger.
  • Do not use a prefilled syringe with a bent or broken needle.
pull the needle cap straight off with the other hand

Figure G

Step 9: Pinch the skin and insert needle

With the needle cap off, hold the prefilled syringe in 1 hand. With your other hand, gently pinch the skin at the injection site (see Figure H).

  • It is important to pinch enough skin to inject under the skin and not into the muscle.

Insert the entire needle at a 45-degree angle into the pinched skin using a dart-like motion (see Figure H).

  • Avoid touching the plunger until the needle is inserted.
gently pinch the skin at the injection site

Figure H

Step 10: Complete the Injection

Push the plunger as far as it will go and it stops, and all the medicine is injected (see Figure I).

Take your thumb off the plunger to allow the needle guard to automatically cover the exposed needle (see Figure J).

Gently lift the syringe away from the injection site (see Figure K).

  • There may be a small amount of blood or liquid at the injection Hold pressure over your skin with a cotton ball or gauze until any bleeding stops.
  • Apply an adhesive bandage, if needed.
  • Do not rub or massage the injection site.
Push the plunger as far as it will go and it stops

Figure I

Take your thumb off the plunger to allow the needle guard to automatically cover the exposed needle

Figure J

Gently lift the syringe away from the injection site

Figure K

Disposing of the VOYXACT Prefilled Syringe

Step 11: Throw away (dispose of) the VOYXACT prefilled syringe

Throw away (dispose of) the used prefilled syringe in a FDA-cleared sharps disposal container right away after use (see Figure L). Do not recycle or throw away the prefilled syringe in your household trash.

  • Throw away the remaining supplies in your household trash or sharps container.
  • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
    • made of a heavy-duty plastic,
    • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak-resistant, and
    • properly labeled to warn of hazardous waste inside the container.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal There may be local or state laws about how to throw away needles and syringes.
  • For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: https://www.fda.gov/safesharpsdisposal.
  • Do not recycle your used sharps disposal container.
Throw away (dispose of) the used prefilled syringe in a FDA-cleared sharps disposal container right away after use

Figure L

If you have questions or concerns about your VOYXACT prefilled syringe, please call your healthcare provider. You can also call 1-800-441-6763 or visit www.VOYXACT.com for more information.

Manufactured by:
Otsuka Pharmaceutical Company, Ltd.
Tokyo 101-8535 Japan
U.S. License No XXXX

Distributed by:
Otsuka America Pharmaceutical, Inc.
Rockville, MD 20850 USA

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