edoxaban (Savaysa)
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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
* 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
- 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]
- 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
* 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
Mechanism of action
Notes
More general terms
References
- ↑ Journal Watch Oncology and Hematology June 5, 2012 Preventing Venous Thromboembolism After Joint Replacement Massachusetts Medical Society http://www.jwatch.org (Subsscription required)
- ↑ 2.0 2.1 The Hokusai-VTE Investigators. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med 2013 Sep 1 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/23991658 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1306638
- ↑ 3.0 3.1 3.2 3.3 Giugliano RP et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2013 Nov 19 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24251359 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1310907
- ↑ 4.0 4.1 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
- ↑ 5.0 5.1 Ansell JE et al Use of PER977 to Reverse the Anticoagulant Effect of Edoxaban. N Engl J Med. November 5, 2014. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25371966 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMc1411800
- ↑ 6.0 6.1 6.2 6.3 6.4 6.5 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
- ↑ 7.0 7.1 7.2 Medical Knowledge Self Assessment Program (MKSAP) 17, 19 American College of Physicians, Philadelphia 2015, 2020
- ↑ 8.0 8.1 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/29231094 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1711948
- ↑ 9.0 9.1 A Pocket Guide to the 2019 Beer's Criteria. American Geriatrics Society
- ↑ 10.0 10.1 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: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/35416910 https://jamanetwork.com/journals/jamacardiology/fullarticle/2790738