View source for Medicine:Factor VIII (medication)

{{Short description|Pharmaceutical drug}}
{{Infobox drug
| drug_name         = Factor VIII
| INN               =
| type              = <!-- empty -->
| image             = Fviii 2R7E.png
| width             =
| alt               =
| caption           = A depiction of factor VIII

<!-- Clinical data -->
| pronounce         =
| tradename         = Aafact, Kovaltry, others<ref>{{cite web|title=Coagulation Factor VIII, Human|url=https://www.drugs.com/international/coagulation-factor-viii-human.html|website=www.drugs.com|access-date=8 January 2017|url-status=live|archive-url=https://web.archive.org/web/20170109023010/https://www.drugs.com/international/coagulation-factor-viii-human.html|archive-date=9 January 2017}}</ref>
| Drugs.com         = {{drugs.com|monograph|antihemophilic-factor-human}}
| MedlinePlus       =
| licence_CA        = <!-- Health Canada may use generic or brand name (generic name preferred) -->
| licence_EU        = yes
| DailyMedID        = Kovaltry
| licence_US        = <!-- FDA may use generic or brand name (generic name preferred) -->
| pregnancy_AU      = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_AU_comment =
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| routes_of_administration = Intravenous (IV)
| class             =
| ATCvet            =
| ATC_prefix        = B02
| ATC_suffix        = BD02
| ATC_supplemental  =

<!-- Legal status -->
| legal_AU = S4
| legal_AU_comment = <ref>{{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}}</ref><ref>{{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}}</ref><ref>{{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}}</ref>
| legal_BR =  <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F-->
| legal_BR_comment =
| legal_CA = Rx-only
| legal_CA_comment = <ref>{{cite web | url=https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.php?lang=en&linkID=RDS00364 | title=Search Page - Drug and Health Product Register | date=23 October 2014 }}</ref>
| legal_DE = <!-- Anlage I, II, III or Unscheduled-->
| legal_DE_comment =
| legal_NZ = <!-- Class A, B, C -->
| legal_NZ_comment =
| legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM / Class A, B, C -->
| legal_UK_comment =
| legal_US = Rx-only
| legal_US_comment =
| legal_EU = Rx-only
| legal_EU_comment =
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV-->
| legal_UN_comment =
| legal_status      = Rx-only

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| IUPHAR_ligand     =
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| ChemSpiderID      = none
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| NIAID_ChemDB      =
| PDB_ligand        =
| synonyms          = octocog alfa

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| C= | H= | Ag= | Al= | As= | Au= | B= | Bi= | Br= | Ca= | Cl= | Co= | F= | Fe= | Gd= | I=
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}}

<!-- Definition and medical uses -->
'''Factor VIII''' is a medication used to treat and prevent [[Medicine:Bleeding|bleeding]] in people with hemophilia A and other causes of low [[Biology:Factor VIII|factor VIII]].<ref name=WHO2008>{{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 |  publisher = World Health Organization | hdl-access=free |pages=259–60 }}</ref><ref name=BNF69/> Certain preparations may also be used in those with von Willebrand's disease.<ref name=BNF69/> It is given by slow injection into a vein.<ref name=WHO2008/>

<!-- Side effects and mechanisms -->
Side effects include skin flushing, shortness of breath, [[Medicine:Fever|fever]], and [[Medicine:Hemolysis|red blood cell breakdown]].<ref name=WHO2008/><ref name=BNF69/> Allergic reactions including [[Medicine:Anaphylaxis|anaphylaxis]] may occur.<ref name=BNF69/> It is unclear if use during [[Medicine:Pregnancy|pregnancy]] is safe for the fetus.<ref name=UK2017>{{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}}</ref> A purified factor VIII concentrate is made from human [[Biology:Blood plasma|blood plasma]].<ref name=BNF69>{{cite book|title=British National Formulary : BNF 69|date=2015|publisher=British Medical Association|isbn=978-0857111562|page=171}}</ref> A recombinant version is also available.<ref name=WHO2008/> People may develop [[Biology:Antibodies|antibodies]] to factor VIII such that this medication becomes less effective.<ref name=UK2017/>

<!-- History and culture -->
Factor VIII was first identified in the 1940s and became available as a medication in the 1960s.<ref>{{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=2017-01-09}}</ref><ref>{{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=2017-01-09}}</ref> Recombinant factor VIII was first made in 1984 and approved for medical use in the United States in 1992.<ref>{{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=2017-01-09}}</ref><ref>{{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=2017-01-09 }}</ref> It is on the [[Medicine:WHO Model List of Essential Medicines|World Health Organization's List of Essential Medicines]].<ref name="WHO21st">{{cite book | vauthors = ((World Health Organization)) | title = World Health Organization model list of essential medicines: 21st list 2019 | year = 2019 | hdl = 10665/325771 |  publisher = World Health Organization | location = Geneva | id = WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO | hdl-access=free }}</ref>

== Available forms ==
Factor VIII is delivered by [[Chemistry:Intravenous therapy|intravenous infusion]].<ref name="Nathwani_2017">{{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 }}</ref>

==History==
This transfer of a [[Biology:Blood plasma|plasma]] byproduct into the blood stream of a hemophiliac often led to the transmission of diseases such as [[Biology:HIV|HIV]] and [[Medicine:Hepatitis|hepatitis]] before purification methods were improved. In the early 1990s, pharmaceutical companies began to produce [[Biology:Recombinant DNA|recombinant]] synthesized factor products, which now prevent nearly all forms of disease transmission during replacement therapy.{{citation needed|date=December 2021}}

== Society and culture ==
=== Economics ===
The cost of Factor VIII and similar clotting factors has been described as "highly expensive".<ref name="Nathwani_2017" />  The cost of the clotting factors is 80% of all medical costs for people with hemophilia.<ref name="Machin_2018">{{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 }}</ref>  They are so expensive that gene therapy for haemophilia might be less expensive, especially for people with severe hemophilia.<ref name="Machin_2018" />

== See also ==
* [[Biology:Damoctocog alfa pegol|Damoctocog alfa pegol]], a recombinant antihemophilic factor VIII
* [[Biology:Efmoroctocog alfa|Efmoroctocog alfa]], a recombinant antihemophilic factor VIII
* [[Biology:Moroctocog alfa|Moroctocog alfa]], a recombinant antihemophilic factor VIII
* Susoctocog alfa, a recombinant antihemophilic factor VIII
* [[Biology:Turoctocog alfa|Turoctocog alfa]], a recombinant antihemophilic factor VIII

== References ==
{{Reflist}}

== External links ==
* {{cite web | url = https://druginfo.nlm.nih.gov/drugportal/rn/113189-02-9 | publisher = U.S. National Library of Medicine | work = Drug Information Portal | title = Blood-coagulation factor VIII, procoagulant }}
* {{cite web | url = https://druginfo.nlm.nih.gov/drugportal/rn/9001-27-8 | publisher = U.S. National Library of Medicine | work = Drug Information Portal | title = Beroctocog alfa }}
* {{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 }}


[[Category:World Health Organization essential medicines]]
[[Category:Wikipedia medicine articles ready to translate]]

{{Sourceattribution|Factor VIII (medication)}}