edoxaban (Rx)

Brand and Other Names:Savaysa
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 15mg
  • 30mg
  • 60mg

Stroke Prophylaxis with Atrial Fibrillation

Indicated to reduce risk of stroke and systemic embolism associated with nonvalvular atrial fibrillation (NVAF)

60 mg PO qDay

Limitation of use

  • CrCL >95 mL/min: Do not use; increased risk of ischemic stroke compared with warfarin in NVAF trial (see Black Box Warnings)

DVT or PE Treatment

Indicated for treatment of deep vein thrombosis (DVT) and pulmonary embolus (PE) in patients who have been initially treated with a parenteral anticoagulant for 5-10 days

>60 kg: 60 mg PO qDay

≤60 kg: 30 mg PO qDay

Dosage Modifications

Treatment of DVT/PE: Decrease dose to 30 mg PO qDay when coadministered with certain P-gp inhibitors (see Drug Interactions)

Renal impairment (NVAF)

  • CrCl >95 mL/min: Do not use; increased ischemic stroke compared with warfarin (see Black Box Warnings)
  • CrCl >50 to 95 mL/min: No dosage adjustment required
  • CrCl 15-50 mL/min: 30 mg PO qDay

Renal impairment (DVT/PE)

  • >50 mL/min: No dosage adjustment required
  • 15-50 mL/min: 30 mg PO qDay

Hepatic impairment

  • Mild (Child-Pugh A): No dose adjustment required
  • Moderate-to-severe (Child-Pugh B/C): Not recommended; these patients have intrinsic coagulation abnormalities

Transition dosing to or from edoxaban

Transition to edoxaban

  • From warfarin or other vitamin K antagonists (VKAs): Discontinue warfarin and start edoxaban when INR ≤2.5
  • From oral anticoagulants other than warfarin or other VKAs: Discontinue current oral anticoagulant and initiate edoxaban at the time of the next scheduled dose of the previous oral anticoagulant
  • From low molecular weight heparin (LMWH): Discontinue LMWH and initiate edoxaban at the time of the next scheduled administration of LMWH
  • From unfractionated heparin: Discontinue heparin infusion and initiate edoxaban 4 hr later

Transition from edoxaban

  • To non-vitamin-K-dependent oral anticoagulants: Discontinue edoxaban and start the other oral anticoagulant at the time of the next dose of edoxaban
  • To parenteral anticoagulants: Discontinue edoxaban and start the parenteral anticoagulant at the time of the next dose of edoxaban
  • To warfarin (oral option)
    • If taking edoxaban 60 mg/day, reduce dose to 30 mg/day and begin warfarin concomitantly
    • If taking edoxaban 30 mg/day, reduce dose to 15 mg/day and begin warfarin concomitantly
    • INR must be measured at least weekly and just prior to the daily dose of edoxaban to minimize the influence on INR measurements
    • Once a stable INR ≥2.0 is achieved, discontinue edoxaban and continue warfarin
  • To warfarin (parenteral option)
    • Discontinue edoxaban and administer a parenteral anticoagulant and warfarin at the time of the next scheduled edoxaban dose
    • Once a stable INR ≥2.0 is achieved, discontinue the parenteral anticoagulant and continue warfarin

Safety and efficacy not established

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Interactions

Interaction Checker

and edoxaban

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            Contraindicated (1)

            • defibrotide

              edoxaban increases effects of defibrotide by pharmacodynamic synergism. Contraindicated. Coadministration of defibrotide is contraindicated with antithrombotic/fibrinolytic drugs. This does not include use for routine maintenance or reopening of central venous lines.

            Serious - Use Alternative (80)

            • abiraterone

              abiraterone will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • afatinib

              afatinib will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • amiodarone

              amiodarone will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • apixaban

              edoxaban, apixaban. Either increases toxicity of the other by anticoagulation. Avoid or Use Alternate Drug. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss. Long-term concomitant treatment with edoxaban and other anticoagulants is not recommended. Short-term coadministration may be needed for patients transitioning to or from edoxaban.

            • argatroban

              edoxaban, argatroban. Either increases toxicity of the other by anticoagulation. Avoid or Use Alternate Drug. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss. Long-term concomitant treatment with edoxaban and other anticoagulants is not recommended. Short-term coadministration may be needed for patients transitioning to or from edoxaban.

            • atorvastatin

              atorvastatin will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • betrixaban

              edoxaban, betrixaban. Either increases levels of the other by anticoagulation. Contraindicated. Therapeutic duplication; may use temporarily when switching anticoagulants.

            • bivalirudin

              edoxaban, bivalirudin. Either increases toxicity of the other by anticoagulation. Avoid or Use Alternate Drug. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss. Long-term concomitant treatment with edoxaban and other anticoagulants is not recommended. Short-term coadministration may be needed for patients transitioning to or from edoxaban.

            • carbamazepine

              carbamazepine will decrease the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration of edoxaban with potent P-gp inducers

            • carvedilol

              carvedilol will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • clarithromycin

              clarithromycin will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • cobicistat

              cobicistat will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • crizotinib

              crizotinib will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • cyclosporine

              cyclosporine will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • dabigatran

              edoxaban, dabigatran. Either increases toxicity of the other by anticoagulation. Avoid or Use Alternate Drug. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss. Long-term concomitant treatment with edoxaban and other anticoagulants is not recommended. Short-term coadministration may be needed for patients transitioning to or from edoxaban.

            • dalteparin

              edoxaban, dalteparin. Either increases toxicity of the other by anticoagulation. Avoid or Use Alternate Drug. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss. Long-term concomitant treatment with edoxaban and other anticoagulants is not recommended. Short-term coadministration may be needed for patients transitioning to or from edoxaban.

            • darunavir

              darunavir will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • dipyridamole

              dipyridamole will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • doxorubicin liposomal

              doxorubicin liposomal will decrease the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration of edoxaban with potent P-gp inducers

            • dronedarone

              dronedarone will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • eliglustat

              eliglustat will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • elvitegravir/cobicistat/emtricitabine/tenofovir DF

              elvitegravir/cobicistat/emtricitabine/tenofovir DF will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • enoxaparin

              edoxaban, enoxaparin. Either increases toxicity of the other by anticoagulation. Avoid or Use Alternate Drug. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss. Long-term concomitant treatment with edoxaban and other anticoagulants is not recommended. Short-term coadministration may be needed for patients transitioning to or from edoxaban.

            • erdafitinib

              erdafitinib will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If coadministration unavoidable, separate administration by at least 6 hr before or after administration of P-gp substrates with narrow therapeutic index.

            • erythromycin base

              erythromycin base will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • erythromycin ethylsuccinate

              erythromycin ethylsuccinate will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • erythromycin lactobionate

              erythromycin lactobionate will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • erythromycin stearate

              erythromycin stearate will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • etravirine

              etravirine will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • Factor X, human

              edoxaban will decrease the level or effect of Factor X, human by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Based on the mechanism of action, Factor X is likely to be counteracted by direct and indirect Factor Xa inhibitors.

            • fosphenytoin

              fosphenytoin will decrease the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration of edoxaban with potent P-gp inducers

            • grapefruit

              grapefruit will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • heparin

              edoxaban, heparin. Either increases toxicity of the other by anticoagulation. Avoid or Use Alternate Drug. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss. Long-term concomitant treatment with edoxaban and other anticoagulants is not recommended. Short-term coadministration may be needed for patients transitioning to or from edoxaban.

            • ibrutinib

              ibrutinib will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • itraconazole

              itraconazole will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • ketoconazole

              ketoconazole will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • lapatinib

              lapatinib will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • lasmiditan

              lasmiditan increases levels of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

            • ledipasvir/sofosbuvir

              ledipasvir/sofosbuvir will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • lomitapide

              lomitapide will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • lopinavir

              lopinavir will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • mefloquine

              mefloquine will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • nefazodone

              nefazodone will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

            • nelfinavir

              nelfinavir will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • nicardipine

              nicardipine will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • nifedipine

              nifedipine will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • nilotinib

              nilotinib will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • ombitasvir/paritaprevir/ritonavir & dasabuvir

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • paliperidone

              paliperidone will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • phenobarbital

              phenobarbital will decrease the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration of edoxaban with potent P-gp inducers

