Belatacept

Belatacept, a selective T cell (lymphocyte) costimulation blocker, binds to CD80 and CD86 on antigen-presenting cells thereby blocking CD28 mediated costimulation of T lymphocytes. In vitro, belatacept inhibits T lymphocyte proliferation and the production of the cytokines interleukin-2, interferon-γ, interleukin-4, and TNF-α.

• • NULOJIX is a selective T cell costimulation blocker indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant. (1.1) • Use in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids.

• NULOJIX is contraindicated in transplant recipients who are Epstein-Barr virus (EBV) seronegative or with unknown EBV serostatus due to the risk of post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system (CNS) [see Boxed Warning and Warnings and Precautions (5.1) ] . Patients who are EBV seronegative or with unknown EBV serostatus.contraindicated

• Use of higher than recommended or more frequent dosing is not recommended due to increased risk of serious infections and malignancy. (5.1 , 5.4 , 6.1) • For complete dosing instructions, see full prescribing information. (2.1) Dosing of NULOJIX for Kidney Transplant Recipients (2.1) Dosing for Initial Phase Dose Day 1 (day of transplantation, prior to implantation) and Day 5 (approximately 96 hours after Day 1 dose) 10 mg per kg End of Week 2 and Week 4 after transplantation 10 mg per kg End of Week 8 and Week 12 after transplantation 10 mg per kg Dosing for Maintenance Phase Dose End of Week 16 after transplantation and every 4 weeks (plus or minus 3 days) thereafter 5 mg per kg • For intravenous infusion only; administer over 30 minutes. (2.1 , 2.2) • Only use the enclosed silicone-free disposable syringe to prepare for administration. (2.2) 2.1 Dosage in Adult Kidney Transplant Recipients NULOJIX should be administered in combination with basiliximab induction, mycophenolate mofetil (MMF), and corticosteroids. In clinical trials the median (25 th to 75 th percentile) corticosteroid doses were tapered to approximately 15 mg (10 to 20 mg) per day by the first 6 weeks and remained at approximately 10 mg (5 to 10 mg) per day for the first 6 months post-transplant. Corticosteroid utilization should be consistent with the NULOJIX clinical trial experience [see Warnings and Precautions (5.7) and Clinical Studies (14.1) ] .

• Post-Transplant Lymphoproliferative Disorder (PTLD) : increased risk, predominantly involving the CNS; monitor for new or worsening neurological, cognitive, or behavioral signs and symptoms. (Boxed Warning , 4 , 5.1 , 5.6) • Other malignancies : increased risk with all immunosuppressants; appears related to intensity and duration of use. Avoid prolonged exposure to UV light and sunlight. (5.3) • Progressive Multifocal Leukoencephalopathy (PML) : increased risk; consider in the diagnosis of patients reporting new or worsening neurological, cognitive, or behavioral signs and symptoms. Recommended doses of immunosuppressants should not be exceeded. (5.4) • Other serious infections : increased risk of bacterial, viral, fungal, and protozoal infections, including opportunistic infections and tuberculosis. Some infections were fatal. Polyoma virus-associated nephropathy can lead to kidney graft loss; consider reduction in immunosuppression. Evaluate for tuberculosis and initiate treatment for latent infection prior to NULOJIX use. Cytomegalovirus and pneumocystis prophylaxis are recommended after transplantation. (5.1 , 5.4 , 5.5) • Liver transplant : use is not recommended. (5.6) • Acute Rejection and Graft Loss with Corticosteroid Minimization : corticosteroid utilization should be consistent with the NULOJIX clinical trial experience. (2.1 , 5.7 , 14.1) • Immunizations : avoid use of live vaccines during treatment.

The most serious adverse reactions reported with NULOJIX are: • PTLD, predominantly CNS PTLD, and other malignancies [see Boxed Warning and Warnings and Precautions (5.1 , 5.3) ] • Serious infections, including JC virus-associated PML and polyoma virus nephropathy [see Warnings and Precautions (5.4 , 5.5 , 5.6) ] Most common adverse reactions (≥20% on NULOJIX treatment) are anemia, diarrhea, urinary tract infection, peripheral edema, constipation, hypertension, pyrexia, graft dysfunction, cough, nausea, vomiting, headache, hypokalemia, hyperkalemia, and leukopenia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice. The data described below primarily derive from two randomized, active-controlled three-year trials of NULOJIX in de novo kidney transplant patients. In Study 1 and Study 2, NULOJIX was studied at the recommended dose and frequency [see Dosage and Administration (2.1) ] in a total of 401 patients compared to a cyclosporine control regimen in a total of 405 patients. These two trials also included a total of 403 patients treated with a NULOJIX regimen of higher cumulative dose and more frequent dosing than recommended [see Clinical Studies (14.1) ] .

• Pregnancy : Based on animal data, may cause fetal harm; pregnancy registry available. (8.1) • Lactation : Discontinue drug or nursing, taking into consideration importance of drug to mother. (8.2) 8.1 Pregnancy Pregnancy Exposure Registry To monitor maternal-fetal outcomes of pregnant women who have received immunosuppressants including NULOJIX or whose partners have received NULOJIX, healthcare providers are strongly encouraged to register pregnant patients in the Transplant Pregnancy Registry International (TPR) by calling 1-877-955-6877. Risk Summary The data with NULOJIX use in pregnant women are insufficient to inform on drug-associated risk. Belatacept is known to cross the placenta of animals. Administration of belatacept to pregnant rats and rabbits during the period of organogenesis was not teratogenic at exposures approximately 16 and 19 times greater than that observed at the maximum recommended human dose (MRHD) of 10 mg per kg body weight administered over the first month of treatment, based on area under the concentration-time curve (AUC). In a pre- and postnatal development study in rats, treatment-related infections in dams were associated with increased pup mortality, presumably secondary to deteriorating maternal health, at exposures 3 times higher than that observed at MRHD [see Animal Data ] .

Metabolism

Table 5 summarizes the pharmacokinetic parameters of belatacept in healthy adult subjects after a single 10 mg per kg intravenous infusion; and in kidney transplant patients after the 10 mg per kg intravenous infusion at Week 12, and after 5 mg per kg intravenous infusion every four weeks at Month 12 post-transplant or later.

Single doses up to 20 mg per kg of NULOJIX have been administered to healthy subjects without apparent toxic effect. The administration of NULOJIX of higher cumulative dose and more frequent dosing than recommended in kidney transplant patients resulted in a higher frequency of CNS-related adverse reactions [see Adverse Reactions (6.1) ] . In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.

• Jun 15, 2011BLABLA125288Bristol Myers Squibb

1. 1Off Label Use4289.4%
2. 2Death2325.1%
3. 3Transplant Rejection2254.9%
4. 4Kidney Transplant Rejection2204.8%
5. 5Drug Ineffective1914.2%
6. 6Cytomegalovirus Infection1773.9%
7. 7Acute Kidney Injury1733.8%
8. 8Product Storage Error1723.8%
9. 9Covid-191483.2%
10. 10Hospitalisation1252.7%
11. 11Pyrexia1152.5%
12. 12Thrombotic Microangiopathy1002.2%
13. 13Diarrhoea962.1%
14. 14Post Transplant Lymphoproliferative Disorder952.1%
15. 15Urinary Tract Infection942.1%

Recent PubMed references pinned to Belatacept as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Cancer risk associated with abatacept among older individuals with rheumatoid arthritis in the United States.
  JNCI cancer spectrum · 2026 · Ahmed S, Mariette X, Seror R, et al.
  PMID 42080708DOI 10.1093/jncics/pkag051
• Belatacept in liver transplantation: Results of a national survey among French specialists.
  Transplant immunology · 2026 · Dumortier J, Conti F, Francoz C, et al.
  PMID 42067156DOI 10.1016/j.trim.2026.102392
• Inhibition of the programmed death protein 1 immune checkpoint and the development of heart failure in the presence of prior cardiac ischaemia.
  Cardiovascular research · 2026 · Gergely TG, Drobni ZD, Kovács T, et al.
  PMID 42019014DOI 10.1093/cvr/cvag085
• Certolizumab pegol, abatacept, tocilizumab or active conventional therapy in early rheumatoid arthritis: 48-week patient-reported outcomes from the NORD-STAR trial.
  The Lancet. Rheumatology · 2026 · Lampa J, Nordström D, van Vollenhoven R, et al.
  PMID 41881637DOI 10.1016/S2665-9913(26)00007-X
• CTLA4-Ig reduces proliferation and inflammatory gene expression in muscle fibroblasts, corresponding to less fibrosis and inflammation in mdx muscular dystrophy.
  American journal of physiology. Cell physiology · 2026 · Wehling-Henricks M, Kannan P, Thomas C, et al.
  PMID 41855092DOI 10.1152/ajpcell.00860.2025
• Systematic review and meta-analysis of belatacept versus calcineurin inhibitors on risk of post-transplant diabetes mellitus in kidney transplant recipients.
  Frontiers in immunology · 2026 · Wang X, Song D, Hou S, et al.
  PMID 41766891DOI 10.3389/fimmu.2026.1615875
• Abatacept treatment shows a modulating effect on Treg subsets in LRBA-deficient patients.
  Frontiers in immunology · 2026 · Donhauser S, Salzmann-Manrique E, Lueck LM, et al.
  PMID 41727438DOI 10.3389/fimmu.2026.1697915
• Model-Informed Abatacept Dose Recommendation in Pediatric Patients With Acute Graft Versus Host Disease.
  Journal of clinical pharmacology · 2026 · Zhong R, Maxwell K, Passarell J, et al.
  PMID 41684189DOI 10.1002/jcph.70156

The 10 most recently updated of 88 ClinicalTrials.gov registrations naming Belatacept as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Comparison of the Effects of Belatacept and Anticalcineurins on Endothelial Function in Renal Transplant Patients - <BELAFENDO>
  Recruiting · Phase 4 · Interventional · 44 enrolled · University Hospital, Rouen
  NCT06291077updated 2026-06-09
• Screening for Subclinical Antibody Mediated Rejection and Efficacy of Belatacept in the Context of de Novo Donor Specific Antibody After Kidney Transplantation (BELA-M-R)
  Not yet recruiting · Phase 2 · Phase 3 · Interventional · 290 enrolled · University Hospital, Rouen
  NCT06291103updated 2026-06-09
• Islet Transplantation With Recipient T-Reg Cells or Deceased Donor Vertebral Bone Marrow Therapy
  Enrolling by invitation · Phase 1 · Interventional · 24 enrolled · Stanford University
  NCT05973734updated 2026-06-08
• Treatment of Antibody-Mediated Rejection (ABMR) With CarBel
  Recruiting · Phase 1 · Interventional · 25 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT06918990updated 2026-05-26
• Evolution of CMV Antiviral T-cell Immunity Over the Next Six Months Initiation of Treatment With Belatacept.
  Active not recruiting · Observational · 28 enrolled · University Hospital, Rouen
  NCT05708534updated 2026-05-22
• Advancing Transplantation Outcomes in Children
  Recruiting · Phase 2 · Interventional · 200 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT06055608updated 2026-05-20
• A Study of TCD601 in de Novo Renal Transplant Recipients
  Completed · Phase 2 · Interventional · 76 enrolled · ITB-Med LLC
  NCT05669001updated 2026-05-05
• Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy
  Recruiting · Phase 2 · Interventional · 50 enrolled · Linda Cendales
  NCT02310867updated 2026-04-09
• Carfilzomib and Belatacept for Desensitization
  Active not recruiting · Phase 1 · Phase 2 · Interventional · 21 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT05017545updated 2026-04-08
• Belatacept in Heart Transplantation
  Recruiting · Phase 2 · Interventional · 66 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT06478017updated 2026-04-07

Frequently asked questions

How does Belatacept work?

Belatacept, a selective T cell (lymphocyte) costimulation blocker, binds to CD80 and CD86 on antigen-presenting cells thereby blocking CD28 mediated costimulation of T lymphocytes. In vitro, belatacept inhibits T lymphocyte proliferation and the production of the cytokines interleukin-2, interferon-γ, interleukin-4, and TNF-α.

What is Belatacept used for?

According to FDA labeling, Belatacept carries indications including: • NULOJIX is a selective T cell costimulation blocker indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant. (1.1) • Use in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Belatacept?

Belatacept is classified as Selective immunosuppressants, Selective T Cell Costimulation Blocker, CD80-directed Antibody Interactions, CD86-directed Antibody Interactions, T Lymphocyte Costimulation Activity Blockade.

What are the brand names for Belatacept?

Belatacept is marketed under brand names including Nulojix.

What are the contraindications for Belatacept?

Belatacept labeling lists contraindications including: NULOJIX is contraindicated in transplant recipients who are Epstein-Barr virus (EBV) seronegative or with unknown EBV serostatus due to the risk of post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system (CNS) [see Boxed Warning and Warnings and Precautions (5.1) ] . Patients who are EBV seronegative or with unknown EBV serostatus.. Always consult the full prescribing information and a clinician.