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Would you reverse the DOAC? Although several studies have attempted to determine the optimal dose of 4F‐PCC using a variety of dosing regimens, no dosing strategy has been found to be superior. Idarucizumab was approved in 2015 (US and Europe) [18,19 Reversal of DOAC therapy may be required in patients with or at risk for bleeding because of trauma or a need for an invasive procedure (e.g., decision making about the approach used to reverse the anticoagulant effects of DOACs. Four‐factor prothrombin complex concentrate (4F‐PCC) has emerged as the preferred option for emergent reversal of vitamin K antagonists (VKAs); however, the optimal dosing strategy is unknown. Rebellion in EM 2018 – DOAC Reversal by Scott Wieters, MD. Depending on the pharmacology of the anti-Xa agent, the DOAC may out-last this, causing rebound bleeding. Fondaparinux 7. Heparin and Low Molecular Weight Heparin 5. I would like to ask you about Kcentra dosing for non-coumadin related indications. Despite the advantages of DOAC therapy, the lack of a reversal agent is sometimes perceived as limiting their broader use 22. 1. The 1 st annual Rebellion in EM Clinical Conference took place in San Antonio, TX on May 11 th – 13 th, 2018. Factor Xa inhibitors - Rivaroxaban (Xarelto®) - Apixaban (Eliquis®) - Edoxaban (Savaysa®) DOAC lineup . The reversal strategy depends on the urgency of the situation; presence, site, and severity of bleeding; DOAC involved; and comorbid conditions. Characteristics of DOAC-specific reversal agents. To reverse vitamin K antagonists (e.g., warfarin), use of 5-10 mg intravenous vitamin K is appropriate for major bleeding events, while 2-5 mg of oral or intravenous vitamin K can be used for nonmajor bleeding events that require hospitalization. From Gabor Varadi, MD, Albert Einstein Cancer Center, Philadelphia. Median dose for DOAC reversal was 23.5 units/kg (IQR 23.5–26.5) or 2000 units (IQR 2000–5000). Dabigatran may be reversed by giving 5 grams of idarucizumab by rapid IV administration. Warfarin and Prothrombin Complex Concentrate (PCC) 2. Our experts recommend not stopping the DOAC in this case, ... Beriplex, Kcentra) at a dose of 50 IU/kg up to 2,000 units. The only DOAC with an actual reversal agent approved by the FDA is the direct thrombin inhibitor dabigatran. 4-factor PCC/Kcentra is approved for urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy in patients with acute major bleeding or a need for an urgent surgery/invasive procedure. 2018 Feb;45(2):300-305. doi: 10.1007/s11239-017-1586-x. Dosing consistent with prescribing information was used for most patients receiving 4F-PCC for warfarin reversal (313/415, 75.4%) and the remainder of patients (102/415, 24.6%) received a fixed-dosing approach of 500 to 1500 units . To quickly view reversal recommendations for specific antithrombotic medications select hyperlink below. Ashley E. Lock, PharmD PGY2 Emergency Medicine Pharmacy Resident Department of Pharmacotherapy Services, University Health System Pharmacotherapy Division, The University of Texas at Austin College of Pharmacy Pharmacotherapy Education and Research Center, UT Health San Antonio September 13, … Specific reversal agents are enzymatically inactive and abrogate the effect of DOACs by direct binding, reducing the concentration of the anticoagulant in the blood. August 2017. Andexxa® vs. Kcentra® for Reversal . Generally recommended as mainstay of reversal (with in vitro evidence and some clinical data). •FDA Indications: VKA reversal in patients with acute major bleeding or need for urgent surgery/invasive procedure Labeled dosing: Pre-treatment INR Dose Maximum Dose 2 - < 4 25 units/kg 2,500 units 4-6 35 units/kg 3,500 units >6 50 units/kg 5,000 units Kcentra® (prothrombin complex concentrate human) [prescribing information]. • PCC (Kcentra ®) to reverse rivaroxaban/apixaban. Introduction. This effect can be measured by anti-Xa