            • phenytoin

              phenytoin will decrease the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration of edoxaban with potent P-gp inducers

            • ponatinib

              ponatinib will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • posaconazole

              posaconazole will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • primidone

              primidone will decrease the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration of edoxaban with potent P-gp inducers

            • progesterone micronized

              progesterone micronized will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • propafenone

              propafenone will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • propranolol

              propranolol will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • quinidine

              quinidine will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • quinine

              quinine will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • ranolazine

              ranolazine will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • rifampin

              rifampin will decrease the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration of edoxaban with potent P-gp inducers

            • ritonavir

              ritonavir will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • rivaroxaban

              edoxaban, rivaroxaban. Either increases toxicity of the other by anticoagulation. Avoid or Use Alternate Drug. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss. Long-term concomitant treatment with edoxaban and other anticoagulants is not recommended. Short-term coadministration may be needed for patients transitioning to or from edoxaban.

            • saquinavir

              saquinavir will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • sotorasib

              sotorasib will decrease the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If use is unavoidable, refer to the prescribing information of the P-gp substrate for dosage modifications.

            • St John's Wort

              St John's Wort will decrease the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration of edoxaban with potent P-gp inducers

            • sunitinib

              sunitinib will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • suvorexant

              suvorexant will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • tacrolimus

              tacrolimus will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • tamoxifen

              tamoxifen will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • tenofovir DF

              tenofovir DF will decrease the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration of edoxaban with potent P-gp inducers

            • tepotinib

              tepotinib will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If concomitant use unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.

            • tipranavir

              tipranavir will decrease the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration of edoxaban with potent P-gp inducers

            • ulipristal

              ulipristal will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • vandetanib

              vandetanib will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • vemurafenib

              vemurafenib will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • verapamil

              verapamil will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • vinblastine

              vinblastine will decrease the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration of edoxaban with potent P-gp inducers

            • warfarin

              edoxaban, warfarin. Either increases toxicity of the other by anticoagulation. Avoid or Use Alternate Drug. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss. Long-term concomitant treatment with edoxaban and other anticoagulants is not recommended. Short-term coadministration may be needed for patients transitioning to or from edoxaban.

            • zanubrutinib

              edoxaban, zanubrutinib. Either increases effects of the other by anticoagulation. Avoid or Use Alternate Drug.

            Monitor Closely (54)

            • abciximab

              edoxaban, abciximab. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding. The need for simultaneous use of platelet aggregation inhibitors with anticoagulants is common for patients with cardiovascular disease, but may result in increased bleeding; monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • aspirin

              edoxaban, aspirin. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding. The need for simultaneous use of low-dose aspirin (<100 mg/day) with anticoagulants are common for patients with cardiovascular disease, but may result in increased bleeding; monitor closely. Promptly evaluate any signs or symptoms of blood loss if treated concomitantly with low-dose aspirin. Avoid coadministration with chronic use of higher dose aspirin.

            • aspirin rectal

              edoxaban, aspirin rectal. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • azithromycin

              azithromycin will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • berotralstat

              berotralstat will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor or titrate P-gp substrate dose if coadministered.

            • caplacizumab

              caplacizumab, edoxaban. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • celecoxib

              edoxaban, celecoxib. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • choline magnesium trisalicylate

              edoxaban, choline magnesium trisalicylate. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • clopidogrel

              edoxaban, clopidogrel. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding. The need for simultaneous use of platelet aggregation inhibitors with anticoagulants is common for patients with cardiovascular disease, but may result in increased bleeding; monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • diclofenac

              edoxaban, diclofenac. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • diflunisal

              edoxaban, diflunisal. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • dipyridamole

              edoxaban, dipyridamole. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding. The need for simultaneous use of platelet aggregation inhibitors with anticoagulants is common for patients with cardiovascular disease, but may result in increased bleeding; monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • elagolix

              elagolix will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • eptifibatide

              edoxaban, eptifibatide. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding. The need for simultaneous use of platelet aggregation inhibitors with anticoagulants is common for patients with cardiovascular disease, but may result in increased bleeding; monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • escitalopram

              escitalopram increases effects of edoxaban by anticoagulation. Use Caution/Monitor. SSRIs may inhibit platelet aggregation, thus increase bleeding risk when coadministered with anticoagulants.

