Edoxaban 60 mg Tablets (Edoxaban Tosilate Hydrate)

Adult dose

This medicine should be taken with water, with or without food. 1. Adults 1) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation • Body weight ≤ 60kg: The recommended dose of this medicine is 30mg once daily. • Body weight > 60kg: The recommended dose of this medicine is 60mg once daily. However, for patients with one or more of the following factors, the recommended dose of this medicine is 30mg once daily. ‣ Moderate to severe renal impairment (15 ≤ CrCL ≤ 50mL/min) ‣ Concomitant use of P-gp inhibitors (cyclosporine, dronedarone, erythromycin, ketoconazole) For elderly patients at high risk of bleeding, a dose of 15mg once daily may be administered depending on age and condition. (See section “9. Use in the Elderly” under Precautions for Use.) 2) Treatment of deep vein thrombosis and pulmonary embolism/Reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism Administer this medicine after at least 5 days of parenteral anticoagulant use. • Body weight ≤ 60kg: The recommended dose of this medicine is 30mg once daily. • Body weight > 60kg: The recommended dose of this medicine is 60mg once daily. However, for patients with one or more of the following factors, the recommended dose of this medicine is 30mg once daily. ‣ Moderate to severe renal impairment (15 ≤ CrCL ≤ 50mL/min) ‣ Concomitant use of P-gp inhibitors (cyclosporine, dronedarone, erythromycin, ketoconazole) 2. Switching medications 2.1 Switching from another medication to this medicine 1) Switching from a vitamin K antagonist to this medicine Discontinue vitamin K antagonist therapy and start this medicine when the international normalized ratio (INR, International Normalized Ratio) is 2.5 or less. 2) Switching from an oral anticoagulant other than a vitamin K antagonist (dabigatran, rivaroxaban, apixaban) to this medicine Discontinue the oral anticoagulant and start this medicine at the time of the next scheduled dose of the oral anticoagulant. 3) Switching from a parenteral anticoagulant to this medicine (1) Low molecular weight heparin (LMWH) Discontinue LMWH and start this medicine at the time of the next scheduled LMWH dose. (2) Unfractionated heparin (UFH) Discontinue the intravenous UFH infusion and start this medicine 4 hours later. 2.2 Switching from this medicine to another medication 1) Switching from this medicine to a vitamin K antagonist Inadequate anticoagulation may occur when switching from this medicine to a vitamin K antagonist. Adequate anticoagulant effect should be maintained continuously while switching to another anticoagulant. (1) Oral option For patients receiving 60mg of this medicine, administer 30mg of this medicine once daily together with an appropriate dose of a vitamin K antagonist. For patients receiving 30mg of this medicine, administer 15mg of this medicine once daily together with an appropriate dose of a vitamin K antagonist. During the first 14 days of concomitant administration, it is recommended that INR be measured at least 3 times. To minimize the effect of this medicine on INR measurement, measure INR before administering this medicine. Once INR ≥ 2.0 is stably achieved, discontinue this medicine and continue vitamin K antagonist therapy. (2) Parenteral option Discontinue this medicine and administer a parenteral anticoagulant and a vitamin K antagonist at the time of the next scheduled dose of this medicine. Once INR ≥ 2.0 is stably achieved, discontinue the parenteral anticoagulant and continue vitamin K antagonist therapy. 2) Switching from this medicine to an oral anticoagulant other than a vitamin K antagonist (dabigatran, rivaroxaban, apixaban) Discontinue this medicine and start the oral anticoagulant at the time of the next scheduled dose of this medicine. 3) Switching from this medicine to a parenteral anticoagulant Discontinue this medicine and start the parenteral anticoagulant at the time of the next scheduled dose of this medicine. 3. Patients with renal impairment No dose adjustment of this medicine is necessary in patients with mild renal impairment (50 < CrCL ≤ 80mL/min). The recommended dose of this medicine is 30mg once daily in patients with moderate to severe renal impairment (15 ≤ CrCL ≤ 50mL/min). For the reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, administration of 15mg once daily should be considered, depending on age and condition, for elderly patients at high risk of bleeding with creatinine clearance of 15 ≤ CrCL < 30mL/min (see section “9. Use in the Elderly” under Precautions for Use). 4. If you forget to take this medicine If you forget to take this medicine, take it immediately on the same day, and take it the next day according to the recommended dosage and administration. Do not take twice the recommended daily dose to make up for a missed dose.

This medication may increase the risk of bleeding, which could lead to serious hemorrhages, and should be used with caution in patients at risk for bleeding. If a life-threatening bleed occurs, the administration of this medication should be stopped immediately, and the bleeding site should be assessed quickly. Patients at high risk for bleeding should be monitored closely for bleeding symptoms and signs of anemia after taking this medication. Patients with allergies to any ingredients of this medication, clinically significant bleeding, severe renal or liver disease should not use this medication. Additionally, patients with recent gastrointestinal ulcers, intracranial hemorrhage, severe hypertension, pregnant or breastfeeding women, and certain genetically predisposed individuals to lactose intolerance are also contraindicated for this medication. The risk of bleeding may also increase when this medication is used in conjunction with other anticoagulants or bleeding-affecting drugs, so careful monitoring is needed during co-administration. In particular, the risk of bleeding increases when combined with aspirin, non-steroidal anti-inflammatory drugs, and selective serotonin reuptake inhibitors. This medication may be affected by liver and kidney functions, so regular liver and kidney function tests must be conducted before and during administration. Prior to any surgical or invasive procedures, this medication should be discontinued to reduce the risk of bleeding, and it can be resumed after hemostasis is confirmed following the procedure. Caution is needed as this medication may cause serious nerve damage during central nervous anesthesia or spinal puncture. Symptoms of dizziness or headache may occur when taking this medication, and allergic reactions such as skin bleeding, rashes, and itching might also be present. Pregnant or breastfeeding women should not use this medication, and women of childbearing age should consult a doctor regarding pregnancy plans. Elderly patients or those with reduced kidney function may require dose adjustments, and administration should be done after closely assessing the risk of bleeding. Taking an overdose of this medication significantly increases the risk of bleeding, so in case of overdose, immediate consultation with medical personnel is essential to receive necessary measures.

• Hemorrhage
• skin soft tissue hemorrhage
• nasal bleeding
• vaginal bleeding
• anemia
• rash
• abnormal liver function tests
• thrombocytopenia
• hypersensitivity
• anaphylaxis

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is recommended to store it at room temperature between 1°C and 30°C, not in excessively hot or cold places.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle