Prothrombin complex concentrate

Source: Wikipedia, the free encyclopedia.

Prothrombin complex concentrate
Combination of
Factor VII
Blood clotting factor
Factor IXBlood clotting factor
Factor XBlood clotting factor
Clinical data
Trade namesBeriplex, Kcentra, Balfaxar, Prothrombinex
Other namesfactor IX complex
AHFS/Drugs.comMonograph
Monograph
License data
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

slow injection into a vein.[7]

Common side effects include

Antibodies may form after long term use such that future doses are less effective.[9]

Prothrombin complex concentrate came into medical use in the 1960s.

human plasma.[10] Recombinant factor IX is also available in a stand-alone preparation.[14]

Medical uses

Prothrombin complex concentrate reverses the effects of

hemophilia.[15] Several guidelines, including those from the American College of Chest Physicians, recommend prothrombin complex concentrate for warfarin reversal in people with serious bleeding.[16][17][18][19]

For rapid anticoagulation reversal for surgery, four-factor prothrombin complex concentrate reduces

international normalized ratio (INR) and decreases bleeding during surgery when compared with administration of fresh frozen plasma. No differences in thromboembolic event was found.[20]

Contraindications

Platelet factor 4 can cause heparin-induced thrombocytopenia.

The package insert states that prothrombin complex concentrate is contraindicated in patients with disseminated intravascular coagulation, a pathological activation of coagulation,[21] because giving clotting factors would only further fuel this process. However, if the PCC is given because factor levels are low, it can restore normal coagulation. As PCC products contain heparin, they are contraindicated in patients with heparin-induced thrombocytopenia.[21]

Chemistry

Prothrombin complex concentrate contains a number of blood clotting factors. Typically this includes

factor VII, protein C, and protein S.[8][21] Heparin may be added to stop early activation of the factors.[8]

History

The US Food and Drug Administration (FDA) announced its approval in 2013.[22] The FDA approved Kcentra's orphan drug status in December 2012.[22][23]

Society and culture

Economics

In the United States a dose of prothrombin complex concentrate costs about US$900.[24] The Australian National Blood Authority sets Prothrombinex (500 IU) at around AUD$327. [25]

Brand names

A number of different formulations are available globally.[26]

References

  1. ^ https://labeling.cslbehring.ca/PM/CA/Beriplex-PN/EN/Beriplex-PN-Product-Monograph.pdf
  2. ^ "Beriplex P/N 250 IU - Summary of Product Characteristics (SmPC)". (emc). 27 January 2021. Retrieved 7 May 2023.
  3. ^ "Kcentra (Prothrombin Complex Concentrate, Human)". U.S. Food and Drug Administration (FDA). 3 May 2023. Retrieved 7 May 2023.
  4. ^ "Balfaxar (prothrombin complex concentrate- human powder, for solution". DailyMed. U.S. National Library of Medicine. 21 July 2023. Retrieved 25 August 2023.
  5. ^ "Balfaxar". U.S. Food and Drug Administration (FDA). 21 July 2023. Retrieved 25 August 2023.
  6. ^ https://www.ema.europa.eu/en/documents/psusa/human-prothrombin-complex-list-nationally-authorised-medicinal-products-psusa/00001638/201604_en.pdf
  7. ^ .
  8. ^ from the original on 5 January 2017.
  9. ^ .
  10. ^ 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.
  11. from the original on 9 January 2017.
  12. . WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
  13. . WHO technical report series;994.
  14. ^ "Factor IX (Recombinant)". The American Society of Health-System Pharmacists. Archived from the original on 24 September 2017. Retrieved 8 December 2016.
  15. ^ a b Haberfeld, H, ed. (2015). Austria-Codex (in German). Vienna: Österreichischer Apothekerverlag. Cofact.
  16. ^ "ACCP 2012 guidelines: 'Evidence-Based Management of Anticoagulant Therapy, Section 9.3 Treatment of Anticoagulant-Related Bleeding'". Chest. Archived from the original on 3 July 2013.
  17. ^ Haemostasis and Thrombosis Task Force for the British Committee for Standards in Haematology. Guidelines on oral anticoagulation: 3rd edition. Br J Haematol. 1998;101:374-387.
  18. S2CID 3035209
    .
  19. .
  20. .
  21. ^ a b c "Kcentra- prothrombin, coagulation factor vii human, coagulation factor ix human, coagulation factor x human, protein c, protein s human, and water kit". DailyMed. U.S. National Library of Medicine. 22 October 2018. Retrieved 21 April 2020.
  22. ^ a b "CSL Behring Receives FDA Approval of Kcentra for Urgent Warfarin Reversal in Patients with Acute Major Bleeding" (Press release). CSL Behring. 29 April 2013. Retrieved 7 May 2023.
  23. ^ "CSL Behring's Kcentra Receives FDA Approval For Use In Warfarin Reversal In Patients Undergoing Surgery" (Press release). CSL Behring. 13 December 2013. Archived from the original on 6 October 2016. Retrieved 5 October 2016.
  24. from the original on 9 January 2017.
  25. ^ "What Blood Products are Supplied - National Product Price List | National Blood Authority". blood.gov.au. Retrieved 18 January 2024.
  26. from the original on 9 January 2017.

Further reading