AndexanetAlfa (Ondexxya) - for adult patients treated with factor Xa (FXa) inhibitors (rivaroxaban or apixaban) when rapid reversal of anticoagulation is needed Return to Article DetailsAndexanet Alfa (Ondexxya)
Andexanetalfa (acute major bleeding) - Addendum to Commission A19-76 1 Translation of addendum A20-02 Andexanetalfa (akute schwere Blutungen) – Addendum zum Auftrag A19-76 (Version 1.0; Status: 31 January 2020). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Addendum 31 January 2020 1.0 Commission: A20-02 Version: Status: IQWiG Reports – Commission No. A20-02 Andexanetalfa (acute severe bleeding) – Addendum to Commission A19-761 Addendum A20-02 Version 1.0 Andexanetalfa – Addendum to Commission A19-76 31 January 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing
Andexanetalfa (Ondexxya) as an antidote to xabans: inadequate clinical evaluation Prescrire IN ENGLISH - Spotlight ''Andexanetalfa (Ondexxya°) as an antidote to xabans: inadequate clinical evaluation'', 1 July 2020 {1}##LOC[OK]## {1} ##LOC[OK]## ##LOC[Cancel]## {1}##LOC[OK]####LOC[Cancel]## Register online| Log in| My Prescrire Issue contents * Current issue * Last 12 issues * All issues * Subscribe now * Solidarity Subscription Rate * Subscribers: register online * Prescrire's other products * Free Special Edition * Sign up to receive the newsletter english.prescrire.org > Spotlight > 100 most recent > Andexanetalfa (Ondexxya°) as an antidote to xabans: inadequate clinical evaluation SpotlightEvery month, the subjects in Prescrire’s Spotlight. 100 most recent: 1|10|20|30|40|50
Andexanetalfa (Ondexxya) - For adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. 1 Published 7 September 2020 1 SMC2273 andexanetalfa 200 mg powder for solution for infusion (Ondexxya®) Portola Pharmaceuticals UK Ltd. 07 August 2020 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and, following review by the SMC executive, advises NHS Boards and Area Drug and Therapeutics Committees on its use in NHSScotland. The advice is summarised as follows: ADVICE: following a full submission andexanetalfa (Ondexxya®) is accepted for use within NHSScotland on an interim basis subject to ongoing evaluation and future
ANNEXA-1: AndexanetAlfa Associated with Harm in DOAC Reversal ANNEXA-1: AndexanetAlfa Associated with Harm in DOAC Reversal - REBEL EM - Emergency Medicine BlogSkip to content * Home * Blog * COVID-19 * Submit a Post * CAST * REVIEWS * PREZ * CRIT * CME/CEH * CORE * About * About Us * Meet The Team * Friends of REBEL EM * REBEL Swag * Disclaimer Menu * Home * Blog * COVID-19 * Submit a Post * CAST * REVIEWS * PREZ * CRIT * CME/CEH * CORE * About * About Us * Meet The Team * Friends of REBEL EM * REBEL Swag * Disclaimer * May 23, 2024 ANNEXA-1: AndexanetAlfa Associated with Harm in DOAC Reversal * Written byAnand Swaminathan * REBEL Cast, REBEL EM * Medical Category:Hematology and Oncology, Neurology Background: In May of 2018, Andexanetalfa gained accelerated approval by the FDA
Efficacy and safety of andexanetalfa for factor Xa inhibitor-associated intracranial haemorrhage. Current international guidelines suggest andexanetalfa (AA) for the management of factor Xa inhibitor-associated intracranial haemorrhage (ICH). However, those recommendations are based on low-quality evidence and there is uncertainty regarding the net clinical benefit of AA. We conducted
Four-factor prothrombin complex concentrate versus andexanetalfa for the reversal of traumatic brain injuries. Andexanetalfa was approved in 2018 for reversal of direct oral anticoagulants but due to issues of cost and access, four-factor prothrombin complex concentrate (4F-PCC) continues to be used for this indication. The objective of this study is to evaluate outcomes of reversal with these agents in patients with isolated traumatic brain injuries (TBI). This is a retrospective review of 35 trauma centres from 2014 to 2021. Patients were included with an Abbreviated Injury Scale (AIS)>2 for head and having received andexanetalfa or 4F-PCC within 24 hours of admission. Patients were excluded if P2Y12 inhibitor use or AIS>2 outside of head. Primary outcome includes rate of mortality
AndexanetAlfa-Associated Heparin Resistance in Cardiac Surgery: Mechanism and In Vitro Perspectives. Andexanetalfa (andexanet) is the only Food and Drug Administration-approved antidote for direct FXa (factor Xa) inhibitors but has been reported to cause resistance to unfractionated heparin (UFH). This has delayed anticoagulation for procedures requiring cardiopulmonary bypass. The mechanism
Andexanetalfa: trials just leave us with more questions. AndexanetAlfa in Acute Intracranial Hemorrhage in Patients Receiving an Oral Factor Xa Inhibitor (ANNEXA-I), the first ever randomized controlled trial of a reversal agent for direct oral anticoagulants, was published in 2024. The trial, which randomized patients with intracranial hemorrhage to andexanetalfa or usual care, was mandated by the United States Food and Drug Administration as part of its conditional approval in 2018. This approval was originally based on the single-arm trial, The AndexanetAlfa, a Novel Antidote to the Anticoagulation Effects of Factor Xa Inhibitors (ANNEXA-4). ANNEXA-I was stopped early for benefit and showed a reduction in the number of patients with significant hematoma expansion. However, the study
