Lixiana Edoxaban Film-coated Tablets

1. Indications and Usage
Reduction in Risk of Stroke and Systemic Embolism (SE) in Nonvalvular Atrial Fibrillation (NVAF): To reduce the risk of stroke and SE in patients with NVAF.
Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE): For the treatment of DVT and PE in patients who have been treated with a parenteral anticoagulant for 5-10 days.
2. Dosage and Administration
Recommended Dose:
NVAF: 60 mg once daily. Reduce to 30 mg once daily for patients with CrCL 15-50 mL/min, body weight ≤60 kg, or those using specific P-gp inhibitors. Do not use if CrCL >95 mL/min due to reduced efficacy.
DVT/PE: 60 mg once daily. Reduce to 30 mg once daily for patients with CrCL 15-50 mL/min, body weight ≤60 kg, or those using specific P-gp inhibitors.
Administration: Oral administration. Can be taken with or without food.
Missed Dose: Take as soon as possible on the same day. If the next dose is due within 6 hours, skip the missed dose. Do not take two doses on the same day.
3. Mechanism of Action
Direct Factor Xa Inhibitor: Edoxaban is an oral, direct Factor Xa inhibitor.
Pathway: It binds reversibly and selectively to the active site of Factor Xa, blocking the conversion of prothrombin to thrombin. This prevents the formation of fibrin clots, thereby reducing the risk of thrombosis.
4. Safety and Warnings
Bleeding Risk: Can cause serious, potentially fatal bleeding. Discontinue in cases of active pathological bleeding.
Spinal/Epidural Anesthesia: Patients undergoing spinal puncture or epidural anesthesia are at risk of spinal or epidural hematomas, which can result in long-term or permanent paralysis.
Contraindications:
Active pathological bleeding.
Severe hypersensitivity to edoxaban.
Renal Impairment: Not recommended for patients with CrCL >95 mL/min (NVAF only) or severe renal impairment (CrCL <15 mL/min) / end-stage renal disease.
5. Adverse Reactions
NVAF: The most common adverse reaction (≥5%) is bleeding. Anemia is also common.
DVT/PE: Common adverse reactions (≥1%) include bleeding, rash, abnormal liver function tests, and anemia.
6. Drug Interactions
P-gp Inhibitors: Concomitant use with P-gp inhibitors (e.g., cyclosporine, dronedarone, erythromycin, ketoconazole) requires dose reduction to 30 mg.
P-gp Inducers: Avoid concomitant use with strong P-gp inducers (e.g., rifampin) as they may significantly decrease edoxaban exposure.
Anticoagulants/Antiplatelets: Concomitant use with other anticoagulants (e.g., heparin) or antiplatelet agents (e.g., aspirin, clopidogrel) increases bleeding risk.
7. Pharmaceutical Information
Chemical Name:N¹-(5-chloropyridin-2-yl)-N²-[(1S,2R,4S)-4-(dimethylcarbamoyl)-2-[(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-carbonyl)amino]cyclohexyl]oxalamide