Turoctocog alfa explained

Tradename:NovoEight, Esperoct
Dailymedid:NovoEight
Pregnancy Au:B2
Pregnancy Au Comment:[1]
Routes Of Administration:Intravenous (IV)
Atc Prefix:B02
Atc Suffix:BD02
Legal Au:Unscheduled
Legal Au Comment:[2] [3] [4] [5]
Legal Ca:Rx-only
Legal Ca Comment:/ Schedule D[6]
Legal Uk:POM
Legal Uk Comment:[7] [8]
Legal Us:Rx-only
Legal Eu:Rx-only
Legal Status:Rx-only
Cas Number:1192451-26-5
Drugbank:DB09109
Chemspiderid:none
Unii:969NZA3X9T
Unii2:P89DR4NY54
Kegg:D10227
Kegg2:D10758
Chembl:2108175
Synonyms:recombinant antihemophilic factor
C:7480
H:11379
N:1999
O:2194
S:68

Turoctocog alfa (trade name NovoEight) is a recombinant antihemophilic factor VIII used for the treatment of and prophylaxis of bleeding patients with haemophilia A. It is marketed by Novo Nordisk.[9] It was approved in the United States, the European Union, and Japan in 2013.[10] [11] [12] [13]

Medical uses

Turoctocog alfa is indicated for the treatment and prophylaxis of bleeding in adults and children with haemophilia A (congenital factor VIII deficiency).

Turoctocog alfa pegol is indicated for the treatment and prophylaxis of bleeding in adults and children twelve years and above with haemophilia A (congenital factor VIII deficiency).

In the safety and efficacy trial for prevention and treatment of bleeds, in hemophilia patients the success rate for treatment of bleeds was 84.5% (excluding bleeds for which there was no outcome reported) and out of a total of nine surgeries in nine patients performed during the trial, haemostasis was successful in all the surgeries and no treatment failures were reported. It is also used for perioperative management and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Turoctocog alfa is not indicated for the treatment of von Willebrand disease.[14]

Benefits and risks

In a study conducted with 150 patients aged twelve and above, adolescents after using turoctocog alfa as a treatment, had an average of 5.55 bleedings per year while the adults had an average of 6.68 bleeding per year. According to data, turoctocog alfa was considered an 'excellent' treatment for 403 out of 499 bleeding episodes.In another study involving 63 patients aged less than twelve years, children had an average of 5.33 bleedings per year after using turoctocog alfa as hemophilia treatment. In this study too turoctocog alfa was considered as an 'excellent' treatment for 116 out of 126 bleeding episodes.[15]

Alongside the benefits, a few of the common turoctocog alfa adverse effects would be injection site reaction, pyrexia and augmented liver enzyme levels. Rare cases of allergic reactions have been reported as well. There is a possibility of patients developing hypersensitivity to the drug since it contains traces of hamster proteins. Activity-neutralising antibodies may be developed whereby expected plasma factor VIII activity levels may not be achieved and thus the bleeding would not be controlled as needed.[14]

Preparation

As cell culture, Chinese hamster ovary cells (CHO) are used in order to acquire proper processing of factor VIII protein, that has demonstrated good efficacy in thrombin generation and clot formation in preclinical evaluations in murine (mouse) and canine (dog) models of hemophilia A and in patient-derived whole blood.[16]

Difference between NovoSeven and NovoEight

Even though both treatments are plasma-derived and recombinant analogues of blood clotting factors, NovoSeven is developed as a congenital FVIIa analogue for hemophilia A and B patients while NovoEight (turoctocog alfa) is for congenital FVIII deficiency. NovoSeven is called a bypassing agent because it skips the need for factor VIII or IX in people with inhibitors and activates factor X directly.[17]

Turoctocog alfa pegol

In February 2019, the FDA approved antihemophilic factor (recombinant), glycopegylated-exei (turoctocog alfa pegol) (Esperoct) for the treatment of hemophilia A.[18] [19] Turoctocog alfa pegol was approved for medical use in the European Union in June 2019.[20]

