Medication
Trastuzumab Trastuzumab
Fab region (cyan) binding HER2/neu (gold)
Type Whole antibody Source Humanized (from mouse )Target HER2/neu Trade names Herceptin, Herceptin SC, others[ 1] Biosimilars trastuzumab-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.com Monograph License data
Pregnancy category Routes of administration Intravenous , subcutaneous Drug class Antineoplastic agent ATC code Legal status
Metabolism Unknown, possibly reticuloendothelial system Elimination half-life 2-12 days CAS Number PubChem SID DrugBank ChemSpider UNII KEGG ChEMBL ECHA InfoCard 100.224.377 Formula C 6470 H 10012 N 1726 O 2013 S 42 Molar mass 145531 .86 g·mol−1 N Y (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]
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^ 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 .
^ 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 .
^ 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 .
^ 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 .
^ a b "Highlights of prescribing information" (PDF) . www.accessdata.fda.gov .
^ Cite error: The named reference Herzuma FDA label
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^ "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 .
^ Cite error: The named reference Ontruzant EPAR
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^ Cite error: The named reference Ontruzant PI
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^ 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 .
^ Cite error: The named reference Tuznue EPAR
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^ Cite error: The named reference Zercepac EPAR
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^ a b "Trastuzumab Pregnancy and Breastfeeding Warnings" . Drugs.com . Archived from the original on 3 December 2019. Retrieved 3 December 2019 .
^ "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 .
^ "Herceptin (trastuzumab) powder for injection" . Roche Products Pty Limited . 7 May 2021. Archived from the original on 8 March 2023. Retrieved 8 January 2023 .
^ "Trastuzumab" . Roche Products Pty Limited . 7 April 2022. Archived from the original on 8 January 2023.
^ "Summary Basis of Decision - Ontruzant" . Health Canada . 23 October 2014. Archived from the original on 6 August 2022. Retrieved 6 August 2022 .
^ 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 .
^ Cite error: The named reference Ogivri EPAR
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^ 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 .
^ "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 .
^ a b "Herceptin EPAR" . European Medicines Agency (EMA) . 17 September 2018. Archived from the original on 28 July 2020. Retrieved 28 July 2020 .
^ British national formulary : BNF 69 (69 ed.). British Medical Association. 2015. p. 626. ISBN 978-0-85711-156-2 .
^ "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 . This article incorporates text from this source, which is in the public domain .
^ 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.