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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.
The following clinically significant adverse reactions are described elsewhere in the labeling:
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.
No information provided.
Included as part of the PRECAUTIONS section.
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.
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.
No carcinogenicity or mutagenicity studies have been conducted with sibeprenlimab- szsi.
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.
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
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)].
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)].
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
No information provided.
VOYXACT is contraindicated in patients with serious hypersensitivity to sibeprenlimab- szsi or any of the excipients of VOYXACT.
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.
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.
Following 400 mg doses of VOYXACT administered subcutaneously every 4 weeks to patients with IgAN, steady-state is reached by 20 weeks of dosing.
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.
The volume of distribution is 4 L.
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.
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.
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).
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
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
Storing VOYXACT Prefilled Syringe
Your VOYXACT Single-Dose Prefilled Syringe
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Getting Your Supplies Ready |
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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.
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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).
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Figure A |
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Step 3: Gather supplies Gather supplies that are not included in the VOYXACT prefilled syringe box:
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Preparing to Inject the VOYXACT Prefilled Syringe |
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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).
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Figure B |
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Step 5: Inspect the VOYXACT Prefilled Syringe
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Figure C |
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Step 6: Choose the injection site Choose an injection site on your bare skin from 1 of the following areas (see Figure D):
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Figure D |
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Step 7: Clean the injection site Wash your hands with soap and clean water (see Figure E).
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Figure E 
Figure F |
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Injecting VOYXACT |
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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).
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Figure G |
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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).
Insert the entire needle at a 45-degree angle into the pinched skin using a dart-like motion (see Figure H).
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Figure H |
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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).
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Figure I 
Figure J 
Figure K |
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Disposing of the VOYXACT Prefilled Syringe |
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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.
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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
