Prothrombin complex concentrate
Combination of | |
---|---|
Factor VII | Blood clotting factor |
Factor IX | Blood clotting factor |
Factor X | Blood clotting factor |
Clinical data | |
Trade names | Beriplex, Kcentra, Balfaxar, Prothrombinex |
Other names | factor IX complex |
AHFS/Drugs.com | Monograph 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
Common side effects include
Prothrombin complex concentrate came into medical use in the 1960s.
Medical uses
Prothrombin complex concentrate reverses the effects of
For rapid anticoagulation reversal for surgery, four-factor prothrombin complex concentrate reduces
Contraindications
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
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
- ^ https://labeling.cslbehring.ca/PM/CA/Beriplex-PN/EN/Beriplex-PN-Product-Monograph.pdf
- ^ "Beriplex P/N 250 IU - Summary of Product Characteristics (SmPC)". (emc). 27 January 2021. Retrieved 7 May 2023.
- ^ "Kcentra (Prothrombin Complex Concentrate, Human)". U.S. Food and Drug Administration (FDA). 3 May 2023. Retrieved 7 May 2023.
- ^ "Balfaxar (prothrombin complex concentrate- human powder, for solution". DailyMed. U.S. National Library of Medicine. 21 July 2023. Retrieved 25 August 2023.
- ^ "Balfaxar". U.S. Food and Drug Administration (FDA). 21 July 2023. Retrieved 25 August 2023.
- ^ https://www.ema.europa.eu/en/documents/psusa/human-prothrombin-complex-list-nationally-authorised-medicinal-products-psusa/00001638/201604_en.pdf
- ^ ISBN 9789241547659.
- ^ ISBN 9780323320290. Archivedfrom the original on 5 January 2017.
- ^ ISBN 9780857111562.
- ^ 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.
- ISBN 9780683062229. Archivedfrom the original on 9 January 2017.
- hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
- ISSN 0512-3054. WHO technical report series;994.
- ^ "Factor IX (Recombinant)". The American Society of Health-System Pharmacists. Archived from the original on 24 September 2017. Retrieved 8 December 2016.
- ^ a b Haberfeld, H, ed. (2015). Austria-Codex (in German). Vienna: Österreichischer Apothekerverlag. Cofact.
- ^ "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.
- ^ 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.
- S2CID 3035209.
- S2CID 202659825.
- PMID 30157037.
- ^ 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.
- ^ 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.
- ^ "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.
- ISBN 9781437703672. Archivedfrom the original on 9 January 2017.
- ^ "What Blood Products are Supplied - National Product Price List | National Blood Authority". blood.gov.au. Retrieved 18 January 2024.
- ISBN 9780323280112. Archivedfrom the original on 9 January 2017.
Further reading
- Pabinger I, Brenner B, Kalina U, Knaub S, Nagy A, Ostermann H, et al. (Beriplex P/N Anticoagulation Reversal Study Group) (April 2008). "Prothrombin complex concentrate (Beriplex P/N) for emergency anticoagulation reversal: a prospective multinational clinical trial". Journal of Thrombosis and Haemostasis. 6 (4): 622–31. S2CID 1533613.
- Bruce D, Nokes TJ (2008). "Prothrombin complex concentrate (Beriplex P/N) in severe bleeding: experience in a large tertiary hospital". Critical Care. 12 (4): R105. PMID 18706082.