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Savaysa
edoxaban
Black Box Warnings .
Reduced Efficacy in Non-valvular Afib Pts w/ CrCl >95 mL/min
incr. ischemic stroke risk in pts on edoxaban 60 mg/day compared to pts on warfarin; use another anticoagulant in these pts
Premature Tx Discontinuation
incr. ischemic event risk when D/C edoxaban for reasons other than pathological bleeding or completion of therapy course; if must D/C edoxaban, consider administering another anticoagulant
Epidural/Spinal Hematoma Risk
epidural/spinal hematoma risk after epidural/spinal anesthesia or spinal puncture in anticoagulated pts; hematoma may result in long-term or permanent paralysis; incr. risk if indwelling epidural catheter use, concomitant use of drugs affecting hemostasis incl. NSAIDs, platelet inhibitors, or other anticoagulants, traumatic or repeated epidural or spinal puncture hx, spinal deformity, or spinal surgery hx; monitor s/sx neurologic impairment, treat urgently if needed; consider benefit vs. risk before neuraxial intervention in anticoagulated pts or planned anticoagulation for thromboprophylaxis
Adult Dosing .
Dosage forms: TAB: 15 mg, 30 mg, 60 mg
thromboembolism/stroke prevention
- [60 mg PO qd]
- Info: for non-valvular atrial fibrillation w/o moderate-severe mitral stenosis or mechanical heart valve; to convert from UFH infusion, start edoxaban 4h after UFH D/C; to convert from warfarin, D/C warfarin, then start edoxaban when INR <2.5; to convert from other anticoagulants, D/C anticoagulant, then start edoxaban at next scheduled dose; depending on bleeding risk, consider holding tx 1-2 days before surgery or invasive procedure; resume tx >24h postop
DVT/PE tx
- [<60 kg]
- Dose: 30 mg PO qd; Start: after 5-10 days of parenteral anticoagulant tx; Info: to convert from UFH infusion, start edoxaban 4h after UFH D/C; to convert from warfarin, D/C warfarin, then start edoxaban when INR <2.5; to convert from other anticoagulants, D/C anticoagulant, then start edoxaban at next scheduled dose; depending on bleeding risk, consider holding tx 1-2 days before surgery or invasive procedure; resume tx >24h postop
- [>60 kg]
- Dose: 60 mg PO qd; Start: after 5-10 days of parenteral anticoagulant tx; Info: to convert from UFH infusion, start edoxaban 4h after UFH D/C; to convert from warfarin, D/C warfarin, then start edoxaban when INR <2.5; to convert from other anticoagulants, D/C anticoagulant, then start edoxaban at next scheduled dose; depending on bleeding risk, consider holding tx 1-2 days before surgery or invasive procedure; resume tx >24h postop
renal dosing
- [thromboembolism/stroke prophylaxis]
- CrCl >95: avoid use; CrCl 51-95: 60 mg qd; CrCl 15-50: 30 mg qd; CrCl <15: avoid use
- HD/PD: avoid use
- [DVT/PE tx]
- CrCl 15-50: 30 mg qd; CrCl <15: avoid use
- HD/PD: avoid use
hepatic dosing
- [see below]
- Child-Pugh Class B or C: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- pregnancy
- bleeding, active major
- antiphospholipid syndrome
- hepatic impairment, Child-Pugh Class B-C
- CrCl >95 (thromboembolism prevention or stroke prevention use)
- CrCl <15
- caution: CrCl 15-50
- caution: wt <60 kg (DVT or PE use)
- caution: pts of childbearing potential
- caution: bleeding risk
- caution: spinal puncture
- caution: epidural anesthesia use
- caution: spinal anesthesia use, concurrent
Drug Interactions .
Overview
edoxaban
factor Xa inhibitor
- P-gp substrate
- anticoagulant
Contraindicated
- defibrotide
- mifepristone
Avoid/Use Alternative
- alteplase
- anagrelide
- antithrombin
- apalutamide
- apixaban
- argatroban
- bivalirudin
- caplacizumab
- carbamazepine
- citalopram
- collagenase clostridium histolyticum
- dabigatran
- dalteparin
- danshen
- desvenlafaxine
- dicloxacillin
- duloxetine
- efavirenz
- enoxaparin
- escitalopram
- fluoxetine
- fluvoxamine
- fondaparinux
- fosphenytoin
- heparin
- ibritumomab tiuxetan
- levomilnacipran
- lifileucel
- lorlatinib
- lumacaftor/ivacaftor
- milnacipran
- paroxetine
- phenobarbital
- phenytoin
- primidone
- reteplase
- rifabutin
- rifampin
- rifapentine
- rivaroxaban
- sertraline
- St. John's wort
- tenecteplase
- tipranavir
- trazodone
- turmeric
- venlafaxine
- vilazodone
- vortioxetine
- warfarin
Monitor/Modify Tx
- abrocitinib
- acalabrutinib
- adagrasib
- ado-trastuzumab emtansine
- aducanumab
- afatinib
- amiodarone
- anacaulase topical
- asciminib
- asparaginase
- aspirin
- avapritinib
- axitinib
- azithromycin
- belumosudil
- berotralstat
- bevacizumab
- binimetinib
- bisoprolol
- brentuximab vedotin
- brigatinib
- bromelain
- bromfenac ophthalmic
- cabazitaxel
