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Andexxa

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1. A New Option for Reversing the Anticoagulant Effect of Factor Xa Inhibitors: Andexanet alfa (Andexxa®). (PubMed)

A New Option for Reversing the Anticoagulant Effect of Factor Xa Inhibitors: Andexanet alfa (Andexxa®). The use of direct oral anticoagulants over traditional warfarin has increased in the United States over the past 10 years because of advantages such as ease of use, predictable pharmacokinetic response, and safety. In 2015, the U.S. Food and Drug Administration approved idarucizumab (Praxbind) for the reversal of the direct thrombin inhibitor dabigatran, but no reversal agent has been (...) available for oral factor Xa (FXa) inhibitors until recently. Andexanet alfa was approved in May 2018, under the brand name ANDEXXA, for the reversal of 2 of FXa inhibitors, apixaban and rivaroxaban, when life-threatening or uncontrolled bleeding occurs. This accelerated approval was based on change in anti-FXa activity from baseline that indicated a reversal of the anticoagulant effect. Any expanded Food and Drug Administration indication will be contingent on results demonstrating improved hemostasis

2018 American Journal of Medicine

2. Andexxa

Andexxa Andexxa Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 Andexxa Andexxa Aka: Andexxa , Inactivated recombinant factor Xa From (...) Related Chapters II. Background Planned release 2018 in U.S. III. Mechanism Antidote for ( ) or ( ), but not other s Binds s IV. Efficacy Limits progression of bleeding within 12 hours of dose (onset as early as 1 hour) V. Adverse Effects Expensive: $25,000 to 50,000 per patient Risk of complications (CVA, VTE) VI. References (2018) Presc Lett 25(7): 37-8 Images: Related links to external sites (from Bing) These images are a random sampling from a Bing search on the term "Andexxa." Click on the image

2018 FP Notebook

3. Andexxa

Andexxa Andexxa Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 Andexxa Andexxa Aka: Andexxa , Inactivated recombinant factor Xa From (...) Related Chapters II. Background Planned release 2018 in U.S. III. Mechanism Antidote for ( ) or ( ), but not other s Binds s IV. Efficacy Limits progression of bleeding within 12 hours of dose (onset as early as 1 hour) V. Adverse Effects Expensive: $25,000 to 50,000 per patient Risk of complications (CVA, VTE) VI. References (2018) Presc Lett 25(7): 37-8 Images: Related links to external sites (from Bing) These images are a random sampling from a Bing search on the term "Andexxa." Click on the image

2018 FP Notebook

4. Pharmaceutical Approval Update (PubMed)

Pharmaceutical Approval Update Fostamatinib (Tavalisse) for thrombocytopenia in adults with chronic immune thrombocytopenia; coagulation factor Xa (recombinant), inactivated-zhzo (Andexxa) for the reversal of anticoagulation; epoetin alfa-epbx (Retacrit), a biosimilar for the treatment of anemia.

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2018 Pharmacy and Therapeutics

5. Andexanet Alfa: First Global Approval (PubMed)

Andexanet Alfa: First Global Approval 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. In May 2018, andexanet alfa received its first global approval in the USA for use in patients treated with rivaroxaban and apixaban, when reversal

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2018 Drugs

6. Andexanet alfa in the treatment of acute major bleeding related to apixaban and rivaroxaban: a profile of its use in the USA (PubMed)

Andexanet alfa in the treatment of acute major bleeding related to apixaban and rivaroxaban: a profile of its use in the USA Andexanet alfa (Andexxa®), a first-in-class recombinant modified factor Xa protein, is currently the only specific agent available to reverse life-threatening or uncontrolled bleeding with the factor Xa inhibitors apixaban and rivaroxaban. Andexanet alfa acts as a decoy and competes with endogenous factor Xa to bind factor Xa inhibitors, thereby reversing

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2018 Drugs & Therapy Perspectives

