Belatacept

Belatacept
Clinical data
Trade namesNulojix
AHFS/Drugs.comMonograph
MedlinePlusa606016
License data
Pregnancy
category
  • AU: C
Routes of
administration
Intravenous
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)
  • UK: POM (Prescription only)
  • US: WARNING[1]Rx-only
  • EU: Rx-only
Identifiers
CAS Number
DrugBank
ChemSpider
  • None
UNII
KEGG
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Belatacept, sold under the brand name Nulojix, is a fusion protein composed of the Fc fragment of a human IgG1 immunoglobulin linked to the extracellular domain of CTLA-4,[2] which is a molecule crucial in the regulation of T cell costimulation, selectively blocking the process of T-cell activation. It is intended to provide extended graft and transplant[3] survival while limiting the toxicity generated by standard immune suppressing regimens, such as calcineurin inhibitors. It differs from abatacept (Orencia) by only two amino acids.[medical citation needed]

Belatacept was developed by Bristol-Myers-Squibb and approved by the U.S. Food and Drug Administration (FDA) on June 15, 2011.[4]

References

  1. ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 Oct 2023.
  2. ^ "Healthvalue.net: CTLA-4 Strategies". Archived from the original on 5 December 2008. Retrieved 2008-10-24.
  3. ^ Vincenti F, Rostaing L, Grinyo J, Rice K, Steinberg S, Gaite L, et al. (January 2016). "Belatacept and Long-Term Outcomes in Kidney Transplantation". The New England Journal of Medicine. 374 (4): 333–43. doi:10.1056/NEJMoa1506027. hdl:2445/178537. PMID 26816011. S2CID 35661528.
  4. ^ "FDA approves Nulojix for kidney transplant patients" (Press release). U.S. Food and Drug Administration. 2011-06-15. Archived from the original on 19 June 2011. Retrieved 2011-06-16.
  • "Belatacept". Drug Information Portal. U.S. National Library of Medicine.