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Why Is KCENTRA Dosed Based On Factor IX?
KCENTRA contains prothrombin complex concentrate (human) [(Factors II, VII, IX, X), Protein C, and Protein S].
Why Is Kcentra Dosed Based On Factor IX?
To be able to prescribe the dose correctly for Kcentra, it is expressed in units of factor IX activity, and administered concurrently with vitamin K.
Kcentra US Boxed Warning
In clinical trials and postmarketing monitoring, prothrombin complex concentrate – Kcentra – has been associated with both fatal and nonfatal arterial and venous thromboembolic events. Patients who are receiving prothrombin complex concentrate should be closely monitored for signs and symptoms of thromboembolic events.
Subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the previous 3 months were not studied with prothrombin complex concentrate (Kcentra). Patients who have had thromboembolic events during the last three months may not be candidates for prothrombin complex concentrate – Kcentra.
Patients who are receiving vitamin K antagonist treatment have underlying illness conditions that predispose them to thromboembolic events, which are life-threatening. Consider the possible advantages of reversing vitamin K antagonists in relation to the potential dangers of thromboembolic events, particularly in individuals who have had a previous thromboembolic event in their lifetime. When the danger of thromboembolic events exceeds the risk of acute bleeding, it is important to carefully evaluate whether or not to resume anticoagulation.