Ustekinumab

Ustekinumab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetIL-12 and IL-23
Clinical data
Trade namesStelara
Other namesCNTO 1275
Biosimilarsustekinumab-aauz,[1] ustekinumab-aekn,[2] ustekinumab-auub,[3] ustekinumab-hmny,[4] ustekinumab-kfce,[5] ustekinumab-srlf,[6] ustekinumab-stba,[7] ustekinumab-ttwe,[8] Absimky,[9][10] Eksunbi,[11][12] Fymskina,[13][14] Imuldosa,[6] Jamteki,[15] Otulfi,[1][16][17] Pyzchiva,[8][18][19] Qoyvolma,[20][21] Selarsdi,[2] Starjemza,[4] Steqeyma,[7][22][23] Uzpruvo,[24] Wezlana,[3][25] Wezenla,[26][27] Yesintek[5]
AHFS/Drugs.comMonograph
MedlinePlusa611013
License data
Pregnancy
category
Routes of
administration		Subcutaneous, intravenous
Drug classImmunosuppressant interleukin inhibitor
ATC code
Legal status
Legal status
Pharmacokinetic data
Metabolismunknown[31]
Elimination half-life15–32 days (average 3 weeks)[31]
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC6482H10004N1712O2016S46
Molar mass145648.06 g·mol−1
 NY (what is this?)  (verify)

Ustekinumab, sold under the brand name Stelara among others, is a monoclonal antibody medication used for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis,[34] targeting both IL-12 and IL-23.[35] It is administered either by intravenous infusion or subcutaneous injection.[34] The antibody targets a subunit of human interleukin 12 and interleukin 23, which are naturally occurring proteins that regulate the immune system and immune-mediated inflammatory disorders.[36] Ustekinumab is a fully human IgG1κ monoclonal antibody that binds to the p40 subunit of interleukin 12 and 23, thereby preventing them from binding to the IL 12Rβ1 receptor expressed on the surface of immune cells.[37] By doing so, ustekinumab prevents the activation of the Th1 and Th17 cytokine pathways, which are central to the pathology of plaque psoriasis, psoriatic arthritis and Crohn's disease.[37] Ustekinumab was developed by Centocor Ortho Biotech.[38]

Ustekinumab is approved to treat Crohn's disease in the United States, Israel, Australia, and the European Union; and ulcerative colitis in the United States, and in the European Union to people who have not responded to more traditional treatments.[32][33][39][40] It was found not effective for multiple sclerosis.[41]

