- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
Review, Journal: A Systematic and Evidence-Based Review of Published and Pending Reports of Andexanet Alfa. (Pubmed Central) - Apr 24, 2021
Only one study could score high because the outcome is patient-oriented evidence, and it could achieve follow-up of 80%. There is a need for well-controlled and blinded evaluation to improve the recommendation strength.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
[VIRTUAL] 4028 - The Standard of Care for the Reversal of anticoagulants in Hospitalized Patients with Life-Threatening or Uncontrolled Bleeding (Industry Theater 1) - Apr 20, 2021 - Abstract #ACC2021ACC_9246;
This presentation will review the burden of life-threatening bleeds related to FXa inhibitors; mechanism of action of ANDEXXA; indication and use of ANDEXXA; Important Safety Information, including Boxed Warning; and the efficacy and safety of ANDEXXA in the reversal of apixaban or rivaroxaban in: Phase 3 studies in older, healthy volunteers; a Phase 3b/4 study in patients with life-threatening or uncontrolled major bleedsIndustry-Expert Theater presentations are not part of ACC.21, as planned by its Program Committee, and do not qualify for continuing medical education (CME), continuing nursing education (CNE) or continuing education (CE) credit. Sponsored by Alexion Pharmaceuticals
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
Journal: Low risk of traumatic intracranial hematoma expansion with factor Xa inhibitors without andexanet reversal. (Pubmed Central) - Mar 31, 2021
Our results indicate that patients on Factor Xa inhibitors with complicated mild TBI have a similar intracranial hemorrhage progression rate to patients who are not anticoagulated or anticoagulated with a reversible agent. The hemostatic outcomes in our cohort were similar to those reported after Andexanet administration.
- |||||||||| Savaysa (edoxaban) / Daiichi Sankyo, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
[VIRTUAL] Andexanet Alfa for Acute Bleeding During Treatment With Edoxaban () - Feb 28, 2021 - Abstract #ISC2021ISC_574;
Excellent or good hemostasis at 12 hours was observed in 75.0% of patients overall and 81.3% of those with ICH. Thrombotic events occurred at a rate expected in such patients.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
[VIRTUAL] Modeling the Clinical Implications of Andexanet Alfa in Factor Xa Inhibitor-Associated Intracerebral Hemorrhage () - Feb 28, 2021 - Abstract #ISC2021ISC_526;
Background: Andexanet alfa was recently approved as a reversal agent for the Factor Xa inhibitors (FXai) apixaban and rivaroxaban, but its impact on long-term outcomes in FXai-associated intracerebral hemorrhage (ICH) is unknown. Even optimistic simulated hemostatic effects suggest that the costs and potential benefits of andexanet alfa should be carefully considered, and placebo-controlled randomized trials are needed before its use can definitively be recommended.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
Journal: Andexanet Alfa, the Possible Alternative to Protamine for Reversal of Unfractionated Heparin. (Pubmed Central) - Feb 25, 2021
Protamine is the approved reversal agent for heparin with few alternatives under investigation. Although andexanet was designed as an antidote for apixaban and rivaroxaban, in vitro studies show that in a dose-dependent technique, andexanet had near full reversal of heparin, reversed anti-factor Xa activity, and neutralized anticoagulant effects of activated partial thromboplastin time and thrombin time induced by heparin.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
[VIRTUAL] ANDEXANET ALFA FOR ACUTE BLEEDING DURING TREATMENT WITH ENOXAPARIN (eAbstract site) - Feb 17, 2021 - Abstract #ACC2021ACC_5042;
Excellent or good hemostasis was observed in 87.5% of patients and in 80.0% of those with intracranial hemorrhage. 30-day rates of thrombotic events and mortality were similar to the overall ANNEXA-4 study population.
- |||||||||| Praxbind (idarucizumab) / Boehringer Ingelheim, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma, Ciraparantag (aripazine) / Norgine, Covis Pharma
Review, Journal: Current Strategies for the Management of Bleeding Associated with Direct Oral Anticoagulants and a Review of Investigational Reversal Agents. (Pubmed Central) - Feb 2, 2021
For other FXa inhibitors, in the absence of a reversal agent, nonspecific strategies that include PCCs are recommended. The population of patients anticoagulated with DOACs is growing, and we hope that specific reversal agents will improve the approach to management of major bleeding in this population.
- |||||||||| apixaban / Generic mfg.
Journal: A comprehensive evaluation of apixaban in the treatment of venous thromboembolism. (Pubmed Central) - Jan 23, 2021
Likewise, there is a dearth of data on pediatric patients and patients with a history of heparin-induced thrombocytopenia or identified forms of thrombophilia. Additional comparator studies on anticoagulation reversal involving andexanet alfa are also necessary to further assess its ability to sustain hemostasis and its potential for prothrombotic risk.
- |||||||||| Savaysa (edoxaban) / Daiichi Sankyo, Praxbind (idarucizumab) / Boehringer Ingelheim, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
Clinical, Review, Journal: HEMATURIA AND OTHER KINDS OF BLEEDINGS ON NON-VITAMIN K ANTAGONIST ORAL ANTICOAGULANTS IN PATIENTS WITH ATRIAL FIBRILLATION: AN UPDATED OVERVIEW ON OCCURRENCE, PATHOMECHANISMS AND MANAGEMENT. (Pubmed Central) - Jan 20, 2021
Specific reversal agents for NOACs have been developed, i.e. more widely available idarucizumab for the factor IIa inhibitor (dabigatran) and andexanet alfa for the factor Xa inhibitors (rivaroxaban, apixaban, edoxaban) with limited availability. This review summarizes the occurrence and management of NOAC-related bleeding complications with a particular emphasis on hematuria.
- |||||||||| Savaysa (edoxaban) / Daiichi Sankyo, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
[VIRTUAL] Management of traumatic intracranial haemorrhage in elderly patients on anticoagulation: a trauma centre experience () - Jan 5, 2021 - Abstract #BSHI2020BSH-I_223;
PCC administration was used less frequently, but was less delayed in Xa‐inhibitor‐associated ICH, which might be relevant in future to administration of the antidote andexanet, although numbers were small...Time to resumption of AC was shorter than recommended and varied widely. Multidisciplinary review of complex cases to consider timing of AC resumption and bleeding risk factor optimisation would help standardise and individualise the best approach.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
[VIRTUAL] Evaluation of fixed 4-factor prothrombin complex concentrate dosing in emergent direct oral anticoagulant reversal in acute major bleeding () - Dec 26, 2020 - Abstract #ASHP2020ASHP_4636;
A targeted antidote for reversal, andexanet alfa is now available, but its cost, high incidence of thrombotic events, and limited availability make this a poor choice in emergent situations...The primary outcome measure will be percentage of patients that achieved clinically meaningful hemostasis, which is defined as a lack of additional 4FPCC or blood products and lack of ongoing bleeding documentation by providers. Secondary outcomes include percentage of patients who experienced thromboembolic events at 30 days and cost of 4FPCC administered.
- |||||||||| Savaysa (edoxaban) / Daiichi Sankyo, Praxbind (idarucizumab) / Boehringer Ingelheim, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
[VIRTUAL] An Assessment of the Appropriate Use of Oral Anticoagulation Reversal Agents According to the University of Pennsylvania Health System (UPHS) Guidelines () - Dec 26, 2020 - Abstract #ASHP2020ASHP_4342;
Purpose: An understanding the clinical profile of the direct oral anticoagulants (DOACs), including the direct thrombin inhibitor, dabigatran and the factor Xa inhibitors, rivaroxaban, apixaban and edoxaban, is critical in establishing comprehensive anticoagulant reversal strategies...Data from the electronic medical record identified patients who received the reversal agents four-factor-prothrombin complex concentrates (4-F-PCCs), idarucizumab, or andexanet alfa, between January 18th, 2018 and June 28th, 2020...Exclusion criteria included patients taking warfarin, duplicate patient encounters, patients less than 18 years of age, and pregnant patients...Descriptive statistics were used to analyze collected data. The University of Pennsylvania institutional review board (IRB) has approved this evaluation.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
[VIRTUAL] Utilization of prothrombin complex concentrate at a community hospital () - Dec 26, 2020 - Abstract #ASHP2020ASHP_4316;
Patients who were included in the sample population for apixaban and rivaroxaban reversal will be further analyzed to determine if patient would have qualified for andexanet alfa based on its dosing approval...PCC dosing received will then be compared with cost of PCC. Once all data has been collected, appropriate statistical analysis will be performed.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
[VIRTUAL] Evaluation of andexanet alfa and four-factor prothrombin complex concentrate guideline adherence at a large academic medical center () - Dec 26, 2020 - Abstract #ASHP2020ASHP_3229;
Overall, andexanet alfa use was consistent with guideline recommendations, however for 4-F PCC there was a larger number of dosing inconsistencies especially in the CT surgery population. We recommend a further analysis of the CT surgery population to determine further adjustments to institutional guideline recommendations and updates to the computerized physician order entry system with 4-F PCC dosing recommendations consistent for the CT surgery population.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
[VIRTUAL] Pharmacist assessment of 4-factor prothrombin complex concentrate use in the setting of urgent anticoagulation reversal () - Dec 26, 2020 - Abstract #ASHP2020ASHP_2298;
It may also be used outside of the Food and Drug Administration (FDA) approved indication for the urgent reversal of oral direct factor Xa inhibitors when andexanet alfa is unavailable...Warfarin reversal required an International Normalized Ratio (INR) of greater than or equal to 1.5...Secondary outcomes evaluated included adverse effects and appropriateness of indications and dose. Data collected from chart reviews included the above criteria for use, anti-Xa and INR lab turn around time, 4-factor PCC order time to administration, post-dose thromboembolic or bleeding events, outpatient anticoagulant and antiplatelet therapy, pre-and post-dose INR, and baseline serum creatinine levels.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
[VIRTUAL] Evaluation of four-factor prothrombin complex concentrate versus andexanet alfa for the reversal of apixaban- or rivaroxaban-associated intracranial hemorrhages () - Dec 26, 2020 - Abstract #ASHP2020ASHP_2033;
The primary outcome is level of hemostasis achieved after administration of the reversal agent as defined by a standardized rating system for effective hemostasis from the International Society of Thrombosis and Haemostasis. Secondary outcomes include hemoglobin change from baseline and 12 hours post-treatment, initial hemorrhage volume as reported on CT scan and 12 and 24 hours post-treatment, rate of adverse events including stroke, myocardial infarction, arterial thromboembolism, deep vein thrombosis, or pulmonary embolism, rate of mortality, and treatment cost.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
[VIRTUAL] Clinical Outcomes and Cost-Analysis of Prothrombin Complex Concentrate (Human) at a Community Hospital () - Dec 26, 2020 - Abstract #ASHP2020ASHP_1219;
Given the potential for cost saving using 4F-PCC fixed dosing, our hospital will be switching from traditional dosing to fixed dosing as recommended in the national guidelines. Randomized clinical trials are still needed to determine the role of andexanet alfa compared to 4-PCC given its high cost, and documented high rate of VTE in the literature (~10%).
