Tocilizumab

Tocilizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetIL-6 receptor
Clinical data
Trade namesActemra, Roactemra
Biosimilarstocilizumab-aazg,[1] tocilizumab-bavi,[2][3] Tofidence,[2][3][4][5][6] Tyenne[1][7]
AHFS/Drugs.comMonograph
MedlinePlusa611004
License data
Pregnancy
category
Routes of
administration		Intravenous, subcutaneous
ATC code
Legal status
Legal status
Pharmacokinetic data
Elimination half-life8–14 days during steady state (dependent on concentration)
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC6428H9976N1720O2018S42
Molar mass144987.06 g·mol−1
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Tocilizumab, sold under the brand name Actemra among others, is an immunosuppressive drug, used for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, cytokine release syndrome, COVID‑19, and systemic sclerosis-associated interstitial lung disease (SSc-ILD). It is a humanized monoclonal antibody against the interleukin-6 receptor (IL-6R). Interleukin 6 (IL-6) is a cytokine that plays an important role in immune response and is implicated in the pathogenesis of many diseases, such as autoimmune diseases, multiple myeloma and prostate cancer. Tocilizumab was jointly developed by Osaka University and Chugai, and was licensed in 2003 by Hoffmann-La Roche.[17]

Tocilizumab was approved for medical use in the European Union in January 2009,[14] and in the United States in January 2010.[18][19]

  1. ^ a b "Tyenne- tocilizumab-aazg injection, solution, concentrate". DailyMed. 6 March 2024. Archived from the original on 25 April 2024. Retrieved 25 April 2024.
  2. ^ a b "Tofidence- tocilizumab injection". DailyMed. 27 March 2024. Retrieved 16 June 2024.
  3. ^ a b "FDA approves first biosimilar to Actemra to treat adult and pediatric arthritis". U.S. Food and Drug Administration (FDA) (Press release). 29 September 2023. Archived from the original on 25 February 2024. Retrieved 6 March 2024.
  4. ^ "FDA Approves Biogen's Tofidence (tocilizumab-bavi), a Biosimilar Referencing Actemra" (Press release). Biogen Inc. 29 September 2023. Archived from the original on 30 September 2023. Retrieved 1 October 2023 – via GlobeNewswire.
  5. ^ a b Cite error: The named reference Tofidence EPAR was invoked but never defined (see the help page).
  6. ^ Cite error: The named reference Tofidence PI was invoked but never defined (see the help page).
  7. ^ a b "Tyenne EPAR". European Medicines Agency. 2 October 2023. Archived from the original on 5 October 2023. Retrieved 5 October 2023.
  8. ^ a b "Australian Product Information Actemra (tocilizumab)" (PDF). MedAdvisor International. 2 September 2022. Archived from the original on 1 October 2023. Retrieved 19 April 2023.
  9. ^ "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 October 2023.
  10. ^ "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.
  11. ^ "Actemra". COVID-19 vaccines and treatments portal. 13 October 2022. Archived from the original on 5 December 2022. Retrieved 29 October 2022.
  12. ^ "Actemra- tocilizumab injection, solution, concentrate Actemra- tocilizumab injection, solution Actemra ACTPen- tocilizumab injection, solution". DailyMed. Archived from the original on 7 June 2021. Retrieved 24 June 2021.
  13. ^ Cite error: The named reference FDA EUA was invoked but never defined (see the help page).
  14. ^ a b "Roactemra EPAR". European Medicines Agency. 17 September 2018. Archived from the original on 18 December 2021. Retrieved 18 December 2021.
  15. ^ "Tyenne Product information". Union Register of medicinal products. 18 September 2023. Archived from the original on 1 October 2023. Retrieved 1 October 2023.
  16. ^ "COVID-19 medicines". European Medicines Agency (EMA). 14 October 2024. Retrieved 14 October 2024.
  17. ^ Markus Harwart (2008). "Die Entwicklung von Tocilizumab" [The development of tocilizumab] (in German). Krankenpflege-Journal. Archived from the original on 15 October 2018. Retrieved 30 April 2016.
  18. ^ "Drug Approval Package: Actemra (Tocilizumab) Injection BLA 125276". U.S. Food and Drug Administration (FDA). 9 March 2010. Archived from the original on 26 January 2022. Retrieved 1 October 2023.
  19. ^ "Drug Approval Package: Actemra (tocilizumab) Solution for Subcutaneous Injection NDA #125472". accessdata.fda.gov. 17 July 2014. Archived from the original on 23 January 2023. Retrieved 1 October 2023.