Prescription medicine
Belatacept Brand names: Nulojix
Belatacept (Nulojix) is a prescription medicine with an FDA approval on record since 2011. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the belatacept FDA label on DailyMed (effective July 28, 2021, E.R. Squibb & Sons, L.L.C.); the BLA 125288 record on Drugs@FDA; every belatacept label on DailyMed.
Highlights of the record
FDA label of July 28, 2021; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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) ]. […]
Used for
From the label: indications and usageNULOJIX is a selective T cell costimulation blocker indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant.
Forms and strengths
- 250 mg
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- June 15, 2011 Nulojix, Bristol Myers Squibb; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 4,651 through July 30, 2026
What is belatacept used for?
From the label: indications and usageNULOJIX 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. (1.1) Limitations of Use:
Use only in patients who are EBV seropositive. (1.2 , 4 , 5.1)
Use has not been established for the prophylaxis of organ rejection in transplanted organs other than the kidney. (1.2 , 5.6) 1.1 Adult Kidney Transplant Recipients NULOJIX ® (belatacept) is indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant. […]
Conditions named in the indications of belatacept's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Selective T Cell Costimulation Blocker.
Source: FDA drug label (NULOJIX), E.R. Squibb & Sons, L.L.C., effective July 28, 2021 (SPL set c16ac648-d5d2-9f7d-8637-e2328572754e), via openFDA; the full label on DailyMed
What does the patient leaflet for belatacept say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about NULOJIX?NULOJIX increases your risk of serious side effects, including: • Post-transplant lymphoproliferative disorder (PTLD). PTLD is a condition that can happen if certain white blood cells grow out of control after an organ transplant because your immune system is weak. PTLD can get worse and become a type of cancer. PTLD can lead to death. People treated with NULOJIX have a higher risk of getting PTLD. If you get PTLD with NULOJIX you are at especially high risk of getting it in your brain. Your risk for PTLD is also higher if you: • have never been exposed to the Epstein-Barr virus (EBV). Your doctor should test you for EBV. Do not receive NULOJIX unless you are EBV positive (you have been exposed to EBV). • get an infection with a virus called cytomegalovirus (CMV). • receive treatment for transplant rejection that lowers certain white blood cells called T lymphocytes. • Increased risk of getting cancers other than PTLD. People who take medicines that weaken the immune system, including NULOJIX, have a higher risk of getting other cancers, including skin cancer. Talk to your doctor about your risk for cancer. See " What should I avoid while receiving NULOJIX? " • Progressive multifocal leukoencephalopathy (PML). PML is a rare, serious brain infection caused by JC virus. People with weakened immune systems are at risk for getting PML. PML can result in death or severe disability. There is no known prevention, treatment, or cure for PML. • Increased risk of getting other serious infections, including tuberculosis (TB) and other infections caused by bacteria, viruses, or fungi. These serious infections may lead to death. Also, a virus called BK virus can affect how your kidney works and cause your transplanted kidney to fail. […]
From the patient leaflet: What should I avoid while receiving NULOJIX?Limit the amount of time you spend in sunlight. Avoid using tanning beds or sunlamps. People who take medicines that weaken the immune system, including NULOJIX, have a higher risk of getting cancer, including skin cancer. Wear protective clothing and use sunscreen with a high protection factor (SPF) when you have to be in the sun. • Avoid receiving live vaccines during treatment with NULOJIX. Talk to your doctor to find out which vaccines are safe for you during this time. Some vaccines may not work as well while you are receiving NULOJIX. See “ What should I tell my doctor before receiving NULOJIX? ”
Source: FDA drug label (NULOJIX), E.R. Squibb & Sons, L.L.C., effective July 28, 2021 (SPL set c16ac648-d5d2-9f7d-8637-e2328572754e), via openFDA; the full label on DailyMed
Is there a generic for belatacept (Nulojix)?
No generic belatacept is approved (Drugs@FDA, October 8, 2026).
- 2011 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the belatacept label say about other medicines?
The belatacept label names 5 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Basiliximab | warnings and precautions | Rejection and Graft Loss with Corticosteroid Minimization In postmarketing experience, use of NULOJIX in conjunction with basiliximab induction, MMF, and corticosteroid minimization to 5 mg per day between Day 3 and Week 6 post-transplant was associated with an increased rate and grade of acute rejection, particularly … |
| Cyclosporine | drug interactions | DRUG INTERACTIONS 7.1 Mycophenolate Mofetil (MMF) Monitor for a need to adjust concomitant mycophenolate mofetil (MMF) dosage when a patient’s therapy is switched between cyclosporine and NULOJIX, as cyclosporine decreases mycophenolic acid (MPA) exposure by preventing enterohepatic recirculation of MPA while NULOJIX … |
| Mycophenolate mofetil | drug interactions | DRUG INTERACTIONS 7.1 Mycophenolate Mofetil (MMF) Monitor for a need to adjust concomitant mycophenolate mofetil (MMF) dosage when a patient’s therapy is switched between cyclosporine and NULOJIX, as cyclosporine decreases mycophenolic acid (MPA) exposure by preventing enterohepatic recirculation of MPA while NULOJIX … |
| Mycophenolic acid | drug interactions | DRUG INTERACTIONS 7.1 Mycophenolate Mofetil (MMF) Monitor for a need to adjust concomitant mycophenolate mofetil (MMF) dosage when a patient’s therapy is switched between cyclosporine and NULOJIX, as cyclosporine decreases mycophenolic acid (MPA) exposure by preventing enterohepatic recirculation of MPA while NULOJIX … |
| Tacrolimus | warnings and precautions | … mofetil (MMF) and corticosteroids, was associated with a higher rate of graft loss and death compared to the tacrolimus control arms. |
Source: FDA drug label (NULOJIX), E.R. Squibb & Sons, L.L.C., effective July 28, 2021 (SPL set c16ac648-d5d2-9f7d-8637-e2328572754e), via openFDA; the full label on DailyMed
What do FAERS reports show for belatacept?
The FDA Adverse Event Reporting System holds 4,651 reports that list belatacept among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 742 are coded as a death and 1,762 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as belatacept?
7 other medicines are given the same way (intravenous) and in the same FDA class as belatacept or labeled mainly for the same use (organ transplant rejection), the same class first. Organ transplant rejection lists all 13 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Mycophenolate mofetil | Organ transplant rejection | 6 labelers | n/a | No current entry |
| Basiliximab | Organ transplant rejection | none listed | n/a | No current entry |
| Tacrolimus | Organ transplant rejection | 1 labeler | n/a | No current entry |
| Azathioprine | Organ transplant rejection | 1 labeler | n/a | No current entry |
| Cyclosporine | Organ transplant rejection | none listed | n/a | No current entry |
| Lapine t-lymphocyte immune globulin | Organ transplant rejection | none listed | n/a | No current entry |
| Sirolimus | Organ transplant rejection | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as belatacept
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to belatacept
- 7 medicines for the same use
- Belatacept side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other