Trastuzumab

Trastuzumab
Trastuzumab Fab region (cyan) binding HER2/neu (gold)
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetHER2/neu
Clinical data
Trade namesHerceptin, Herceptin SC, others[1]
Biosimilarstrastuzumab-anns,[2] trastuzumab-dkst,[3] trastuzumab-dttb,[4] trastuzumab-pkrb, trastuzumab-qyyp,[5] trastuzumab-strf,[6] Hercessi,[6] Herzuma,[7][8][9] Herwenda,[10][11] Kanjinti,[2][12][13] Ogivri,[3][14] Ontruzant,[4][15][16] Trastucip,[17] Trazimera,[5] Tuznue,[18][19] Tuzucip,[17] Zercepac[20][21]
AHFS/Drugs.comMonograph
License data
Pregnancy
category
Routes of
administration
Intravenous, subcutaneous
Drug classAntineoplastic agent
ATC code
Legal status
Legal status
Pharmacokinetic data
MetabolismUnknown, possibly reticuloendothelial system
Elimination half-life2-12 days
Identifiers
CAS Number
PubChem SID
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
ECHA InfoCard100.224.377 Edit this at Wikidata
Chemical and physical data
FormulaC6470H10012N1726O2013S42
Molar mass145531.86 g·mol−1
 ☒NcheckY (what is this?)  (verify)

Trastuzumab, sold under the brand name Herceptin among others, is a monoclonal antibody used to treat breast cancer and stomach cancer.[30][27][31][32] It is specifically used for cancer that is HER2 receptor positive.[30] It may be used by itself or together with other chemotherapy medication.[30] Trastuzumab is given by slow injection into a vein and injection just under the skin.[30][33]

Common side effects include fever, infection, cough, headache, trouble sleeping, and rash.[30] Other severe side effects include heart failure, allergic reactions, and lung disease.[30] Use during pregnancy may harm the baby.[22] Trastuzumab works by binding to the HER2 receptor and slowing down cell replication.[30]

Trastuzumab was approved for medical use in the United States in September 1998, and in the European Union in August 2000.[34][32] It is on the World Health Organization's List of Essential Medicines.[35]

  1. ^ Cite error: The named reference generic was invoked but never defined (see the help page).
  2. ^ a b "Kanjinti- trastuzumab-anns injection, powder, lyophilized, for solution; Kanjinti- trastuzumab-anns kit". DailyMed. 13 October 2022. Archived from the original on 5 December 2021. Retrieved 11 December 2023.
  3. ^ a b "Ogivri- trastuzumab kit; Ogivri- trastuzumab injection, powder, lyophilized, for solution". DailyMed. 8 February 2021. Archived from the original on 7 December 2022. Retrieved 11 December 2023.
  4. ^ a b "Ontruzant- trastuzumab injection, powder, lyophilized, for solution; Ontruzant- ontruzant kit". DailyMed. 31 January 2023. Archived from the original on 13 August 2022. Retrieved 11 December 2023.
  5. ^ a b "Trazimera- trastuzumab-qyyp kit; Trazimera- trastuzumab-qyyp injection, powder, lyophilized, for solution". DailyMed. 14 February 2022. Archived from the original on 7 December 2022. Retrieved 11 December 2023.
  6. ^ a b "Highlights of prescribing information" (PDF). www.accessdata.fda.gov.
  7. ^ Cite error: The named reference Herzuma FDA label was invoked but never defined (see the help page).
  8. ^ Cite error: The named reference Herzuma EPAR was invoked but never defined (see the help page).
  9. ^ Cite error: The named reference Herzuma PI was invoked but never defined (see the help page).
  10. ^ Cite error: The named reference Herwenda EPAR was invoked but never defined (see the help page).
  11. ^ Cite error: The named reference Herwenda PI was invoked but never defined (see the help page).
  12. ^ Cite error: The named reference Kanjinti EPAR was invoked but never defined (see the help page).
  13. ^ Cite error: The named reference Kanjinti PI was invoked but never defined (see the help page).
  14. ^ "Ogivri- trastuzumab kit; Ogivri- trastuzumab injection, powder, lyophilized, for solution". DailyMed. 28 July 2023. Archived from the original on 10 March 2024. Retrieved 11 December 2023.
  15. ^ Cite error: The named reference Ontruzant EPAR was invoked but never defined (see the help page).
  16. ^ Cite error: The named reference Ontruzant PI was invoked but never defined (see the help page).
  17. ^ a b c d "Trastucip and Tuzucip APMDS". Therapeutic Goods Administration (TGA). 29 July 2022. Archived from the original on 30 July 2022. Retrieved 2 August 2022.
  18. ^ Cite error: The named reference Tuznue EPAR was invoked but never defined (see the help page).
  19. ^ Cite error: The named reference Tuznue PI was invoked but never defined (see the help page).
  20. ^ Cite error: The named reference Zercepac EPAR was invoked but never defined (see the help page).
  21. ^ Cite error: The named reference Zercepac PI was invoked but never defined (see the help page).
  22. ^ a b "Trastuzumab Pregnancy and Breastfeeding Warnings". Drugs.com. Archived from the original on 3 December 2019. Retrieved 3 December 2019.
  23. ^ "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.
  24. ^ "Herceptin (trastuzumab) powder for injection". Roche Products Pty Limited. 7 May 2021. Archived from the original on 8 March 2023. Retrieved 8 January 2023.
  25. ^ "Trastuzumab". Roche Products Pty Limited. 7 April 2022. Archived from the original on 8 January 2023.
  26. ^ "Summary Basis of Decision - Ontruzant". Health Canada. 23 October 2014. Archived from the original on 6 August 2022. Retrieved 6 August 2022.
  27. ^ a b "Herceptin- trastuzumab kit Herceptin- trastuzumab injection, powder, lyophilized, for solution". DailyMed. 30 September 2019. Archived from the original on 4 August 2020. Retrieved 28 July 2020.
  28. ^ Cite error: The named reference Ogivri EPAR was invoked but never defined (see the help page).
  29. ^ Cite error: The named reference Ogivri PI was invoked but never defined (see the help page).
  30. ^ a b c d e f g "Trastuzumab". The American Society of Health-System Pharmacists. Archived from the original on 21 December 2016. Retrieved 8 December 2016.
  31. ^ "FDA approves first biosimilar for the treatment of certain breast and stomach cancers". U.S. Food and Drug Administration (FDA) (Press release). 10 September 2019. Archived from the original on 15 December 2019. Retrieved 18 February 2020.
  32. ^ a b "Herceptin EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 28 July 2020. Retrieved 28 July 2020.
  33. ^ British national formulary : BNF 69 (69 ed.). British Medical Association. 2015. p. 626. ISBN 978-0-85711-156-2.
  34. ^ "Trastuzumab Product Approval Information - Licensing Action 9/25/98". U.S. Food and Drug Administration (FDA). 18 December 2015. Archived from the original on 28 January 2017. Retrieved 3 December 2019. Public Domain This article incorporates text from this source, which is in the public domain.
  35. ^ World Health Organization (2023). The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023). Geneva: World Health Organization. hdl:10665/371090. WHO/MHP/HPS/EML/2023.02.