KCENTRA Quick Guide for Pc

1. Kcentra was not studied in 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 prior 3 months.

2. Kcentra®, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA—eg, warfarin) therapy in adult patients with acute major bleeding or the need for urgent surgery or other invasive procedure.

3. Kcentra is contraindicated in patients with known anaphylactic or severe systemic reactions to Kcentra or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin).

4. Monitor patients receiving Kcentra, and inform them of signs and symptoms of thromboembolic events.

5. Kcentra might not be suitable for patients with thromboembolic events in the prior 3 months.

6. Patients being treated with Vitamin K antagonist therapy have underlying disease states that predispose them to thromboembolic events.

7. Kcentra is made from human blood and may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

8. In clinical trials, the most frequent (≥2.8%) adverse reactions observed in subjects receiving Kcentra were headache, nausea/vomiting, hypotension, and anemia.

9. Kcentra is also contraindicated in patients with disseminated intravascular coagulation.

10. Potential benefits of reversing VKA should be weighed against the risk of thromboembolic events, especially in patients with history of such events.

11. Because Kcentra contains heparin, it is contraindicated in patients with heparin-induced thrombocytopenia (HIT).

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