Factor VIII (medication)
{{Short description|Pharmaceutical drug}}
{{Use dmy dates|date=March 2024}}
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{{Infobox drug
| drug_name = Factor VIII
| image = Fviii 2R7E.png
| width =
| alt =
| caption = A depiction of factor VIII
| pronounce =
| Drugs.com = {{drugs.com|monograph|antihemophilic-factor-human}}
| MedlinePlus =
| DailyMedID = Kovaltry
| pregnancy_AU =
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| routes_of_administration = Intravenous (IV)
| class =
| ATC_prefix = B02
| ATC_suffix = BD02
| ATC_supplemental =
| legal_AU = S4
| legal_AU_comment = {{cite web | title=Prescription medicines: registration of new chemical entities in Australia, 2017 | website=Therapeutic Goods Administration (TGA) | date=21 June 2022 | url=https://www.tga.gov.au/resources/publication/publications/prescription-medicines-registration-new-chemical-entities-australia-2017 | access-date=9 April 2023}}{{cite web | title=Prescription medicines: registration of new chemical entities in Australia, 2016 | website=Therapeutic Goods Administration (TGA) | date=21 June 2022 | url=https://www.tga.gov.au/prescription-medicines-registration-new-chemical-entities-australia-2016 | access-date=10 April 2023}}{{cite web | title=Prescription medicines: registration of new chemical entities in Australia, 2014 | website=Therapeutic Goods Administration (TGA) | date=21 June 2022 | url=https://www.tga.gov.au/resources/resource/guidance/prescription-medicines-registration-new-chemical-entities-australia-2014 | access-date=10 April 2023}}{{cite web | title=Prescription medicines and biologicals: TGA annual summary 2017 | website=Therapeutic Goods Administration (TGA) | date=21 June 2022 | url=https://www.tga.gov.au/resources/publication/publications/prescription-medicines-and-biologicals-tga-annual-summary-2017 | access-date=31 March 2024}}
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| legal_BR_comment =
| legal_CA = Rx-only
| legal_CA_comment = /{{nbsp}}Schedule D{{cite web | url=https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.php?lang=en&linkID=RDS00364 | title=Regulatory Decision Summary for Alphanate | date=23 October 2014 }}{{cite web | title=Health Canada New Drug Authorizations: 2016 Highlights | website=Health Canada | date=14 March 2017 | url=https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/health-canada-new-drug-authorizations-2016-highlights.html | access-date=7 April 2024}}
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| legal_status = Rx-only
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| synonyms = octocog alfa
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{{Infobox drug
| drug_name = rurioctocog alfa pegol
| image =
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| tradename = Adynovi
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| ATC_prefix = None
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| legal_EU = Rx-only
| legal_EU_comment = {{cite web | title=Adynovi EPAR | website=European Medicines Agency | date=8 January 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/adynovi | access-date=20 June 2024}}
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{{Infobox drug
| drug_name = octocog alfa
| image =
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| tradename = Advate
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| ATC_prefix = None
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| legal_US_comment =
| legal_EU = Rx-only
| legal_EU_comment = {{cite web | title=Advate EPAR | website=European Medicines Agency | date=2 March 2004 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/advate | access-date=20 June 2024}}
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| C= | H= | Ag= | Al= | As= | Au= | B= | Bi= | Br= | Ca= | Cl= | Co= | F= | Fe= | Gd= | I=
| K= | Li= | Mg= | Mn= | N= | Na= | O= | P= | Pt= | S= | Sb= | Se= | Sr= | Tc= | Zn= | charge=
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{{Infobox drug
| drug_name = von Willebrand factor
| INN =
| image =
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| pronounce =
| tradename = Wilate
| Drugs.com =
| MedlinePlus =
| DailyMedID = von Willebrand factor
