Recombinant factor IX

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Recombinant factor IX
Names
Trade namesBenefix, Rixubis,[1] Ixinity, Alprolix Idelvion, Rebinyn, others
Other namesCoagulation factor IX; recombinant factor IX; nonacog alfa; albutrepenonacog alfa; eftrenonacog alfa; nonacog beta pegol
Clinical data
Main usesHaemophilia B[1]
Side effectsFever, cough, pain at the site of injection, nausea, allergic reactions[2][3]
External links
AHFS/Drugs.comMonograph

Recombinant factor IX, also known as nonacog alfa among others, is a medication used to treat haemophilia B.[1] Specifically it is used to treat and prevent bleeding.[1] Its use improves quality of life.[1] It is given by slow injection into a vein.[1]

Common side effects include fever, cough, pain at the site of injection, and nausea.[2] It may also result in allergic reactions including angioedema, hives, wheezing, or low blood pressure.[3] Antibodies that block its ability to work may also develop.[3] It is a manufactured version of the blood clotting enzyme factor IX, made by recombinant methods.[1]

Recombinant versions were approved for medical use in the United States and Europe in 1997.[2][3][4] It is on the World Health Organization's List of Essential Medicines.[5] In the United Kingdom 1,000 units costs the NHS about £600 as of 2023.[6] This amount in the United States costs about 1,600 USD.[7] There are also versions made from human plasma, but these are associated with risks of infection.[8][6][4]

Types

Recombinant factor IX formulations include:

  • nonacog alfa (brand name BeneFix)[3]
  • albutrepenonacog alfa (brand name Idelvion)[9]
  • eftrenonacog alfa (brand name Alprolix)[10]
  • nonacog beta pegol (brand name Refixia)[11]

History

Factor IX concentrates were developed from human plasma in the late 1960s.[4] Recombinant versions came into medical use in 1997.[4] In the 1950s and 1960s fresh frozen plasma (FFP) was often used.[4]

References

  1. 1.0 1.1 1.2 1.3 1.4 1.5 1.6 "Factor IX (Recombinant) (Monograph)". Drugs.com. American Society of Health-System Pharmacists. Archived from the original on 24 September 2017. Retrieved 12 September 2023.
  2. 2.0 2.1 2.2 "BENEFIX (coagulation factor ix- recombinant kit". Dailymed. Archived from the original on 29 January 2023. Retrieved 12 September 2023.
  3. 3.0 3.1 3.2 3.3 3.4 "BeneFIX EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 17 June 2020. Retrieved 17 June 2020.
  4. 4.0 4.1 4.2 4.3 4.4 "Hemophilia: From Plasma to Recombinant Factors". 2008. Archived from the original on 29 May 2023. Retrieved 13 September 2023.
  5. World Health Organization (2023). The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023). Geneva: World Health Organization. hdl:10665/371090. WHO/MHP/HPS/EML/2023.02.
  6. 6.0 6.1 "Factor IX fraction, dried [Specialist drug] Medicinal forms". BNF. Archived from the original on 13 September 2023. Retrieved 13 September 2023.
  7. "Benefix". GoodRx. Retrieved 13 September 2023.
  8. "Haemonine 500 / Haemonine 1000". EMC. Archived from the original on 11 April 2022. Retrieved 13 September 2023.
  9. "Idelvion EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 17 June 2020. Retrieved 17 June 2020.
  10. "Alprolix EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 11 August 2020. Retrieved 17 June 2020.
  11. "Refixia EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 18 June 2020. Retrieved 17 June 2020.

External links