- cabozantinib
- calaspargase
- canagliflozin
- cangrelor
- cannabidiol
- capmatinib
- captopril
- carfilzomib
- carvedilol
- cefaclor
- cefadroxil
- cefazolin
- cefdinir
- cefepime
- cefixime
- cefotetan
- cefoxitin
- cefpodoxime
- cefprozil
- ceftazidime
- ceftriaxone
- cefuroxime axetil
- cefuroxime sodium
- celecoxib
- cephalexin
- cilostazol
- cimetidine
- clarithromycin
- clopidogrel
- cobicistat
- conivaptan
- cyclosporine
- cysteamine
- danicopan
- daridorexant
- darunavir
- dasatinib
- deferasirox
- deuruxolitinib
- diclofenac
- diclofenac ophthalmic
- diclofenac topical
- diflunisal
- diltiazem
- dimethyl fumarate
- diosmin
- dipyridamole
- diroximel fumarate
- donanemab
- dronedarone
- elacestrant
- elagolix
- elexacaftor/tezacaftor/ivacaftor
- eliglustat
- enasidenib
- encorafenib
- entrectinib
- enzalutamide
- epoprostenol
- eptifibatide
- erdafitinib
- erlotinib
- erythromycin
- ethanol
- etodolac
- evening primrose oil
- felodipine
- fenoprofen
- fenugreek
- flibanserin
- flurbiprofen
- flurbiprofen ophthalmic
- fostamatinib
- fruquintinib
- futibatinib
- garlic
- gefitinib
- gemtuzumab ozogamicin
- gilteritinib
- ginkgo
- glecaprevir
- hydrocortisone
- ibrutinib
- ibuprofen
- ibuprofen lysine
- icosapent ethyl
- iloprost inhaled
- imatinib
- indomethacin
- isavuconazonium
- istradefylline
- itraconazole
- ivacaftor
- ketoconazole
- ketoprofen
- ketorolac
- ketorolac ophthalmic
- lapatinib
- lasmiditan
- lecanemab
- ledipasvir
- lenacapavir
- lenvatinib
- levacetylleucine
- levoketoconazole
- lomitapide
- lonafarnib
- lopinavir/ritonavir
- magnesium salicylate
- maribavir
- mavorixafor
- meclofenamate
- mefenamic acid
- meloxicam
- methotrexate
- methyl salicylate topical
- milk thistle
- mirabegron
- mitapivat
- mitotane
- monomethyl fumarate
- mycophenolate mofetil
- mycophenolic acid
- nabumetone
- naproxen
- nattokinase
- nefazodone
- nelfinavir
- nepafenac ophthalmic
- neratinib
- niacin (vitamin B3)
- nifedipine
- nilotinib
- nintedanib
- nusinersen
- omega-3-acid
- osimertinib
- oxaliplatin
- oxaprozin
- pacritinib
- pazopanib
- pegaspargase
- penicillin G
- pentosan polysulfate sodium
- pentoxifylline
- pibrentasvir
- piperacillin
- piroxicam
- pirtobrutinib
- plasminogen, human
- ponatinib
- porfimer
- posaconazole
- pralsetinib
- prasugrel
- pretomanid
- propafenone
- quercetin
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- quinine
- ramucirumab
- ranibizumab
- ranolazine
- regorafenib
- resveratrol
- revakinagene taroretcel
- ritonavir
- rolapitant
- rucaparib
- salsalate
- sarecycline
- saw palmetto
- selpercatinib
- selumetinib
- sirolimus albumin-bound
- sorafenib
- sotagliflozin
- sotatercept
- sotorasib
- sparsentan
- stiripentol
- sugammadex
- sulindac
- sunitinib
- suvorexant
- tacrolimus
- telmisartan
- temsirolimus
- tepotinib
- testosterone
- tezacaftor/ivacaftor
- ticagrelor
- tirofiban
- tisotumab vedotin
- tivozanib
- tolmetin
- tolvaptan
- tovorafenib
- trametinib
- treprostinil
- trimethoprim
- tucatinib
- upadacitinib
- uridine triacetate
- vadadustat
- valbenazine
- valproic acid
- vandetanib
- vanzacaftor/tezacaftor/deutivacaftor
- velpatasvir
- vemurafenib
- venetoclax
- verapamil
- vimseltinib
- vinpocetine
- voclosporin
- vorapaxar
- voxilaprevir
- willow bark
- xanomeline
- zanubrutinib
- ziv-aflibercept
- zonisamide
Caution Advised
- meropenem
- oxcarbazepine
- vaborbactam
Adverse Reactions .
Serious Reactions
- epidural hematoma
- spinal hematoma
- bleeding, severe
- thrombosis if premature D/C
- thrombocytopenia
- angioedema
- nephropathy
Common Reactions
- bleeding
- anemia
- rash
- ALT or AST elevated
Safety/Monitoring .
Monitoring Parameters
LFTs at baseline, then periodically; Cr at baseline, then q6-12mo if CrCl >50 or q3mo if CrCl <50
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use during pregnancy; inadequate human data available; no known risk of teratogenicity, though risk of hemorrhage in pregnant pts and embryo-fetal death based on animal data at up to 49x MRHD; risk of hemorrhage in pregnant pts during delivery and fetal bleeding based on drug's mechanism of action
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm, though possible drug excretion into milk based on drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: minimal; CYP450: 3A4 substrate
Excretion: urine 50% (primarily unchanged), bile, feces, other; Half-life: 10-14h
Subclass: Anticoagulants
Mechanism of Action
selectively blocks active site of factor Xa, inhibiting blood coagulation (factor Xa inhibitor)
Formulary .
No Formulary Selected
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