| pregnancy_AU =
| pregnancy_AU_comment =
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| routes_of_administration =
| class = Anticoagulant
| ATC_prefix = B02
| ATC_suffix = BD10
| ATC_supplemental = {{ATC|B02|BD06}}
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| legal_US = Rx-only
| legal_US_comment = {{cite web | title=von Willebrand Factor/Coagulation Factor VIII Complex (Human) (von willebrand factor/coagulation factor viii complex- human powder, for solution | website=DailyMed | date=20 August 2010 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d0379e0c-bb51-554e-a58b-b2afa60019d4 | access-date=13 November 2024}}
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| CAS_number = 109319-16-6
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| DrugBank = DB13133
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| UNII = ZE22NE22F1
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| C= | H= | Ag= | Al= | As= | Au= | B= | Bi= | Br= | Ca= | Cl= | Co= | F= | Fe= | Gd= | I=
| K= | Li= | Mg= | Mn= | N= | Na= | O= | P= | Pt= | S= | Sb= | Se= | Sr= | Tc= | Zn= | charge=
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Factor VIII, an essential blood coagulation protein,{{cite journal | vauthors = Mazurkiewicz-Pisarek A, Płucienniczak G, Ciach T, Płucienniczak A | title = The factor VIII protein and its function | journal = Acta Biochimica Polonica | volume = 63 | issue = 1 | pages = 11–16 | date = 2016-01-28 | pmid = 26824291 | doi = 10.18388/abp.2015_1056 | doi-access = free }} is used as a medication to treat and prevent bleeding in people with hemophilia A and other causes of low factor VIII.{{cite book | title = WHO Model Formulary 2008 | year = 2009 | isbn = 9789241547659 | vauthors = ((World Health Organization)) | veditors = Stuart MC, Kouimtzi M, Hill SR | hdl = 10665/44053 | author-link = World Health Organization | publisher = World Health Organization | hdl-access=free |pages=259–60 }} Certain preparations may also be used in those with von Willebrand's disease. It is given by slow injection into a vein.
Side effects include skin flushing, shortness of breath, fever, and red blood cell breakdown. Allergic reactions including anaphylaxis may occur. It is unclear if use during pregnancy is safe for the fetus.{{cite web|title=Alphanate – Summary of Product Characteristics (SPC) – (eMC)|url=https://www.medicines.org.uk/emc/medicine/21167|website=www.medicines.org.uk|access-date=8 January 2017|url-status=live|archive-url=https://web.archive.org/web/20170109021426/https://www.medicines.org.uk/emc/medicine/21167|archive-date=9 January 2017}} A purified factor VIII concentrate is made from human blood plasma.{{cite book|title=British National Formulary : BNF 69|date=2015|publisher=British Medical Association|isbn=978-0857111562|page=171}} A recombinant version is also available. People may develop antibodies to factor VIII such that this medication becomes less effective.
Factor VIII was first identified in the 1940s and became available as a medication in the 1960s.{{cite book| vauthors = Potts DM |title=Queen Victoria's Gene: Haemophilia and the Royal Family | chapter = Chapter 5 |publisher=The History Press|year=2011|isbn=978-0752471969| chapter-url=https://books.google.com/books?id=tKwTDQAAQBAJ&pg=PT61|url-status=live|archive-url=https://web.archive.org/web/20170109021311/https://books.google.ca/books?id=tKwTDQAAQBAJ&pg=PT61|archive-date=9 January 2017}}{{cite book| vauthors = High KA | chapter = In vivo characteristics of rDNA Factor VIII: The impact for the future in hemophilia care | veditors = Sibinga CS, Das PC, Overby LR |title=Biotechnology in blood transfusion: Proceedings of the Twelfth Annual Symposium on Blood Transfusion, Groningen 1987, organized by the Red Cross Blood Bank Groningen-Drenthe|date=2012|publisher=Springer Science & Business Media|isbn=978-1461317616 | doi = 10.1007/978-1-4613-1761-6_19 |page=224|chapter-url=https://books.google.com/books?id=z1IlBAAAQBAJ&pg=PA224|url-status=live|archive-url=https://web.archive.org/web/20170109022859/https://books.google.ca/books?id=z1IlBAAAQBAJ&pg=PA224|archive-date=9 January 2017}} Recombinant factor VIII was first made in 1984 and approved for medical use in the United States in 1992.