Belimumab
Belimumab is a biologic medication classified as a BLyS-specific inhibitor used to treat autoimmune conditions, primarily systemic lupus erythematosus (SLE) and lupus nephritis. It works by targeting and blocking BLyS, a protein that promotes B-cell survival, thereby reducing the number of autoreactive B cells that contribute to autoimmune disease activity.
Belimumab is a biologic immunosuppressant that targets B-cell survival factors to treat lupus and related autoimmune conditions.
Key facts at a glance
- ATC
- L04AG04
- RxNorm
- 1092437
- Generic
- Belimumab
- Class
- atc-l04
- Brands
- Benlysta
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- prefilled syringe, injection
- 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
avoid use during pregnancy unless benefits outweigh risks; women of childbearing potential should use effective contraception during treatment and for at least 4 months after discontinuation
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second third trimesteravoid if possible
avoid use during pregnancy; discontinue therapy if pregnancy occurs
regular fetal monitoring including ultrasound assessments
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingdiscontinue breastfeeding or discontinue drug
belimumab should not be administered to breastfeeding women; women should not breastfeed during treatment and for at least 4 months after the last dose
monitor infant for signs of infection or immunosuppression
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderly 65 years and olderno specific dose adjustment required
use with caution; start at lower end of dosing range; monitor for infections
regular monitoring for infections, particularly respiratory and urinary tract infections
Use with caution and monitor for adverse effects.
pediatric_age
children 5 to 17 yearsweight-based dosing; 10 mg/kg IV every 4 weeks
approved for pediatric patients 5 years and older with active, autoantibody-positive SLE; not recommended for patients with severe active CNS lupus
monitor for infusion reactions; regular assessment of disease activity and infections
renal_impairment
mild moderateno dose adjustment needed
can be used in patients with mild to moderate renal impairment; no dose adjustment required
monitor renal function regularly
renal_impairment
severeuse with caution
use with caution in patients with severe renal impairment; limited clinical trial data
monitor renal function closely; monitor for infections
Use with caution and monitor for adverse effects.
hepatic_impairment
mildno specific dose adjustment required
belimumab is not metabolized by hepatic cytochrome P450; limited clinical data in hepatic impairment
monitor liver function tests periodically
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Monoclonal antibody therapeutic class
FDA approval year
FDA approval date for Benlysta
Common uses
Primary therapeutic indication
Mechanism of action
Pharmacologic mechanism of action
Belimumab is primarily indicated for the treatment of active systemic lupus erythematosus (SLE) in patients who are receiving standard therapy, and for lupus nephritis in combination with immunosuppressive therapy.
Belimumab is a monoclonal antibody that binds specifically to B-lymphocyte stimulator (BLyS), preventing it from interacting with B-cell receptors. By blocking this B-cell survival factor, it reduces the population of B cells, including autoreactive B cells that drive autoimmune inflammation.
Belimumab is administered via intravenous infusion or subcutaneous injection and carries warnings for serious infections, hypersensitivity reactions, and psychiatric events including depression. It should not be used in combination with other biologic therapies. Patients should be monitored for signs of infection during treatment.
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