Back دينوسوماب Arabic Denosumab German Δενοσουμάμπη Greek Denosumab Spanish Denosumab French דנוסומאב HE Denosumab ID Denosumab Italian デノスマブ Japanese 데노수맙 Korean
 Denosumab injection | |
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | RANK ligand |
| Clinical data | |
| Trade names | Prolia, Xgeva, others |
| Other names | AMG-162 |
| Biosimilars | denosumab-bbdz,[1] denosumab-dssb,[2] Jubbonti,[1][3][4] Obodence,[5][6] Osenvelt,[7] Ospomyv,[2] Wyost[1][8][9] Xbryk[2][10][11] |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a610023 |
| License data | |
| Pregnancy category |
|
| Routes of administration | Subcutaneous |
| ATC code | |
| Legal status | |
| Legal status | |
| Pharmacokinetic data | |
| Bioavailability | N/A |
| Metabolism | Proteolysis |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
|
| UNII | |
| KEGG | |
| ChEMBL | |
| Chemical and physical data | |
| Formula | C6404H9912N1724O2004S50 |
| Molar mass | 144722.80 g·mol−1 |
  (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.[19][20]
The most common side effects are joint and muscle pain in the arms or legs.[21]
Denosumab is an inhibitor of RANKL (receptor activator of nuclear factor kappa-Β ligand),[19] 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.[7] Denosumab binds to RANKL with high affinity and specificity, preventing the interaction between RANKL and RANK.[7] Increased osteoclast activity stimulated by RANKL is a key mediator of bone destruction in metastatic bone disease.[7] This leads to a reduction in osteoclast numbers and function, and a decrease in bone resorption, cancer-induced bone destruction.[7] It also leads to a decrease in bone resorption in cortical and trabecular bones.[22] It was developed by the biotechnology company Amgen.[23]
- ^ a b c https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761362s000lbl.pdf
- ^ a b c Cite error: The named reference
Ospomyv/Xbryk FDA labelwas invoked but never defined (see the help page). - ^ 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.
- ^ a b Cite error: The named reference
Jubbonti EPARwas invoked but never defined (see the help page). - ^ Cite error: The named reference
Obodence EPARwas invoked but never defined (see the help page). - ^ Cite error: The named reference
Obodence PIwas invoked but never defined (see the help page). - ^ a b c d e Cite error: The named reference
Osenvelt EPARwas invoked but never defined (see the help page). - ^ 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.
- ^ Cite error: The named reference
Wyost EPARwas invoked but never defined (see the help page). - ^ Cite error: The named reference
Xbryk EPARwas invoked but never defined (see the help page). - ^ Cite error: The named reference
Xbryk PIwas invoked but never defined (see the help page). - ^ "Jubbonti (Sandoz Pty Ltd)". Therapeutic Goods Administration (TGA). 13 September 2024. Retrieved 15 September 2024.
- ^ "Summary Basis of Decision for Wyost". Drug and Health Products Portal. Retrieved 13 November 2024.
- ^ "Summary Basis of Decision for Jubbonti". Drug and Health Products Portal. Retrieved 13 November 2024.
- ^ "Prolia- denosumab injection". DailyMed. 24 January 2024. Archived from the original on 7 June 2023. Retrieved 6 March 2024.
- ^ "Xgeva- denosumab injection". DailyMed. 9 June 2020. Archived from the original on 13 April 2023. Retrieved 6 March 2024.
- ^ Cite error: The named reference
Prolia EPARwas invoked but never defined (see the help page). - ^ Cite error: The named reference
Xgeva EPARwas invoked but never defined (see the help page). - ^ 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.
- ^ 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.
- ^ Cite error: The named reference
EMEAwas invoked but never defined (see the help page). - ^ Cite error: The named reference
Stoboclo EPARwas invoked but never defined (see the help page). - ^ "Prolia (denosumab)". Products. Amgen. Archived from the original on 29 September 2015. Retrieved 6 May 2012.