            • etodolac

              edoxaban, etodolac. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • fenoprofen

              edoxaban, fenoprofen. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • fish oil triglycerides

              fish oil triglycerides will increase the level or effect of edoxaban by anticoagulation. Use Caution/Monitor. Prolonged bleeding reported in patients taking antiplatelet agents or anticoagulants and oral omega-3 fatty acids. Periodically monitor bleeding time in patients receiving fish oil triglycerides and concomitant antiplatelet agents or anticoagulants.

            • fluoxetine

              fluoxetine increases effects of edoxaban by anticoagulation. Use Caution/Monitor. SSRIs may inhibit platelet aggregation, thus increase bleeding risk when coadministered with anticoagulants.

            • flurbiprofen

              edoxaban, flurbiprofen. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • fluvoxamine

              fluvoxamine will increase the level or effect of edoxaban by anticoagulation. Use Caution/Monitor. SSRIs affect platelet activation; coadministration may increase risk of bleeding

            • fostamatinib

              fostamatinib will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Concomitant use of fostamatinib may increase concentrations of P-gp substrates. Monitor for toxicities of the P-gp substrate drug that may require dosage reduction when given concurrently with fostamatinib.

            • glecaprevir/pibrentasvir

              glecaprevir/pibrentasvir will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • ibrutinib

              ibrutinib will increase the level or effect of edoxaban by anticoagulation. Use Caution/Monitor. Ibrutinib may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and monitor for signs of bleeding.

            • ibuprofen

              edoxaban, ibuprofen. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • ibuprofen IV

              edoxaban, ibuprofen IV. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • indomethacin

              edoxaban, indomethacin. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • istradefylline

              istradefylline will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of P-gp substrates in clinical trials. Consider dose reduction of sensitive P-gp substrates.

            • ivacaftor

              ivacaftor will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • ketoprofen

              edoxaban, ketoprofen. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • ketorolac

              edoxaban, ketorolac. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • ketorolac intranasal

              edoxaban, ketorolac intranasal. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • lonafarnib

              lonafarnib will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Lonafarnib is a weak P-gp inhibitor. Monitor for adverse reactions if coadministered with P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. Reduce P-gp substrate dose if needed.

            • meclofenamate

              edoxaban, meclofenamate. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • mefenamic acid

              edoxaban, mefenamic acid. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • meloxicam

              edoxaban, meloxicam. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • nabumetone

              edoxaban, nabumetone. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • naproxen

              edoxaban, naproxen. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • oxaprozin

              edoxaban, oxaprozin. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • paroxetine

              paroxetine increases effects of edoxaban by anticoagulation. Use Caution/Monitor. SSRIs may inhibit platelet aggregation, thus increase bleeding risk when coadministered with anticoagulants.

            • piroxicam

              edoxaban, piroxicam. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • prasugrel

              edoxaban, prasugrel. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding. The need for simultaneous use of platelet aggregation inhibitors with anticoagulants is common for patients with cardiovascular disease, but may result in increased bleeding; monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • salsalate

              edoxaban, salsalate. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • sarecycline

              sarecycline will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor for toxicities of P-gp substrates that may require dosage reduction when coadministered with P-gp inhibitors.

            • saw palmetto

              saw palmetto increases toxicity of edoxaban by unspecified interaction mechanism. Use Caution/Monitor. May increase risk of bleeding.

            • sertraline

              sertraline increases effects of edoxaban by pharmacodynamic synergism. Use Caution/Monitor. Combination may increase risk of bleeding.

            • stiripentol

              stiripentol will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing the dose of P-glycoprotein (P-gp) substrates, if adverse reactions are experienced when administered concomitantly with stiripentol.

