the problem [15:<30 mL/minute, respectively, compared with those with normal renal function (Cl cr ≥80 mL/minute). 1 Systemic exposure increased by 93% in patients undergoing peritoneal dialysis. 1 Systemic exposure also increased in patients with low body weight (e.g., 60 kg), but not influenced by age, gender, or race/ethnicity. 1 Stability Storage Oral Tablet 20 25 C (may be exposed to 15 30 C). 1 Actions Binds directly and selectively to factor Xa; inhibits both free and prothrombinase-bound factor Xa and thrombin-induced platelet aggregation. 1 3 8 23 Inhibition of coagulation factor Xa prevents prothrombin to thrombin conversion and subsequent thrombus formation. 1 3 8 Does not require a cofactor (antithrombin III) to exert anticoagulant activity. 1 Inhibits factor Xa activity and prolongs PT, aPTT, and INR in a dose-dependent manner. 1 23 28 Advice to Patients Importance of taking the drug exactly as prescribed and not discontinuing therapy without first consulting clinician. 1 Importance of informing patients that they may bruise and/or bleed more easily and that a longer than normal time may be required to stop bleeding when taking edoxaban. 1 Importance of patient informing clinicians about any unusual bleeding or bruising during therapy. 1 Importance of advising patients that if a dose is missed, it should be taken as soon as possible on the same day; the regular dosing schedule should be resumed the following day. 1 A dose should not be doubled to make up for a missed dose. 1 Importance of advising patients undergoing neuraxial anesthesia or spinal puncture procedures to immediately report manifestations of spinal or epidural hematoma (e.g., tingling or numbness in lower limbs, muscle weakness, back pain, stool or urine incontinence) to clinician. 1 Importance of patients informing clinicians that they are receiving edoxaban therapy before scheduling any medical, surgical, or invasive procedure, including dental procedures. 1 Importance of women immediately informing clinicians if they are or plan to become pregnant or plan to breast-feed. 1 Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements. 1 Importance of informing patients of other important precautionary information. 1 (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Edoxaban Tosylate Routes Dosage Forms Strengths Brand Names Manufacturer Oral Tablets 15 mg (of edoxaban) Savaysa Daiichi Sankyo 30 mg (of edoxaban) Savaysa Daiichi Sankyo 60 mg (of edoxaban) Savaysa Daiichi Sankyo AHFS DI Essentials. Copyright 2017, Selected Revisions November 12, 2015. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. References 1. Daiichi Sankyo. Savaysa (edoxaban) oral tablets prescribing information. Parsippany, NJ. 2015 Jan. 2. Giugliano RP, Ruff CT, Braunwald E et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med . 2013; 369:2093-104. [PubMed 24251359] 3. Ruff CT, Giugliano RP, Antman EM et al. Evaluation of the novel factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: design and rationale for the Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation-Thrombolysis In Myocardial Infarction study 48 (ENGAGE AF-TIMI 48). Am Heart J . 2010; 160:635-41. [PubMed 20934556] 4. Ruff CT, Giugliano RP, Braunwald E et al. Association between edoxaban dose, concentration, anti-Factor Xa activity, and outcomes: an analysis of data from the randomised, double-blind ENGAGE AF-TIMI 48 trial. Lancet . 2015; :. 5. Ruff CT, Giugliano RP, Braunwald E et al. Transition of patients from blinded study drug to open-label anticoagulation: the ENGAGE AF-TIMI 48 trial. J Am Coll Cardiol . 2014; 64:576-84. [PubMed 25104527] 6. O'Donoghue ML, Ruff CT, Giugliano RP et al. Edoxaban vs. warfarin in vitamin K antagonist experienced and naive patients with atrial fibrillation†. Eur Heart J . 2015; :. 7. Giugliano RP, Ruff CT, Rost NS et al. Cerebrovascular events in 21 105 patients with atrial fibrillation randomized to edoxaban versus warfarin: Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48. Stroke . 2014; 45:2372-8. [PubMed 24947287] 8. Minor C, Tellor KB, Armbruster AL. Edoxaban, a Novel Oral Factor Xa Inhibitor. Ann Pharmacother . 2015; :. [PubMed 25855704] 9. . Edoxaban (Savaysa)--the fourth new oral anticoagulant. Med Lett Drugs Ther . 2015; 57:43-5. [PubMed 25853577] 10. Chung N, Jeon HK, Lien LM et al. Safety of edoxaban, an oral factor Xa inhibitor, in Asian patients with non-valvular atrial fibrillation. Thromb Haemost . 2011; 105:535-44. [PubMed 21136011] 11. Eikelboom JW, Vanassche T, Connolly SJ. Switching patients from blinded study drug to warfarin at the end of the ENGAGE AF-TIMI 48 trial: setting a new standard. J Am Coll Cardiol . 2014; 64:585-7. [PubMed 25104528] 12. Patel MR, Washam JB. Edoxaban and the need for outcomes-based NOAC dosing. Lancet . 2015; :. 13. Salazar DE, Mendell J, Kastrissios H et al. Modelling and simulation of edoxaban exposure and response relationships in patients with atrial fibrillation. Thromb Haemost . 2012; 107:925-36. [PubMed 22398655] 14. Weitz JI, Connolly SJ, Patel I et al. Randomised, parallel-group, multicentre, multinational phase 2 study comparing edoxaban, an oral factor Xa inhibitor, with warfarin for stroke prevention in patients with atrial fibrillation. Thromb Haemost . 