Usual Adult Dose for Atrial Fibrillation

60 mg orally once a day

Use: Prevention of stroke and systemic embolism in nonvalvular atrial fibrillation.

Usual Adult Dose for Deep Vein Thrombosis

60 mg orally once a day following 5 to 10 days of initial therapy with a parenteral anticoagulant

Use: Treatment of deep vein thrombosis and pulmonary embolism following 5 to 10 days of initial parenteral anticoagulant therapy.

Usual Adult Dose for Pulmonary Embolism

60 mg orally once a day following 5 to 10 days of initial therapy with a parenteral anticoagulant

Use: Treatment of deep vein thrombosis and pulmonary embolism following 5 to 10 days of initial parenteral anticoagulant therapy.

Renal Dose Adjustments

Prevention of stroke and systemic embolism in nonvalvular atrial fibrillation:
CrCl greater than 95 mL/min: Not recommended
CrCl 51 to 95 mL/min: No adjustment recommended
CrCl 15 to 50 mL/min: 30 mg orally once a day
CrCl less than 15 mL/min: Not recommended

Treatment of deep venous thrombosis or pulmonary embolism:
CrCl greater than 50 mL/min: No adjustment recommended
CrCl 15 to 50 mL/min: 30 mg orally once a day
CrCl less than 15 mL/min: Not recommended

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh A): No adjustment recommended
Moderate or severe liver dysfunction (Child-Pugh B or C): Not recommended

Dose Adjustments

Patients who weigh 60 kg or less:

• Treatment of deep venous thrombosis or pulmonary embolism: 30 mg orally once a day

Patients taking certain concomitant P-glycoprotein (P-gp) inhibitors (verapamil and quinidine or short-term azithromycin, clarithromycin, erythromycin, oral itraconazole, or oral ketoconazole):

• Treatment of deep vein thrombosis or pulmonary embolism: 30 mg orally once a day

SWITCHING FROM ANOTHER ANTICOAGULANT TO EDOXABAN:
Switching from vitamin K antagonist (VKA) therapy to edoxaban: Discontinue VKA and start edoxaban when the INR is 2.5 or less

Switching from an oral anticoagulant other than VKA therapy to edoxaban: Discontinue current therapy and start edoxaban at the time of the next scheduled dose of the discontinued anticoagulant

Switching from low molecular weight heparin (LMWH) to edoxaban: Discontinue LMWH and start edoxaban at the time of the next scheduled LMWH dose

Switching from unfractionated heparin to edoxaban: Discontinue the infusion and start edoxaban 4 hours later

SWITCHING FROM EDOXABAN TO ANOTHER ANTICOAGULANT:
Switching from edoxaban to VKA therapy (oral option):

• For patients taking 60 mg of edoxaban, reduce the dose to 30 mg and begin concomitant VKA therapy
• For patients taking 30 mg of edoxaban, reduce the dose to 15 mg and begin concomitant VKA therapy
• Measure INR at least weekly and just prior to the daily dose of edoxaban
• Once INR is stable and measured at 2 or above, discontinue edoxaban and continue VKA therapy

Switching from edoxaban to VKA therapy (parenteral option):

• Discontinue edoxaban and administer a parenteral anticoagulant and VKA therapy at the time of the next scheduled edoxaban dose
• Once INR is stable and measured at 2 or above, discontinue the parenteral anticoagulant and continue VKA therapy

Switching from edoxaban to an oral anticoagulant other than VKA therapy: Discontinue edoxaban and start the other oral anticoagulant at the time of the next scheduled edoxaban dose

Switching from edoxaban to parenteral anticoagulant therapy: Discontinue edoxaban and start the parenteral anticoagulant at the time of the next scheduled edoxaban dose

DISCONTINUATION FOR SURGERY AND OTHER INTERVENTIONS:

• If clinically possible, therapy should be stopped at least 24 hours prior to the procedure and restarted after the procedure as soon as hemostasis has been established.
• If a decision needs to be made whether to delay a procedure until 24 hours after the last dose of this drug, the increased risk of bleeding should be weighed against the urgency of the intervention.

SPINAL OR EPIDURAL ANESTHESIA OR PUNCTURE:

• An epidural catheter must not be removed earlier than 12 hours after the last dose of this drug. The next dose should be administered at least 2 hours after the catheter is removed.

Precautions

US BOXED WARNINGS:

• RENAL FUNCTION: This drug should not be used in nonvalvular atrial fibrillation patients with a CrCl greater than 95 mL/min due to increased risk of ischemic stroke. Use of an alternative anticoagulant agent is advised.
• DISCONTINUING THERAPY: Premature discontinuation of therapy increases the risk of ischemic events. If therapy is discontinued for reasons other than pathological bleeding or completion of therapy, coverage with another anticoagulant is advised.
• SPINAL/EPIDURAL HEMATOMA: Spinal and epidural hematoma may occur in patients taking this drug who receive neuraxial anesthesia or undergo a spinal puncture. These hematomas may lead to long-term or permanent paralysis. Monitor for signs and symptoms of neurological impairment. Consider the benefits and risks prior to neuraxial intervention in anticoagulated patients or patients to be anticoagulated for thromboprophylaxis. Urgent treatment is required if neurological compromise is noted.

CONTRAINDICATIONS: Active pathological bleeding

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• May take with or without food.
• If a dose is missed, take the missed dose immediately and continue the following day per the regular schedule. The dose should not be doubled within the same day.
• For patients who cannot swallow tablets whole or those who require a gastric tube, this drug may be crushed and combined with 2 to 3 ounces of water and administered immediately thereafter.

General:

• There is no specific agent to reverse the anticoagulant effect of this drug.
• This drug can contribute to an elevated INR; INR measurements made during coadministration with a vitamin K antagonist (VKA) may not be useful for determining the appropriate dose of the VKA.

Monitoring:

• Hematologic: Signs or symptoms of bleeding complications (bruises, bloody noses, bleeding gums, blood in stool or urine).
• Hepatic: Liver function tests (prior to treatment and periodically thereafter).
• Neurologic: Signs or symptoms suggestive of epidural or spinal hematoma (back pain, tingling, numbness, muscle weakness, stool or urine incontinence) in patients undergoing neuraxial anesthesia or spinal puncture.
• Renal: Renal function.

Patient advice:

• Inform the patient that they may bleed and bruise more easily and to notify their healthcare provider immediately of any unusual bleeding.
• Advise the patient to inform their healthcare providers that they are taking this drug prior to any surgery, medical, or dental procedure.
• Advise patient to inform their healthcare provider of any prescription or over-the-counter medications that they are taking or plan to take.