            • sulindac

              edoxaban, sulindac. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • ticagrelor

              edoxaban, ticagrelor. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding. The need for simultaneous use of platelet aggregation inhibitors with anticoagulants is common for patients with cardiovascular disease, but may result in increased bleeding; monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • ticlopidine

              edoxaban, ticlopidine. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding. The need for simultaneous use of platelet aggregation inhibitors with anticoagulants is common for patients with cardiovascular disease, but may result in increased bleeding; monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • tirofiban

              edoxaban, tirofiban. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding. The need for simultaneous use of platelet aggregation inhibitors with anticoagulants is common for patients with cardiovascular disease, but may result in increased bleeding; monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • tolmetin

              edoxaban, tolmetin. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            • tucatinib

              tucatinib will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.

            • vorapaxar

              edoxaban, vorapaxar. Either increases toxicity of the other by anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding. The need for simultaneous use of platelet aggregation inhibitors with anticoagulants is common for patients with cardiovascular disease, but may result in increased bleeding; monitor closely. Promptly evaluate any signs or symptoms of blood loss.

            Minor (0)

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              Adverse Effects

              1-10% (ENGAGE AF-TIMI-48 study)

              Abnormal LFTs (4.8%)

              Rash (4.2%)

              1-10% (Hokusai VTE study)

              Abnormal LFTs (7.8%)

              Rash (3.6%)

              Anemia (1.7%)

              <1% (ENGAGE AF-TIMI-48 study)

              Interstitial lung disease (0.2%)

              Bleeding (ENGAGE AF-TIMI-48 study)

              Clinically relevant nonmajor bleeding (9.4%); warfarin (10.9%)

              Anemia-related adverse events (9.6%); warfarin (6.8%)

              Gastrointestinal bleeding

              • Major GI bleed (1.8%); warfarin (1.3%)
              • Upper GI (1.06%); warfarin (0.74%)
              • Lower GI (0.73%); warfarin (0.54%)
              • Severe, caused hemodynamic compromise requiring intervention (0.14%); warfarin (0.14%)
              • Fatal (<0.1%); warfarin (<0.1%)

              Major bleeding

              • Major (3.1%); warfarin (3.7%)
              • Intracranial (0.5%); warfarin (1%)
              • Type of intracranial bleeding
                • Hemorrhagic stroke (0.3%); warfarin (0.6%)
                • Other ICH (0.2%); warfarin (0.5%)

              Fatal bleeding

              • Fatal (1.8%); warfarin (0.4%)
              • ICH (0.2%); warfarin (0.4%)
              • Non-intracranial (<0.1%); warfarin (<0.1%)

              Bleeding (Hokusai VTE study)

              Any bleed (21.7%); warfarin (25.6%)

              Clinically relevant major bleeding (8.5%); warfarin (10.3%)

              Clinically relevant nonmajor bleeding (7.2%); warfarin (8.9%)

              Nonfatal, noncritical organ bleeding (1%); warfarin (0.8%)

              Decreased Hgb ≥2 g/dL (1%); warfarin (0.8%)

              Transfusion ≥2 units of RBC (0.7%); warfarin (0.5%)

              Major bleeding

              • Major (1.4%); warfarin (1.6%)
              • Fatal bleeding (<0.1%); warfarin (0.2%)
              • Intracranial, fatal (none); warfarin 0.1%)

              Critical organ bleeding

              • Nonfatal (0.3%); warfarin (0.6%)
              • Intracranial (0.1%); warfarin (0.3%)

              Bleeding ADRs

              • Vaginal (9%); warfarin (7.2%)
              • Cutaneous soft tissue (5.9%); warfarin (10%)
              • Epistaxis (4.7%); warfarin (5.7%)
              • GI bleed (4.2%); warfarin 3.6%)
              • Lower GI bleed (3.4%); warfarin (3.1%)
              • Oral/pharyngeal (3.4%); warfarin (3.9%)
              • Macroscopic hematuria/urethral (2.2%); warfarin (2.8%)
              • Puncture site (1.4%); warfarin (2.4%)

              Postmarketing Reports

              Gastrointestinal disorders: Abdominal pain

              Nervous system disorders: Dizziness, headache

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              Warnings

              Black Box Warnings

              Reduced efficacy with CrCl >95 mL/min

              • Do not use with CrCL >95 mL/min
              • In the ENGAGE AF-TIMI 48 study, patients with NVAF with CrCL >95 mL/min had an increased rate of ischemic stroke with edoxaban 60 mg/day compared with patients treated with warfarin
              • In these patients, another anticoagulant should be used

