Rivoraxaban 60 mg (Edoxaban tosylate monohydrate)

Adult dose

This medicine should be administered with water, regardless of meals. 1. Adults 1) Reduction in 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. Administration to the Elderly’ under Precautions for Use.) 2) Treatment of deep vein thrombosis and pulmonary embolism/Reduction in 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) 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 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 during the transition 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; measurements should be taken before administration of this medicine to minimize its effect on INR measurement. Once an INR ≥ 2.0 has been 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 has been 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 in patients with moderate to severe renal impairment (15 ≤ CrCL ≤ 50mL/min) is 30mg once daily. For reduction in 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, in elderly patients at high risk of bleeding with creatinine clearance of 15 ≤ CrCL < 30mL/min (see section ‘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 unable to swallow tablets For patients unable to swallow tablets, this medicine may be crushed immediately before use, mixed with a liquid such as water or applesauce, and administered orally. Alternatively, this medicine may 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 plays a role in preventing blood from becoming overly coagulated, thereby preventing thrombosis. However, taking this medication may increase the risk of bleeding; therefore, it should be used with great caution in conditions where there is a high risk of bleeding. If symptoms of bleeding are suspected or if there is an unexplained reduction in blood counts, the bleeding site should be checked immediately. If serious bleeding occurs, this medication should be discontinued and the bleeding site should be examined promptly. Patients at high risk of bleeding should be closely monitored for symptoms of bleeding or anemia after taking this medication. This medication should not be administered to patients with a known allergy to it, clinically significant bleeding, or severe renal or liver disease. Additionally, it should not be used in patients with recent history of gastrointestinal ulcer, intracranial hemorrhage, significant trauma or surgical history, or in combination with other anticoagulants. Caution is advised when taking this medication together with other medications that affect hemostasis, as the risk of bleeding may increase. Patients with impaired liver or kidney function should also be administered with caution. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing age should consult their physician regarding pregnancy plans. The safety and efficacy of this medication have not been established in children. Elderly patients or those with decreased kidney function may require dose adjustments. This medication should be discontinued before surgery or invasive procedures, and can be resumed once hemostasis is stable post-surgery. Stopping this medication suddenly may increase the risk of thrombosis, so it should be discussed with a physician before discontinuation. This medication can interact with certain drugs, so it is important to consult with a physician or pharmacist regarding other medications being taken. Overdosage significantly increases the risk of bleeding, so it is essential to adhere strictly to the prescribed dosing regimen. Throughout the course of taking this medication, it is important to carefully observe any symptoms of bleeding or adverse reactions. If bleeding is suspected, medical personnel should be notified immediately for appropriate action.

• Hemorrhage
• soft tissue hemorrhage
• nosebleeds
• vaginal bleeding
• anemia
• rash
• abnormal liver function tests
• thrombocytopenia
• hypersensitivity
• anaphylactic reactions

This medication should be stored in a sealed container to protect it from air and moisture, and should be kept at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain its effectiveness over time.

Appearance

Yellow round film-coated tablet

Package unit

28 tablets/box, 30 tablets/box [10 tablets/PTP x 3]