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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Patients 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 TEespecially 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. Source Plasma 21 CFR Factor IX is the lead factor for the potency of the preparation as stated on the vial label. The excipients are human antithrombin III, heparin, human albumin, sodium chloride, and sodium citrate.
Kcentra is sterile, pyrogen-free, and does not contain preservatives. The product contents are shown in Table 7 and listed as ranges for the blood coagulation factors. Only plasma that passed virus screening is used for production. Table 8 shows the virus clearance during the manufacturing process for Kcentra, expressed as the mean log10 reduction factor.
Virus Reduction Factors [log10] of Kcentra. Studies using human parvovirus B19, which are considered experimental in nature, have demonstrated a virus reduction factor of 3.
Clinical pharmacology Mechanism of Action: A dose-dependent acquired deficiency of the Vitamin K-dependent coagulation factors occurs during Vitamin K antagonist treatment. Vitamin K antagonists exert anticoagulant effects by blocking carboxylation of glutamic acid residues of the Vitamin K-dependent coagulation factors during hepatic synthesis, lowering both factor synthesis and function.
Factor Xa forms a complex with activated FV FVa that converts prothrombin to thrombin in the presence of phospholipids and calcium ions. Protein C, when activated by thrombin, exerts an antithrombotic effect by inhibiting FVa and FVIIIa leading to a decrease in thrombin formation, and has indirect profibrinolytic activity by inhibiting plasminogen activator inhibitor 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.
The most serious ARs were thromboembolic events including stroke, pulmonary embolism, and deep vein thrombosis. No human or animal data.
Prothrombin Complex Concentrate, human | – A Hematology Oncology Wiki
Use only if clearly needed. For intravenous use only. For patients weighing more than kg, maximum dose should not be exceeded. Example dosing calculation for 80 kg patient For example, an 80 kg patient with a baseline of Pzckage of 5. Monitor INR and clinical response during and after treatment.
The relationship between this or other INR values and clinical hemostasis in patients has not been established. The procedures provided in Table 2 are general guidelines for the preparation and reconstitution of Kcentra. Reconstitute at room temperature as follows: National Institutes of Health, U.
Please review the latest applicable package insert for additional information and possible updates. A local search option of this data icentra be found here. The authors make no kecntra of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment.
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.
Monitor patients receiving Kcentra for 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 may not be suitable in patients with thromboembolic events in the prior 3 months. Kcentra is contraindicated in: Patients with disseminated intravascular coagulation DIC. Patients with known heparin-induced thrombocytopenia Kcentrx.
If necessary, discontinue administration and institute appropriate treatment. Arterial and venous thromboembolic complications have been reported in patients receiving Kcentra. Kcentra was not studied in subjects who had a thrombotic or thromboembolic TE event within the prior 3 months. Kcentra is made from human blood and may carry a risk of transmitting infectious agents, e.
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.
KCENTRA™ – GlobalRPH
Administer Vitamin K concurrently to patients receiving Kcentra. Vitamin K is administered to maintain Vitamin K-dependent clotting factor levels once the pavkage of Kcentra have diminished. The safety and effectiveness of repeat dosing have not been established and is not recommended. Dose ranging within pre-treatment INR groups has not been studied in randomized clinical trials of Kcentra.
Nominal potency is or units per vial, approximately 25 units per mL after reconstitution. The relationship between this or other INR values and clinical hemostasis in patients has not been established Preparation and Reconstitution: Reconstitute using aseptic technique with 20 mL U kit or 40 mL U kit of diluent provided with the kit.
Visually inspect kcenta drug products for particulate matter and discoloration prior to administration whenever solution and container permit. Reconstituted Kcentra solution packaye be colorless, clear to slightly opalescent, and free from visible particles. Do not use solutions that are cloudy or have deposits.
Kcentra is for single use only.
Prothrombin Complex Concentrate, human
Discard partially used vials. Ensure that the Kcentra vial and diluent vial inesrt at room temperature. Prepare and administer using aseptic technique.
Remove Kcentra and diluent vial flip caps.
Wipe the stoppers with the alcohol swab provided and allow to dry prior to opening the Mix2Vial transfer set package. Open the Mix2Vial transfer set package by peeling away the lid. Place the diluent vial on a flat surface and hold the vial tightly.
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 the stopper of the diluent vial.
Carefully remove the clear package from the Mix2Vial transfer set. Packaage sure that you pull up only the clear package, not the Mix2Vial transfer set. Ineert the Kcentra vial placed firmly on a flat surface, invert the diluent vial with the Mix2Vial transfer set attached and push the plastic spike of the transparent adapter firmly through the center of the stopper of the Kcentra vial.
With the diluent and Kcentra vial still attached to the Mix2Vial transfer set, gently swirl the Kcentra vial to ensure that the Kcentra is fully dissolved. With one hand, grasp the Kcentra side of the Mix2Vial transfer set and with the other hand grasp the blue diluent-side of the Mix2Vial transfer set, and unscrew the set into two pieces.
Draw air indert an empty, sterile syringe. While the Kcentra vial is upright, screw the syringe to the Kcenra transfer set. Inject air into the Kcentra vial.
While keeping the syringe plunger pressed, invert the system upside down and draw the concentrate into the syringe by pulling the plunger back slowly.
Now that the concentrate has been transferred into the syringe, firmly grasp the barrel of the syringe keeping the plunger facing down and unscrew the syringe from the Mix2Vial transfer set.
After reconstitution, administration should begin promptly or within 4 hours. If the same patient is to receive more than one vial, you may pool the contents of multiple vials. Use a separate unused Mix2Vial transfer set for each product vial. Do not mix Kcentra with other medicinal products; administer through a separate infusion line. Use aseptic technique when administering Kcentra. Administer at room temperature.
Administer by intravenous infusion at a rate of 0. No blood should enter the syringe, as there is a possibility of fibrin clot formation. Kcentra potency units is defined by Factor IX content. The range of Factor IX units per vial is units for the U kit and units for the U kit.
The actual content of Factor IX as measured in units of potency is stated on the vial. Reference s National Institutes of Health, U. Disclaimer The authors make no inseet of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment.
See warnings and precautions below.