assays, in the case of FXa … If you missed out in 2018, the Rebellion is coming back June 28 th – 30 th, 2019. TM A TRADEMARK OF ALLINA HEALTH SYSTEM. Written by Salim Rezaie REBEL EM Medical Category: Hematology and Oncology 3 Comments. Over the past several years a new era for patients requiring anticoagulation has arrived. Unlike VKA reversal, DOAC reversal has, until recently, been a clinical challenge due to limited availability of/access to specific reversal agents . Kcentra Reversal of DOAC Overdose. Role of laboratory testing . Overview of reversal agents . Use of a reversal agent should be reserved only for patients with a life-threatening bleed or a major bleed in a critical site. In this study, apixaban steady‐state PD effects were demonstrated by changes in several thrombin generation parameters, clotting time assessments, and AXA. Though its use for neutralizing the direct oral anticoagulants (DOACs) is off-label, it appears to partially reverse rivaroxaban and apixaban overdose-generated bleeding per the attached meta-analysis, Kreuziger LMB, Keenan JC, Morton CT, Dries DJ. Aspirin 8. 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—eg, warfarin) therapy in adult patients with acute major bleeding or the need for urgent surgery or other invasive procedure. At the same time, the reversal of warfarin is not performed effectively or consistently across institutions. In 2015, idarucizumab was approved by the FDA for the reversal of direct thrombin inhibitor dabigatran. Discuss DOAC-reversal strategies for severe bleeding and for perioperative management . Fixed Dose 4-factor Prothrombin Complex Concentrate for the Emergent Reversal of Warfarin: A Retrospective Analysis J Thromb Thrombolysis. Dec 22, 2015 12:18pm. Kcentra is for intravenous use only. Kcentra is for intravenous use only. Case-based examples for application to practice Objectives . George Fritsma. Contraindicated in patients with a history of heparin-induced thrombocytopenia (contains small amounts of heparin). If the bleeding does not resolve in an appropriate amount of time, this dose may be repeated. Two specific reversal agents are now available: idarucizumab for dabigatran , and andexanet alfa for apixaban and rivaroxaban . Note that if you highly suspect a Xa inhibitor intracranial bleed before obtaining a CT head, it is reasonable to give 1,500 units of 4 factor PCC on speculation. ... (Beriplex/Kcentra) may normalize PT more effectively than 3-factor PCC (Profilnine), but it had less of an effect on normalizing thrombin generation. 3 Direct Oral Anticoagulants (DOACs) Guide S414386A 281375 0517 ©2017 ALLINA HEALTH SYSTEM. One vial of PCC also contains factors II, VII, IX, X, Proteins C and S, Antithrombin III and a small amount of heparin. Four factor PCC (Kcentra) is dosed on the amount of factor IX. Clinical Controversies in DOAC Reversal Karen Berger, PharmD, FCCM, BCPS, BCCCP Neurocritical Care Clinical Pharmacist NewYork-Presbyterian Hospital/Weill Cornell Medical Center. Despite these benefits, DOAC reversal has proven difficult. Anti-Xa: Apixaban, Rivaroxaban, Edoxaban 4. This would be for treating life threatening bleeding or urgent reversal prior to surgery for patients receiving targeted anticoagulants. Reversal Strategies for NOACs accidental ingestion Activated Charcoal ... Kcentra Feiba® NF NovoSeven® RT Dose based on Units of factor IX activity Units of factor IX activity Units of factor IX activity Units of factor VIII inhibitor bypassing activity Units of recombinant factor VIIa dose Administrationtime Max 2 ml/min Max 10 ml/min Max 8.4 ml/min Max 2 units/kg/min Bolus over 2-5 … 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—eg, warfarin) therapy in adult patients with acute major bleeding or the need for urgent surgery or other invasive procedure. PCCs contain factors II, VII, IX and X and proteins C and S, along with heparin and human albumin. How much factor is in a vial of PCC versus a unit of FFP? Each vial has about 500 units of factor IX. As PCCs are the most commonly used DOAC reversal agents, it is important to compare their mechanism of action with those of the specific reversal agents. PCC/Kcentra®) as described below. The efficacy of 25 to 50 U/kg of four-factor PCC (Kcentra) for reversal of elevated INR in warfarin patients has recently received FDA approval. Generally works for ~6-8 hours. Non-steroidal Anti-inflammatory Drugs … Neither PCC product corrected anti-Xa activity. of Factor Xa Inhibitor-Associated Intracranial Hemorrhage . 