Quick answers
- What is Belatacept used for?
- The FDA-approved label (Nulojix, E.R. Squibb & Sons, L.L.C., July 28, 2021) says: “• 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Belatacept have a boxed warning?
- Yes. The FDA label for Nulojix has a boxed warning (“WARNING: POST-TRANSPLANT LYMPHOPROLIFERATIVE DISORDER, OTHER MALIGNANCIES, AND SERIOUS INFECTIONS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Belatacept?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Belatacept been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Belatacept?
- 1 company lists prescription products of Belatacept in the FDA NDC Directory, including E.R. Squibb & Sons, L.L.C..
What Belatacept is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
• 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. …
— FDA label: Nulojix, E.R. Squibb & Sons, L.L.C., effective July 28, 2021. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: POST-TRANSPLANT LYMPHOPROLIFERATIVE DISORDER, OTHER MALIGNANCIES, AND SERIOUS INFECTIONS
. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Nulojix |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- E.R. Squibb & Sons, L.L.C.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125288 NULOJIX | Bristol Myers Squibb | June 15, 2011 | 8, latest July 28, 2021 2021: Labeling · 2018: Efficacy · 2017: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1112976, 1112980 |
|---|---|
| SPL set ID of the quoted label | c16ac648-d5d2-9f7d-8637-e2328572754e |
| FDA labels (SPL) | 1 |
| FDA applications | BLA125288 |
| Active ingredients (FDA) | BELATACEPT |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Nulojix, E.R. Squibb & Sons, L.L.C., effective July 28, 2021; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →