Molecule
Belatacept is a selective T cell costimulation blocker indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant, among other approved uses. It is available as powder for injection for intravenous use. MedsAcross supplies Belatacept for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
• 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.
Source: US FDA prescribing information
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. Activated T 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.
Source: US FDA prescribing information
• Use of higher than recommended or more frequent dosing is not recommended due to increased risk of serious infections and malignancy. • For complete dosing instructions, see full prescribing information. Dosing of NULOJIX for Kidney Transplant Recipients. 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. • Only use the enclosed silicone-free disposable syringe to prepare for administration.
Source: US FDA prescribing information
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). Patients who are EBV seronegative or with unknown EBV serostatus.
Source: US FDA prescribing information
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. • 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.
Source: US FDA prescribing information
The most serious adverse reactions reported with NULOJIX are: • PTLD, predominantly CNS PTLD, and other malignancies • Serious infections, including JC virus-associated PML and polyoma virus nephropathy 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.
Source: US FDA prescribing information
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 does not: • A higher MMF dosage may be needed after switching from NULOJIX to cyclosporine, since this may result in lower MPA concentrations and increase the risk of graft rejection. • A lower MMF dosage may be needed after switching from cyclosporine to NULOJIX, since this may result in higher MPA concentrations and increase the risk for adverse reactions related to MPA (review the Full Prescribing Information for MMF).
Source: US FDA prescribing information
NULOJIX lyophilized powder is stored refrigerated at 2°C to 8°C (36°F to 46°F). If not used immediately, the infusion solution may be stored under refrigeration conditions: 2°C to 8°C (36°F to 46°F) and protected from light for up to 24 hours (a maximum of 4 hours of the total 24 hours can be at room temperature: 20°C to 25°C [68°F to 77°F] and room light).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Belatacept, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Nulojix 250 mg powder for injectionIntravenous Cold chain | ER Squibb & Sons | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Belatacept and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Belatacept, including Nulojix.
Yes. The US FDA first approved Belatacept on 15 June 2011, according to Drugs@FDA.
Yes. Belatacept has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Belatacept must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Belatacept is classified under ATC code L04AA28 (Belatacept).
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