- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
Journal: Request for an Andexxa Value Analysis. (Pubmed Central) - Nov 2, 2020 Based on the safety and efficacy concerns of andexanet alfa, a value statement in and or as an addendum to society guidelines is vital considering the high cost of therapy. In this era of ever-increasing health care costs, every clinician, health system, national society, insurer, and pharmaceutical company should work to be good stewards of our society's resources.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
[VIRTUAL] There Will be Blood: A Cautionary Tale of Triple Therapy (OnDemand) - Oct 10, 2020 - Abstract #AHA2020AHA_5166; The pericardial pressure improved from 24 mmHg to 4 mmHg with complete resolution of the patient’s shock and neurological deficits. Our case demonstrates the risks associated with triple antithrombotic therapy as well as the nuanced clinical decision-making and risk-benefit assessment required when considering the use of anticoagulant reversal agents to prevent bleeding complications in the context of recent ischemic events and the need for urgent invasive procedures.
- |||||||||| Xarelto (rivaroxaban) / J&J, Bayer, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma, Pradaxa (dabigatran etexilate) / Boehringer Ingelheim
Journal: Scalable manufacture of a disposable, storage-stable eight-channel microfluidic device for rapid testing of platelet, coagulation, and drug function under whole blood flow. (Pubmed Central) - Oct 7, 2020 We demonstrate the ability to manufacture single-use, storage-stable eight-channel chips. In clinical settings, such chips may help evaluate patient bleeding risk, therapy choice, drug activity, or reversal.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
[VIRTUAL] Exhibitor Symposium: Portola - Andexxa (coagulations factor Xa (recombinant), inactivated-zhzo) () - Sep 21, 2020 - Abstract #AAST2020AAST_370; Learning Objectives: Identify reversal management options for patients with Factor Xa inhibitor related bleeding. Speakers: Alan Brockhurst, MD, Trauma Medical Director, Sarasota Memorial Hospital Moderator: Sebastian D. Schubl, MD, FACS Irvine, CA USA Register at www.hlxregister.com refer to program code: RT2LE2
- |||||||||| Journal: Analysis of anticoagulation reversal survey (ARES). (Pubmed Central) - Sep 20, 2020
However, only 58.7% used the labeled dose of 4-PCC for warfarin reversal...In addition, the majority of respondents utilized idarucizumab for dabigatran reversal. The only involvement activity in which <50% of respondents said they were frequently involved or always involved was 'administration of reversal agent.' There is considerable variability in which agents were utilized for anticoagulant-associated bleeding reversal.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Enrollment closed, Trial completion date, Trial primary completion date: ANNEXA-4: A Study in Participants With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants (Extension Study) (clinicaltrials.gov) - Sep 19, 2020 P3, N=479, Active, not recruiting, The only involvement activity in which <50% of respondents said they were frequently involved or always involved was 'administration of reversal agent.' There is considerable variability in which agents were utilized for anticoagulant-associated bleeding reversal. Recruiting --> Active, not recruiting | Trial completion date: Nov 2022 --> Sep 2020 | Trial primary completion date: Nov 2022 --> Sep 2020
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
Journal: Andexanet alfa for reversal of factor Xa inhibitors: a critical review of the evidence. (Pubmed Central) - Sep 4, 2020 In the ANNEXA-4 study, treatment with andexanet was associated with a 92% reduction in median anti-Xa activity levels and excellent or good hemostasis in 82% of patients presenting with serious bleeding while receiving apixaban or rivaroxaban. In this review, we discuss the burden of bleeding in anticoagulated patients and the need for reversal agents, review the mechanism of action of andexanet and critically evaluate the evidence for its efficacy and safety.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
Journal: Andexanet Alfa: Considerations and Practical Applications. (Pubmed Central) - Sep 1, 2020 In this review, we discuss the burden of bleeding in anticoagulated patients and the need for reversal agents, review the mechanism of action of andexanet and critically evaluate the evidence for its efficacy and safety. No abstract available
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
Clinical, Review, Journal: Institutional Experience of Using Andexanet Alfa. (Pubmed Central) - Aug 18, 2020 Anticoagulation was never started in all patients. This review tends to show the real-world utilization data of andexanet in a community hospital setting.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Enrollment change: Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor (clinicaltrials.gov) - Aug 8, 2020 P4, N=900, Recruiting, This review tends to show the real-world utilization data of andexanet in a community hospital setting. N=440 --> 900
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Clinical, Journal, Real-world evidence: Real-world utilization of andexanet alfa. (Pubmed Central) - Aug 2, 2020 There were no thrombotic complications. Yet, larger and comparative studies are needed to clarify the optimal agent and patient selection for reversal of factor Xa inhibitors.
- |||||||||| Review, Journal: Antidotes for reversal of direct oral anticoagulants. (Pubmed Central) - Jul 29, 2020
Ciraparantag, has potential to reverse the anticoagulant activity of multiple agents. The pharmacology, preclinical, and clinical data that have developed these specific antidotes are reviewed in this manuscript.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
Clinical, Journal, Real-World Evidence: Real-world utilization of andexanet alfa. (Pubmed Central) - Jul 29, 2020 The pharmacology, preclinical, and clinical data that have developed these specific antidotes are reviewed in this manuscript. No abstract available
- |||||||||| Praxbind (idarucizumab) / Boehringer Ingelheim, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma, Pradaxa (dabigatran etexilate) / Boehringer Ingelheim
Journal: The Diagnosis and Treatment of Acute Traumatic Bleeding and Coagulopathy. (Pubmed Central) - Jul 9, 2020 The evidence-based treatment of patients with hemorrhage from severe trauma, in accordance with the existing guidelines, can improve the clinical outcome. Corresponding algorithms, adapted to local logistics and infrastructure, must be developed and implemented.
- |||||||||| simvastatin / Generic mfg.
[VIRTUAL] Spontaneous Non-Traumatic Subdural Intra-Spinal Thoracolumbar Hematoma Secondary to Standard Apixiban Dose for Atrial Fibrillation, Resulting in Acute Bilateral Lower Extremity Flaccid Paralysis (ATS 2020 Virtual) - Jul 6, 2020 - Abstract #ATSI2020ATS-I_6951; We present a case involving a non-traumatic spontaneous subdural intra-spinal thoracolumbar hematoma in a patient on standard atrial fibrillation dosing of apixiban, who developed progressive bilateral lower extremity flaccid paralysis, requiring Andexanet alfa and laminectomy nerve decompression...Medications were notable for aspirin, apixiban at 5 mg twice daily, lisinopril, and simvastatin...Anticoagulation was held post-operatively and the patient was continued on lisinopril, metoprolol, and atorvastatin in the ICU for further evaluation and monitoring...This uncommon case signifies the importance of anticoagulation evaluation, and the monitoring of standard apixiban dosing for atrial fibrillation, even without trauma or procedural provocation. Furthermore, diagnosis is challenging and requires a high level of clinical suspicion due to possible irreversible neurological impairment.
- |||||||||| Retrospective data, Review, Journal: The Reversal of Bleeding Caused by New Oral Anticoagulants (NOACs): A Systematic Review and Meta-Analysis. (Pubmed Central) - Jun 15, 2020
Specific antidotes (idarucizumab for dabigatran and andexanet alfa for FXa inhibitors) and hemostatic reversal agents were used for lowering bleeding, but their efficacies were still uncertain...In conclusion, specific reversal agents might be useful for reversal of bleeding and lowering the risk of death than standard reversal agents. Our findings were based on case reports/series and selected cohorts, further comparative studies are thus needed.
- |||||||||| Praxbind (idarucizumab) / Boehringer Ingelheim, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Portola Pharma, Pradaxa (dabigatran etexilate) / Boehringer Ingelheim
Journal: What we have learned about direct oral anticoagulant reversal. (Pubmed Central) - Jun 11, 2020 Importantly, patients with DOAC-related major bleeding have substantial short-term risks of thrombosis and mortality, emphasizing the need for individualized patient assessment and protocolized bleed management strategies that include assessment of candidacy for safe resumption of OACs. With expanding indications and increasing prevalence of DOAC-eligible patients, bleeding complications and their management represent an ever-greater major health problem.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Portola Pharma
Journal: Andexanet alfa: the best antidote for factor Xa inhibitors? (Pubmed Central) - May 21, 2020 With the recent approval by the European Medicines Agency (EMA) but unknown Dutch reimbursement status, the role of andexanet for daily clinical practice in the Netherlands remains to be determined. Notably, and importantly, when treating patients with anticoagulant-associated major bleeding, local haemostatic control and-if relevant-adequate fluid resuscitation are at least as important as choosing the optimal anticoagulation antidote.
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