Wikipedia

Factor VIII (medication)

(Redirected from Recombinant factor VIII)

Factor VIII is a medication used to treat and prevent bleeding in people with hemophilia A and other causes of low factor VIII.[12][13] Certain preparations may also be used in those with von Willebrand's disease.[13] It is given by slow injection into a vein.[12]

Factor VIII
A depiction of factor VIII
Clinical data
Trade namesAafact, Kovaltry, others[1]
Other namesoctocog alfa
AHFS/Drugs.comMonograph
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Routes of
administration		Intravenous (IV)
ATC code
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Identifiers
ChemSpider
  • none
rurioctocog alfa pegol
Clinical data
Trade namesAdynovi
ATC code
  • None
Legal status
Legal status
octocog alfa
Clinical data
Trade namesAdvate
ATC code
  • None
Legal status
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von Willebrand factor
Clinical data
Trade namesWilate
License data
Drug classAnticoagulant
ATC code
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Identifiers
CAS Number
DrugBank
UNII

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

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

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Factor VIII is delivered by intravenous infusion.[20]

History

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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.[citation needed]

Society and culture

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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.[10][21]

Economics

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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.[22] They are so expensive that gene therapy for haemophilia might be less expensive, especially for people with severe hemophilia.[22]

See also

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References

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  1. ^ "Coagulation Factor VIII, Human". www.drugs.com. Archived from the original on 9 January 2017. 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. ^ a b "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.
  11. ^ "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.
  12. ^ a b c d World Health Organization (2009). Stuart MC, Kouimtzi M, Hill SR (eds.). WHO Model Formulary 2008. World Health Organization. pp. 259–60. hdl:10665/44053. ISBN 9789241547659.
  13. ^ a b c d e British National Formulary : BNF 69. British Medical Association. 2015. p. 171. ISBN 978-0857111562.
  14. ^ a b "Alphanate – Summary of Product Characteristics (SPC) – (eMC)". www.medicines.org.uk. Archived from the original on 9 January 2017. Retrieved 8 January 2017.
  15. ^ Potts DM (2011). "Chapter 5". Queen Victoria's Gene: Haemophilia and the Royal Family. The History Press. ISBN 978-0752471969. Archived from the original on 9 January 2017.
  16. ^ High KA (2012). "In vivo characteristics of rDNA Factor VIII: The impact for the future in hemophilia care". In Sibinga CS, Das PC, Overby LR (eds.). 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. p. 224. doi:10.1007/978-1-4613-1761-6_19. ISBN 978-1461317616. Archived from the original on 9 January 2017.
  17. ^ Brownlee GG, Giangrande PL (2012). "Clotting factors VIII and IX". In Buckel P (ed.). Recombinant Protein Drugs. Birkhäuser. p. 79. ISBN 978-3034883467. Archived from the original on 9 January 2017.
  18. ^ Zimring JC, Duncan A (2006). "Chapter 25 - Coagulation Factor Preparations". In Hillyer CD (ed.). Blood Banking and Transfusion Medicine: Basic Principles & Practice. Elsevier Health Sciences. p. 353. doi:10.1016/B978-0-443-06981-9.50030-2. ISBN 0443069816. Archived from the original on 9 January 2017.
  19. ^ World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
  20. ^ a b Nathwani AC, Davidoff AM, Tuddenham EG (October 2017). "Gene Therapy for Hemophilia". Hematology/Oncology Clinics of North America. 31 (5): 853–868. doi:10.1016/j.hoc.2017.06.011. PMID 28895852. S2CID 3779939.
  21. ^ "Wilate". U.S. Food and Drug Administration. 13 November 2024. Retrieved 13 November 2024.
  22. ^ a b Machin N, Ragni MV, Smith KJ (July 2018). "Gene therapy in hemophilia A: a cost-effectiveness analysis". Blood Advances. 2 (14): 1792–1798. doi:10.1182/bloodadvances.2018021345. PMC 6058236. PMID 30042145.
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