2010; 104:633-41. [PubMed 20694273] 15. Daiichi Sankyo, Parsipanny, NJ: Personal communication. 16. Hokusai-VTE Investigators, Büller HR, Décousus H et al. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med . 2013; 369:1406-15. [PubMed 23991658] 17. Raskob G, Büller H, Prins M et al. Edoxaban for the long-term treatment of venous thromboembolism: rationale and design of the Hokusai-venous thromboembolism study--methodological implications for clinical trials. J Thromb Haemost . 2013; 11:1287-94. [PubMed 23574579] 20. Morishima Y, Kamisato C. Laboratory measurements of the oral direct factor Xa inhibitor edoxaban: comparison of prothrombin time, activated partial thromboplastin time, and thrombin generation assay. Am J Clin Pathol . 2015; 143:241-7. [PubMed 25596250] 21. Cuker A, Husseinzadeh H. Laboratory measurement of the anticoagulant activity of edoxaban: a systematic review. J Thromb Thrombolysis . 2015; 39:288-94. [PubMed 25669624] 22. Mikkaichi T, Yoshigae Y, Masumoto H et al. Edoxaban transport via P-glycoprotein is a key factor for the drug's disposition. Drug Metab Dispos . 2014; 42:520-8. [PubMed 24459178] 23. Lip GY, Agnelli G. Edoxaban: a focused review of its clinical pharmacology. Eur Heart J . 2014; 35:1844-55. [PubMed 24810388] 24. Yin OQ, Tetsuya K, Miller R. Edoxaban population pharmacokinetics and exposure-response analysis in patients with non-valvular atrial fibrillation. Eur J Clin Pharmacol . 2014; 70:1339-51. [PubMed 25168620] 26. Mendell J, Noveck RJ, Shi M. A randomized trial of the safety, pharmacokinetics and pharmacodynamics of edoxaban, an oral factor Xa inhibitor, following a switch from warfarin. Br J Clin Pharmacol . 2013; 75:966-78. [PubMed 22924409] 27. Mendell J, Tachibana M, Shi M et al. Effects of food on the pharmacokinetics of edoxaban, an oral direct factor Xa inhibitor, in healthy volunteers. J Clin Pharmacol . 2011; 51:687-94. [PubMed 20534818] 28. Ogata K, Mendell-Harary J, Tachibana M et al. Clinical safety, tolerability, pharmacokinetics, and pharmacodynamics of the novel factor Xa inhibitor edoxaban in healthy volunteers. J Clin Pharmacol . 2010; 50:743-53. [PubMed 20081065] 29. Zahir H, Matsushima N, Halim AB et al. Edoxaban administration following enoxaparin: a pharmacodynamic, pharmacokinetic, and tolerability assessment in human subjects. Thromb Haemost . 2012; 108:166-75. [PubMed 22628060] 30. Mendell J, Noveck RJ, Shi M. Pharmacokinetics of the direct factor Xa inhibitor edoxaban and digoxin administered alone and in combination. J Cardiovasc Pharmacol . 2012; 60:335-41. [PubMed 23064240] 31. Mendell J, Zahir H, Matsushima N et al. Drug-drug interaction studies of cardiovascular drugs involving P-glycoprotein, an efflux transporter, on the pharmacokinetics of edoxaban, an oral factor Xa inhibitor. Am J Cardiovasc Drugs . 2013; 13:331-42. [PubMed 23784266] 32. Lamberts M, Lip GY, Hansen ML et al. Relation of nonsteroidal anti-inflammatory drugs to serious bleeding and thromboembolism risk in patients with atrial fibrillation receiving antithrombotic therapy: a nationwide cohort study. Ann Intern Med . 2014; 161:690-8. [PubMed 25402512] 33. Mendell J, Lee F, Chen S et al. The effects of the antiplatelet agents, aspirin and naproxen, on pharmacokinetics and pharmacodynamics of the anticoagulant edoxaban, a direct factor Xa inhibitor. J Cardiovasc Pharmacol . 2013; 62:212-21. [PubMed 23615159] 34. Zahir H, Brown KS, Vandell AG et al. Edoxaban effects on bleeding following punch biopsy and reversal by a 4-factor prothrombin complex concentrate. Circulation . 2015; 131:82-90. [PubMed 25403645] 35. Greinacher A, Thiele T, Selleng K. Reversal of anticoagulants: an overview of current developments. Thromb Haemost . 2015; 113:. [PubMed 25832311] 70. Potpara TS, Lip GY, Apostolakis S. New anticoagulant treatments to protect against stroke in atrial fibrillation. Heart . 2012; 98:1341-7. [PubMed 22730480] 73. Christensen TD, Hasenkam JM, Larsen TB. Letter by christensen et Al regarding article, new oral anticoagulants should not be used as first-line agents to prevent thromboembolism in patients with atrial fibrillation . 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Next Interactions Print this page Add to My Med List More about edoxaban Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En Español 1 Review Add your own review/rating Drug class: factor Xa inhibitors Consumer resources Edoxaban Edoxaban (Advanced Reading) Professional resources Edoxaban (Wolters Kluwer) Other brands: Savaysa Related treatment guides Pulmonary Embolism Atrial Fibrillation Deep Vein Thrombosis Prevention of Thromboembolism in Atrial Fibrillation> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Factor Xa inhibitors Related Drugs Atrial Fibrillation diltiazem , Xarelto , propranolol , digoxin , sotalol , flecainide , More... Prevention of Thromboembolism in Atrial Fibrillation aspirin , warfarin , Xarelto , Eliquis , Coumadin , More... Deep Vein Thrombosis Xarelto , Eliquis , Pradaxa , apixaban , Lovenox , enoxaparin , More... Pulmonary Embolism Xarelto , Eliquis , Pradaxa , apixaban , rivaroxaban , heparin , More... Edoxaban Rating 1 User Review 1.0 /10 1 User Review 1.0 Rate it!} } do not forget that
for this reason Edoxaban Tosylate for enhancing
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