NULOJIX
Nulojix (belatacept) is a selective T cell costimulation blocker indicated for the prophylaxis of organ rejection in adult kidney transplant recipients. The medication is used in a combination regimen that includes basiliximab induction, mycophenolate mofetil, and corticosteroids. Its use is limited to patients who are Epstein-Barr Virus (EBV) seropositive, and its efficacy has not been established for the transplant of organs other than the kidney.
How NULOJIX Works
Belatacept binds to CD80 and CD86 on antigen-presenting cells, which blocks the CD28-mediated costimulation of T lymphocytes. By preventing this costimulation, the drug inhibits the proliferation of T lymphocytes and the production of inflammatory cytokines like interleukin-2 and interferon-γ. This suppression of T lymphocyte activity, the primary mediator of immunologic rejection, helps prolong graft survival and decrease the production of anti-donor antibodies.
Details
- Status
- Prescription
- First Approved
- 2011-06-15
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
NULOJIX Approval History
What NULOJIX Treats
1 indicationsNULOJIX is approved for 1 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Organ Rejection
NULOJIX Boxed 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)...
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
NULOJIX Target & Pathway
ProTarget
A pro-inflammatory cytokine that plays a central role in immune responses and inflammation. Excess TNF contributes to autoimmune diseases like rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Blocking TNF reduces inflammation and prevents tissue damage.
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NULOJIX FDA Label Details
ProIndications & Usage
FDA Label (PDF)• NULOJIX is a selective T cell costimulation blocker indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant. • Use in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids. Limitations of Use : • Use only in patients who are EBV seropositive. • Use has not been established for the prophylaxis of organ rejection in transplanted organs other than the kidney. 1.1 Adult Kidney Transplant Recipients NULOJIX ® (belatacept) is indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant. NULOJIX is to ...
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 a...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.