Kcentra Hotline representatives are trained to answer medical and treatment questions, which differentiates them from other hotlines that are strictly for product information and ordering/reimbursement support.
Review data from the Kcentra Urgent Surgery/Invasive Procedures trial and Acute Major Bleeding trial.
Overview of clinical guidelines supporting use of PCC over plasma for warfarin reversal and a useful guide for identifying bleed severity.
Important product information for Kcentra, including disease state, in-depth review of clinical study results, and safety information.
Learn more about Kcentra, including calculating a dose, reconstitution, and monitoring patients. You can use this tool to present information about Kcentra to your hospital colleagues.
Dr. Morey Blinder describes the use of Kcentra, reviews the approved indications, and presents data from the pivotal trials. You can learn about Kcentra firsthand from a clinical consultant perspective.
Dr. Glen Tinkoff reports from the News Channel about the history of warfarin, how it works, and the prevalence of adverse events associated with its use. Learn how warfarin carries a risk that sometimes makes reversal necessary.
CSL Behring is committed to saving lives and improving lives of people with rare and serious diseases. This commitment is reflected in our history as a leader in coagulation therapies.
CSL Behring is committed to maintaining the highest standards of quality and safety of manufacturing and marketing a range of plasma-derived and recombinant therapies worldwide.
Our integrated safety system and extensive quality control measures ensure that only the highest quality plasma is selected for use in manufacturing and only safe and effective therapies are released.
Important Safety Information
WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS
Patients being treated with Vitamin K antagonist therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the risk of thromboembolic events, especially in patients with history of such events. Resumption of anticoagulation therapy should be carefully considered once the risk of thromboembolic events outweighs the risk of acute bleeding. Both fatal and nonfatal arterial and venous thromboembolic complications have been reported in clinical trials and postmarketing surveillance. Monitor patients receiving Kcentra, and inform them of signs and symptoms of thromboembolic events. 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. Kcentra might not be suitable for patients with thromboembolic events in the prior 3 months.
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). Kcentra is also contraindicated in patients with disseminated intravascular coagulation. Because Kcentra contains heparin, it is contraindicated in patients with heparin-induced thrombocytopenia (HIT).
Hypersensitivity reactions to Kcentra may occur. If patient experiences severe allergic or anaphylactic type reactions, discontinue administration and institute appropriate treatment.
In clinical trials, the most frequent (≥2.8%) adverse reactions observed in subjects receiving Kcentra were headache, nausea/vomiting, hypotension, and anemia. The most serious adverse reactions were thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.
Kcentra is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.
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. Kcentra is for intravenous use only.
Please see full prescribing information for Kcentra.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.