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, Cofact
AHFS/Drugs.com kcentra
Routes of
administration		 Injection
ATC code B02BD01 (WHO)
Legal status
Legal status
  • ℞ (Prescription only)
Identifiers
CAS Number 37224-63-8

Prothrombin complex concentrate (PCC, trade names Beriplex, Octaplex,[1] Kcentra, Cofact, among others) is a combination of blood clotting factors II, VII, IX and X, as well as protein C and S,[1] prepared from fresh-frozen human blood plasma. It is used to reverse the effects of oral anticoagulation therapy when bleeding occurs (e.g. in the brain or gut) requiring rapid action to accelerate coagulation.[2][3] PCC is effective but expensive. In the UK, it is prescribed in discussion with a haematologist. It is available as a powder and solvent for solution for injection.[2]

Indications

PCC reverses the effects of warfarin and other vitamin K antagonist anti-coagulants and is used in cases of significant bleeding in patients with a coagulopathy (INR > 8.0, prolonged prothrombin time). It is also used when such a patient must undergo an emergency operation treatment.[2] Other indications include a deficiency of one of the included clotting factors, either congenital or due to liver disease, and hemophilia.[2] Several guidelines, including American College of Chest Physicians,[4] recommend PCC for warfarin reversal in patients with serious bleed.[5][6][7]

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,[8] 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.[8]

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.[9]

References

  1. 1 2 FASS.se (Farmaceutiska Specialiteter i Sverige - the Swedish official drug catalog) > Ocplex Last updated: 2009–09–03
  2. 1 2 3 4 Haberfeld, H, ed. (2015). Austria-Codex (in German). Vienna: Österreichischer Apothekerverlag. Cofact.
  3. ↑ Drugs.com: kcentra.
  4. ↑ "ACCP 2012 guidelines: 'Evidence-Based Management of Anticoagulant Therapy, Section 9.3 Treatment of Anticoagulant-Related Bleeding'". Chest Journal.
  5. ↑ 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.
  6. ↑ 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.
  7. ↑ Palareti, G. (1998). "A guide to oral anticoagulant therapy. Italian Federation of Anticoagulation Clinics". Haemostasis. 28 Suppl 1: 1–46. PMID 9820837.
  8. 1 2 Kcentra Prescribing Information
  9. ↑ "Kcentra, from CSL Behring, Receives FDA Approval for Use in Warfarin Reversal in Patients Undergoing Surgery". CSL Behring. 13 December 2013.

Further reading

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