Sibeprenlimab
Sibeprenlimab (VOYXACT) is a monoclonal antibody that targets and binds to APRIL (A Proliferation-Inducing Ligand), a protein essential for B cell survival and maturation. By blocking APRIL signaling through the BCMA and TACI receptors, it reduces B cell populations, making it an immunomodulatory therapy under investigation for B cell-mediated autoimmune diseases.
Sibeprenlimab is an anti-APRIL monoclonal antibody that inhibits B cell maturation and survival for the treatment of B cell-mediated autoimmune conditions.
Key facts at a glance
- ATC
- L04AG18
- RxNorm
- 2728380
- Generic
- Sibeprenlimab
- Class
- atc-l04
- Brands
- Voyxact
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- prefilled syringe
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
8 groupspregnancy
first trimesteravoid if possible
use only if potential benefits justify potential risks to fetus; consider discontinuation if pregnancy occurs
regular fetal monitoring and ultrasound assessments
Use with caution and monitor for adverse effects.
pregnancy
second third trimesteruse lowest effective dose
continue only if benefits outweigh risks; discuss with maternal-fetal medicine specialist
routine prenatal care with additional fetal growth monitoring
Use with caution and monitor for adverse effects.
lactation
breastfeedingno specific adjustment
decision to continue or discontinue breastfeeding should consider infant exposure and maternal need for therapy
monitor infant for immune system changes and infection susceptibility
pediatric_age
adolescents 12 to 17no pediatric-specific dosing established
use only if prescribed by pediatric specialist; monitor growth and development
regular monitoring of growth parameters, immune function, and vaccination status
Use with caution and monitor for adverse effects.
pediatric_age
children under 12not recommended
not approved for use in children under 12 years; use alternative therapies
N/A
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderly 65 and olderno specific dose adjustment required based on age alone
use with caution due to potential increased susceptibility to infections; assess overall health status
monitor for infections, immune-related adverse events, and response to therapy
Use with caution and monitor for adverse effects.
renal_impairment
severe renal impairmentno specific dose adjustment recommended
use with caution; monitor renal function and for adverse effects
regular monitoring of renal function and disease activity
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate to severeno specific dose adjustment recommended
use with caution; limited clinical data available
monitor liver function tests and for signs of hepatic toxicity
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Classification as biologic immunomodulator agent
Mechanism of action
Primary pharmacologic mechanism
Development status
Current regulatory status
Brand name
Commercial brand name
Under investigation for B cell-mediated autoimmune diseases, including systemic lupus erythematosus (SLE) and IgA nephropathy, where B cell dysregulation plays a key role in disease pathology.
Sibeprenlimab binds to APRIL with high affinity (KD of 0.95 pM), blocking its interaction with BCMA and TACI receptors on B cells. This inhibition prevents B cell maturation, survival, and antibody production, effectively reducing pathogenic B cell populations.
As an immunomodulatory therapy affecting B cells, patients may experience increased susceptibility to infections. Monitoring for infections and appropriate vaccination before initiation is recommended. Safety and efficacy profiles are still being established through clinical trials.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy