- |||||||||| Savaysa (edoxaban) / Daiichi Sankyo, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Clinical guideline, Journal: Clinical guideline on reversal of direct oral anticoagulants in patients with life threatening bleeding. (Pubmed Central) - Apr 7, 2024
In the clinical scenarios of DOAC intake before urgent procedures and DOAC-induced bleeding, practitioners should evaluate the risk of bleeding of the procedure and the severity of the DOAC-induced bleeding before initiating treatment. Optimal reversal strategy remains to be determined in future trials for most clinical settings.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Journal: Use of Andexanet Alfa for Factor Xa Inhibitor Reversal in US Verified Trauma Centers: A National Survey. (Pubmed Central) - Mar 22, 2024
Respondents indicated that cost burden was an overriding factor (76.3%); 42.4% cited lack of high-level efficacy data of andexanet alfa for reversal of factor Xa inhibitors. Additional double-blinded multi-institutional randomized controlled trials comparing 4F-PCC and andexanet alfa for factor Xa inhibitor reversal are needed to support efficacy especially with the increased cost associated.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
LABORATORY CONSIDERATIONS ON DOAC LEVELS (INCLUDING PRECISION AND WHAT WE'VE LEARNED FROM EXTERNAL QA; COMMENT ON ANDEXANET) (Chicago Ballroom VII; Virtual) - Mar 14, 2024 - Abstract #THSNA2024THSNA_316;
The strengths and limitations of monitoring strategies will be discussed. In the absence of prospective data validating a particular monitoring strategy, obtaining baseline coagulation studies (aPTT, anti-Xa, and PT/INR) before initiating heparin therapy, followed by subsequent paired aPTT and anti-Xa measurements can identify this group of patients with high all-cause mortality and presents an opportunity to use these tests to individualize care of these patients based on their presentation and risks of bleeding and thrombosis.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Clinical, Journal, Real-world evidence, Real-world: Andexanet Alfa: What We Have Learned from Clinical Trials and Real-World Data. (Pubmed Central) - Mar 8, 2024
Finally, management of patients at high risk of thrombosis or recent arterial/venous thrombotic events needs to be further explored. In this current opinion, we address these urgent questions in the light of recent literature and clinical trial data.
- |||||||||| Praxbind (idarucizumab) / Boehringer Ingelheim, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Journal: Direct oral anticoagulants in trauma patients. (Pubmed Central) - Feb 23, 2024
Compared to VKAs, DOACs do not carry a higher bleeding risk. DOAC specific antagonists facilitate the individual bleeding management.
- |||||||||| Praxbind (idarucizumab) / Boehringer Ingelheim, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Journal: Antidote vs. unspecific hemostatic agents for the management of direct oral anticoagulant-related bleeding in trauma. (Pubmed Central) - Feb 23, 2024
Current guidelines recommend specific antidots and PCCs in DOAC-related major bleeding. Prospective randomized trials comparing specific vs. nonspecific hemostatic agents in the perioperative setting are needed to evaluate the effectiveness and safety of the hemostatic agents.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Journal: Four-factor prothrombin complex concentrate versus andexanet alfa for the reversal of traumatic brain injuries. (Pubmed Central) - Feb 22, 2024
Prospective randomized trials comparing specific vs. nonspecific hemostatic agents in the perioperative setting are needed to evaluate the effectiveness and safety of the hemostatic agents. There was no firm conclusion on the treatment effect in mortality/hospice or serious complications among isolated TBI patients reversed with 4F-PCC as compared with andexanet alfa.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Journal: The use of andexanet alfa vs. 4-factor prothrombin complex concentrates in the setting of life-threatening intracranial hemorrhage. (Pubmed Central) - Feb 15, 2024
Among patients with life-threatening intracranial hemorrhage in the setting of DOAC therapy, no clinical differences were observed with respect to selection of reversal agent. Prothrombin complex concentrates remain a viable alternative to reversal of DOAC therapy though multicenter, randomized, prospective studies are needed to further evaluate the role of 4F-PCC in the reversal of DOAC therapy.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Journal: Andexanet (Pubmed Central) - Jan 22, 2024
Use of andexanet alfa compared to any other non-specific treatment strategy was associated with decreased odds for hematoma expansion, without increased odds for thromboembolic complications. This study in
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Preclinical, Journal: Comparative analysis of andexanet (Pubmed Central) - Jan 22, 2024
This study in In contrast to thrombin generation measurements, haemostatic reversal of rivaroxaban using high-dose 4F-PCCs exhibited similar efficacy as andexanet
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Journal: Recommendations of Polish Cardiac Society expert regarding the use of andexanet alpha in the Polish context. An interdisciplinary protocol. (Pubmed Central) - Jan 17, 2024
The maximum reversal of anti-Xa activity occurs within two minutes of the end of the bolus treatment, with the continuation of the continuous i.v. infusion allowing the effect to be maintained for up to two hours afterwards. Because anticoagulant activity can reappear after the infusion is completed, it is currently unclear at what point after AA administration FXa inhibitors or heparin should be readministered.
- |||||||||| Journal: Treatment of atrial fibrillation. (Pubmed Central) - Jan 9, 2024
Lower anti-FXa levels (<50?ng/mL) with andexanet 500-mg bolus? No abstract available
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
ADVERSE OUTCOMES OF ANDEXANET ALFA () - Jan 4, 2024 - Abstract #SCCM2024SCCM_1745;
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Andexanet Alfa Is Preferred for Intracerebral Hemorrhage Management (West-301BC) - Dec 24, 2023 - Abstract #SCCM2024SCCM_494;
The speaker will defend the use of andexanet alfa as primary therapy for ICH. Previous use has been limited by cost of the agent, which has recently become more affordable, particularly with consignment options.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Management of Bleeding due to Anticoagulants (North-122) - Dec 24, 2023 - Abstract #SCCM2024SCCM_359;
This lecture will discuss evidence based reversal of medications such as: warfarin, oral anti-Xa inhibitors (DOACS - apixaban, rivaroxaban, etc.), subcutaneous anti-Xa inhibitors (enoxaparin), direct thrombin inhibitors (argatroban, bivalirudin). The use of plasma, prothrombin complex concentrates and specific antidotes (andexanet alfa) will be discussed, reviewed with risks and benefits of each.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Pro/Con Debate: Flip It and Reverse It: ICH Management (West-301BC) - Dec 24, 2023 - Abstract #SCCM2024SCCM_143;
The cost of andexanet alfa has previously been prohibitive, but recent changes have led institutions to reevaluate its role in ICH therapy for ICH management. Learning Objectives: Discuss acute reversal of factor Xa inhibitors after intracranial hemorrhage (ICH), highlighting the use of prothrombin complex concentrates (PCCs) and andexanet alfa Debate the evidence associated with the use of andexanet alfa and 4-factor PCC for ICH reversal Evaluate the use of contemporary clinical trial data to determine optimal therapy for factor Xa-associated ICH reversal
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Journal: Basics for the Use of Andexanet (Pubmed Central) - Dec 17, 2023
Learning Objectives: Discuss acute reversal of factor Xa inhibitors after intracranial hemorrhage (ICH), highlighting the use of prothrombin complex concentrates (PCCs) and andexanet alfa Debate the evidence associated with the use of andexanet alfa and 4-factor PCC for ICH reversal Evaluate the use of contemporary clinical trial data to determine optimal therapy for factor Xa-associated ICH reversal ?This article aims to facilitate the management of patients with andexanet by all medical disciplines involved, thereby ensuring optimal care of patients during bleeding episodes.
- |||||||||| Praxbind (idarucizumab) / Boehringer Ingelheim, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Review, Journal: Efficacy and Safety of Novel Oral Anticoagulants in Atrial Fibrillation: A Systematic Review. (Pubmed Central) - Nov 6, 2023
Although clinical situations are complex, DOAC testing facilitates clinical decision-making, including reversal, justifying more widespread implementation of these assays. In recent times, novel oral anticoagulants (NOACs)/direct oral anticoagulants (DOACs) have emerged as an alternative to the traditionally used Vitamin
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Retrospective data, Journal: Treatment of Factor-Xa Inhibitor-associated Bleeding with Andexanet Alfa or 4 Factor PCC: A Multicenter Feasibility Retrospective Study. (Pubmed Central) - Oct 7, 2023
Important patient characteristics are often documented supporting the feasibility of a large observational study comparing real-life outcomes in patients with FXa-I-associated bleeds treated with andexanet alfa or 4F-PCC. The small sample size in the current study precluded definitive conclusions regarding the safety and efficacy of andexanet alfa or 4F-PCC in FXa-I-associated bleeds.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Observational data, Journal: Lower mortality with andexanet (Pubmed Central) - Sep 27, 2023
P=N/A
The small sample size in the current study precluded definitive conclusions regarding the safety and efficacy of andexanet alfa or 4F-PCC in FXa-I-associated bleeds. In this large observational study, treatment with andexanet
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Debate: PCC or Andexanet alfa for Managing Bleeding in Patients on Oral Xa Inhibitors? (Room 29 (San Diego Convention Center)) - Sep 23, 2023 - Abstract #ASH2023ASH_97;
The participants in this debate will take the opposite sides of the question: should most patients with FXa-inhibitor-associated bleeding receive andexanet alpha (over prothrombin complex concentrates and/or best supportive care)? The session will include a detailed examination of the risks and the benefits of different managements strategies that may be considered for patients who are in this potentially precarious clinical situation.
- |||||||||| Praxbind (idarucizumab) / Boehringer Ingelheim, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Journal: Antagonizing anticoagulants in intracranial hemorrhage - step by step (Pubmed Central) - Sep 20, 2023
However, until recently direct therapeutic options for intracranial hemorrhage under existing anticoagulation were not available. With the introduction of two new medications - Idarucizumab and Andexanet alfa - neurologists take a more targeted approach in treating these patients.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Trial completion, Enrollment change: Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor (clinicaltrials.gov) - Sep 13, 2023
P4, N=530, Completed,
With the introduction of two new medications - Idarucizumab and Andexanet alfa - neurologists take a more targeted approach in treating these patients. Active, not recruiting --> Completed | N=1200 --> 530
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Heparin Resistance following administration of Anexanet Alpha for Type A Aortic Dissection (Exhibit Hall) - Aug 23, 2023 - Abstract #ASA2023ASA_4293;
80 year old female patient with history of Atrial Fibrillation on Apixaban presenting with Type-A Aortic Dissection post Motor vehicle accident...She received Andexxa Alpha followed immediately by surgical repair requiring Cardio-pulmonary bypass necessitating the use of IV Heparin...She continued to need frequent Heparin Redosing to maintain therapeutic Activated Clotting Time. Patient had uneventful course thereafter.
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