These highlights do not include all the information needed to use KCENTRA safely and effectively. See full prescribing information for KCENTRA.
KCENTRA (Prothrombin Complex Concentrate (Human))
For Intravenous Use, Lyophilized Powder for Reconstitution
Initial U.S. Approval: 2013
WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS
being treated with Vitamin K antagonists (VKA) therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the potential risks of thromboembolic events, especially in patients with the history of a thromboembolic event. Resumption of anticoagulation should be carefully considered as soon as the risk of thromboembolic events outweighs the risk of acute bleeding.
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Both fatal and non-fatal arterial and venous thromboembolic complications have been reported with Kcentra in clinical trials and post marketing surveillance. Monitor patients receiving Kcentra for signs and symptoms of thromboembolic events.
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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 may not be suitable in patients with thromboembolic events in the prior 3 months. (5.2)
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Indications and Usage (1) |
12/2013 |
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Dosage and Administration (2.1) |
11/2013 |
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Warnings and Precautions (5.2) |
12/2013 |
INDICATIONS AND USAGE
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, e.g., warfarin) therapy in adult patients with:
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acute major bleeding or
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need for an urgent surgery/invasive procedure. (1)
DOSAGE AND ADMINISTRATION
For intravenous use only.
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Kcentra dosing should be individualized based on the patient's baseline International Normalized Ratio (INR) value, and body weight. (2.1)
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Administer Vitamin K concurrently to patients receiving Kcentra to maintain factor levels once the effects of Kcentra have diminished.
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The safety and effectiveness of repeat dosing have not been established and it is not recommended. (2.1)
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Administer reconstituted Kcentra at a rate of 0.12 mL/kg/min (~3 units/kg/min) up to a maximum rate of 8.4 mL/min (~210 units/min). (2.3)
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Pre-treatment INR |
2–< 4 |
4–6 |
> 6 |
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Dose* of Kcentra (units† of Factor IX) / kg body weight |
25 |
35 |
50 |
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Maximum dose‡ (units of Factor IX) |
Not to exceed 2500 |
Not to exceed 3500 |
Not to exceed 5000 |
DOSAGE FORMS AND STRENGTHS
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Kcentra is available as a single-use vial containing coagulation Factors II, VII, IX and X, and antithrombotic Proteins C and S as a lyophilized concentrate. (3)
CONTRAINDICATIONS
Kcentra is contraindicated in patients with:
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Known anaphylactic or severe systemic reactions to Kcentra or any components in Kcentra including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin. (4)
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Disseminated intravascular coagulation. (4)
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Known heparin-induced thrombocytopenia. Kcentra contains heparin. (4)
WARNINGS AND PRECAUTIONS
