Sibeprenlimab

Voyxact

400MG/2ML injectableEstados UnidosComercializadoAutorizado el 25 nov 2025

Contenido en inglés

Indicaciones

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. ( 1 ) 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.

( 1 )

Contraindicaciones

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. ( 4 )

Advertencias y precauciones

Immunosuppression and Increased Risk of Infections: Before initiating VOYXACT, assess for active infections. During treatment, monitor for signs and symptoms of infection. ( 5.1 ) Immunosuppression and Immunization Risks: Live vaccines not recommended within 30 days prior to initiation of VOYXACT or during treatment. ( 5.2 )

5.1Immunosuppression 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.

Indicaciones

( 1 )

Advertencias y precauciones

5.1Immunosuppression and Increased Risk of Infections

Embarazo y lactancia

8.1Pregnancy 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.

Voyxact

Indicaciones

Contraindicaciones

Advertencias y precauciones

5.1Immunosuppression and Increased Risk of Infections

¿Dos medicamentos en una misma pregunta?

Voyxact

Indicaciones

Contraindicaciones

Advertencias y precauciones

5.1Immunosuppression and Increased Risk of Infections

¿Dos medicamentos en una misma pregunta?

5.2Immunosuppression and Immunization Risks Because

Embarazo y lactancia

8.1Pregnancy Risk Summary

Reacciones adversas

6.1Clinical Trials Experience

Presentaciones

Documentos

Fuentes y licencias

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