- |||||||||| Praxbind (idarucizumab) / Boehringer Ingelheim, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
[VIRTUAL] The Utilization of Anticoagulation Reversal Agents within the New Mexico VA Healthcare System () - Dec 26, 2020 - Abstract #ASHP2020ASHP_1024;
Overall, this medication use evaluation found that 73.5 percent of patients that received an anticoagulant reversal agent were utilized appropriately. However, this did not include patients that were considered inappropriate, but the reversal agent was administered based on clinical judgement.
- |||||||||| Praxbind (idarucizumab) / Boehringer Ingelheim, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
Journal: Current Evidence for Pharmacologic Reversal Using Direct Oral Anticoagulants: What's New? (Pubmed Central) - Dec 20, 2020
Therefore, these antidotes are a significant step towards improving the field of urgent and emergency reversal. From a practical perspective, post-market surveillance will be crucial to monitor the safety and effectiveness of these agents.
- |||||||||| Praxbind (idarucizumab) / Boehringer Ingelheim, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
Journal: Perioperative Management of Anticoagulation. (Pubmed Central) - Dec 18, 2020
Patient specific factors for thromboembolic risk and procedural bleeding risk determine timing of anticoagulation hold prior to and resumption after invasive procedures. Clinical trials and management studies in recent years have helped inform our approach to these patients but much of the guidance is still based on expert consensus.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
Preclinical, Journal: Andexanet versus prothrombin complex concentrates: Differences in reversal of factor Xa inhibitors in in vitro thrombin generation. (Pubmed Central) - Dec 17, 2020
Andexanet alfa (andexanet) is a modified human factor Xa (FXa) approved for anticoagulation reversal in patients with life-threatening bleeding treated with rivaroxaban or apixaban...In the TF-TG assay, 4F-PCC completely reversed warfarin anticoagulation...The data are consistent with healthy volunteer studies where TF-TG is not normalized until inhibitor levels are substantially decreased. Both the theoretical calculations and experimental data demonstrated that 4F-PCCs are only able to normalize TG over a low and narrow range of FXa inhibitor concentrations (<75 ng/mL).
- |||||||||| Journal: How Do I Reverse Oral and Parenteral Anticoagulants? (Pubmed Central) - Nov 25, 2020
So far, there are promising but only limited data on the efficacy of this approach available. Each reversal strategy needs an adequate management beyond the hemostatic treatment (volume replacement, stabilization of homeostasis, e.g., pH and temperature, resumption of anticoagulation after successful treatment of bleeding, etc.) that is crucial for the successful management of acute bleedings, urgent high-risk surgery, thrombolytic therapies or thrombectomies as well as overdosing of anticoagulants.
- |||||||||| Review, Journal: Direct oral anticoagulants: a review on the current role and scope of reversal agents. (Pubmed Central) - Nov 12, 2020
New guideline recommendations prefer direct oral anticoagulants (DOACs) over warfarin in DOAC-eligible patients with atrial fibrillation and patients with venous thromboembolism...In cases of life-threatening or uncontrolled bleeding or when patients require emergency surgery or urgent procedures, idarucizumab has been recently approved for reversal of anticoagulation in dabigatran-treated patients and andexanet alfa for factor Xa inhibitor-treated treated patients. The current review summarizes the current clinical evidence and scope of these agents with the potential impact on DOAC use in clinical practice.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Alexion Pharma
[VIRTUAL] Assay Dependent Reversal of the Oral and Parenteral Anti-Xa Agents By Andexanet Alfa (Poster Hall (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_1864;
The data also points to the varying inhibitory effects of anti-Xa agents which are differentially neutralized by andexanet alfa. These results also underscore that the in-vitro anti-Xa potency of both the oral and parenteral anti-Xa agents does not fully reflect their inhibitory effects on the overall coagulation process.
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