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The authors indicate no relationships that could be perceived as a conflict of interest. Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. With a subscription, the monographs are sent in print and are also available on-line. Monographs can be customized to meet the needs of a facility. A drug class review is now published monthly with The Formulary Monograph Service.

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The authors indicate no relationships that could be perceived as a conflict of interest. Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. With a subscription, the monographs are sent in print and are also available on-line. Monographs can be customized to meet the needs of a facility. A drug class review is now published monthly with The Formulary Monograph Service.

Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. The December monograph topics are vortioxetine, mechlorethamine gel, brimonidine tartrate topical gel, obinutuzumab, and miltefosine. Prothrombin complex concentrate human is indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist eg, warfarin therapy in adult patients with acute major bleeding.

Strategies to reverse the effects of vitamin K antagonists include interruption of therapy, administration of vitamin K, and administration of fresh frozen plasma or prothrombin complex concentrates.

Fresh frozen plasma carries a risk of infection transmission, has been associated with volume overload, requires cross-matching, and takes time to thaw and administer. Prothrombin complex concentrate human is a purified, heat-treated, nanofiltered, preservative-free, lyophilized nonactivated 4-factor concentrate prepared from human plasma obtained from subjects in the United States.

The product excipients include human antithrombin III, heparin, human albumin, sodium chloride, and sodium citrate; heparin and antithrombin are added to minimize thrombosis risk. Composition per vial of prothrombin complex concentrate units 1. In patients with an acquired coagulation factor deficiency due to vitamin K antagonist treatment, the administration of prothrombin complex concentrate can rapidly increase plasma levels of the vitamin K—dependent coagulation factors II, VII, IX, and X and the antithrombotic proteins C and S.

Reductions were greater with the prothrombin complex concentrate than plasma through 12 hours see Table 2. Fresh frozen plasma was less effective than prothrombin complex concentrate in shortening INR and recovering thrombin generation or factor II levels. The onset of thrombus formation was shortened with prothrombin complex concentrate, but not with fresh frozen plasma.

Median INR after start of infusion of prothrombin complex concentrate or plasma in patients treated with warfarin 1. Preliminary studies suggest that prothrombin complex concentrate may reverse the effects of dabigatran or rivaroxaban anticoagulation; however, consistent results have not been apparent, and more trials are necessary to establish its clinical efficacy in these situations before a formal recommendation can be made.

Mean residence times varied from 6. In patients undergoing treatment for acute major bleeding, administration of prothrombin complex concentrate mean volume mL over mean duration of 24 minutes compared with placebo mean volume mL over mean duration of minutes was associated with a greater increase in factor II and factor X and a quicker increase in factor IX, factor VI, and protein C. Reference: Holbrook A, et al, Comments: Guidelines recommend the use of 4-factor prothrombin complex concentrate rather than plasma for the management of patients with vitamin K antagonist-associated major bleeding, with the additional use of vitamin K 5 to 10 mg administered by slow IV injection rather than reversal with coagulation factors alone.

Reference: Kcentra prescribing information, 1 , Study Design: Randomized, open-label, multicenter, noninferiority study. All patients also received IV vitamin K. Hemostatic efficacy with respect to adequacy of stopping an ongoing major bleed based on assessments including vital signs, hemoglobin measurements, and computed tomography assessments: Reduction of INR to 1. Hemostatic efficacy for visible and musculoskeletal nonvisible bleeding: results not reported.

Comments: A similar study comparing prothrombin complex concentrate CSL Behring with fresh frozen plasma in patients receiving oral vitamin K antagonist therapy and requiring an urgent surgical procedure with need to reverse the anticoagulant effect is described, but results have not been reported.

Limitations: Study results are only available in the product package insert. Reference: Kcentra prescribing information, ; Pabinger I, et al, 1 , Patients: 43 patients receiving vitamin K antagonists with an INR greater than 2 and requiring emergency surgical or urgent invasive diagnostic intervention 26 patients or experiencing an acute bleeding event 17 patients.

Reduction in INR to 1. Median INR declined to 1. Response of factor IX, factor II, factor VII, factor X, protein C, and protein S: rapid increases were observed, with normal or near normal concentrations persisting throughout the hour observation period. Adverse events: suspected thromboembolic complications occurred in 2 patients, including a fatal pulmonary embolism.

In 42 patients treated at 1 institution, median INR was reduced from 3. Prothrombin complex concentrate is contraindicated in patients with known anaphylactic or severe systemic reactions to the product or any components of the product including heparin, factors II, VII, IX, X, proteins C and S, antithrombin III and human albumin; patients with disseminated intravascular coagulation; or patients with known heparin-induced thrombocytopenia.

Prothrombin complex concentrate labeling contains a black box warning of the risk of arterial and venous thromboembolic complications.

Both fatal and nonfatal arterial and venous thromboembolic complications have been reported with the use of prothrombin complex concentrate. Such events occurred more frequently with the use of prothrombin complex concentrate than the use of plasma in a randomized study in patients requiring urgent reversal of vitamin K antagonist anticoagulation due to acute major bleeding.

Patients treated with vitamin K antagonists have underlying conditions that predispose them to thromboembolic events. The potential impact of reversing vitamin K antagonist therapy should be considered in relation to the potential risk of thromboembolic events. Resumption of anticoagulant therapy should be considered as soon as the risk of thromboembolic events outweighs the risk of acute bleeding.

Following administration of prothrombin complex concentrate, patients should be monitored for signs and symptoms of thromboembolic events. Prothrombin complex concentrate was not studied in patients 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.

