Keywords: Kcentra, four factor prothrombin complex concentrate, acute . from package insert with written permission from CSL Behring. inherent risks of factor concentrate therapy. For VKA reversal, Kcentra is dosed to correct INRs of or greater per the package insert.1 Dosing varies by the. Grip the Mix2Vial transfer set together with the clear package and push the plastic spike at the blue end of the Mix2Vial transfer set firmly through the center of.
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Draw air into an empty, sterile syringe. Not indicated for the urgent reversal of vitamin K antagonist anticoagulation in patients without acute major bleeding. Carefully remove the clear package from the Mix2Vial transfer set. Importance of informing patients of signs and symptoms of thrombosis e. In rare instances, thrombosis leading to acute myocardial infarction or gangrene has been reported in patients with hemophilia receiving combination therapy with factor IX concentrate and aminocaproic acid.
Administer vitamin K concurrently to maintain vitamin K-dependent clotting factor concentrations once the effects of prothrombin complex concentrate have diminished.
Resumption of anticoagulation should be carefully considered as soon as the risk of thromboembolic events outweighs the risk of acute bleeding Both fatal and non-fatal arterial and venous thromboembolic complications have been reported with Kcentra in clinical trials and post marketing surveillance.
No blood should enter the syringe, as there is a possibility of fibrin clot formation. Protein C is activated by thrombin then exerts an antithrombotic effect by inhibiting factor Va and factor VIIIa leading to a decrease in thrombin formation and has indirect profibrinolytic activity by inhibiting plasminogen activator inhibitor The manufacturing processes are designed to reduce the risk of transmitting viral infection; however, disease may still be potentially transmitted.
Monitor for signs and symptoms of thromboembolism during and after administration of PCC. Measurement of INR prior to treatment and close to the time of dosing is important because coagulation factors may be unstable in patients with acute major bleeding or an urgent need for surgery and other invasive procedures.
Use only if clearly needed. Each vial contains no preservatives and is for single use only. Kcentra, Prothrombin Complex Concentrate Humanis a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist VKA, e.
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. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Patients receiving vitamin K antagonists e.
Serious, and sometimes fatal, thromboembolic events reported in clinical trials and during postmarketing surveillance. Rapid reversal of oral anticoagulation with warfarin by a prothrombin complex concentrate Beriplex: Used for the urgent reversal of vitamin K antagonist e.
Individualize dosage based on pre-treatment INR and body weight. Studies using human parvovirus B19, which are considered experimental in nature, have demonstrated a virus reduction factor of 3.
From FDA web site http: The factor VIIa-tissue factor complex activates factor IX and initiates the primary coagulation pathway by activating factor X in the presence of phospholipids and calcium ions. Most common serious adverse effects include thromboembolic events i. The coagulation cascade is a series of procoagulant and antithrombotic reactions involving the activation of zymogens. Factor II is converted to thrombin by factor Xa in the presence of calcium, factor V, and phospholipids.
Vitamin K antagonists exert anticoagulant effects by blocking carboxylation of glutamic acid residues of the Vitamin K-dependent jcentra factors during hepatic synthesis, lowering both factor synthesis and function.
Administer by intravenous infusion at a rate of 0. Safety of prothrombin complex concentrates for rapid anticoagulation reversal of vitamin K antagonists.
The range of Factor IX units per vial is units for the U kit and units for the U kit. Weigh the benefits of reversing VKA therapy against the potential risks of thromboembolism, especially in patients with a history of thromboembolic disease. Carefully remove the clear package from the Mix2Vial transfer set. If kccentra breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed. Los Angeles, CA; Aug.
Kcentra Monograph for Professionals –
We comply with the HONcode standard for trustworthy health information – verify here. Evidence-based management of anticoagulant therapy: There is also the possibility that unknown infectious agents may be present. Following administration of the drug, carefully consider resuming oral anticoagulant therapy as soon as risk of thromboembolism outweighs risk of acute bleeding.
Wipe the stoppers with the alcohol swab provided and allow to dry prior to opening the Mix2Vial transfer set package. Subscribe to receive email notifications whenever new articles are published.
Prothrombin Complex Concentrate, human
Innsert clicking Subscribe, I agree to the Drugs. BL Warning Risk of Thromboembolism Risk of serious, and potentially fatal arterial and venous thromboembolic events e. Administer by IV infusion as a single dose. The free form of protein S functions as a cofactor for activated protein C in the inactivation of factor Va and factor VIIIa, leading to antithrombotic activity.
In a trial of 98 anticoagulated patients with acute major bleeding, the pavkage INR was 3. Administer within 4 hours after reconstitution. Ensure vials of prothrombin complex concentrate PCC and diluent provided are at room temperature, and use aseptic technique to reconstitute.
Do not store for later use. Do not mix with other medicinal products; administer through a separate infusion line. During vitamin K antagonist therapy, a dose-dependent acquired deficiency of the vitamin K-dependent coagulation factors occurs.