Edoxaban Oral Disintegrating Tablet 15 mg (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 recurrent 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 medicine to this medicine 1) Switching from a vitamin K antagonist to this medicine Discontinue vitamin K antagonist treatment and start this medicine when the international normalized ratio (INR) is 2.5 or less. 2) Switching from a non-vitamin K antagonist oral anticoagulant (dabigatran, rivaroxaban, apixaban) to this medicine Discontinue oral anticoagulant treatment 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 medicine 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 anticoagulant effect 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. To minimize the effect of this medicine on INR measurements, measure INR before administering this medicine. Once INR ≥ 2.0 is stably achieved, discontinue this medicine and continue vitamin K antagonist treatment. (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 treatment. 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 Dose adjustment of this medicine is not necessary in patients with mild renal impairment (50 < CrCL ≤ 80mL/min). The recommended dose of this medicine in patients with moderate to severe renal impairment (15 ≤ CrCL ≤ 50mL/min) is 30mg once daily. 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 prevents blood clots by inhibiting the coagulation process, but it can significantly increase the risk of bleeding and should be used with caution. Patients with conditions that increase the risk of bleeding must consult a physician before using this medication, and should closely monitor for signs of bleeding or anemia during treatment. If bleeding is suspected or severe bleeding occurs, the use of this medication should be stopped immediately and the bleeding site should be promptly examined and treated. This medication should not be administered to patients with certain diseases or conditions, such as severe renal or liver diseases, pregnant women, or patients at high risk of bleeding. When used in conjunction with other anticoagulants or drugs that may increase bleeding risk, the bleeding risk is further increased, requiring strict medical supervision. Regular blood tests and liver function tests during the use of this medication are important to monitor physical condition. Prior to undergoing surgery or invasive procedures, this medication should be discontinued for a period of time to reduce bleeding risk, and after the procedure, it should not be resumed until there is confirmation that there is no bleeding risk. This medication should not be administered to pregnant or breastfeeding women, and women of childbearing age should discuss pregnancy planning with their physician. Safety and effectiveness in children and adolescents have not been adequately established, so caution is needed for their use. Older adults and patients with impaired renal function may require dosage adjustment, and caution is also needed when taking other interacting medications. Overdose can lead to a very high risk of bleeding, and there is no specific antidote for this medication, so overdose should be avoided. This medication comes in oral disintegrating tablet form and can be taken without water, but the method of ingestion must be followed accurately. Finally, this medication should be kept out of reach of children, and it is safer not to transfer it to another container.

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

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is best to maintain a storage temperature between 1 to 30 degrees Celsius to safely preserve the effectiveness of the medication.

Appearance

White round oral disintegrating tablet

Package unit

30 tablets/PTP