              Premature discontinuation increases risk for ischemic events

              • Premature discontinuation of any oral anticoagulant in the absence of adequate alternative anticoagulation increases the risk of ischemic events
              • If discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant as described in the transition guidance (see Adult Dosing)

              Spinal/epidural hematoma

              • Epidural or spinal hematomas may occur in patients treated with edoxaban who are receiving neuraxial anesthesia or undergoing spinal puncture
              • These hematomas may result in long-term or permanent paralysis; consider these risks when scheduling patients for spinal procedures
              • Monitor patients frequently for signs and symptoms of neurological impairment; if neurological compromise is noted, urgent treatment is necessary
              • Factors that can increase the risk of developing epidural or spinal hematomas in these patients include
                • use of indwelling epidural catheters
                • concomitant use of other drugs that affect hemostasis (eg, NSAIDs, platelet inhibitors, other anticoagulants, antithrombotic agents, fibrinolytic therapy, norepinephrine reuptake inhibitors)
                • history of traumatic or repeated epidural or spinal punctures
                • history of spinal deformity or spinal surgery
                • optimal timing between the administration of edoxaban and neuraxial procedures is not known

              Contraindications

              Active pathological bleeding

              Cautions

              Efficacy reduced in patients with nonvalvular atrial fibrillation (NVAF) with CrCl >95 mL/min (see Black Box Warnings)

              Increased risk of stroke with discontinuation in patients with NVAF (see Black Box Warnings)

              The risk of developing epidural or spinal hematoma may be increased by postoperative use of indwelling epidural catheters or concomitant use of medicinal products affecting hemostasis; indwelling epidural or intrathecal catheters should not be removed earlier than 12 hours after last administration of therapy; the next dose should not be administered earlier than 2 hours after removal of catheter; the risk may also be increased by traumatic or repeated epidural or spinal puncture

              Prior to neuraxial intervention the physician should consider the potential benefit versus the risk in anticoagulated patients or in patients to be anticoagulated for thromboprophylaxis

              Do not use neuraxial anesthesia (spinal/epidural anesthesia) or spinal/epidural puncture; patients treated with antithrombotic agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma, which can result in long-term or permanent paralysis (see Black Box Warnings)

              Increases the risk of bleeding and can cause serious and potentially fatal bleeding; promptly evaluate any signs or symptoms of blood loss; discontinue if patient experiences active pathological bleeding; concomitant drugs that affect coagulation can increase this risk

              Not recommended for patients with mechanical heart valves or moderate-to-severe mitral stenosis; safety and efficacy have not been established

              Patients with triple positive antiphospholipid syndrome have experienced increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy; direct-acting oral anticoagulants not recommended in this patient population

              Coadministration with P-gp inhibitors

              • Edoxaban is a P-gp substrate; avoid coadministration with P-gp inducers (eg, rifampin)
              • NVAF: No dose reduction recommended when coadministered with P-gp inhibitors; based on clinical experience from the ENGAGE AF-TIMI 48 study, dose reduction in patients concomitantly receiving P-gp inhibitors resulted in edoxaban blood levels that were lower than in patients who were given the full dose
              • DVT/PE treatment: Dose reduction recommended when coadministered with P-gp inhibitors

              Reversal of anticoagulant effects

              • There is not established way to reverse anticoagulant effects od edoxaban
              • Effects may persist for 24 hr after the last dose
              • Anticoagulant effects cannot be reliably monitored with standard laboratory testing
              • Agent for edoxaban is not available; hemodialysis does not significantly contribute to edoxaban clearance
              • Protamine sulfate, vitamin K, and tranexamic acid are not expected to reverse the anticoagulant activity of edoxaban; the use of prothrombin complex concentrates, or other procoagulant reversal agents such as activated prothrombin complex concentrate or recombinant factor VIIa (rFVIIa) may be considered but has not been evaluated in clinical outcome studies; when PCCs are used, monitoring for anticoagulation effect of edoxaban using clotting test or anti-FXa activity is not useful and not recommended
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              Pregnancy & Lactation

