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edoxaban (Savaysa)

Indications: - prevention of venous thromboembolism (non-inferior to warfarin) - prevention of embolic stroke with atrial fibrillation [3,6] - treatment of deep vein thrombosis [6] - treatment of pulmonary embolism [6] - cancer-associated venous thromboembolism [8] Contraindications: - renal failure: eGFR < 30 mL/min - creatinine clearance > 95 ml/min - pregnancy - valvular heart disease - severe obesity - high-risk antiphospholipid antibody syndrome [7] Dosage: - 60 mg PO QD - 30 mg PO QD < 60 kg [3,7] - 15 mg PO QD in elderly > 80 years of age [10] * For use in patients with venous thromboembolism (deep vein thrombosis or pulmonary embolism) only after patient has completed 5 days of LMW heparin or fondaparinux Dosage adjustment in renal failure: - 30 mg PO QD for eGFR of 30-50 mL/m2/min, ;ow body weight or taking strong P-glycoprotein inhibitor [11] - less effective than warfarin in atrial fibrillation patients with a creatinine clearance > 95 ml/min [6] - lack of efficacy for eGFR < 30 mL/min [9] - 30 mg PO QD for patients >= 80 years with atrial fibrillation [11] - also see perioperative anticoagulation Pharmacokinetics: - renal clearance: 35% - time to maximum concentration: 1-2 hours - 1/2life: 5-11 hours - protein binding: 54% Adverse effects: - major bleeding* less frequent than with warfarin - 8.5% vs 10.3% [2] - 2.75% with high-dose, 1.61% with low-dose edoxaban vs 3.43% with warfarin [3] * PER977 may be a useful antidote in treatment of major bleeding [5]; no FDA-approved treatment of bleeding due to edoxaban [6] Bleeding: andexanet reverses factor Xa inhibition Laboratory: - edoxaban in serum/plasma Mechanism of action: - factor Xa inhibitor Notes: - FDA advisory panel recommends approval [4]

Interactions

drug adverse effects of direct oral anticoagulants

General

coagulation factor Xa inhibitor direct oral anticoagulant; novel oral anticoagulant (DOAC, NOAC)

Database Correlations

PUBCHEM correlations

References

  1. Journal Watch Oncology and Hematology June 5, 2012 Preventing Venous Thromboembolism After Joint Replacement Massachusetts Medical Society http://www.jwatch.org (Subsscription required)
  2. The Hokusai-VTE Investigators. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med 2013 Sep 1 PMID: 23991658 http://www.nejm.org/doi/full/10.1056/NEJMoa1306638
  3. Giugliano RP et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2013 Nov 19 PMID: 24251359 http://www.nejm.org/doi/full/10.1056/NEJMoa1310907
  4. Husten L, Sadoughi S, Sofair A FDA Advisory Panel Gives Tepid Support to New Anticoagulant. Physician's First Watch, Nov 3, 2014 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org
  5. Ansell JE et al Use of PER977 to Reverse the Anticoagulant Effect of Edoxaban. N Engl J Med. November 5, 2014. PMID: 25371966 http://www.nejm.org/doi/full/10.1056/NEJMc1411800
  6. FDA News Release. January 8, 2015 FDA approves anti-clotting drug Savaysa Drug approved to treat atrial fibrillation, deep vein thrombosis, and pulmonary embolism. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm429523.htm
  7. Medical Knowledge Self Assessment Program (MKSAP) 17, 19 American College of Physicians, Philadelphia 2015, 2020
  8. Raskob GE, van Es N, Verhamme P et al Edoxaban for the Treatment of Cancer-Associated Venous Thromboembolism. N Engl J Med. Dec 12, 2017 PMID: 29231094 http://www.nejm.org/doi/full/10.1056/NEJMoa1711948
  9. A Pocket Guide to the 2019 Beer's Criteria. American Geriatrics Society
  10. Okumura K, Akao M, Yoshida T et al. Low-dose edoxaban in very elderly patients with atrial fibrillation. N Engl J Med 2020 Aug 30; [e-pub] PMID: 32865374 https://www.nejm.org/doi/10.1056/NEJMoa2012883 - Kuroda M, Tamiya E, Nose T et al Effect of 15-mg Edoxaban on Clinical Outcomes in 3 Age Strata in Older Patients With Atrial Fibrillation.A Prespecified Subanalysis of the ELDERCARE- AF Randomized Clinical Trial. JAMA Cardiol. Published online April 13, 2022. PMID: 35416910 https://jamanetwork.com/journals/jamacardiology/fullarticle/2790738
  11. Zimerman A et al. Dose reduction of edoxaban in patients 80 years and older with atrial fibrillation: Post hoc analysis of the ENGAGE AF-TIMI 48 randomized clinical trial. JAMA Cardiol 2024 Jul 10; [e-pub]. PMID: 38985461 https://jamanetwork.com/journals/jamacardiology/fullarticle/2820443