VOYXACT

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE 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 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION Recommended dosage: 400 mg injected subcutaneously once every 4 weeks. ( 2.1 ) 2.1 Recommended Dosage The recommended dosage of VOYXACT is 400 mg administered by subcutaneous injection once every 4 weeks. 2.2 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. 2.3 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. Warnings and cautions 5 WARNINGS AND PRECAUTIONS 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 ) 5.1 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. 5.2 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 8.1 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