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.

Author: Shagor Taukinos
Country: Paraguay
Language: English (Spanish)
Genre: Personal Growth
Published (Last): 21 May 2015
Pages: 160
PDF File Size: 2.83 Mb
ePub File Size: 3.39 Mb
ISBN: 408-5-68400-440-8
Downloads: 91625
Price: Free* [*Free Regsitration Required]
Uploader: Kigajar

The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Not indicated for the urgent reversal of vitamin K antagonist anticoagulation in patients without acute major bleeding.

Importance of informing patients of signs and symptoms of thrombosis e. Administer within 4 hours after reconstitution.

Prepare and administer using aseptic technique. Example dosing calculation for 80 kg patient For example, an 80 kg patient with a baseline of INR of 5.


Carefully consider resuming anticoagulation after administration of PCC once the risk of thromboembolic events outweighs the risk of acute bleeding.

The relationship between this or other INR values and clinical hemostasis in patients has not been established Preparation and Reconstitution: During vitamin K antagonist therapy, a dose-dependent acquired deficiency of the vitamin K-dependent coagulation factors occurs. Experts generally consider PCCs such as prothrombin complex concentrate human Kcentra to be a reasonable and in some cases, preferred alternative to fresh frozen plasma for the urgent reversal of anticoagulation in patients with warfarin-induced bleeding.

  IRAM 2099 PDF

Patients being treated with Vitamin K antagonists VKA therapy have underlying disease states that predispose them to thromboembolic events. Carefully weigh benefits of treatment against risk of thromboembolism, particularly in those with a history of a thromboembolic event. Patients with a thromboembolic event, myocardial infarction, DIC, stroke, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the previous 3 months were excluded from clinical trials of PCC.

If more than one vial is required for a dose, may pool reconstituted contents of multiple vials; however, use separate transfer filter sets to reconstitute each vial. No blood should enter the syringe, as there is a possibility of fibrin clot formation. 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.

Place the diluent vial on a flat surface and hold the vial tightly. From FDA web site http: Make sure that you pull up only the clear package, not the Mix2Vial transfer set. Concurrent anticoagulant medication may have been responsible for these bleeding episodes.

PDR Search

Send the page ” ” to a friend, relative, colleague or yourself. The pharmacokinetic parameters of PCC were obtained in healthy subjects and may not be applicable to patients with acute major bleeding and elevated INR due to vitamin K antagonist therapy.

Major The concomitant use of protein C concentrate and alteplase, tPA may further increase the risk of bleeding from tPA.

Known anaphylactic or severe systemic reactions to any component in the Kcentra formulation i. Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are insery.


Administer concurrently with phytonadione.

Administer by intravenous infusion at a rate of 0. For patients weighing more than kg, maximum dose should not be exceeded. If a 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. Reconstitute at room temperature kcetra follows: Patients with disseminated intravascular coagulation DIC.

Major The risk of a potential interaction between factor VIIa, recombinant, and factor IX replacement products has not been adequately evaluated. Prothrombin complex concentrate comprised of factors II, VII, IX, X and proteins C and S For inserr reversal of vitamin K antagonist VKA therapy in patients with acute major bleeding or need for urgent surgery or invasive procedure Weigh benefits of reversing VKA therapy against risk of fatal and non-fatal arterial and venous thromboembolic complications.

Major In general, aminocaproic acid should not be administered simultaneously with factor IX complex, factor IX concentrates, factor IX Fc fusion protein, recombinant, and factor IX albumin fusion protein, recombinant due to the increased risk of thrombosis.

Do not allow blood to enter the syringe as there is a possibility of fibrin clot formation.