11 While dabigatran targets thrombin, it is hypothesized that administration of factors may overcome dabigatran’s effects on the coagulation cascade, allowing for PCC to play a role in its reversal. Kcentra is a four factor prothrombin complex concentrate that was FDA approved in 2013 and is used as an antidote to treat people with bleeding associated with taking warfarin. However, reversal of factor Xa inhibitors remains challenging due a lack of specific antidote. Tel: 612-863-6800 | Reviewed August 2016 Direct thrombin inhibitor - Dabigatran (Pradaxa®) . Direct Thrombin Inhibitors: Argatroban and Bivalirudin 6. The use of fresh frozen plasma (FFP) has so far not been studied. All increase the risk of thrombosis and are usually reserved for the most critical cases. Dabigatran 3. The approval of the first DOAC reversal agent in 2015 and the continuing development of at least two additional reversal agents present both new opportunities and challenges. Fixed Dose Kcentra for Warfarin Reversal; Weight = 100 kg or INR = 6 Weight > 100 kg or INR > 6 ; No CNS Bleed* 1500 units : 2000 units : CNS Bleed : 2000 units : 2500 units : Give all Kcentra doses with phytonadione 10 mg IVPB over 30 minutes. Kcentra is a 4-factor PCC, indicating it provides therapeutic levels of factors II, VII, IX, and X, whereas current PCCs provide little VII. With the approval of four-factor prothrombin complex concentrate (4F-PCC, Kcentra) for the reversal of vitamin K antagonist-associated bleeding in the US, it has become a relatively common practice for 4F-PCC to be used in an 'off-label' fashion to correct coagulopathy caused by direct oral anticoagulants (DOACs) such as anti-Xa inhibitors. Dabigatran reversal. 11/6/2013 24 FEIBA ®and Kcentra ®Cautions • Increase risk of thromboembolism • Reversal is OFF-LABEL • Weigh risk/benefit • Blood products • Kcentra ®contains heparin Roadmap for today • Characteristics of novel anticoagulants • Approach to the bleeding patient • Specific reversal agents • UCSF guidelines. GUIDELINES FOR REVERSAL OF ANTICOAGULANTS NAMES ELIMINATION HALF-LIFE REMOVED BY HD STRATEGIES TO REVERSE OR MINIMIZE DRUG EFFECT apixaban (UWMedicine: (Eliquis) 8-15 hours (longer in renal impairment) NO Drug activity can be assessed with anti-factor Xa activity assay apixaban assay [APIXN1]) If ingested within 2 hours, administer activated charcoal Consider 4-factor PCC (KCentra… It contains clotting factors II, VII, IX and X derived from donated blood and could be effective in reversing the anticoagulation effects of the factor Xa inhibitor, apixaban. For reversal of other NOACs in cases of life-threatening bleeding, a four-factor prothrombin complex concentrate (PCC) such as Kcentra is an option. The approval of new target specific oral anticoagulants offers practitioners several advantages over traditionally used vitamin K antagonist agents including predictable pharmacokinetics, rapid onset of action, comparable efficacy and safety, all without the need for routine monitoring. MINNEAPOLIS HEART INSTITUTE® AND MHI ® ARE TRADEMARKS OF MINNEAPOLIS HEART INSTITUTE, INC. Thrombophilia and Anticoagulation Clinic, Minneapolis Heart Institute®, Abbott Northwestern Hospital. Repeat INR in 30 minutes after Kcentra *life-threatening GI bleed, retroperitoneal bleed, fall in Hg >= 2 g/dl or Hg = 8 g/dl if no baseline.
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