Last reviewed 2026-04-20 · How we verify

Nulojix (BELATACEPT)

Nulojix blocks the activation of T cells by binding to CD80, preventing an immune response.

At a glance

Mechanism of action

Belatacept, selective cell (lymphocyte) costimulation blocker, binds to CD80 and CD86 on antigen-presenting cells thereby blocking CD28 mediated costimulation of lymphocytes. In vitro, belatacept inhibits lymphocyte proliferation and the production of the cytokines interleukin-2, interferon-, interleukin-4, and TNF-. Activated lymphocytes are the predominant mediators of immunologic rejection.In non-human primate models of renal transplantation, belatacept monotherapy prolonged graft survival and decreased the production of anti-donor antibodies, compared to vehicle.

Approved indications

• Renal transplant rejection

Boxed warnings

• WARNING: POST-TRANSPLANT LYMPHOPROLIFERATIVE DISORDER, OTHER MALIGNANCIES, AND SERIOUS INFECTIONS Increased risk for developing post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system (CNS). Recipients without immunity to Epstein-Barr virus (EBV) are at a particularly increased risk; therefore, use in EBV seropositive patients only. Do not use NULOJIX in transplant recipients who are EBV seronegative or with unknown EBV serostatus [see Contraindications (4) and Warnings and Precautions (5.1) ] . Only physicians experienced in immunosuppressive therapy and management of kidney transplant patients should prescribe NULOJIX. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient [see Warnings and Precautions (5.2) ] . Increased susceptibility to infection and the possible development of malignancies may result from immunosuppression [see Warnings and Precautions (5.1 , 5.3 , 5.4 , 5.5) ] . Use in liver transplant patients is not recommended due to an increased risk of graft loss and death [see Warnings and Precautions (5.6) ] . WARNING: POST-TRANSPLANT LYMPHOPROLIFERATIVE DISORDER, OTHER MALIGNANCIES, AND SERIOUS INFECTIONS See full prescribing information for complete boxed warning. • Increased risk for developing post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system (CNS). Recipients without immunity to Epstein-Barr virus (EBV) are at a particularly increased risk; therefore, use in EBV seropositive patients only. Do not use NULOJIX in transplant recipients who are EBV seronegative or with unknown serostatus. (4 , 5.1) • Only physicians experienced in immunosuppressive therapy and management of kidney transplant patients should prescribe NULOJIX. (5.2) • Increased susceptibility to infection and the possible development of malignancies may result from immunosuppression. (5.1 , 5.3 , 5.4 , 5.5) • Use in liver transplant patients is not recommended due to an increased risk of graft loss and death. (5.6)

Common side effects

• PTLD
• Cytomegalovirus infection
• Complications of transplanted kidney
• Anemia
• Diarrhea
• Urinary tract infection
• Peripheral edema
• Constipation
• Hypertension
• Pyrexia
• Graft dysfunction
• Cough

Key clinical trials

• Use of Belatacept to Delay Tacrolimus Initiation in Kidney Transplant Patients With Delayed Graft Function
• Treatment of Antibody-Mediated Rejection (ABMR) With CarBel (PHASE2)
• Advancing Transplantation Outcomes in Children (PHASE2)
• Carfilzomib and Belatacept for Desensitization (PHASE1,PHASE2)
• 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) (PHASE2,PHASE3)
• Tolerance by Engaging Antigen During Cellular Homeostasis (PHASE1)
• Comparison of the Effects of Belatacept and Anticalcineurins on Endothelial Function in Renal Transplant Patients - <BELAFENDO> (PHASE4)
• A Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Kidney Transplant Recipients Aged 12 to <18 Years to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications (PHASE3)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Nulojix CI brief — competitive landscape report
• Nulojix updates RSS · CI watch RSS
• Bristol-Myers Squibb portfolio CI