Prothrombin complex concentrate

From Wikipedia, the free encyclopedia
Jump to: navigation, search
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 entry
Legal status
  • Prescription only
Routes Injection
Identifiers
CAS number 37224-63-8
ATC code B02BD01

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.

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.

Indications[edit]

PCC reverses the effect of warfarin and other coumarin anti-coagulants and is used in cases of significant bleeding in patients with a coagulopathy (INR > 8.0, prolonged prothrombin time, raised d-dimer). It is also used when such a patient must undergo an emergency operation treatment. Other indications include a deficiency of one of the included clotting factors, either congenital or due to liver disease, and hemophilia.

Several guidelines, including American College of Chest Physicians,[2] recommend PCC for warfarin reversal in patients with serious bleed.[3][4][5]

Contraindications[edit]

The package insert states that PCC is contraindicated in patients with disseminated intravascular coagulation, a pathological activation of coagulation,[6] 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.[6]

History[edit]

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.

References[edit]

  1. ^ a b FASS.se (Farmaceutiska Specialiteter i Sverige - the Swedish official drug catalog) > Ocplex Last updated: 2009–09–03
  2. ^ "ACCP 2012 guidelines: 'Evidence-Based Management of Anticoagulant Therapy, Section 9.3 Treatment of Anticoagulant-Related Bleeding'". Chest Journal. 
  3. ^ 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.
  4. ^ 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.  edit
  5. ^ Palareti, G. (1998). "A guide to oral anticoagulant therapy. Italian Federation of Anticoagulation Clinics". Haemostasis. 28 Suppl 1: 1–46. PMID 9820837.  edit
  6. ^ a b Kcentra Prescribing Information

External links[edit]