T-cell co-stimulation blocker (CTLA-4 fusion) Pregnancy: The data in pregnant women are insufficient to inform on drug-associated risk. Belatacept is known to cross the placenta of animals; administration to pregnant rats and rabbits during organogenesis was not teratogenic at exposures approximately 16 and 19 times the maximum recommended human dose of 10 mg/kg over the first month, and in a rat pre- and postnatal study, treatment-related infections in dams were associated with increased pup mortality at exposures 3 times the human exposure. Healthcare providers are encouraged to register pregnant patients in the Transplant Pregnancy Registry International.

Belatacept

Brand names: Nulojix

Belatacept is a fusion protein used for prophylaxis of organ rejection in adult kidney transplant recipients, given as a maintenance immunosuppressant.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Initial phase 10 mg/kg per dose; maintenance phase 5 mg/kg per dose (adult kidney transplant recipients)

Route: Intravenous infusion only, administered over 30 minutes. No premedication is required

Frequency: Initial phase (10 mg/kg): Day 1 (day of transplantation, prior to implantation) and Day 5 (approximately 96 hours after the Day 1 dose), then at the end of Week 2, Week 4, Week 8 and Week 12 after transplantation. Maintenance phase (5 mg/kg): at the end of Week 16 after transplantation and every 4 weeks (plus or minus 3 days) thereafter

Max: No numeric ceiling is given, but the label states that use of higher than recommended or more frequent dosing is not recommended because of the increased risk of serious infections and malignancy; the pregnancy section refers to 10 mg/kg over the first month of treatment as the maximum recommended human dose

Indication in this label: prophylaxis of organ rejection in adult kidney transplant recipients, administered in combination with basiliximab induction, mycophenolate mofetil and corticosteroids. In clinical trials the median corticosteroid doses were tapered to approximately 15 mg (10 to 20 mg) per day by the first 6 weeks and remained at approximately 10 mg (5 to 10 mg) per day for the first 6 months post-transplant; corticosteroid use should be consistent with that trial experience. WEIGHT BASIS: the total infusion dose should be based on the patient's actual body weight at the time of transplantation and should not be modified during the course of therapy unless body weight changes by more than 10%. DOSE ROUNDING: the prescribed dose must be evenly divisible by 12.5 mg so it can be prepared accurately (evenly divisible increments are 0, 12.5, 25, 37.5, 50, 62.5, 75, 87.5 and 100). Worked example from the label: a 64 kg patient at 10 mg/kg = 640 mg; the nearest dose evenly divisible by 12.5 mg is 637.5 mg, so 637.5 mg is prescribed. PREPARATION: 250 mg lyophilised powder per vial, reconstituted with 10.5 mL of sterile water for injection, 0.9% sodium chloride or 5% dextrose using ONLY the silicone-free disposable syringe provided (discard any solution prepared with a siliconised syringe), giving 25 mg/mL; volume of reconstituted solution (mL) = prescribed dose (mg) divided by 25 mg/mL, then further diluted with a compatible infusion fluid. Liver transplant: use is not recommended (section 5.6). PAEDIATRIC: safety and efficacy in patients under 18 years of age have not been established; because T cell development continues into the teenage years, the potential concern for autoimmunity in neonates applies to paediatric use as well. Verify any under-18 use against a children's formulary. SOURCE: no UK SPC (eMC) record was retrieved in this bundle - the dose above is from US prescribing information (NULOJIX, E.R. Squibb & Sons, label date 2021-07-28, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9057087d-7e59-4e5a-8e4a-96a532efb0ab) and must be verified against UK labelling.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Transplant recipients who are Epstein-Barr virus (EBV) seronegative or whose EBV serostatus is unknown, because of the risk of post-transplant lymphoproliferative disorder (PTLD) predominantly involving the central nervous system

Side effects

Post-transplant lymphoproliferative disorder (predominantly CNS PTLD) and other malignancies - the most serious reported reactions (boxed warning)
Serious infections, including JC virus-associated progressive multifocal leukoencephalopathy and polyoma virus nephropathy, plus bacterial, fungal, protozoal and tuberculous infections; some have been fatal
Anaemia, leukopenia, hypokalaemia and hyperkalaemia
Diarrhoea, nausea, vomiting and constipation
Urinary tract infection, peripheral oedema, hypertension, pyrexia, graft dysfunction, cough and headache (all among the most common reactions, 20% or more)

Interactions

Mycophenolate mofetil (MMF) - monitor for a need to adjust the MMF dose when switching between ciclosporin and belatacept: a higher MMF dose may be needed after switching from belatacept to ciclosporin (lower mycophenolic acid concentrations, increased rejection risk), and a lower MMF dose may be needed after switching from ciclosporin to belatacept (higher mycophenolic acid concentrations, increased risk of MPA-related adverse reactions)
Cytochrome P450 substrates - no dosage adjustments are needed for drugs metabolised via CYP1A2, CYP2C9, CYP2D6, CYP3A and CYP2C19
Anti-thymocyte globulin (or any other cell-depleting induction treatment) - coadministration at the same or nearly the same time in de novo kidney transplant recipients, especially those with other predisposing risk factors, may pose a risk of venous thrombosis of the renal allograft

Clinical monograph

How it works

It is a selective T-cell co-stimulation blocker that binds CD80 and CD86 on antigen-presenting cells, preventing the CD28 co-stimulatory signal required for full T-cell activation.

Prescribing in practice

It must only be used in patients who are Epstein-Barr virus seropositive, because EBV-seronegative recipients have a markedly increased risk of post-transplant lymphoproliferative disorder, predominantly affecting the central nervous system.
There is an increased risk of serious infections, including progressive multifocal leukoencephalopathy.
It is given by intravenous infusion as part of a regimen with other immunosuppressants.

Monitoring

Monitor for signs of infection, neurological symptoms and features suggestive of lymphoproliferative disease, alongside graft function.

Counselling the patient

Report new or worsening neurological symptoms such as confusion, weakness or vision changes promptly.
Report any signs of infection without delay.
Attend all scheduled infusions and clinic appointments.

Evidence & guidelines

Belatacept is licensed for kidney transplant rejection prophylaxis restricted to EBV-seropositive recipients owing to lymphoproliferative risk.

Reference: KDIGO transplant; BTS/NHSBT; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways