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, Ocplex, 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, Ocplex,[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 senior haematologist. It is available as a powder and solvent for solution for injection.
Indications
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
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. The idea that clotting factors fuel DIC is a myth.[citation needed] As PCC products contain heparin, they are contraindicated in patients with heparin-induced thrombocytopenia.[6]
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.
References
- ↑ 1.0 1.1 FASS.se (Farmaceutiska Specialiteter i Sverige - the Swedish official drug catalog) > Ocplex Last updated: 2009–09–03
- ↑ "ACCP 2012 guidelines: 'Evidence-Based Management of Anticoagulant Therapy, Section 9.3 Treatment of Anticoagulant-Related Bleeding'". Chest Journal.
- ↑ 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.
- ↑ 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.
- ↑ Palareti, G. (1998). "A guide to oral anticoagulant therapy. Italian Federation of Anticoagulation Clinics". Haemostasis. 28 Suppl 1: 1–46. PMID 9820837.
- ↑ 6.0 6.1 Kcentra Prescribing Information
External links
- Beriplex package insert from CSL Behring
- Kcentra official site from CSL Behring
- 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.
| ||||||||||||||||||||||||||