              Pregnancy

              Available data about use in pregnant women are insufficient to determine whether there are drug-associated risks for adverse developmental outcomes; in animal developmental studies, no adverse developmental effects were seen when administered orally to pregnant rats and rabbits during organogenesis at up to 16-times and 8-times, respectively, the human exposure, when based on body surface area and AUC, respectively

              Pregnancy confers an increased risk of thromboembolism that is higher for women with underlying thromboembolic disease and certain high-risk pregnancy conditions; published data describe that women with a previous history of venous thrombosis are at high risk for recurrence during pregnancy

              Use may increase risk of bleeding in fetus and neonate; monitor neonates for bleeding

              Labor or delivery

              • All patients receiving anticoagulants, including pregnant women, are at risk for bleeding; use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas; consider use of a shorter acting anticoagulant as delivery approaches

              Females of reproductive potential

              • Females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician
              • The risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions, identified with oral anticoagulants should be assessed in females of reproductive potential and those with abnormal uterine bleeding

              Lactation

              There are no data on presence in human milk, or effects on breastfeeding infant or on milk production; drug was present in rat milk; because of potential for serious adverse reactions in nursing infants, including hemorrhage, advise patients that breastfeeding is not recommended during treatment

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Factor Xa (FXa) inhibitor; inhibits platelet activation by selectively and reversibly blocking the active site of FXa without requiring a cofactor (eg, antithrombin III) for activity

              Inhibits free FXa, prothrombinase activity, and thrombin-induced platelet aggregation

              Inhibition of FXa in the coagulation cascade reduces thrombin generation and reduces thrombus formation

              Absorption

              Bioavailability: 62%

              Peak plasma concentration: 1-2 hr

              Food does not affect total systemic exposure

              Substrate of P-gp transporter

              Distribution

              Disposition is biphasic

              Steady-state reached: 3 days

              Vd (steady-state): 107 L

              Protein bound: 55%

              Metabolism

              Unchanged edoxaban is the predominant form in plasma

              Minimal metabolism via hydrolysis (mediated by carboxylesterase 1), conjugation, and oxidation by CYP3A4

              <10% is hydrolyzed to the predominant metabolite M-4

              Exposure to other metabolites is <5%

              Elimination

              Half-life: 10-14 hr

              Renal clearance: 11 L/hr

              Total clearance: 22 L/hr

              Excretion: Primarily as unchanged drug in urine; metabolism and biliary/intestinal excretion account for the remaining clearance

              Hemodialysis: 4 hr hemodialysis session reduced total edoxaban exposure by <7%

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              Administration

              Instructions

              May take with or without food

              No data are available regarding the bioavailability upon crushing and/or mixing of edoxaban tablets into food, liquids, or administration through feeding tubes

              Discontinuation before surgery/interventions and then restarting

              • Discontinue at least 24 hr before invasive or surgical procedures because of the risk of bleeding
              • If surgery cannot be delayed, there is an increased risk of bleeding; risk of bleeding should be weighed against the urgency of intervention
              • Can be restarted after the surgical or other procedure as soon as adequate hemostasis has been established, noting that the time to onset of pharmacodynamic effect is 1-2 hr
              • Administer a parenteral anticoagulant and then switch to oral edoxaban, if oral medication cannot be taken during or after surgical intervention

              Missed dose

              • Take as soon as possible on the same day; resume normal dosing schedule on the next day
              • Do not double the dose to make up for a missed dose
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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Savaysa oral
              -
              30 mg tablet
              Savaysa oral
              -
              60 mg tablet
              Savaysa oral
              -
              15 mg tablet

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              edoxaban oral

              EDOXABAN - ORAL

              (e-DOX-a-ban)

