Edoxaban 60mg (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 a P-gp inhibitor (cyclosporine, dronedarone, erythromycin, ketoconazole) For elderly patients at high risk of bleeding, a dose of 15mg once daily may be used, depending on age and condition. (See “9. Administration to 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 therapy. • 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 therapy and start this medicine when the international normalized ratio (INR) is ≤ 2.5. 2) Switching from an oral anticoagulant other than a vitamin K antagonist (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 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 must 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 the INR be measured at least 3 times. To minimize the effect of this medicine on INR measurements, the INR should be measured before taking this medicine. Once an 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 an 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, a dose 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 “9. Administration to the Elderly” under Precautions for Use). 4. If you forget to take this medicine If you forget to take this medicine, take it as soon as possible 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. 5. Patients who cannot swallow tablets For patients who cannot swallow tablets, this medicine may be crushed immediately before use, mixed with water or a beverage such as applesauce, and administered orally. It may also be crushed, suspended in a small amount of water, and administered through a nasogastric tube, followed by flushing the tube with water. Crushed this medicine is stable in water and applesauce for up to 4 hours.

This medication may increase the risk of bleeding, which can lead to serious hemorrhages, so it should be used with caution in states with a high bleeding risk. During treatment, if there is unexplained decrease in blood parameters or drop in blood pressure, the site of bleeding should be checked immediately. If a serious hemorrhage occurs, dosing should be stopped and the bleeding site should be promptly examined. Patients at high risk of bleeding should be closely monitored for signs of bleeding and anemia after starting this medication. This medication should not be taken by those allergic to it, or by individuals with serious bleeding, end-stage renal disease, liver impairment, or recent high-risk bleeding conditions. It should also not be used in conjunction with other anticoagulants or in cases of uncontrolled hypertension, severe heart disease, or during pregnancy. This medication can interact with various drugs that affect blood coagulation, so if taking such drugs, consult a doctor. Patients with impaired liver function or kidney function should use this medication cautiously and undergo liver and kidney function tests before and during treatment. When undergoing surgery or invasive procedures, this medication should be stopped for a certain period to reduce the risk of bleeding, and should be resumed once hemostasis is stable after the procedure. Caution is necessary when taking this medication during spinal anesthesia or lumbar puncture as it may cause serious nerve damage. Abrupt discontinuation can increase the risk of thrombosis, so consult a doctor for appropriate alternative treatment when discontinuing. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing age should consult with a physician about planning for pregnancy. Elderly patients, especially those with decreased kidney function, may require dose adjustments. In case of overdose, the risk of bleeding increases, and there is no antidote for this medication, so inform medical staff immediately in case of overdose. This medication cannot be accurately monitored with standard coagulation tests, and special laboratory tests may be necessary. It does not generally have a significant effect on daily activities like driving or operating machinery, but attention should be paid to signs of bleeding.

• Bleeding
• anemia
• rash
• abnormal liver function tests
• thrombocytopenia
• hypersensitivity
• anaphylactic reaction
• allergic edema
• dizziness
• headache

Store this medication in a tightly closed container to protect it from air and moisture. The recommended storage temperature is between 1 degree and 30 degrees Celsius. This way, the effectiveness and safety of the medication can be maintained for a longer period.

Appearance

Yellow round film-coated tablet

Package unit

28 tablets/box