  1. ^ a b Cite error: The named reference Otulfi FDA label was invoked but never defined (see the help page).
  2. ^ a b "Alvotech and Teva Announce U.S. FDA Approval of Selarsdi (ustekinumab-aekn), biosimilar to Stelara (ustekinumab)" (Press release). Alvotech. 16 April 2024. Archived from the original on 17 April 2024. Retrieved 17 April 2024 – via GlobeNewswire.
  3. ^ a b Cite error: The named reference FDA Wezlana press release was invoked but never defined (see the help page).
  4. ^ a b Cite error: The named reference Hikma PR was invoked but never defined (see the help page).
  5. ^ a b Cite error: The named reference Yesintek PR was invoked but never defined (see the help page).
  6. ^ a b Cite error: The named reference Imuldosa PR 20241014 was invoked but never defined (see the help page).
  7. ^ a b Cite error: The named reference Steqeyma FDA label was invoked but never defined (see the help page).
  8. ^ a b Cite error: The named reference Pyzchiva FDA label was invoked but never defined (see the help page).
  9. ^ Cite error: The named reference Absimky EPAR was invoked but never defined (see the help page).
  10. ^ Cite error: The named reference Absimky PI was invoked but never defined (see the help page).
  11. ^ Cite error: The named reference Eksunbi EPAR was invoked but never defined (see the help page).
  12. ^ Cite error: The named reference Eksunbi PI was invoked but never defined (see the help page).
  13. ^ Cite error: The named reference Fymskina EPAR was invoked but never defined (see the help page).
  14. ^ Cite error: The named reference Fymskina PI was invoked but never defined (see the help page).
  15. ^ Cite error: The named reference Jamteki CA SBD was invoked but never defined (see the help page).
  16. ^ Cite error: The named reference Otulfi EPAR was invoked but never defined (see the help page).
  17. ^ Cite error: The named reference Otulfi PI was invoked but never defined (see the help page).
  18. ^ Cite error: The named reference Pyzchiva EPAR was invoked but never defined (see the help page).
  19. ^ Cite error: The named reference Pyzchiva PI was invoked but never defined (see the help page).
  20. ^ Cite error: The named reference Qoyvolma EPAR was invoked but never defined (see the help page).
  21. ^ Cite error: The named reference Qoyvolma PI was invoked but never defined (see the help page).
  22. ^ Cite error: The named reference Steqeyma EPAR was invoked but never defined (see the help page).
  23. ^ Cite error: The named reference Steqeyma PI was invoked but never defined (see the help page).
  24. ^ Cite error: The named reference Uzpruvo EPAR was invoked but never defined (see the help page).
  25. ^ a b c "Wezlana APMDS". Therapeutic Goods Administration (TGA). 30 January 2024. Archived from the original on 8 February 2024. Retrieved 7 March 2024.
  26. ^ Cite error: The named reference Wezenla EPAR was invoked but never defined (see the help page).
  27. ^ Cite error: The named reference Wezenla PI was invoked but never defined (see the help page).
  28. ^ "Ustekinumab (Stelara) Use During Pregnancy". Drugs.com. 26 November 2019. Archived from the original on 22 May 2020. Retrieved 6 April 2020.
  29. ^ "Prescription medicines and biologicals: TGA annual summary 2017". Therapeutic Goods Administration (TGA). 21 June 2022. Archived from the original on 31 March 2024. Retrieved 31 March 2024.
  30. ^ "Regulatory Decision Summary for Stelara". Health Canada. 16 June 2020. Retrieved 28 August 2024.
  31. ^ a b c "Stelara 45 mg solution for injection (vials) - Summary of Product Characteristics (SmPC)". (emc). 27 February 2020. Archived from the original on 6 April 2020. Retrieved 6 April 2020.
  32. ^ a b Cite error: The named reference Stelara FDA label was invoked but never defined (see the help page).
  33. ^ a b Cite error: The named reference Stelara EPAR was invoked but never defined (see the help page).
  34. ^ a b Cite error: The named reference AHFS2017 was invoked but never defined (see the help page).
  35. ^ Cingoz O (2009). "Ustekinumab". mAbs. 1 (3): 216–221. doi:10.4161/mabs.1.3.8593. PMC 2726595. PMID 20069753.
  36. ^ Reddy M, Davis C, Wong J, Marsters P, Pendley C, Prabhakar U (May 2007). "Modulation of CLA, IL-12R, CD40L, and IL-2Ralpha expression and inhibition of IL-12- and IL-23-induced cytokine secretion by CNTO 1275". Cellular Immunology. 247 (1): 1–11. doi:10.1016/j.cellimm.2007.06.006. PMID 17761156.
  37. ^ a b Cite error: The named reference Yesintek EPAR was invoked but never defined (see the help page).
  38. ^ Cite error: The named reference Stelara approval package was invoked but never defined (see the help page).
  39. ^ "EC approves expanded use of Stelara for moderately to severely active ulcerative colitis". Healio.com. Archived from the original on 9 September 2019. Retrieved 26 September 2019.
  40. ^ "Ustekinumab (Stelara) PBS listed for severe Crohn's disease". NPS Medicinewise. 26 October 2017. Archived from the original on 18 April 2019. Retrieved 4 October 2019.
  41. ^ Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH (September 2008). "Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study". The Lancet. Neurology. 7 (9): 796–804. doi:10.1016/S1474-4422(08)70173-X. PMID 18703004. S2CID 20290673.
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