Denosumab

Denosumab
Denosumab injection
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetRANK ligand
Clinical data
Trade namesProlia, Xgeva, others
Other namesAMG-162
Biosimilarsdenosumab-bbdz,[1][2] denosumab-bmwo,[3] denosumab-bnht,[4][5] denosumab-dssb,[6] Bomyntra,[4] Conexxence,[5] Denbrayce,[7][8] Enwylma,[9][10] Evfraxy,[11] Izamby,[12][13] Jubbonti,[1][14][15] Jubereq,[16][17] Junod,[18][19] Obodence,[20][21] Osenvelt,[22][23] Ospomyv,[6] Osvyrti,[24][25] Stoboclo,[3][26] Vevzuo,[27] Wyost[2][28][29] Xbryk,[6][30][31] Yaxwer,[32][33] Zadenvi[34][35]
AHFS/Drugs.comMonograph
MedlinePlusa610023
License data
Pregnancy
category
  • AU: D
Routes of
administration		Subcutaneous
ATC code
Legal status
Legal status
Pharmacokinetic data
BioavailabilityN/A
MetabolismProteolysis
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC6404H9912N1724O2004S50
Molar mass144722.80 g·mol−1
 NY (what is this?)  (verify)

Denosumab, sold under the brand name Prolia among others, is a human monoclonal antibody used for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone, and giant cell tumor of bone.[43][44]

The most common side effects are joint and muscle pain in the arms or legs.[45]

Denosumab is an inhibitor of RANKL (receptor activator of nuclear factor kappa-Β ligand),[43] which works by decreasing the development of osteoclasts, which are cells that break down bone. Denosumab is a human monoclonal IgG2 antibody that targets the protein RANKL, which is essential for the formation, function and survival of osteoclasts, the cell type responsible for bone resorption.[23] Denosumab binds to RANKL with high affinity and specificity, preventing the interaction between RANKL and RANK.[23] Increased osteoclast activity stimulated by RANKL is a key mediator of bone destruction in metastatic bone disease.[23] This leads to a reduction in osteoclast numbers and function, and a decrease in bone resorption, cancer-induced bone destruction.[23] It also leads to a decrease in bone resorption in cortical and trabecular bones.[26] It was developed by the biotechnology company Amgen.[46]

  1. ^ a b Cite error: The named reference Jubbonti FDA label was invoked but never defined (see the help page).
  2. ^ a b Cite error: The named reference Wyost FDA label was invoked but never defined (see the help page).
  3. ^ a b Cite error: The named reference Stoboclo FDA label was invoked but never defined (see the help page).
  4. ^ a b Cite error: The named reference Bomyntra FDA label was invoked but never defined (see the help page).
  5. ^ a b Cite error: The named reference Conexxence FDA label was invoked but never defined (see the help page).
  6. ^ a b c Cite error: The named reference Ospomyv/Xbryk FDA label was invoked but never defined (see the help page).
  7. ^ Cite error: The named reference Denbrayce EPAR was invoked but never defined (see the help page).
  8. ^ Cite error: The named reference Denbrayce PI was invoked but never defined (see the help page).
  9. ^ Cite error: The named reference Enwylma EPAR was invoked but never defined (see the help page).
  10. ^ Cite error: The named reference Enwylma PI was invoked but never defined (see the help page).
  11. ^ Cite error: The named reference Evfraxy PI was invoked but never defined (see the help page).
  12. ^ Cite error: The named reference Izamby EPAR was invoked but never defined (see the help page).
  13. ^ Cite error: The named reference Izamby PI was invoked but never defined (see the help page).
  14. ^ a b "Regulatory Decision Summary for Jubbonti". Drug and Health Products Portal. 16 February 2024. Archived from the original on 1 April 2024. Retrieved 1 April 2024.
  15. ^ a b Cite error: The named reference Jubbonti EPAR was invoked but never defined (see the help page).
  16. ^ Cite error: The named reference Jubereq EPAR was invoked but never defined (see the help page).
  17. ^ Cite error: The named reference Jubereq PI was invoked but never defined (see the help page).
  18. ^ Cite error: The named reference Junod EPAR was invoked but never defined (see the help page).
  19. ^ Cite error: The named reference Junod PI was invoked but never defined (see the help page).
  20. ^ Cite error: The named reference Obodence EPAR was invoked but never defined (see the help page).
  21. ^ Cite error: The named reference Obodence PI was invoked but never defined (see the help page).
  22. ^ Cite error: The named reference Osenvelt FDA label was invoked but never defined (see the help page).
  23. ^ a b c d e Cite error: The named reference Osenvelt EPAR was invoked but never defined (see the help page).
  24. ^ Cite error: The named reference Osvyrti EPAR was invoked but never defined (see the help page).
  25. ^ Cite error: The named reference Osvyrti PI was invoked but never defined (see the help page).
  26. ^ a b Cite error: The named reference Stoboclo EPAR was invoked but never defined (see the help page).
  27. ^ Cite error: The named reference Vevzuo PI was invoked but never defined (see the help page).
  28. ^ a b "Regulatory Decision Summary for Wyost". Drug and Health Products Portal. 1 March 2024. Archived from the original on 1 April 2024. Retrieved 1 April 2024.
  29. ^ Cite error: The named reference Wyost EPAR was invoked but never defined (see the help page).
  30. ^ Cite error: The named reference Xbryk EPAR was invoked but never defined (see the help page).
  31. ^ Cite error: The named reference Xbryk PI was invoked but never defined (see the help page).
  32. ^ Cite error: The named reference Yaxwer EPAR was invoked but never defined (see the help page).
  33. ^ Cite error: The named reference Yaxwer PI was invoked but never defined (see the help page).
  34. ^ Cite error: The named reference Zadenvi EPAR was invoked but never defined (see the help page).
  35. ^ Cite error: The named reference Zadenvi PI was invoked but never defined (see the help page).
  36. ^ "Jubbonti (Sandoz Pty Ltd)". Therapeutic Goods Administration (TGA). 13 September 2024. Retrieved 15 September 2024.
  37. ^ "Summary Basis of Decision for Wyost". Drug and Health Products Portal. Retrieved 13 November 2024.
  38. ^ "Summary Basis of Decision for Jubbonti". Drug and Health Products Portal. Retrieved 13 November 2024.
  39. ^ "Prolia- denosumab injection". DailyMed. 24 January 2024. Archived from the original on 7 June 2023. Retrieved 6 March 2024.
  40. ^ "Xgeva- denosumab injection". DailyMed. 9 June 2020. Archived from the original on 13 April 2023. Retrieved 6 March 2024.
  41. ^ Cite error: The named reference Prolia EPAR was invoked but never defined (see the help page).
  42. ^ Cite error: The named reference Xgeva EPAR was invoked but never defined (see the help page).
  43. ^ a b Pageau SC (2009). "Denosumab". mAbs. 1 (3): 210–5. doi:10.4161/mabs.1.3.8592. PMC 2726593. PMID 20065634. Archived from the original on 8 March 2012. Retrieved 27 March 2011.
  44. ^ McClung MR, Lewiecki EM, Cohen SB, Bolognese MA, Woodson GC, Moffett AH, et al. (February 2006). "Denosumab in postmenopausal women with low bone mineral density". The New England Journal of Medicine. 354 (8): 821–31. doi:10.1056/NEJMoa044459. PMID 16495394.
  45. ^ Cite error: The named reference EMEA was invoked but never defined (see the help page).
  46. ^ "Prolia (denosumab)". Products. Amgen. Archived from the original on 29 September 2015. Retrieved 6 May 2012.
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