Drug Guide
Edoxaban Tosylate
Classification
Therapeutic: Anticoagulant, Factor Xa inhibitor
Pharmacological: Direct oral anticoagulant (DOAC)
FDA Approved Indications
- Stroke prevention in non-valvular atrial fibrillation
- Treatment of venous thromboembolism (deep vein thrombosis and pulmonary embolism) and reduction of risk of recurrent DVT and PE
Mechanism of Action
Edoxaban selectively inhibits factor Xa, which decreases thrombin generation and thrombus development.
Dosage and Administration
Adult: 60 mg once daily; dose may be reduced to 30 mg once daily in renally impaired patients, or in those taking specific interacting drugs.
Pediatric: Not approved for pediatric use.
Geriatric: Adjust dose based on renal function rather than age alone.
Renal Impairment: Adjust dose based on creatinine clearance: 15-50 mL/min requires dose reduction; contraindicated if CrCl <15 mL/min.
Hepatic Impairment: Use with caution; avoid in severe hepatic impairment.
Pharmacokinetics
Absorption: Rapid and complete absorption; Food increases bioavailability.
Distribution: Protein binding approximately 55%.
Metabolism: Minimal hepatic metabolism; primarily eliminated unchanged.
Excretion: Renal and fecal excretion.
Half Life: 10-14 hours, allowing once-daily dosing.
Contraindications
- Active pathological bleeding
- Severe hypersensitivity to edoxaban
Precautions
- Renal impairment, hepatic impairment, elderly, low body weight, concomitant use of other anticoagulants or antiplatelet agents, risk of bleeding
Adverse Reactions - Common
- Bleeding (Common)
- Anemia (Less common)
Adverse Reactions - Serious
- Major bleeding (e.g., intracranial, gastrointestinal) (Less common but serious)
- Hepatic injury (Rare)
Drug-Drug Interactions
- Other anticoagulants, antiplatelet agents, NSAIDs, selective serotonin reuptake inhibitors (SSRIs), CYP3A4 inhibitors/inducers
Drug-Food Interactions
- No significant food interactions reported
Drug-Herb Interactions
- Herbal products affecting coagulation (e.g., ginkgo, garlic)
Nursing Implications
Assessment: Monitor for signs of bleeding, renal function, and adherence.
Diagnoses:
- Risk for bleeding
Implementation: Administer once daily, counsel on bleeding precautions, monitor renal function periodically.
Evaluation: Assess for bleeding, effectiveness in preventing thromboembolism.
Patient/Family Teaching
- Take medication exactly as prescribed.
- Report any signs of bleeding or unusual bruising.
- Use caution with activities that may cause injury.
- Inform healthcare providers about this medication prior to procedures.
Special Considerations
Black Box Warnings:
- Increased risk of thrombotic events upon abrupt discontinuation in patients with atrial fibrillation.
- Risk of bleeding.
Genetic Factors: No specific genetic testing required.
Lab Test Interference: Can affect certain coagulation tests, but routine laboratory monitoring is generally not necessary.
Overdose Management
Signs/Symptoms: Excessive bleeding, hypotension.
Treatment: Discontinue edoxaban, supportive measures, and use of reversal agents (if available) such as andexanet alfa in certain cases.
Storage and Handling
Storage: Store at room temperature, 20-25°C (68-77°F).
Stability: Stable until expiration date when stored properly.