*****Andexanet alfa (Andexxa) was NOT ADDED to the UW Medicine formulary at this time due to unclear risk vs benefit and high cost. Consult cardiology if patient has mechanical heart valve (high risk of thrombosis) ** According to the European Union Stroke Initiative (EUSI), patients with oral anticoagulation treatment (OAT) associated ICH and an INR above 1.4 should have OAT discontinued and the INR normalized with 4 … As a reminder, this division of the FDA also gave a boxed warning to KCentra for the reversal of warfarin and it did not have an impact on the uptake of KCentra for this indication. B. Coagulation factor Xa (recombinant), inactivated-zhzo (Andexxa®) 1. The recently approved reversal agent andexanet alfa has limited data, an unclear safety profile, and imparts a substantial financial burden. Although this medication is now FDA approved, quantities are limited and only available at certain institutions. Ensure INR is obtained iii. Diagnosis Related Groups (DRGs) is a classification system which assigns a hospital stay to one of approximately 750 DRG codes. ... v. Renal or hepatic failure vi. KCentra (4-factor PCC) is first line unless otherwise contraindicated b. It has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to other anticoagulants. CMS pays a flat payment for a specific DRG to cover all costs associated with a hospital stay. 4 CONTRAINDICATIONS None. In patients with edoxaban-asscociated or betrixaban-associated major bleeding in whom a reversal agent is warranted, suggest high dose Andexxa or Kcentra 2000 units. Minutes with vs hours with FFP 2) Rate of INR correction. How often do you guys see andexxa used vs. PCC (like kcentra) and what would be the first line? Andexanet alfa ist in den USA als lyophilisiertes Pulver zu 100 mg und 200 mg erhältlich (Handelsname: Andexxa ®). Dabei sollte das Lösungsmittel langsam an die Innenseite des Vials gespritzt werden, um eine Schaumbildung zu minimieren. Treatment with an investigational drug < 30 days prior to consent. Andexxa® (Portola Pharmaceuticals) Praxbind® (Boehringer Ingelheim) Kcentra® (CSL Behring) FEIBA® (Takeda) Classification: Specific antidote: Specific antidote: Non‐specific prohemostatic agent: Non‐specific prohemostatic agent: Onset of action: 2 to 5 min 59 <5 min 60: Unknown in DOAC patients: Unknown in DOAC patients: Half‐life be reversed with Andexanet (ANDEXXA). Each dose of KCentra (4-factor PCC) will be rounded to the nearest vial size c. The KCentra dosing and administration information is in Appendix B d. The responsibility of the clinical provider (MD, PA, NPP) i. Andexxa is a modified form of human Factor Xa which works by acting as a decoy that binds to factor Xa (FXa) inhibitors. Prothrombin Complex Concentrate products (PCC, e.g., KCentra®) or recombinant factor VIIa (rfVIIa) (e.g., NovoSeven®), or anti-inhibitor coagulant complex (e.g., FEIBA®). PCC/Kcentra®) as described below. In patients with rivaroxaban-associated or apixaban-associated major bleeding in whom a reversal agent is warranted, suggest Andexxa and if Andexxa is unavailable suggest Kcentra 2000 units. One particular of note is Kcentra (4 factor PCC) 50 units/kg 2. Das Pulver wird mit Wasser zur Injektion rekonstituiert, beispielsweise mithilfe einer 20-ml-Spritze und einer 20-G-Kanüle. However, the use of activated and nonactivated PCCs are still being used for DOAC reversal, although primarily limited to factor Xa DOACs. ANDEXXA is available as a white to off-white lyophilized powder in single-use vials of 200 mg of coagulation factor Xa (recombinant), inactivated-zhzo. 1) Product contents: Depending on the products previously used at a given institution (here it was Profilnine), there are several differences in the contents compared to Kcentra. Symptoms were mild to moderate in severity, and 90% (35/39) did not require treatment. Kcentra might not be suitable for patients with thromboembolic events in the prior 3 months. Past use of andexanet (or planned use of commercial andexanet). Re: Kcentra cost versus Andexxa cost after NTAP The cost of Kcentra® is $1.27 per unit; a single dose of Kcentra® for an 80 kg patient costs $5,080. 78% Upvoted. Infusion-related reactions occurred in 18% (39/223) of ANDEXXA-treated healthy volunteers vs. 6% (6/94) of placebo-treated subjects. Ensure patient is on warfarin ii. Cost comparison between Andexxa and Kcentra is a no contest and affects critical bleed decisions. Using an electrochemiluminescence (ECL)-based assay, 145 ANDEXXA-treated healthy subjects were tested for antibodies to ANDEXXA as well as antibodies cross-reacting with Factor X (FX) and FXa. *****Andexanet alfa (Andexxa) was NOT ADDED to the UW Medicine formulary at this time due to unclear risk vs benefit and high cost. Ordering: i. PCC. ii. Using an electrochemiluminescence (ECL)-based assay, 145 ANDEXXA-treated healthy subjects were tested for antibodies to ANDEXXA as well as antibodies cross-reacting with Factor X (FX) and FXa. 5 WARNINGS AND PRECAUTIONS 5.1 Thromboembolic and Ischemic Risks 352 bleeding subjects who received ANDEXXA. There is considerable controversy