Sibeprenlimab
Generic Name: sibeprenlimab
Brand Names:
Voyxact
11 DESCRIPTION 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.
Overview
11 DESCRIPTION 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.
Uses
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.
Dosage
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.
Side Effects
6 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) ] Most common adverse reactions are upper respiratory tract infection and injection site erythema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Warnings
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. 4 CONTRAINDICATIONS 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 )
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 progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimester of pregnancy (see Clinical Considerations ) .
Storage
Storage and Handling Store VOYXACT in a refrigerator at 36°F to 46°F (2°C to 8°C). Keep the prefilled syringe in its original box to protect it from light. Do not freeze. Do not shake. Do not expose to heat or direct sunlight. Once VOYXACT prefilled syringe has reached room temperature, do not return it to the refrigerator.
Frequently Asked Questions
What is Sibeprenlimab used for?▼
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.
What are the side effects of Sibeprenlimab?▼
6 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) ] Most common adverse reactions are upper respiratory tract infection and injection site erythema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Sibeprenlimab during 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 progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimester of pregnancy (see Clinical Considerations ) .
What are the important warnings for Sibeprenlimab?▼
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. 4 CONTRAINDICATIONS 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 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.