Drug Guide
Edoxaban
Classification
Therapeutic: Anticoagulant
Pharmacological: Factor Xa Inhibitor
FDA Approved Indications
- Prevention of stroke and systemic embolism in non-valvular atrial fibrillation
- Treatment of deep vein thrombosis (DVT) and pulmonary embolism (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 adjusted based on renal function, body weight, and concomitant medications.
Pediatric: Not approved for pediatric use.
Geriatric: Efficacy and safety are similar; dose adjustment based on renal function is recommended.
Renal Impairment: Reduced doses are recommended for renal impairment (eGFR 15-50 mL/min).
Hepatic Impairment: Use is contraindicated in patients with hepatic disease expected to result in coagulopathy or increased bleeding risk.
Pharmacokinetics
Absorption: Orally absorbed with a bioavailability of approximately 62%.
Distribution: Moderate binding to plasma proteins (~55%).
Metabolism: Primarily metabolized via hydrolysis and conjugation; minor CYP3A4 involvement.
Excretion: Excreted mainly via feces (~50%) and urine (~35%).
Half Life: approximately 10-14 hours.
Contraindications
- Active pathological bleeding
- Known hypersensitivity to edoxaban or any component of the formulation.
Precautions
- Bleeding risk assessment prior to therapy.
- Use with caution in patients with renal impairment, hepatic impairment, or those at high risk of bleeding.
Adverse Reactions - Common
- Bleeding (including hematoma, hematuria, epistaxis) (Common)
- Anemia (Less common)
Adverse Reactions - Serious
- Bleeding complications requiring medical intervention (Rare)
- Spinal/epidural hematoma if used with neuraxial anesthesia (Rare)
Drug-Drug Interactions
- Other anticoagulants, antiplatelet agents, NSAIDs, CYP3A4 or P-gp inhibitors (e.g., ketoconazole, ritonavir)
Drug-Food Interactions
- Limit alcohol intake; no significant food interactions reported.
Drug-Herb Interactions
N/ANursing Implications
Assessment: Monitor for signs of bleeding, renal function, and adherence.
Diagnoses:
- Risk for bleeding related to anticoagulant therapy.
Implementation: Administer orally once daily, assess renal function periodically, educate patient on bleeding precautions.
Evaluation: Monitor for effectiveness and adverse effects; reassess renal function and bleeding risk regularly.
Patient/Family Teaching
- Report signs of bleeding immediately.
- Take medication as prescribed, at the same time each day.
- Avoid activities that increase bleeding risk.
- Inform healthcare providers of all medications, supplements, and herbal products.
Special Considerations
Black Box Warnings:
- Risk of spinal/epidural hematoma with neuraxial anesthesia or spinal puncture.
Genetic Factors: No specific genetic testing required.
Lab Test Interference: May prolong clotting times (e.g., PT, aPTT), but these are not reliable measures of anticoagulant effect.
Overdose Management
Signs/Symptoms: Excessive bleeding, hypotension, pallor.
Treatment: Discontinue edoxaban, provide supportive care, consider use of reversal agents like andexanet alfa if available, supportive measures like transfusions as needed.
Storage and Handling
Storage: Store at room temperature (20°C to 25°C).
Stability: Stable until expiration date on packaging.