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Prothrombin complex concentrate information


Prothrombin complex concentrate
Combination of
Factor IIBlood clotting factor
Factor VIIBlood clotting factor
Factor IXBlood clotting factor
Factor XBlood clotting factor
Clinical data
Trade namesKcentra, others
Other namesfactor IX complex
AHFS/Drugs.comMonograph
Monograph
License data
  • US DailyMed: Kcentra
Routes of
administration
Intravenous
ATC code
  • B02BD01 (WHO) B02BD04 (WHO)
Legal status
Legal status
  • CA: ℞-only[1][2][3]
  • UK: POM (Prescription only)[4]
  • US: ℞-only[5][6][7]
  • EU: Rx-only[8]
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
  • 37224-63-8
DrugBank
  • DB11330
  • DB13152

Prothrombin complex concentrate (PCC), also known as factor IX complex, sold under the brand name Kcentra among others, is a combination medication made up of blood clotting factors II, IX, and X.[9] Some versions also contain factor VII.[10] It is used to treat and prevent bleeding in hemophilia B if pure factor IX is not available.[9][11] It may also be used for reversal of warfarin therapy.[11] It is given by slow injection into a vein.[9]

Common side effects include allergic reactions, headache, vomiting, and sleepiness.[9][12] Other serious side effects include blood clots which may result in a heart attack, stroke, pulmonary embolism, or deep vein thrombosis.[12] Antibodies may form after long term use such that future doses are less effective.[11]

Prothrombin complex concentrate came into medical use in the 1960s.[13] It is on the World Health Organization's List of Essential Medicines.[14][15] It is made from human plasma.[12] Recombinant factor IX is also available in a stand-alone preparation.[16]

  1. ^ https://labeling.cslbehring.ca/PM/CA/Beriplex-PN/EN/Beriplex-PN-Product-Monograph.pdf
  2. ^ "Blood health (non-cancer)". Health Canada. 11 May 2018. Retrieved 13 April 2024.
  3. ^ "Regulatory Decision Summary for Rebinyn". Drug and Health Products Portal. 29 November 2017. Retrieved 13 April 2024.
  4. ^ "Beriplex P/N 250 IU - Summary of Product Characteristics (SmPC)". (emc). 27 January 2021. Retrieved 7 May 2023.
  5. ^ "Kcentra (Prothrombin Complex Concentrate, Human)". U.S. Food and Drug Administration (FDA). 3 May 2023. Retrieved 7 May 2023.
  6. ^ "Balfaxar (prothrombin complex concentrate- human powder, for solution". DailyMed. U.S. National Library of Medicine. 21 July 2023. Retrieved 25 August 2023.
  7. ^ "Balfaxar". U.S. Food and Drug Administration (FDA). 21 July 2023. Retrieved 25 August 2023.
  8. ^ https://www.ema.europa.eu/en/documents/psusa/human-prothrombin-complex-list-nationally-authorised-medicinal-products-psusa/00001638/201604_en.pdf
  9. ^ 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.
  10. ^ Wilson MD, Davis JE (2014). "Antithrombotic Reversal Agents". In Perkins JC (ed.). Hematology/Oncology Emergencies, An Issue of Emergency Medicine Clinics of North America. Elsevier Health Sciences. p. 720. ISBN 9780323320290. Archived from the original on 5 January 2017.
  11. ^ a b c British national formulary : BNF 69 (69 ed.). British Medical Association. 2015. p. 171. ISBN 9780857111562.
  12. ^ a b c "Factor IX (Human), Factor IX Complex (Human)". The American Society of Health-System Pharmacists. Archived from the original on 24 September 2017. Retrieved 8 December 2016.
  13. ^ Besa EC (1992). "Clinical Aspects of Transfusion Therapy". Hematology. Lippincott Williams & Wilkins. p. 276. ISBN 9780683062229. Archived from the original on 9 January 2017.
  14. ^ 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.
  15. ^ World Health Organization (2015). The selection and use of essential medicines. Twentieth report of the WHO Expert Committee 2015 (including 19th WHO Model List of Essential Medicines and 5th WHO Model List of Essential Medicines for Children). Geneva: World Health Organization. p. 510. hdl:10665/189763. ISBN 9789241209946. ISSN 0512-3054. WHO technical report series;994.
  16. ^ "Factor IX (Recombinant)". The American Society of Health-System Pharmacists. Archived from the original on 24 September 2017. Retrieved 8 December 2016.

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