Factor VIII (medication) explained

Drug Name:Factor VIII
Tradename:Aafact, Kovaltry, others[1]
Dailymedid:Kovaltry
Routes Of Administration:Intravenous (IV)
Atc Prefix:B02
Atc Suffix:BD02
Legal Au:S4
Legal Au Comment:[2] [3] [4] [5]
Legal Ca:Rx-only
Legal Ca Comment:/Schedule D[6] [7]
Legal Us:Rx-only
Legal Eu:Rx-only
Legal Status:Rx-only
Chemspiderid:none
Synonyms:octocog alfa
Drug Name:rurioctocog alfa pegol
Tradename:Adynovi
Atc Prefix:None
Legal Eu:Rx-only
Legal Eu Comment:[8]
Drug Name:octocog alfa
Tradename:Advate
Atc Prefix:None
Legal Eu:Rx-only
Legal Eu Comment:[9]

Factor VIII is a medication used to treat and prevent bleeding in people with hemophilia A and other causes of low factor VIII.[10] Certain preparations may also be used in those with von Willebrand's disease. It is given by slow injection into a vein.[10]

Side effects include skin flushing, shortness of breath, fever, and red blood cell breakdown.[10] Allergic reactions including anaphylaxis may occur. It is unclear if use during pregnancy is safe for the fetus.[11] A purified factor VIII concentrate is made from human blood plasma.[12] A recombinant version is also available.[10] People may develop antibodies to factor VIII such that this medication becomes less effective.[11]

Factor VIII was first identified in the 1940s and became available as a medication in the 1960s.[13] [14] Recombinant factor VIII was first made in 1984 and approved for medical use in the United States in 1992.[15] [16] It is on the World Health Organization's List of Essential Medicines.[17]

Available forms

Factor VIII is delivered by intravenous infusion.[18]

History

This transfer of a plasma byproduct into the blood stream of a hemophiliac often led to the transmission of diseases such as HIV and hepatitis before purification methods were improved. In the early 1990s, pharmaceutical companies began to produce recombinant synthesized factor products, which now prevent nearly all forms of disease transmission during replacement therapy.

Society and culture

Economics

The cost of Factor VIII and similar clotting factors has been described as "highly expensive". The cost of the clotting factors is 80% of all medical costs for people with hemophilia.[19] They are so expensive that gene therapy for haemophilia might be less expensive, especially for people with severe hemophilia.

See also

External links

Notes and References

  1. Web site: Coagulation Factor VIII, Human. www.drugs.com. 8 January 2017. live. https://web.archive.org/web/20170109023010/https://www.drugs.com/international/coagulation-factor-viii-human.html. 9 January 2017.
  2. Web site: Prescription medicines: registration of new chemical entities in Australia, 2017 . Therapeutic Goods Administration (TGA) . 21 June 2022 . 9 April 2023.
  3. Web site: Prescription medicines: registration of new chemical entities in Australia, 2016 . Therapeutic Goods Administration (TGA) . 21 June 2022 . 10 April 2023.
  4. Web site: Prescription medicines: registration of new chemical entities in Australia, 2014 . Therapeutic Goods Administration (TGA) . 21 June 2022 . 10 April 2023.
  5. Web site: Prescription medicines and biologicals: TGA annual summary 2017 . Therapeutic Goods Administration (TGA) . 21 June 2022 . 31 March 2024.
  6. Web site: Regulatory Decision Summary for Alphanate . 23 October 2014 .
  7. Web site: Health Canada New Drug Authorizations: 2016 Highlights . . 14 March 2017 . 7 April 2024.
  8. Web site: Adynovi EPAR . European Medicines Agency . 8 January 2018 . 20 June 2024.
  9. Web site: Advate EPAR . European Medicines Agency . 2 March 2004 . 20 June 2024.
  10. Book: WHO Model Formulary 2008 . 2009 . 9789241547659 . ((World Health Organization)) . Stuart MC, Kouimtzi M, Hill SR . 10665/44053 . World Health Organization . World Health Organization . free . 259–60 .
  11. Web site: Alphanate – Summary of Product Characteristics (SPC) – (eMC). www.medicines.org.uk. 8 January 2017. live. https://web.archive.org/web/20170109021426/https://www.medicines.org.uk/emc/medicine/21167. 9 January 2017.
  12. Book: British National Formulary : BNF 69. 2015. British Medical Association. 978-0857111562. 171.
  13. Book: Potts DM . Queen Victoria's Gene: Haemophilia and the Royal Family . Chapter 5 . The History Press. 2011. 978-0752471969. https://books.google.com/books?id=tKwTDQAAQBAJ&pg=PT61. live. https://web.archive.org/web/20170109021311/https://books.google.ca/books?id=tKwTDQAAQBAJ&pg=PT61. 9 January 2017.
  14. Book: High KA . In vivo characteristics of rDNA Factor VIII: The impact for the future in hemophilia care . Sibinga CS, Das PC, Overby LR . Biotechnology in blood transfusion: Proceedings of the Twelfth Annual Symposium on Blood Transfusion, Groningen 1987, organized by the Red Cross Blood Bank Groningen-Drenthe. 2012. Springer Science & Business Media. 978-1461317616 . 10.1007/978-1-4613-1761-6_19 . 224. https://books.google.com/books?id=z1IlBAAAQBAJ&pg=PA224. live. https://web.archive.org/web/20170109022859/https://books.google.ca/books?id=z1IlBAAAQBAJ&pg=PA224. 9 January 2017.
  15. Book: Brownlee GG, Giangrande PL . Clotting factors VIII and IX . Buckel P . Recombinant Protein Drugs. 2012. Birkhäuser. 978-3034883467. 79. https://books.google.com/books?id=cSX3BwAAQBAJ&pg=PA79. live. https://web.archive.org/web/20170109022522/https://books.google.ca/books?id=cSX3BwAAQBAJ&pg=PA79. 9 January 2017.
  16. Book: Zimring JC, Duncan A . Chapter 25 - Coagulation Factor Preparations . Hillyer CD . Blood Banking and Transfusion Medicine: Basic Principles & Practice. Elsevier Health Sciences. 0443069816 . 10.1016/B978-0-443-06981-9.50030-2 . 2006. 353. https://books.google.com/books?id=3QwXx_enKbcC&pg=PT374. live. https://web.archive.org/web/20170109022838/https://books.google.ca/books?id=3QwXx_enKbcC&pg=PT374 . 9 January 2017 .
  17. Book: ((World Health Organization)) . World Health Organization model list of essential medicines: 21st list 2019 . 2019 . 10665/325771 . World Health Organization . World Health Organization . Geneva . WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO . free .
  18. Nathwani AC, Davidoff AM, Tuddenham EG . Gene Therapy for Hemophilia . Hematology/Oncology Clinics of North America . 31 . 5 . 853–868 . October 2017 . 28895852 . 10.1016/j.hoc.2017.06.011 . 3779939 .
  19. Machin N, Ragni MV, Smith KJ . Gene therapy in hemophilia A: a cost-effectiveness analysis . Blood Advances . 2 . 14 . 1792–1798 . July 2018 . 30042145 . 6058236 . 10.1182/bloodadvances.2018021345 .

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