{{cite book| vauthors = Brownlee GG, Giangrande PL | chapter = Clotting factors VIII and IX | veditors = Buckel P |title=Recombinant Protein Drugs|date=2012|publisher=Birkhäuser|isbn=978-3034883467|page=79|chapter-url=https://books.google.com/books?id=cSX3BwAAQBAJ&pg=PA79|url-status=live|archive-url=https://web.archive.org/web/20170109022522/https://books.google.ca/books?id=cSX3BwAAQBAJ&pg=PA79|archive-date=9 January 2017}}{{cite book| vauthors = Zimring JC, Duncan A | chapter = Chapter 25 - Coagulation Factor Preparations | veditors = Hillyer CD |title=Blood Banking and Transfusion Medicine: Basic Principles & Practice|publisher=Elsevier Health Sciences|isbn=0443069816 | doi = 10.1016/B978-0-443-06981-9.50030-2 |year=2006|page=353| chapter-url= https://books.google.com/books?id=3QwXx_enKbcC&pg=PT374|url-status=live|archive-url= https://web.archive.org/web/20170109022838/https://books.google.ca/books?id=3QwXx_enKbcC&pg=PT374 |archive-date=9 January 2017 }} It is on the World Health Organization's List of Essential Medicines.{{cite book | vauthors = ((World Health Organization)) | title = World Health Organization model list of essential medicines: 21st list 2019 | year = 2019 | hdl = 10665/325771 | author-link = World Health Organization | publisher = World Health Organization | location = Geneva | id = WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO | hdl-access=free }}
Available forms
Factor VIII is delivered by intravenous infusion.{{cite journal | vauthors = Nathwani AC, Davidoff AM, Tuddenham EG | title = Gene Therapy for Hemophilia | journal = Hematology/Oncology Clinics of North America | volume = 31 | issue = 5 | pages = 853–868 | date = October 2017 | pmid = 28895852 | doi = 10.1016/j.hoc.2017.06.011 | s2cid = 3779939 }}
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.{{citation needed|date=December 2021}}
Society and culture
= Legal status =
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.{{cite web | title=von Willebrand Factor/Coagulation Factor VIII Complex (Human) (von willebrand factor/coagulation factor viii complex- human powder, for solution | website=DailyMed | date=20 November 2019 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a8ef06b8-b041-054e-e58d-fd8a994a8071 | access-date=13 November 2024}}{{cite web | title=Wilate | website=U.S. Food and Drug Administration | date=13 November 2024 | url=https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/wilate | archive-url=https://web.archive.org/web/20240222091149/https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/wilate | url-status=dead | archive-date=22 February 2024 | access-date=13 November 2024}}
= 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.{{cite journal | vauthors = Machin N, Ragni MV, Smith KJ | title = Gene therapy in hemophilia A: a cost-effectiveness analysis | journal = Blood Advances | volume = 2 | issue = 14 | pages = 1792–1798 | date = July 2018 | pmid = 30042145 | pmc = 6058236 | doi = 10.1182/bloodadvances.2018021345 }} They are so expensive that gene therapy for haemophilia might be less expensive, especially for people with severe hemophilia.
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
{{Reflist}}
External links
- {{cite web | title=Antihemophilic Factor (Recombinant) Monograph for Professionals | website=Drugs.com | url=https://www.drugs.com/monograph/antihemophilic-factor-recombinant.html }}
- {{cite web | title=Antihemophilic Factor (Recombinant), Porcine Sequence Monograph for Professionals | website=Drugs.com | url=https://www.drugs.com/monograph/antihemophilic-factor-recombinant-porcine-sequence.html }}
- {{cite web | title=Antihemophilic Factor (recombinant), Fc Fusion Protein Monograph for Professionals | website=Drugs.com | url=https://www.drugs.com/monograph/antihemophilic-factor-recombinant-fc-fusion-protein.html }}
- {{cite web | title=Antihemophilic Factor (recombinant), Glycopegylated-exei Monograph for Professionals | website=Drugs.com | url=https://www.drugs.com/monograph/antihemophilic-factor-recombinant-glycopegylated-exei.html }}
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Category:Drugs developed by Bayer
Category:Drugs developed by Takeda Pharmaceutical Company