7. Factor Xa Inhibitor

: Factor Xa Inhibitor , FXa Inhibitor , Direct Factor Xa Inhibitors , Betrixiban , Andexxa From Related Chapters II. Class Direct Factor Xa Inhibitor Factor Xa is the first step in the III. Mechanism: Based on naturally occurring substances Antistasin Isolated in 1980s from Mexican leach extract Tick peptide (TAP) Isolated from the tick Ornithodoros moubata IV. Preparations ( ) in (especially in Deep Vein ) Oral for as a second line alternative to or ( ) Bridging to and early cardioversion in (ideal (...) . immobility, age) Expensive ($600) for an NNT 167 to prevent 1 VTE, and NNH 90 for 1 signficant bleeding episode ( ) Otamixaban V. Management: Reversal ral measures Stop offending Xa agent Consider if presenting within 2 hours of suspected ingestion Bleeding unlikely due to Xa agent if Anti-Xa level <0.1 IU/ml is not effective (protein bound) No human data to suggest any non-specific reversal agent is significantly effective For serious, life threatening bleeding (e.g. CNS following ) See Andexxa

2018 FP Notebook

10. Stroke Anticoagulation and Prophylaxis (Diagnosis)

=0.01%) compared with warfarin. [ ] In May 2018, (AndexXa) was approved for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed because of life-threatening or uncontrolled bleeding. Approval was supported by data from two Phase 3 ANNEXA studies (ANNEXA-R and ANNEXA-A), which evaluated the safety and efficacy of Andexxa in reversing the anticoagulant activity of the Factor Xa inhibitors rivaroxaban and apixaban in healthy older volunteers. Results demonstrated

2014 eMedicine.com

12. Stroke Anticoagulation and Prophylaxis (Treatment)

=0.01%) compared with warfarin. [ ] In May 2018, (AndexXa) was approved for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed because of life-threatening or uncontrolled bleeding. Approval was supported by data from two Phase 3 ANNEXA studies (ANNEXA-R and ANNEXA-A), which evaluated the safety and efficacy of Andexxa in reversing the anticoagulant activity of the Factor Xa inhibitors rivaroxaban and apixaban in healthy older volunteers. Results demonstrated

2014 eMedicine.com

14. Stroke Anticoagulation and Prophylaxis (Overview)

=0.01%) compared with warfarin. [ ] In May 2018, (AndexXa) was approved for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed because of life-threatening or uncontrolled bleeding. Approval was supported by data from two Phase 3 ANNEXA studies (ANNEXA-R and ANNEXA-A), which evaluated the safety and efficacy of Andexxa in reversing the anticoagulant activity of the Factor Xa inhibitors rivaroxaban and apixaban in healthy older volunteers. Results demonstrated

2014 eMedicine.com

15. Stroke Anticoagulation and Prophylaxis (Follow-up)

=0.01%) compared with warfarin. [ ] In May 2018, (AndexXa) was approved for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed because of life-threatening or uncontrolled bleeding. Approval was supported by data from two Phase 3 ANNEXA studies (ANNEXA-R and ANNEXA-A), which evaluated the safety and efficacy of Andexxa in reversing the anticoagulant activity of the Factor Xa inhibitors rivaroxaban and apixaban in healthy older volunteers. Results demonstrated

2014 eMedicine.com

16. Perioperative Anticoagulation Management

bleeding (with slight oozing), while just one had moderately abnormal yet controlled bleeding. Among 35 of 51 patients who had serious bleeding were able to be assessed, hemostasis, as determined by local investigators, was restored at a median of 11.4 hours. [ ] In May 2018, (AndexXa) was approved for patients treated with or , when reversal of anticoagulation is needed because of life-threatening or uncontrolled bleeding. Approval was supported by data from two Phase 3 ANNEXA studies (ANNEXA-R (...) and ANNEXA-A), which evaluated the safety and efficacy of Andexxa in reversing the anticoagulant activity of the Factor Xa inhibitors rivaroxaban and apixaban in healthy older volunteers. Results demonstrated a rapid and significant reversal of anti-Factor Xa (FXa) activity. Anti-FXa activity was reduced among apixaban-treated participants by 94% compared with 21% for placebo (p<0.001). A 92% reduction of anti-FXa activity was observed in the rivaroxaban-treated participants compared with 18% for placebo

2014 eMedicine.com

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