surrounding available reversal strategies. See Table 3 for dosing. In 2018, Andexxa was FDA approved as a specific reversal agent for rivaroxaban and apixaban. A Study in Patients With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants (Extension Study) - Full Text View. of Factor Xa Inhibitor-Associated Intracranial Hemorrhage . At this point cost should also be considered. Any tumor-related bleeding. BackgroundAndexanet alfa (andexanet) is a recombinant modified human factor Xa decoy protein that has been shown to reverse the inhibition of factor Xa in … Kcentra is contraindicated in patients with known anaphylactic or severe systemic reactions to Kcentra or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). Kcentra™ does contain heparin and may not be option in patients who are sensitive to heparin or have a recent diagnosis of heparin-induced thrombocytopenia. Kcentra’s ICD 10 procedure code of 30283B1 is used by Hospitals to get NTAP payments over and above the DRG payment amount. It binds to direct and indirect anti-Xa oral ant … Symptoms were mild to moderate in severity, and 90% (35/39) did not require treatment. 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. Andexanet alfa, a recombinant modified human "decoy" factor Xa (FXa) protein, is the first and only available antidote approved by the Food and Drug Administration to manage life-threatening or uncontrolled bleeding associated with the anti-Xa agents. save hide report. ... Andexanet alfa for reversal of FXa inhibitor acute major bleeding has a higher rate of hemostatic efficacy compared to 4-factor prothrombin complex concentrate. Andexxa (c) is supplied through Portola Pharmaceuticals Inc. as a lyophilized powder in single-use vials containing 100 mg coagulation factor Xa recombinant, inactivated zhzo. ®After KCentra dose is complete, administer a 50 mL bag of normal saline using the same IV tubing at the same rate as KCentra® dose to ensure administration of full dose. Kcentra Administration After the inclusion of Kcentra to the armamentarium for acute reversal of anticoagulation, a few practical issues have come up that are worth sharing. Methods We … Minutes vs hours. 4-Factor PCC ( Kcentra). Andexxa binds directly to the Xa inhibitor and inactivates the drug. Andexxa® vs. Kcentra® for Reversal . share. Of the 63 subjects who experienced a thrombotic event, the median time to first event was 7 days, and … Kcentra is literally Factors II, VII, IX and X, trying to overwhelm the drug by adding coagulation proteins, which risks re-bound clotting in these patients who were put on Xa inhibitors for a pro-thrombotic state. ANDEXXA was recently approved by the FDA for the reversal of Factor Xa Inhibitors. The average wholesale price (AWP) for a package containing 4 vials is $13,200. NEW - Andexanet Alfa (Andexxa) Information on the new factor Xa inhibitor reversal agent has been added to the website. Abstract Background Andexanet alfa is a modified recombinant inactive form of human factor Xa developed for reversal of factor Xa inhibitors. Infusion-related reactions occurred in 18% (39/223) of Andexxa-treated healthy volunteers vs. 6% (6/94) of placebo-treated subjects. Kcentra™ may be an option for eminent life threatening bleed due to rivaroxaban, apixaban, edoxaban, or dabigatran. The hospital I work at as a technician doesn’t even have andexxa on formulary I believe so I wanted to double check. Providers should continue to order 4F-PCC (Kcentra) for urgent reversal of anti-Xa inhibitors per UW Medicine guidelines. It has been shown in vitro to rapidly reduce anti-FXa activity. ®Andexxa is restricted to use for intracranial hemorrhage only and must be ordered or Complete correction versus a best case INR correction of 1.6 3) Time of preparation. The recommended dose (low dose vs high dose) is based on the type of Factor Xa Inhibitor and the These reactions were characterized by a range of symptoms, including flushing, feeling hot, cough, dysgeusia, and dyspnea. PCC (not blood group specific and does not need to thaw) 4) Hemostasis. Kcentra (4 factor PCC) 50 units/kg Rivaroxaban (Xarelto®) Reverse if patient shows signs of life threatening bleeding and has an INR > 1.5 1. Known hypersensitivity to any component of andexanet. (Page 1 Executive Summary line 8-9). Portola Pharmaceuticals Announces New Interim Results from Ongoing ANNEXA-4 Study of Factor Xa Inhibitor Reversal Agent AndexXa® (Andexanet … Providers should continue to order 4F-PCC (Kcentra) for urgent reversal of anti-Xa inhibitors per UW Medicine guidelines. Oral factor Xa (fXa) inhibitor-related bleeding is a concerning drug safety problem. These reactions were characterized by a range of symptoms, including flushing, feeling hot, cough, dysgeusia, and dyspnea. USE DOSING PROTOCOL PER PHARMACY (page 4-5) Do not repeat dose of Kcentra. The half-life of Andexxa is far shorter than the FXa inhibitors. 20 comments. Tie so for, but there is growing evidence that PCC may be superior in certain scenarios Andexxa is also the recommended standard of care in CHEST.
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