Ondexxya (andexanet alfa) is a medication used for the treatment of patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Manufacturers Packagers Dosage Forms Prices Patents. Introduction of Andexanet Alfa, Factor Xa Inhibitor Reversal Agent into Central Vein, Percutaneous Approach, New Technology Group 2. Andexanet Alfa. Anti-Xa activity can rebound after completing the infusion of andexanet. [2], It was approved for medical use in the United States in May 2018. Truven Health Analytics, DOAC Market Data Report. Idarucizumab is a humanized, monoclonal, antibody fragment that reverses the direct thrombin inhibitor dabigatran. The US Food and Drug Administration (FDA) has cleared andexanet alfa (Andexxa) as a reversal agent for the anticoagulant effects of the two most commonly used factor Xa inhibitors in patients with life-threatening or uncontrolled bleeding, manufacturer Portola Pharmaceuticals announced late yesterday.. That is why we need science. Based largely on that publication, the Food and Drug Administration already approved andexanet alfa in 2018. [1], There are no randomised clinical trials as of 2019. Intravenous andexanet alfa [coagulation factor Xa (recombinant), inactivated-zhzo; Andexxa®] is a first-in-class recombinant modified factor Xa protein that has been developed by Portola Pharmaceuticals as a universal antidote to reverse anticoagulant effects of direct or indirect factor Xa inhibitors. Andexanet alfa is a modified recombinant factor Xa molecule that reverses oral direct (e.g., apixaban, edoxaban, rivaroxaban) and injectable indirect (e.g., enoxaparin, fondaparinux) factor Xa inhibitors. [7], Common side effects include pneumonia and urinary tract infections. Manufacturer: Portola Pharmaceuticals, Inc. As a rule, all of our actions can be harmful. Andexanet alfa produced rapid reversal of the anticoagulant effect of apixaban, as measured by anti-Factor Xa activity, which was sustained for the duration of the infusion. Human physiology is complex, which makes it very difficult to predict the outcomes of our interventions. Andexanet alfa is clearly not a parachute, as 14% of a healthy population still died. Doctors were hopeful that the drug might quickly be approved to help prevent potentially extreme Xarelto bleeding episodes. [2] Severe side effects may include blood clots or cardiac arrest. andexanet alfa (UNII: BI009E452R) (andexanet alfa - UNII:BI009E452R) andexanet alfa: 200 mg in 20 mL: Packaging # Item Code Package Description Marketing Start Date Marketing End Date; 1: NDC:69853-0102-1: 4 in 1 CARTON: 01/08/2019: 1: 20 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product: Marketing Information : Marketing Category Application Number or Monograph … Among the watchful eyes will surely be a handful of big pharma players — Pfizer Inc., Bristol-Myers Squibb Co., Daiichi Sankyo Inc., Bayer Pharma AG and Janssen Pharmaceuticals Inc. — that have partnered with Portola to develop the highly anticipated drug. While people who were expected to die in 30 days were excluded from the study, 14% of participants died. Manufacturer; Andexanet alfa (Andexxa) Indicated for patients treated with rivaroxaban and … ANDEXXA contains no preservatives. Consequently in August 2016, the FDA requested additional efficacy and safety data for … In adults with potentially life-threatening acute major bleeding, what is the efficacy and safety of andexanet alfa for reversing the anticoagulant effects of the factor Xa inhibitors apixaban, rivaroxaban, edoxaban, or enoxaparin? If you are allergic to andexanet alfa; any part of andexanet alfa; or any other drugs, foods, or substances. Portola has entered into Phase 3 clinical collaboration agreements with all of the manufacturers of direct Factor Xa inhibitors while retaining all commercial rights to andexanet alfa. •Andexanet alfa prolongs aPTT in a concentration-dependent manner in-vitro, with negligible effects on PT or TCT •Andexanet alfa (250μg/mL) neutralises rivaroxaban and apixaban by ~85-90%, based on anti-Xa assays •Rivaroxaban induces a false-positive LA test via dRVVT in a concentration-dependent manner. [2], Andexanet alfa has a boxed warning that it is associated with arterial and venous blood clots, ischemic events, cardiac arrest, and sudden deaths. have a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and. As part of the regulatory approval process, the manufacturer has requested a label that includes the reversal of apixaban, rivaroxaban, edoxaban, and enoxaparin. 