Pharmaceutical drug
Factor VIII is a medication used to treat and prevent bleeding in people with hemophilia A and other causes of low factor VIII .[ 10] [ 11] Certain preparations may also be used in those with von Willebrand's disease .[ 11] 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] [ 11] Allergic reactions including anaphylaxis may occur.[ 11] It is unclear if use during pregnancy is safe for the fetus.[ 12] A purified factor VIII concentrate is made from human blood plasma .[ 11] A recombinant version is also available.[ 10] People may develop antibodies to factor VIII such that this medication becomes less effective.[ 12]
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]
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^ "Prescription medicines: registration of new chemical entities in Australia, 2017" . Therapeutic Goods Administration (TGA) . 21 June 2022. Retrieved 9 April 2023 .
^ "Prescription medicines: registration of new chemical entities in Australia, 2016" . Therapeutic Goods Administration (TGA) . 21 June 2022. Retrieved 10 April 2023 .
^ "Prescription medicines: registration of new chemical entities in Australia, 2014" . Therapeutic Goods Administration (TGA) . 21 June 2022. Retrieved 10 April 2023 .
^ "Prescription medicines and biologicals: TGA annual summary 2017" . Therapeutic Goods Administration (TGA) . 21 June 2022. Retrieved 31 March 2024 .
^ "Regulatory Decision Summary for Alphanate" . 23 October 2014.
^ "Health Canada New Drug Authorizations: 2016 Highlights" . Health Canada . 14 March 2017. Retrieved 7 April 2024 .
^ "Adynovi EPAR" . European Medicines Agency . 8 January 2018. Retrieved 20 June 2024 .
^ "Advate EPAR" . European Medicines Agency . 2 March 2004. Retrieved 20 June 2024 .
^ 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 .
^ a b c d e British National Formulary : BNF 69 . British Medical Association. 2015. p. 171. ISBN 978-0857111562 .
^ 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 .
^ 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.
^ 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.
^ 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.
^ 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.
^ 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.