Factor VIII (medication)

Factor VIII, an essential blood coagulation protein,[11] is used as a medication to treat and prevent bleeding in people with hemophilia A and other causes of low factor VIII.[12] Certain preparations may also be used in those with von Willebrand's disease. It is given by slow injection into a vein.[12]

Side effects include skin flushing, shortness of breath, fever, and red blood cell breakdown.[12] Allergic reactions including anaphylaxis may occur. It is unclear if use during pregnancy is safe for the fetus.[13] A purified factor VIII concentrate is made from human blood plasma.[14] A recombinant version is also available.[12] People may develop antibodies to factor VIII such that this medication becomes less effective.[13]

Factor VIII was first identified in the 1940s and became available as a medication in the 1960s.[15][16] Recombinant factor VIII was first made in 1984 and approved for medical use in the United States in 1992.[17][18] It is on the World Health Organization's List of Essential Medicines.[19]

Available forms

Factor VIII is delivered by intravenous infusion.[20]

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

von Willebrand Factor/Coagulation Factor VIII Complex (Human) (sold under the brand name Wilate) was approved for medical use in the United States in 2009.[21][22]

Economics

The cost of Factor VIII and similar clotting factors has been described as "highly expensive".[20] The cost of the clotting factors is 80% of all medical costs for people with hemophilia.[23] They are so expensive that gene therapy for haemophilia might be less expensive, especially for people with severe hemophilia.[23]

See also

  • Damoctocog alfa pegol, a recombinant antihemophilic factor VIII
  • Efmoroctocog alfa, a recombinant antihemophilic factor VIII
  • Moroctocog alfa, a recombinant antihemophilic factor VIII
  • Susoctocog alfa, a recombinant antihemophilic factor VIII
  • Turoctocog alfa, a recombinant antihemophilic factor VIII

References

  1. Coagulation Factor VIII, Human www.drugs.com, retrieved 8 January 2017^
  2. Prescription medicines: registration of new chemical entities in Australia, 2017 Therapeutic Goods Administration (TGA), 21 June 2022, retrieved 9 April 2023^
  3. Prescription medicines: registration of new chemical entities in Australia, 2016 Therapeutic Goods Administration (TGA), 21 June 2022, retrieved 10 April 2023^
  4. Prescription medicines: registration of new chemical entities in Australia, 2014 Therapeutic Goods Administration (TGA), 21 June 2022, retrieved 10 April 2023^
  5. Prescription medicines and biologicals: TGA annual summary 2017 Therapeutic Goods Administration (TGA), 21 June 2022, retrieved 31 March 2024^
  6. Regulatory Decision Summary for Alphanate 23 October 2014^
  7. Health Canada New Drug Authorizations: 2016 Highlights Health Canada, 14 March 2017, retrieved 7 April 2024^
  8. Adynovi EPAR European Medicines Agency, 8 January 2018, retrieved 20 June 2024^
  9. Advate EPAR European Medicines Agency, 2 March 2004, retrieved 20 June 2024^
  10. von Willebrand Factor/Coagulation Factor VIII Complex (Human) (von willebrand factor/coagulation factor viii complex- human powder, for solution DailyMed, 20 August 2010, retrieved 13 November 2024^
  11. The factor VIII protein and its function Acta Biochimica Polonica, 2016-01-28^
  12. WHO Model Formulary 2008 World Health Organization, 2009^
  13. Alphanate – Summary of Product Characteristics (SPC) – (eMC) www.medicines.org.uk, retrieved 8 January 2017^
  14. British National Formulary: BNF 69 British Medical Association, 2015^
  15. Queen Victoria's Gene: Haemophilia and the Royal Family The History Press, 2011^
  16. Biotechnology in blood transfusion: Proceedings of the Twelfth Annual Symposium on Blood Transfusion, Groningen 1987, organized by the Red Cross Blood Bank Groningen-Drenthe Springer Science & Business Media, 2012^
  17. Recombinant Protein Drugs Birkhäuser, 2012^
  18. Blood Banking and Transfusion Medicine: Basic Principles & Practice Elsevier Health Sciences, 2006^
  19. The selection and use of essential medicines, 2025: WHO Model List of Essential Medicines, 24th list World Health Organization, 2025^
  20. Gene Therapy for Hemophilia Hematology/Oncology Clinics of North America, October 2017^
  21. von Willebrand Factor/Coagulation Factor VIII Complex (Human) (von willebrand factor/coagulation factor viii complex- human powder, for solution DailyMed, 20 November 2019, retrieved 13 November 2024^
  22. Wilate U.S. Food and Drug Administration, 13 November 2024, retrieved 13 November 2024^
  23. Gene therapy in hemophilia A: a cost-effectiveness analysis Blood Advances, July 2018^