Prothrombin complex concentrate (PCC), also known as factor IX complex, is a medication made up of blood clotting factors II, IX, and X. Some versions also contain factor VII. It is used to treat and prevent bleeding in hemophilia B if pure factor IX is not available. It may also be used in those with not enough of these factors due to other reasons such as warfarin therapy. It is given by slow injection into a vein.
Common side effects include allergic reactions, headache, vomiting, and sleepiness. Other serious side effects include blood clots which may result in a heart attack, stroke, pulmonary embolism, or deep vein thrombosis. Antibodies may form after long term use such that future doses are less effective.
Prothrombin complex concentrate came into medical use in the 1960s. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system. It is made from human plasma. A version that is made by recombinant methods which only contains factor IX is also available. In the United States a dose of PCC costs about 900 USD. A number of different formulations are available globally.
Video Prothrombin complex concentrate
Medical uses
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. 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, recommend PCC for warfarin reversal in patients with serious bleed.
Maps Prothrombin complex concentrate
Contraindications
The package insert states that PCC is contraindicated in patients with disseminated intravascular coagulation, a pathological activation of coagulation, 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.
Chemistry
PCC contains a number of blood clotting factors. Typically this includes factor II, IX, and X. Some versions also contain factor VII, protein C, and protein S. Heparin may be added to stop early activation of the factors.
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
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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