Hypersensitivity reactions including flushing, urticaria, tachycardia, anxiety, angioedema, wheezing, nausea, vomiting, hypotension, tachypnea, dyspnea, pulmonary edema, and bronchospasm have been observed with prothrombin complex concentrate. If severe reactions occur, administration should be immediately discontinued and appropriate treatment initiated.

Because this product is derived from human blood, it may carry a risk of transmitting infectious agents. There were no differences in the safety profile in any age group. Prothrombin complex concentrate is classified as Pregnancy Category C. It should only be prescribed for a pregnant woman if clearly needed. The most common adverse reactions, observed in at least 2. Adverse reactions reported in 3 or more subjects following administration of Kcentra or plasma in the randomized controlled trial for the treatment of acute major bleeding 1.

Serious adverse reactions associated with the use of prothrombin complex concentrate have included stroke, pulmonary embolism, and deep vein thrombosis. INR and clinical response should be monitored during and after treatment. Vitamin K should be administered concurrently with prothrombin complex concentrate. Repeat dosing of the prothrombin complex concentrate has not been studied and is not recommended. Dosing recommendations for Kcentra 1. Diluted prothrombin complex concentrate should be administered by IV infusion at a rate of 0.

Prothrombin complex concentrate received FDA approval on April 29, and was approved in Europe in The 4-factor prothrombin complex concentrate human offers advantages over 3-factor prothrombin complex concentrate and fresh frozen plasma in patients requiring urgent reversal of warfarin anticoagulation due to acute major bleeding. Compared with fresh frozen plasma, prothrombin complex concentrate does not require cross-matching, is virally inactivated, does not cause volume overload, and can be quickly infused.

In clinical trials, prothrombin complex concentrate was able to produce a rapid reduction in INR and hemostatic efficacy. National Center for Biotechnology Information , U.

Journal List Hosp Pharm v. Hosp Pharm. Published online Dec 9. Dennis J. Terri L. Danial E. Find articles by Danial E.

Author information Copyright and License information Disclaimer. Abstract Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. Indications Prothrombin complex concentrate human is indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist eg, warfarin therapy in adult patients with acute major bleeding.

Clinical Pharmacology Prothrombin complex concentrate human is a purified, heat-treated, nanofiltered, preservative-free, lyophilized nonactivated 4-factor concentrate prepared from human plasma obtained from subjects in the United States.

Open in a separate window. Table 2. Comparative Efficacy Indication: Vitamin K Antagonist-Associated Major Bleeding Guideline: Evidence-Based Management of Anticoagulation Therapy, Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Reference: Holbrook A, et al, 13 Comments: Guidelines recommend the use of 4-factor prothrombin complex concentrate rather than plasma for the management of patients with vitamin K antagonist-associated major bleeding, with the additional use of vitamin K 5 to 10 mg administered by slow IV injection rather than reversal with coagulation factors alone.

Results: Primary Endpoint s : Hemostatic efficacy with respect to adequacy of stopping an ongoing major bleed based on assessments including vital signs, hemoglobin measurements, and computed tomography assessments: Secondary Endpoint s : Hemostatic efficacy for visible and musculoskeletal nonvisible bleeding: results not reported. Time from infusion start until INR correction: results not reported.

Time from randomization until INR correction: results not reported. Transfusions of red blood cells: results not reported. Drug: Prothrombin Complex Concentrate Reference: Kcentra prescribing information, ; Pabinger I, et al, 1 , 16 Study Design: Open-label, single-arm, multicenter study Study Funding: CSL Behring Patients: 43 patients receiving vitamin K antagonists with an INR greater than 2 and requiring emergency surgical or urgent invasive diagnostic intervention 26 patients or experiencing an acute bleeding event 17 patients.

Other Endpoint s : Adverse events: suspected thromboembolic complications occurred in 2 patients, including a fatal pulmonary embolism. Contraindications, Warnings, and Precautions Contraindications Prothrombin complex concentrate is contraindicated in patients with known anaphylactic or severe systemic reactions to the product or any components of the product including heparin, factors II, VII, IX, X, proteins C and S, antithrombin III and human albumin; patients with disseminated intravascular coagulation; or patients with known heparin-induced thrombocytopenia.

Warnings and Precautions Prothrombin complex concentrate labeling contains a black box warning of the risk of arterial and venous thromboembolic complications. Adverse Reactions The most common adverse reactions, observed in at least 2.

Table 3. Drug Interactions Drug interactions have not been reported. Recommended Monitoring INR and clinical response should be monitored during and after treatment. Conclusion The 4-factor prothrombin complex concentrate human offers advantages over 3-factor prothrombin complex concentrate and fresh frozen plasma in patients requiring urgent reversal of warfarin anticoagulation due to acute major bleeding.

References 1. Kcentra [package insert]. Oral anticoagulant therapy, antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Accessed May 17, [ Google Scholar ]. A comparative study of prothrombin complex concentrates and fresh-frozen plasma for warfarin reversal under static and flow conditions.

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Prothrombin Complex Concentrate

Use of prothrombin complex concentrate can help control acute major bleeding that may result from acquired deficiency of vitamin K-dependent coagulation factors supratherapeutic INR in patients who are using vitamin K antagonists VKA such as Warfarin Coumadin. For conciseness and simplicity, HemOnc. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex , Lexicomp , UpToDate courtesy of Lexicomp , or the prescribing information. From HemOnc. Jump to: navigation , search. Categories : Fractionated plasma products Intravenous medications Hematology medications Hemostasis medications Coagulation factors FDA approved in Navigation menu Personal tools Create account Log in.

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