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 |
|
| Routes of administration |
Injection |
| Identifiers | |
| CAS Number | 37224-63-8 |
| ATC code | B02BD01 (WHO) |
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
PCC reverses the effects 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). 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. 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
- ↑ Lua error in package.lua at line 80: module 'strict' not found.
- ↑ 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.
- ↑ Lua error in package.lua at line 80: module 'strict' not found.
- ↑ Lua error in package.lua at line 80: module 'strict' not found.
- ↑ 6.0 6.1 Kcentra Prescribing Information
External links
- Beriplex package insert from CSL Behring[dead link]
- Kcentra official site from CSL Behring
- Lua error in package.lua at line 80: module 'strict' not found.
- Lua error in package.lua at line 80: module 'strict' not found.
- Drugs with non-standard legal status
- Drugs that are a combination of chemicals
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- Blood products
- Coagulation system