Notes and References

  1. Web site: Antihemophilic factor Use During Pregnancy . Drugs.com . 20 January 2020 . 11 March 2020 . 16 July 2020 . https://web.archive.org/web/20200716175058/https://www.drugs.com/pregnancy/antihemophilic-factor.html . live .
  2. Web site: Prescription medicines: registration of new chemical entities in Australia, 2014 . Therapeutic Goods Administration (TGA) . 21 June 2022 . 10 April 2023 . 10 April 2023 . https://web.archive.org/web/20230410065838/https://www.tga.gov.au/resources/resource/guidance/prescription-medicines-registration-new-chemical-entities-australia-2014 . live .
  3. Web site: Turoctocog alfa (rch) . 29 April 2023 . 16 May 2022 . https://web.archive.org/web/20220516083949/https://www.tga.gov.au/sites/default/files/auspar-turoctocog-140507-pi.pdf . live .
  4. Web site: Esperoct (Novo Nordisk Pharmaceuticals Pty Ltd) . Therapeutic Goods Administration (TGA) . 23 June 2023 . 10 September 2023.
  5. Web site: Esperoct . Therapeutic Goods Administration (TGA) . 19 June 2023 . 10 September 2023.
  6. Web site: Summary Basis of Decision (SBD) for Esperoct . . 23 October 2014 . 29 May 2022 . 31 May 2022 . https://web.archive.org/web/20220531053604/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00453&lang=en . live .
  7. Web site: NovoEight 250 IU powder and solvent for solution for injection - Summary of Product Characteristics (SmPC) . (emc) . 23 December 2019 . 11 March 2020 . 17 January 2021 . https://web.archive.org/web/20210117230858/https://www.medicines.org.uk/emc/product/7382/smpc . live .
  8. Web site: Esperoct 1000 IU powder and solvent for solution for injection - Summary of Product Characteristics (SmPC) . (emc) . 2 October 2020 . 15 January 2021 . https://web.archive.org/web/20210115172542/https://www.medicines.org.uk/emc/product/11590/smpc . live .
  9. Spreitzer H . 7 January 2014. Neue Wirkstoffe – NovoEight. Österreichische Apothekerzeitung. 1/2014. 18. German.
  10. Web site: Novo Nordisk annual report 2013 . Novo Nordisk . 11 March 2020 . 20 November 2017 . https://web.archive.org/web/20171120223728/https://www.novonordisk.com/content/dam/Denmark/HQ/investors/irmaterial/annual_report/2014/20140203_Annual%20Report%202013_UK.pdf . live .
  11. Web site: NovoEight . U.S. Food and Drug Administration (FDA) . 19 July 2017 . 22 July 2017 . https://wayback.archive-it.org/7993/20170722071242/https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm371092.htm . 11 March 2020 . dead .
  12. Web site: NovoEight EPAR . European Medicines Agency (EMA) . 17 September 2018 . 11 March 2020 . 30 October 2020 . https://web.archive.org/web/20201030163108/https://www.ema.europa.eu/en/medicines/human/EPAR/novoeight . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  13. Web site: NovoEight (- antihemophilic factor, recombinant kit . DailyMed . 30 November 2018 . 11 March 2020 . 24 March 2021 . https://web.archive.org/web/20210324013144/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0a19a631-f494-48ac-8cab-7d572bf7b03d . live .
  14. Web site: FDA Approval Document. Food and Drug Administration. 27 April 2014. 7 February 2019. https://web.archive.org/web/20190207204537/https://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM371094.pdf. live.
  15. Web site: European Drug Assessment Report. 27 April 2014. 2 May 2014. https://web.archive.org/web/20140502215938/http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002719/WC500157556.pdf. live.
  16. Web site: Haddley K . Turoctog alfa for the treatment of hemophilia A. Drugs today. 7 April 2014. dead. https://web.archive.org/web/20140502181228/http://0-www.ncbi.nlm.nih.gov.elis.tmu.edu.tw/pubmed/24619589. 2 May 2014.
  17. Web site: How NovoSeven Works. 27 April 2014. 2 May 2014. https://web.archive.org/web/20140502195518/https://www.novosevenrt.com/hemophilia-bleed-control/how-works.html. live.
  18. Web site: Esperoct . U.S. Food and Drug Administration (FDA) . 19 February 2019 . 11 March 2020 . STN: BL 125671 . 17 December 2019 . https://web.archive.org/web/20191217015641/https://www.fda.gov/vaccines-blood-biologics/esperoct . live .
  19. Web site: Esperoct (antihemophilic factor- recombinant, glycopegylated-exei kit . DailyMed . 30 October 2019 . 11 March 2020 . 26 March 2021 . https://web.archive.org/web/20210326002915/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=562f94e8-825f-4d7f-b93c-b783ac3a43bc . live .
  20. Web site: Esperoct EPAR . European Medicines Agency (EMA) . 24 April 2019 . 11 March 2020 . 24 October 2020 . https://web.archive.org/web/20201024192859/https://www.ema.europa.eu/en/medicines/human/EPAR/esperoct . live .

This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Turoctocog alfa".

Except where otherwise indicated, Everything.Explained.Today is © Copyright 2009-2024, A B Cryer, All Rights Reserved. Cookie policy.