              COMMON BRAND NAME(S): Savaysa

              WARNING: Your doctor should order a blood test to check your kidney function before you start edoxaban. Edoxaban is affected by the kidneys and may not work well to prevent blood clots from atrial fibrillation in certain people due to their kidney function. Talk to your doctor for more details and to see if this medication is right for you.Do not stop taking edoxaban unless directed by your doctor. If you stop taking this medication early, you have a higher risk of forming a serious blood clot (such as a stroke, blood clot in the legs/lungs). Your doctor may direct you to take a different "blood thinning" or antiplatelet medication to reduce your risk. Get medical help right away if you have weakness on one side of the body, trouble speaking, sudden vision changes, confusion, chest pain, trouble breathing, pain/warmth/swelling in the legs.People taking this medication may bleed near the spinal cord after certain spinal procedures. Bleeding in this area can cause paralysis that lasts a long time or could become permanent. Ask your doctor about the benefits and risks before any spinal procedure. The risk of bleeding may be higher if you have a deformed spine, or have had spinal procedures/surgery before (such as epidural catheter placement, difficult epidural/spinal puncture), or are taking other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, "blood thinners" such as warfarin/enoxaparin, nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen). Tell your doctor right away if you notice symptoms such as back pain, leg numbness/tingling/weakness, loss of control of the bowels or bladder (incontinence).

              USES: Edoxaban is used to prevent serious blood clots from forming due to a certain irregular heartbeat (atrial fibrillation). It is also used to treat certain blood clots (such as in deep vein thrombosis-DVT or pulmonary embolus-PE).Edoxaban is an anticoagulant that works by blocking certain clotting proteins in your blood.

              HOW TO USE: See also Warning section.Read the Medication Guide provided by your pharmacist before you start taking edoxaban and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once daily. The dosage is based on your medical condition, weight, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).If you have trouble swallowing the tablet whole, you may crush the tablet and mix it with 2 to 3 ounces (60 to 90 milliliters) of water or applesauce. Drink or eat the entire mixture right away. Do not prepare a supply for future use.If you are giving this medication through a tube into the stomach (gastric tube), ask your health care professional for detailed instructions on how to properly mix and give it.Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

              SIDE EFFECTS: See also Warning section.Easy bruising or minor bleeding (such as nosebleed, bleeding from cuts) may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication can cause serious bleeding if it affects your blood clotting proteins too much. Tell your doctor right away if you have any signs of serious bleeding, including: unusual pain/swelling/discomfort, unusual bruising, prolonged bleeding from cuts or gums, persistent/frequent nosebleeds, unusually heavy/prolonged menstrual flow, pink/dark urine, coughing up blood, vomit that is bloody or looks like coffee grounds, severe headache, dizziness/fainting, unusual or persistent tiredness/weakness, bloody/black/tarry stools, difficulty swallowing.Get medical help right away if you have any signs of very serious bleeding, including: vision changes, confusion, trouble speaking, weakness on one side of the body.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before taking edoxaban, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, bleeding problems (such as bleeding of the stomach/intestines, bleeding in the brain), blood disorders (such as anemia, hemophilia, thrombocytopenia), recent major injury/surgery, frequent falls/injuries, stroke, a certain clotting disorder (antiphospholipid syndrome).Before having surgery or any medical/dental procedures (especially spinal puncture or spinal/epidural anesthesia), tell your doctor or dentist that you are taking this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop taking edoxaban before your surgery. Ask for specific instructions about stopping or starting this medication.This medication may cause stomach bleeding. Daily use of alcohol while using this medicine may increase your risk for stomach bleeding. Limit alcoholic beverages. Ask your doctor or pharmacist about how much alcohol you may safely drink.This medication can cause bleeding. To lower the chance of getting cut, bruised, or injured, use great caution with sharp objects like safety razors and nail cutters. Use an electric razor when shaving and a soft toothbrush when brushing your teeth. Avoid activities such as contact sports. If you fall or injure yourself, especially if you hit your head, contact your doctor right away. Your doctor may need to check you for hidden bleeding that could be serious.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor before using this medication.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: mifepristone, other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, "blood thinners" such as warfarin, enoxaparin), certain antidepressants (including SSRIs such as fluoxetine, SNRIs such as desvenlafaxine/venlafaxine).Other medications can affect the removal of edoxaban from your body, which may affect how edoxaban works. One example is rifampin, among others.Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as ibuprofen or naproxen) that may increase your risk for bleeding if taken together with this medication. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: bloody/black/tarry stools, pink/dark urine, unusual/prolonged bleeding.

              NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as kidney function, hematocrit/hemoglobin, red blood cell count) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

              MISSED DOSE: If you miss a dose, take it as soon as you remember on the same day. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

              STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

              MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

              Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.