7. [8] FXa inhibitors bind to andexanet alfa with the same affinity as to natural FXa. Andexanet alfa for the reversal of Factor Xa inhibitor related anticoagulation. What do I need to tell my doctor BEFORE I take Andexanet Alfa? It was developed by Portola Pharmaceuticals and was approved in in May 2018. Portola proposed two dosing regimens for ANDEXXA. The drug is not effective against factor IIa inhibitor dabigatran. [5] This study reports results on 352 people and demonstrates a reduction of anti-fXa-activity while also showing an excellent or good hemostatic efficacy in 82%. The active ingredient in ANDEXXA is a genetically modified variant of human FXa. Indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding, Indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (NM-CRPC), Indicated to treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure, Indicated for the treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours, Indicated for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults, Indicated to treat unresectable or metastatic melanoma, Indicated to treat X-linked hypophosphataemia (XLH) in adult and pediatric patients 1 year of age and older, Indicated to treat acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years, Indicated to treat acquired thrombotic thrombocytopenic purpura (aTTP), Indicated to treat adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation, Indicated for the first-line treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with confirmed epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations. Andexanet alfa (coagulation factor Xa [recombinant], inactivated-zhzo) is a modified recombinant inactive form of human factor Xa designed specifically to bind and sequester factor Xa … Andexanet alfa (andexanet; r-Antidote, PRT064445; Portola Pharmaceuticals, South San Francisco, CA) is a modified, recombinant human factor Xa that binds to direct factor Xa inhibitors such as apixaban, edoxaban, and rivaroxaban and indirect factor Xa inhibitors, such as LMWHs. [1] It was developed by Portola Pharmaceuticals. Coagulation factor Xa (recombinant), inactivated-zhzo (andexanet alfa; Andexxa – Portola) has received accelerated approval from the FDA for urgent reversal of the anticoagulant effect of the direct factor Xa inhibitors apixaban (Eliquis) and rivaroxaban (Xarelto). Medscape - Factor Xa inhibitor antidote dosing for AndexXa, andexanet alfa (coagulation factor Xa recombinant, inactivated-zhzo), frequency-based adverse effects, comprehensive interactions, contraindications, pregnancy & lactation schedules, and cost information. Available at: "Andexxa- andexanet alfa injection, powder, lyophilized, for solution", "Andexanet Alfa for the Reversal of Factor Xa Inhibitor Activity", "Full Study Report of Andexanet Alfa for Bleeding Associated with Factor Xa Inhibitors", https://clinicaltrials.gov/ct2/show/NCT03661528, "Trial of Andexanet in ICH Patients Receiving an Oral FXa Inhibitor", "Andexanet Alfa for Acute Major Bleeding Associated with Factor Xa Inhibitors", "Ondexxya (andexanet alfa): Avoid use of andexanet prior to heparinization", https://en.wikipedia.org/w/index.php?title=Andexanet_alfa&oldid=988263296, Chemicals that do not have a ChemSpider ID assigned, Infobox drug articles without a structure image, Articles containing unverified chemical infoboxes, Creative Commons Attribution-ShareAlike License, Coagulation factor Xa (recombinant), inactivated-zhzo, PRT06445, r-Antidote, PRT4445, This page was last edited on 12 November 2020, at 03:05. The Company is currently evaluating andexanet alfa in the Phase 3 and Phase 4 ANNEXA™ (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of FXa Inhibitors) registration studies. Targets (1) Identification Name Andexanet alfa Accession Number DB14562 Description. TFPI by andexanet alfa resulted in a transient increase in the level of prothrombin fragments 1 and 2, thrombin-antithrombin complex and D-dimer. Andexanet alfa, a U.S. Food and Drug Administration (FDA)-designated breakthrough therapy, is a recombinant protein specifically designed to … Andexanet alfa will likely correct anti-Xa values, but the correlation of lab results with improved clinical outcomes has not been established. [2] Severe side effects may include blood clots, heart attacks, strokes, or cardiac arrest. Table 1 Assignment of patients to either high dose or low dose regimen . ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) is also referred to by the US adopted name (USAN) of andexanet alfa. J Blood Med. Properties. Frontera JA, Lewin JJ 3rd, Rabinstein AA, et al. In-vitro data suggest binding of andexanet alfa to the heparin-antithrombin III (ATIII) complex and neutralisation of the anticoagulant effect of heparin. The spotlight on AndexXa (andexanet alfa) is even brighter now that an new decision date is on the calendar. There was no relationship between hemostatic efficacy and reduced anti-Xa-activity. The following table provides supplementary information on the manufacturer and approved indication(s) for each medicine that received first-time market authorization by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and/or Health Canada in 2018. Off-label use of andexanet alfa to reverse FXa anticoagulation prior to surgery with intended heparin anticoagulation has been reported to cause unresponsiveness to heparin and healthcare professionals are advised to avoid such use. Since it is a genetically modified variant of human factor Xa, andexanet alfa is not able to cleave and activate Andexanet alfa (AA) is an antidote for factor Xa inhibitors and its usage has been associated with thrombotic complications. Portola applied for FDA approval of its Xarelto antidote AndexXa back in 2015. Truven Health Analytics, DOAC Market Data Report. Targets (1) Andexanet alfa. Andexanet alfa reverses effect of all anticoagulants that act directly through FXa or by binding antithrombin III. Medicare New Technology Add-on Payment (NTAP) In addition to the MS-DRG payment, NTAP may facilitate an additional payment, … Truven Bleeding Events Report: Commercial, Medicare, & Medicaid Populations. Clinical trials suggest peak anti-Xa activity at 4 hours after infusion, then decrease at a rate similar to clearance of the factor Xa inhibitor. [4] The only published clinical trial is a prospective, open label, single group study. Subsequently, this may result in increased tissue factor-initiated thrombin generation. Andexanet alfa. Andexanet alfa, sold under the trade name Andexxa among others, is an antidote for the medications rivaroxaban and apixaban, when reversal of anticoagulation is needed due to uncontrolled bleeding. State Experimental Properties. The Company is currently evaluating andexanet alfa in the Phase 3 and Phase 4 ANNEXA™ (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of FXa Inhibitors) registration studies. 8. 10. 2. 1. Data month ending September 2019. Based on the last dose of apixaban/rivaroxaban and the time since the last drug intake, the manufacturer’s instructions propose either a high dose regimen or a low dose regimen (table 1). Data month ending November 2018. [3][9] In other words, it acts as a decoy receptor. Andexanet alfa, sold under the trade name Andexxa among others, is an antidote for the medications rivaroxaban and apixaban, when reversal of anticoagulation is needed due to uncontrolled bleeding. [1], Andexanet alfa is a biologic agent, a recombinant modified version of human activated factor X (FXa). Justin Morgenstern, "Andexanet Alfa: More garbage science in the New England Journal of Medicine", First10EM blog, February 11, 2019. Data source: US Food and Drug Administration Novel Drugs 2018; European Medicines Agency Human Medicines Highlights 2018; Health Canada databases. As a consequence in the presence of andexanet alfa natural FXa is partially freed, which can lead to effective hemostasis. The trick is to ensure that benefit is likely to outweigh that harm. Tell … [5][11], Initial pricing (AWP) is $58,000 per reversal (800 mg bolus + 960 mg infusion, $3,300 per 100 mg vial) which is higher than reversal agents for other DOAC agents (idarucizumab for use in dabigatran reversal is $4,200 per reversal).[12]. Indication: For patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. [2], Common side effects include pneumonia and urinary tract infections. Although ANNEXA-A and ANNEXA-R study the reversal of apixaban and rivaroxaban by andexanet, they exclude edoxaban and enoxaparin. [3], Andexanet alfa is used to stop life threatening or uncontrollable bleeding in people who are taking rivaroxaban or apixaban. [30][31] [32] [33] While andexanet alfa is … Andexanet alfa (andexanet) is a specific reversal agent that is designed to neutralize the anticoagulant effects of both direct and indirect factor Xa inhibitors.
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