Prothrombin complex concentrate

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
Routes of
administration		Intravenous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank

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](3-factor PCC) or, when also containing factor VII as does Kcentra, 4-factor PCC.[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] Another product, activated prothrombin complex concentrate or FEIBA (Factor Eight Inhibitor Bypassing Agent), may be used for acquired hemophilia.[12]

Common side effects include allergic reactions, headache, vomiting, and sleepiness.[9][13] Other serious side effects include blood clots which may result in a heart attack, stroke, pulmonary embolism, or deep vein thrombosis.[13] 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.[14] It is on the World Health Organization's List of Essential Medicines.[15][16] It is made from human plasma.[13] Recombinant factor IX is also available in a stand-alone preparation.[17]

  1. ^ CSL Behring Canada 2019
  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. ^ "Active substance: human prothrombin complex" (PDF). List of nationally authorised medicinal products. European Medicines Agency. January 2017. EMA/45481/2017, PSUSA/00001638/201604.
  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 978-92-4-154765-9. OCLC 609852935.
  10. ^ Wilson MD, Davis JE (2014). "Antithrombotic Reversal Agents". In Perkins JC (ed.). Hematology/Oncology Emergencies. Emergency Medicine Clinics of North America. Vol. 3. Elsevier. p. 720. ISBN 978-0-323-32029-0. OCLC 893676529.
  11. ^ a b c British national formulary : BNF 69 (69th ed.). British Medical Association. 2015. p. 171. ISBN 978-0-85711-156-2. OCLC 910448191.
  12. ^ Negrier C, Voisin S, Baghaei F, Numerof R, Novack A, Doralt JE, et al. (July 2016). "Global Post-Authorization Safety Surveillance Study: real-world data on prophylaxis and on-demand treatment using FEIBA (an activated prothrombin complex concentrate)". Blood Coagul Fibrinolysis. 27 (5): 551–6. doi:10.1097/MBC.0000000000000525. PMC 4935538. PMID 26829366.
  13. ^ 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.
  14. ^ Besa EC (1992). "Clinical Aspects of Transfusion Therapy". Hematology. Lippincott Williams & Wilkins. p. 276. ISBN 978-0-683-06222-9. OCLC 1175934487.
  15. ^ 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.
  16. ^ 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). Vol. 994. Geneva: World Health Organization. p. 510. hdl:10665/189763. ISBN 978-92-4-120994-6. ISSN 0512-3054. WHO technical report series.
  17. ^ "Factor IX (Recombinant)". The American Society of Health-System Pharmacists. Archived from the original on 24 September 2017. Retrieved 8 December 2016.