belatacept
Nulojix · ATC code L04AA28
Also known as: Belatasept
- Key facts
- Active substance
- belatacept
- Drug class
- Immunosuppressive drug
- ATC code
- L04AA28
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- NULOJIX 250 mg powder for concentrate for solution for infusion
- Marketing authorisation holder
- Bristol-Myers Squibb Pharma EEIG
- Information as of
- 2026-10-29
Key facts
Belatacept (Nulojix) is a selective immunosuppressant (fusion protein) used to prevent graft rejection in adults who have received a kidney transplant.
What it is used for
- In combination with corticosteroids and a mycophenolic acid (MPA), prophylaxis of graft rejection in adult recipients of a renal transplant.
Dosing
- Prescribed and supervised by specialists experienced in immunosuppressive therapy and renal transplantation; dose based on body weight (kg), given by intravenous infusion.
- Initiation at transplantation (initial phase): 10 mg/kg on the day of transplantation before implantation (Day 1), on Days 5, 14 and 28, and at the end of Week 8 and Week 12; addition of an IL-2 receptor antagonist is recommended (basiliximab induction, mycophenolate mofetil, corticosteroids).
- Maintenance phase: 6 mg/kg every 4 weeks (± 3 days), starting at the end of Week 16 after transplantation.
- Conversion from a calcineurin inhibitor (CNI) at least 6 months post-transplant: 6 mg/kg every 2 weeks for the first 8 weeks, then every 4 weeks; the CNI is continued in tapering doses for at least 4 weeks.
- Elderly and renal impairment (including dialysis): no dose adjustment; no dose recommendation can be made in hepatic impairment. No data in children and adolescents.
Contraindications
- Transplant recipients who are Epstein-Barr virus (EBV) seronegative or whose serostatus is unknown.
- Hypersensitivity to the active substance or any excipient.
Important warnings
- Post-transplant lymphoproliferative disorder (PTLD): higher incidence than with ciclosporin, especially in EBV-seronegative patients; most often in the central nervous system. EBV serology must be ascertained before starting.
- Increased susceptibility to infection, including fatal and opportunistic infections, tuberculosis and herpes; CMV prophylaxis for at least 3 months and Pneumocystis pneumonia prophylaxis for at least 6 months after transplantation are recommended; test for tuberculosis before starting.
- Progressive multifocal leukoencephalopathy (PML): recommended doses of belatacept and concomitant immunosuppressants should not be exceeded.
- Infusion-related reactions: discontinue immediately if a serious allergic or anaphylactic reaction occurs.
- Taper corticosteroids cautiously, particularly with 4 to 6 HLA mismatches; after conversion from a CNI, more frequent monitoring for acute rejection for at least 6 months.
Side effects
- Most common (≥ 20%) up to Year 3: diarrhoea, anaemia, urinary tract infection, peripheral oedema, constipation, hypertension, pyrexia, nausea, graft dysfunction, cough, vomiting, leukopenia, hypophosphataemia and headache.
- Most common serious reactions (≥ 2%): urinary tract infection, CMV infection, pyrexia, increased blood creatinine, pyelonephritis, diarrhoea, gastroenteritis, graft dysfunction, leukopenia, pneumonia, basal cell carcinoma, anaemia, dehydration.
- Renal vein thrombosis and CMV infection led to interruption or discontinuation in ≥ 1% of patients.
Interactions
- At a given MMF dose, MPA exposure is approximately 40% higher with belatacept than with ciclosporin.
- Vaccinations may be less effective; live vaccines should be avoided.
Pregnancy and breastfeeding
- Women of childbearing potential should use effective contraception during treatment and up to 8 weeks after the last dose.
- Should not be used in pregnancy unless clearly necessary.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- NulojixBristol-Myers Squibb Pharma EEIG · EMEA/H/C/002098
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Nulojix
- Liechtenstein
- Nulojix
- Norway
- Nulojix
EMA – Article 57 product data (EU/EEA), 2026-10-29
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Sources
- European Medicines Agency. Nulojix – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/nulojix-epar-product-information_en.pdf
- Wikidata (CC0): ATC L04AA.
Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.