Voyxact Drug Information
Generic name: SIBEPRENLIMAB
Uses of Voyxact
is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. 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 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. 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.
Dosage & Administration of Voyxact
Recommended Dosage
The recommended dosage of VOYXACT is 400 mg administered by subcutaneous injection once every 4 weeks.
Missed Dose
If a scheduled dose of VOYXACT is missed, administer the missed dose as soon as possible and then resume dosing every 4 weeks thereafter.
Preparation and
Administration VOYXACT is intended for patient self-administration or for administration by a caregiver. Provide proper training to patients and/or caregivers on the administration of VOYXACT prior to use according to the "Instructions for Use". Visually inspect the prefilled syringe for particulate matter and discoloration. The solution should be clear to opalescent and colorless to yellow.
Do not use the prefilled syringe if the solution contains visible particulate matter, is cloudy or discolored (other than clear to opalescent, colorless to yellow). Allow VOYXACT prefilled syringe to come to room temperature up to 77°F (25°C) for 15 to 30 minutes before giving an injection. Keep VOYXACT prefilled syringe in the original carton to protect it from light. Once VOYXACT prefilled syringe has reached room temperature, do not return it to the refrigerator.
Do not use VOYXACT if it has been at room temperature for 7 days or longer. Administer VOYXACT by subcutaneous injection only. Inject into the front of the thigh or abdomen.
The back of the upper arm can also be used as an injection site if administered subcutaneously by a caregiver. Do not inject into the same site used for the previous injection, or into moles, scars, bruises or areas where the skin is tender, damaged, red, scaly, or hard.
Side Effects of Voyxact
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.
Warnings & Cautions 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.
Pregnancy Safety for Voyxact
Pregnancy Risk Summary There are no available data on VOYXACT use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Monoclonal antibodies, such as sibeprenlimab-szsi, can be actively transported across the placenta as pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimester of pregnancy (see Clinical Considerations ). In an enhanced prenatal and postnatal development (ePPND) toxicity study, administration of sibeprenlimab-szsi subcutaneously to pregnant monkeys did not result in any adverse effects on embryofetal or postnatal development at exposures approximately 10-times the clinical exposure at the maximum recommended human dose (MRHD) based on area under the curve (AUC) ( see Data ). The background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Pregnant women exposed to VOYXACT, or their healthcare providers, should report VOYXACT exposure by calling 1-833-869-9228 or visiting www.VOYXACT.com. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk IgA nephropathy is associated with adverse maternal outcomes, including increased rates of cesarean section, pregnancy-induced hypertension, pre-eclampsia and preterm delivery, and adverse fetal/neonatal outcomes, including stillbirth and low birth weight.
Fetal/Neonatal Adverse Reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Therefore, VOYXACT may be present in infants exposed in utero. Consider the potential clinical impact of VOYXACT exposure in infants who were exposed to VOYXACT in utero.
Data Animal Data In an ePPND toxicity study, subcutaneous administration of sibeprenlimab-szsi once every two weeks to pregnant cynomolgus monkeys from gestation Day 20 through delivery (includes the period of organogenesis) did not result in any adverse effect on embryofetal or postnatal development at the single tested dose of 101 mg/kg, which provided an approximately 10-fold margin to the clinical exposure at the MRHD based on AUC.
Pediatric Use of Voyxact
Pediatric Use Safety and effectiveness of VOYXACT in pediatric patients have not been established.
Contraindications for Voyxact
is contraindicated in patients with serious hypersensitivity to sibeprenlimab-szsi or any of the excipients of VOYXACT. Serious hypersensitivity to sibeprenlimab-szsi or any excipients in VOYXACT.
Clinical Studies of Voyxact
The effect of VOYXACT on proteinuria was evaluated in a randomized, double-blind, placebo-controlled, multicenter, global study (VISIONARY, NCT05248646) in adults with biopsy-confirmed IgAN, an eGFR ≥30 mL/min/1.73 m 2, proteinuria (defined as either urine protein/creatinine ratio based on 24-hour urine collections ≥0.75 g/g or urine protein ≥1.0 g/day), and on a stable and maximally tolerated dose of an angiotensin-converting enzyme inhibitor (ACEi) and/or angiotensin receptor blocker (ARB) with or without a sodium-glucose co-transporter 2 inhibitor (SGLT2i). Patients with other glomerulopathies or those who had been treated with systemic immunosuppressants in the 16 weeks prior to screening were excluded. Patients were randomized 1:1 to receive either VOYXACT or placebo injected subcutaneously once every 4 weeks. The study enrolled a total of 510 patients.
An interim analysis for efficacy was conducted on the first 320 (63%) randomized patients who had the opportunity to reach the Month 9 visit, 152 of whom were randomized to receive VOYXACT while 168 were randomized to receive placebo. Baseline demographics and disease characteristics were generally balanced between treatment groups. At baseline, the median age was 42 years (range 18 to 83 years); 63% were male, 59% were Asian, 38% were White, and 3% were of Other race.
At baseline, mean uPCR-24h was 1.5 g/g, mean estimated glomerular filtration rate (eGFR) was 63 mL/min/1.73 m 2, and 74% had hematuria (based on urine dipstick). Approximately 67% of patients had a history of hypertension and 7% had a history of type 2 diabetes mellitus. At baseline, 98% were treated with an ACEi and/or ARB and 40% of patients were also on an SGLT2i. The primary endpoint was the relative change from baseline in uPCR-24h at Month 9. The mean estimated percent change from baseline in uPCR-24h is shown in Figure 1. The observed geometric mean percent change from baseline over time for uPCR from spot first morning void samples is shown in Figure 2. Figure 1: Estimated Percent Change Compared to Baseline in uPCR-24h at Month 9 in Patients with IgAN in the VISIONARY Study CI = Confidence Interval 24-hour uPCR at Month 9 compared to baseline is defined as uPCR-24h 9months /uPCR-24h Baseline.
The bar indicates the geometric mean percentage change at 9 months compared with baseline, and the whiskers indicate the 95% CI. Data were included in the analysis regardless of early treatment discontinuation and initiation of confounding therapy (treatment policy strategy). Missing data were imputed using multiple imputation. VOYXACT -50% Placebo 2% VOYXACT vs. Placebo (96.5% CI) 96.5% CI corresponds to the two-sided significance level of 0.035 for the interim analysis (IA). 51% (43%, 58%) p-value <0.0001 Figure 2: Percent Change Compared to Baseline in Spot uPCR Over Time in Patients with IgAN in the VISIONARY Study CI = Confidence Interval Spot uPCR at specific week is defined as spot uPCR/spot uPCRbaseline The dots indicate the geometric mean percentage change at specific weeks compared with baseline and the whiskers indicate the corresponding 95% CIs based on observed and non-imputed spot uPCR. The treatment effect (percentage reduction in uPCR-24h between VOYXACT and placebo) was consistent across the following subgroups and pre-specified stratification factors: sex, age, race, ethnicity, and geographic region, baseline proteinuria (uPCR-24h), baseline eGFR, and SGLT2i use.
Figure 1 Figure 2
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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