AndexanetAlfa for the Reversal of Factor Xa Inhibitor Activity: Prespecified Subgroup Analysis of the ANNEXA-4 Study in Japan. Andexanetalfa, a specific antidote to factor Xa (FXa) inhibitors, has been approved for clinical use in several countries, including Japan, based on the results from the phase 3 trial ANNEXA-4. W e aimed to assess the efficacy and safety of andexanetalfa treatment patients (88%) achieved excellent or good hemostasis (apixaban, 5/5; rivaroxaban, 6/7; edoxaban, 3/4). Within 30 days, treatment-related adverse events (AEs) and serious AEs occurred in 2 and 5 patients, respectively. One patient died during follow-up, and 2 patients experienced thrombotic events. Treatment with andexanetalfa rapidly reduced anti-FXa activity with favorable hemostatic efficacy
The use of andexanetalfa and 4-factor prothrombin complex concentrate in intracranial hemorrhage. to describe the clinical and safety outcomes between andexanetalfa (AA) and 4-factor prothrombin complex concentrate (4F-PCC) for the reversal of apixaban or rivaroxaban in the setting of an intracranial hemorrhage (ICH). A retrospective, multicentered descriptive study was conducted survived to hospital discharge with no 30-day morality and 86.7% patients in the 4F-PCC group. This study suggests that real-world clinical and safety outcomes between andexanetalfa and 4F-PCC for the reversal of factor Xa inhibitors in the setting of ICH are similar to ones reported in clinical trials.
Comparative analysis of andexanetalfa and prothrombin complex concentrate in reversing anticoagulation by rivaroxaban ex vivo. The comparative effectiveness of the specific antidote andexanetalfa vs the nonspecific therapy four-factor prothrombin complex concentrates (4F-PCCs) as reversal agents for direct factor Xa (FXa) inhibitors in severely bleeding patients is unclear. We hypothesised that specific reversal using andexanetalfa would be more effective than a high dose of PCC (50 IU kg) for reversing the FXa inhibitor rivaroxaban. The reversal potential of andexanetalfa, various 4F-PCCs, and activated PCC was investigated ex vivo in human blood anticoagulated with rivaroxaban (37.5, 75, 150, and 300 ng ml) using a panel of coagulation parameters, including conventional coagulation assays
Andexanetalfa or prothrombin complex concentrate for acute reversal of oral factor Xa inhibitors: monitoring of antidote effects. This study in vitro comprehensively assessed reversal of the anticoagulant effects of rivaroxaban, an oral factor Xa inhibitor, using andexanetalfa and various prothrombin complex concentrate (PCC) products in a battery of tests. In static coagulation assays
Real world utilization of Andexanetalfa in the management of oral factor Xa inhibitor-associated gastrointestinal bleeding. Andexanetalfa (AA) is approved for reversal of factor Xa inhibitor (FXaI) bleeds; however, there are limited reports of its use for gastrointestinal bleeding (GIB) in real-world populations. The objective of this study was to report real-world utilization and evaluation
Final Study Report of AndexanetAlfa for Major Bleeding With Factor Xa Inhibitors. Andexanetalfa is a modified recombinant inactive factor Xa (FXa) designed to reverse FXa inhibitors. ANNEXA-4 (AndexanetAlfa, a Novel Antidote to the Anticoagulation Effects of Factor Xa Inhibitors) was a multicenter, prospective, phase-3b/4, single-group cohort study that evaluated andexanetalfa in patients with acute major bleeding. The results of the final analyses are presented. Patients with acute major bleeding within 18 hours of FXa inhibitor administration were enrolled. Co-primary end points were anti-FXa activity change from baseline during andexanetalfa treatment and excellent or good hemostatic efficacy, defined by a scale used in previous reversal studies, at 12 hours. The efficacy population
Andexanetalfa effectiveness and safety versus four-factor prothrombin complex concentrate (4F-PCC) in intracranial hemorrhage while on apixaban or rivaroxaban: A single-center, retrospective, matched cohort analysis. There is limited information directly comparing andexanetalfa (AA) versus four-factor prothrombin complex concentrate (4F-PCC) in intracranial hemorrhage (ICH) on apixaban
Andexanetalfa versus four-factor prothrombin complex concentrate for the reversal of apixaban- or rivaroxaban-associated intracranial hemorrhages. Existing research recommends either andexanetalfa (AA) or four-factor prothrombin complex concentrate (4F-PCC) as an antidote for major bleeding events due to apixaban or rivaroxaban. Currently, there is limited published research that directly
Four-factor prothrombin complex concentrate administration after expanding intracranial hemorrhage status post administration of andexanetalfa. With respect to reversal of life threatening bleeds associated with the use of oral factor Xa inhibitors, current guidelines provide few recommendations for a preferred reversal agent. When the initial reversal agent fails to achieve the desired hemostatic response, there is little to no recommendations for the use of additional reversal agents. An 86-year-old female on apixaban (ELIQUIS) for atrial fibrillation, presented from an outside hospital due to a spontaneous intracranial hemorrhage (sICH). Computed tomography (CT) scan revealed multifocal left sided sICH. Due to use of apixaban in the setting to sICH, patient received andexanetalfa (AA