Benefits and Risks of Anticoagulant Therapy

There are many conditions for which a patient may be treated with a Vitamin K antagonist (VKA), such as warfarin. The use of VKA anticoagulants helps prevent thrombosis, but also puts patients at risk of hemostatic failure and uncontrollable bleeding.2

Serious bleeding is a potential complication of warfarin use10:

  • Gastrointestinal bleeds
  • Intracranial hemorrhage
  • Musculoskeletal bleeds

Coagulation Factors Involved

VKAs like warfarin act by inhibiting the synthesis of fully functional Vitamin K-dependent coagulation Factors II, VII, IX, and X. Warfarin also results in a functional deficit of the antithrombotic Proteins C and S, which results in a disruption of normal hemostasis.11

A solution for emergency hemorrhage control should therefore12:

  • contain all essential Vitamin K-dependent coagulation factors (II, VII, IX, and X), as well as Proteins C and S
  • rapidly replace the deficient coagulation factors without increasing blood volume
  • carry a reduced risk of virus transmission and other plasma-related complications

INR / Prothrombin Time

Although warfarin is a highly effective antithrombotic agent, it has a narrow therapeutic window with wide patient variability in dosage requirements.12

The INR is a standardized means of expressing the prothrombin time ratio and provides an indication of hemorrhagic risk in patients taking warfarin.11, 12

Close monitoring of INR and warfarin dose adjustment is necessary to maintain optimal anticoagulation.11

The risk of hemorrhage increases greatly as the INR rises close to 5.0, but is heightened even when the INR is low. The target INR range is 2.0 – 3.0.12

The INR is a standardized means of expressing the prothrombin time ratio and provides an indication of hemorrhagic risk in patients taking warfarin

Kcentra Product Brochure

Important product information for Kcentra, including efficacy, safety, and administration.

Home Why Use Kcentra Anticoagulant Therapy
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Important Safety Information

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.

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 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.

Please see full prescribing information for Kcentra.

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CSL Behring
Kcentra is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC.
Kcentra® and Beriplex® are registered trademarks of CSL Behring GmbH.
Biotherapies for Life® is a registered trademark of CSL Behring LLC
All other products mentioned are trademarks or registered trademarks of their respective companies.
© 2017 CSL Behring. The product information presented on this site is intended for US residents only.
KCT15-11-0051 12/2015