Belatacept
Belatacept is an immunosuppressant medication used to prevent organ rejection in adult kidney transplant patients. It works by blocking T cell activation, which is essential for the immune response that would otherwise attack the transplanted organ. This medication is used in patients who are EBV-seropositive and is typically administered intravenously.
Belatacept is an immunosuppressant that prevents kidney transplant rejection by blocking T cell activation.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- L04AA28
- RxNorm
- 1112973
- Generic
- Belatacept
- Class
- atc-l04
- Brands
- Nulojix
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- 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
9 groupspregnancy
first trimesteravoid if possible
use during pregnancy only if benefits outweigh potential risks to fetus
regular fetal monitoring recommended
Use with caution and monitor for adverse effects.
pregnancy
second trimesteravoid if possible
continue only if benefits outweigh risks
regular fetal monitoring
Use with caution and monitor for adverse effects.
pregnancy
third trimesteravoid if possible
use only if benefits outweigh risks
regular fetal monitoring and assessment of maternal condition
Use with caution and monitor for adverse effects.
lactation
breastfeedingdiscontinue nursing or drug
decide whether to discontinue nursing or discontinue belatacept considering importance of drug to mother
monitor infant for signs of immunosuppression
geriatric
elderlyno specific adjustment
use with caution; no overall differences in safety and efficacy observed but greater sensitivity possible
monitor renal function and for infections
Use with caution and monitor for adverse effects.
pediatric_age
children 2 to 17 yearsweight-based dosing
safety and efficacy established in pediatric patients 2-17 years; not recommended for patients less than 2 years
monitor for infections and immune system effects
Use with caution and monitor for adverse effects.
renal_impairment
all stagesno adjustment needed
no dosage adjustment required for patients with any degree of renal impairment including hemodialysis
standard transplant monitoring
hepatic_impairment
mild to moderateuse with caution
limited data in hepatic impairment; use with caution
monitor liver function tests
Use with caution and monitor for adverse effects.
hepatic_impairment
severeinsufficient data
not studied in severe hepatic impairment; use only if benefits outweigh risks
close monitoring of liver function
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Belatacept is a fusion protein classified as an immunosuppressant
FDA approval year
Belatacept was approved by the FDA in 2011 under the brand name Nulojix
Primary indication
Belatacept is indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant
Route of administration
Belatacept is administered as an intravenous infusion
Belatacept is indicated for prophylaxis of organ rejection in adult kidney transplant recipients who are Epstein-Barr virus (EBV) seropositive. It is used as part of an immunosuppressive regimen that typically includes basiliximab, mycophenolate mofetil, and corticosteroids.
Belatacept is a selective T cell costimulation blocker that binds to CD80 and CD86 molecules on antigen-presenting cells. By blocking these molecules, it prevents CD28-mediated costimulation of T lymphocytes, thereby inhibiting T cell proliferation and the production of inflammatory cytokines that would otherwise trigger an immune response against the transplanted organ.
Belatacept carries a boxed warning for increased risk of post-transplant lymphoproliferative disorder (PTLD) and progressive multifocal leukoencephalopathy (PML), particularly in EBV-seronegative patients. It is administered as an intravenous infusion and requires careful monitoring. Healthcare providers should verify EBV serostatus before initiating therapy.
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
WellAlly may earn a referral fee from linked resources at no extra cost to you. Editorial content is never influenced by commercial relationships.
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