Edoxaban Oral Disintegrating Tablets 60mg (Edoxaban Tosilate Monohydrate)

Adult dose

This medicine may be taken with or without food. Place it on the tongue and allow it to dissolve in saliva before swallowing, or take it with water. 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 a P-gp inhibitor (cyclosporine, dronedarone, erythromycin, ketoconazole) 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 a P-gp inhibitor (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) is ≤ 2.5. 2) Switching from a non-vitamin K antagonist oral anticoagulant (dabigatran, rivaroxaban, apixaban) to this medicine Discontinue oral anticoagulant therapy 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 while switching from this medicine to a vitamin K antagonist. Adequate anticoagulation should be maintained continuously while switching to another anticoagulant. (1) Oral option For patients taking 60mg of this medicine, administer 30mg of this medicine once daily together with an appropriate dose of a vitamin K antagonist. For patients taking 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; measurements should be taken before administration of this medicine to minimize its effect on INR measurements. Once INR ≥ 2.0 is achieved and stable, 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 achieved and stable, discontinue the parenteral anticoagulant and continue vitamin K antagonist therapy. 2) Switching from this medicine to a non-vitamin K antagonist oral anticoagulant (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). 4. If you miss a dose of this medicine If you miss a dose of this medicine, take it immediately on the same day and take the next dose the following 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 is used to prevent or treat blood clots by thinning the blood. However, taking this medication can increase the risk of bleeding, so it must be used with great caution in conditions with a high risk of bleeding. Signs of suspected bleeding must be reported to medical staff immediately, and in case of severe bleeding, this medication should be discontinued, and the bleeding site must be examined rapidly. It is contraindicated in patients with allergies to this medication or with severe bleeding, in patients with very poor kidney or liver function, and in patients with conditions that pose a high bleeding risk, such as recent cerebral hemorrhage or gastrointestinal ulcers. Additional caution is necessary when used with other anticoagulants, and it should not be used in patients with uncontrolled hypertension or in pregnant or nursing women. When taking medications like aspirin, non-steroidal anti-inflammatory drugs, or selective serotonin reuptake inhibitors that may increase the risk of bleeding alongside this medication, careful monitoring is necessary. In addition to bleeding, side effects such as dizziness, headache, skin rash, and liver function abnormalities may occur. If any unusual symptoms arise, medical staff should be consulted immediately. Before undergoing surgery or invasive procedures, this medication should be discontinued in advance, and after surgery, it should only be resumed once the risk of bleeding is appropriately managed. This medication is not recommended for women who are pregnant or breastfeeding, and it is important for women of childbearing age to consult with a physician regarding pregnancy plans. Safety and efficacy have not been established in children, and elderly patients or those with impaired kidney function may require dose adjustments. Overdosing on this medication can significantly increase the risk of bleeding, so adherence to the prescribed dosage and administration is essential. This medication is in the form of oral disintegrating tablets, which can be taken without water, but should be stored out of reach of children.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

White rectangular oral disintegrating tablet

Package unit

30 tablets/PTP