Prothrombin complex concentrate

Prothrombin complex concentrate
Combination of
Factor II Blood clotting factor
Factor VII Blood clotting factor
Factor IX Blood clotting factor
Factor X Blood clotting factor
Clinical data
Trade names Beriplex, Octaplex, Kcentra, others
Synonyms factor IX complex
AHFS/Drugs.com Monograph
Routes of
administration		 injection
ATC code
Legal status
Legal status
  • In general: ℞ (Prescription only)
Identifiers
CAS Number

Prothrombin complex concentrate (PCC), also known as factor IX complex, is a medication made up of blood clotting factors II, IX, and X.[1] Some versions also contain factor VII.[2] It is used to treat and prevent bleeding in hemophilia B if pure factor IX is not available.[1][3] It may also be used in those with not enough of these factors due to other reasons such as warfarin therapy.[3] It is given by slow injection into a vein.[1]

Common side effects include allergic reactions, headache, vomiting, and sleepiness.[1][4] Other serious side effects include blood clots which may result in a heart attack, stroke, pulmonary embolism, or deep vein thrombosis.[4] Antibodies may form after long term use such that future doses are less effective.[3]

Prothrombin complex concentrate came into medical use in the 1960s.[5] It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system.[6][7] It is made from human plasma.[4] A version that is made by recombinant methods which only contains factor IX is also available.[8] In the United States a dose of PCC costs about 900 USD.[9] A number of different formulations are available globally.[10]

Medical uses

PCC reverses the effects of warfarin and other vitamin K antagonist anti-coagulants and is used in cases of significant bleeding in people with a coagulopathy. It is also used when such a person must undergo an emergency operation treatment.[11] Other uses include a deficiency of one of the included clotting factors, either congenital or due to liver disease, and hemophilia.[11] Several guidelines, including those from the American College of Chest Physicians, recommend PCC for warfarin reversal in people with serious bleeding.[12][13][14][15]

Contraindications

Platelet factor 4 can cause heparin-induced thrombocytopenia.

The package insert states that PCC is contraindicated in patients with disseminated intravascular coagulation, a pathological activation of coagulation,[16] 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.[16]

Chemistry

PCC contains a number of blood clotting factors. Typically this includes factor II, IX, and X.[1] Some versions also contain factor VII, protein C, and protein S.[2] Heparin may be added to stop early activation of the factors.[2]

History

The U.S. Food and Drug Administration (FDA) announced its approval of Kcentra on April 30, 2013. The FDA approved Kcentra's orphan drug status in December 2012.[17]

References

  1. 1 2 3 4 5 WHO Model Formulary 2008 (PDF). World Health Organization. 2009. pp. 259–260. ISBN 9789241547659. Archived (PDF) from the original on 13 December 2016. Retrieved 8 December 2016.
  2. 1 2 3 Perkins, John C. (2014). Hematology/Oncology Emergencies, An Issue of Emergency Medicine Clinics of North America,. Elsevier Health Sciences. p. 720. ISBN 9780323320290. Archived from the original on 2017-01-05.
  3. 1 2 3 British national formulary : BNF 69 (69 ed.). British Medical Association. 2015. p. 171. ISBN 9780857111562.
  4. 1 2 3 "Factor IX (Human), Factor IX Complex (Human)". The American Society of Health-System Pharmacists. Archived from the original on 23 September 2017. Retrieved 8 December 2016.
  5. ↑ Besa, Emmanuel C. (1992). Hematology. Lippincott Williams & Wilkins. p. 276. ISBN 9780683062229. Archived from the original on 2017-01-09.
  6. ↑ "19th WHO Model List of Essential Medicines (April 2015)" (PDF). WHO. April 2015. Archived (PDF) from the original on May 13, 2015. Retrieved May 10, 2015.
  7. ↑ 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) (PDF). WHO. 2015. p. 510. ISBN 9789240694941. Archived (PDF) from the original on 20 December 2016. Retrieved 8 December 2016.
  8. ↑ "Factor IX (Recombinant)". The American Society of Health-System Pharmacists. Archived from the original on 23 September 2017. Retrieved 8 December 2016.
  9. ↑ Murray, Michael J.; Rose, Steven H.; Wedel, Denise J.; Wass, C. Thomas; Harrison, Barry A.; Mueller, Jeff T. (2014). Faust's Anesthesiology Review: Expert Consult (4 ed.). Elsevier Health Sciences. p. 543. ISBN 9781437703672. Archived from the original on 2017-01-09.
  10. ↑ Miller, Ronald D.; Eriksson, Lars I.; Fleisher, Lee A.; Wiener-Kronish, Jeanine P.; Cohen, Neal H.; Young, William L. (2014). Miller's Anesthesia (8 ed.). Elsevier Health Sciences. p. 1892. ISBN 9780323280112. Archived from the original on 2017-01-09.
  11. 1 2 Haberfeld, H, ed. (2015). Austria-Codex (in German). Vienna: Österreichischer Apothekerverlag. Cofact.
  12. ↑ "ACCP 2012 guidelines: 'Evidence-Based Management of Anticoagulant Therapy, Section 9.3 Treatment of Anticoagulant-Related Bleeding'". Chest Journal.
  13. ↑ 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.
  14. ↑ Baker, R. I.; Coughlin, P. B.; Gallus, A. S.; Harper, P. L.; Salem, H. H.; Wood, E. M.; Warfarin Reversal Consensus, G. (2004). "Warfarin reversal: Consensus guidelines, on behalf of the Australasian Society of Thrombosis and Haemostasis". The Medical Journal of Australia. 181 (9): 492–497. PMID 15516194.
  15. ↑ Palareti, G. (1998). "A guide to oral anticoagulant therapy. Italian Federation of Anticoagulation Clinics". Haemostasis. 28 Suppl 1: 1–46. PMID 9820837.
  16. 1 2 Kcentra Prescribing Information Archived 2013-10-26 at the Wayback Machine.
  17. ↑ "Kcentra, from CSL Behring, Receives FDA Approval for Use in Warfarin Reversal in Patients Undergoing Surgery". CSL Behring. 13 December 2013. Archived from the original on 6 October 2016.

Further reading

  • Pabinger, I.; Brenner, B.; Kalina, U.; Knaub, S.; Nagy, A.; Ostermann, H.; Beriplex P/N Anticoagulation Reversal Study Group (2008). "Prothrombin complex concentrate (Beriplex P/N) for emergency anticoagulation reversal: A prospective multinational clinical trial". Journal of Thrombosis and Haemostasis. 6 (4): 622–631. doi:10.1111/j.1538-7836.2008.02904.x. PMID 18208533.
  • Bruce, D.; Nokes, T. J. (2008). "Prothrombin complex concentrate (Beriplex P/N) in severe bleeding: Experience in a large tertiary hospital". Critical Care. 12 (4): R105. doi:10.1186/cc6987. PMC 2575594. PMID 18706082.
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