Rixazone 60mg (Edoxaban Tosilate Monohydrate)

Adult dose

Dosage: 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 administered depending on age and condition. (Refer to “9. Use in the Elderly” in 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 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 initiate this medicine when the International Normalized Ratio (INR) is 2.5 or less. 2) Switching from an oral anticoagulant other than a vitamin K antagonist (dabigatran, rivaroxaban, apixaban) to this medicine Discontinue oral anticoagulant therapy and initiate 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 initiate this medicine at the time of the next scheduled LMWH dose. (2) Unfractionated heparin (UFH) Discontinue the intravenous UFH infusion and initiate 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 taking this medicine at a dose of 60mg, administer this medicine at a dose of 30mg once daily together with an appropriate dose of a vitamin K antagonist. For patients taking this medicine at a dose of 30mg, administer this medicine at a dose of 15mg 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, the INR should be measured 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 initiate 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 initiate 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 required 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 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, in elderly patients at high risk of bleeding whose creatinine clearance is 15 ≤ CrCL < 30mL/min (refer to “9. Use in the Elderly” in 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. 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 taken 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 for up to 4 hours in water and applesauce.

This medication prevents blood coagulation and the formation of clots. However, its use may increase the risk of bleeding, so patients with a high risk of bleeding should be particularly cautious. If any unexplained decrease in blood counts or blood pressure occurs during treatment, it is essential to check for bleeding. If severe bleeding occurs, stop using the medication immediately and promptly examine the bleeding site. Patients at high risk of bleeding should closely monitor for symptoms of bleeding or anemia after taking this medication. Patients with allergies to this medication, severe bleeding, or severe renal or liver disease should not use it. Additionally, patients with recent gastrointestinal ulcers, intracranial bleeding, severe hypertension, or certain cardiac conditions should also refrain from taking this medication. The risk of bleeding significantly increases when used in combination with other anticoagulants. This medication may heighten the bleeding risk when taken with aspirin, antiplatelet agents, non-steroidal anti-inflammatory drugs, or certain antidepressants. Pregnant or breastfeeding women should not use this medication, and women planning to become pregnant must consult a doctor. Elderly patients or those with reduced kidney function may require dosage adjustments, so they should follow their doctor's instructions. Before undergoing surgery or invasive procedures, patients should stop taking this medication, and after the risk of bleeding has decreased post-surgery, they may resume taking it. This medication may cause side effects such as bleeding, skin rash, liver function abnormalities, dizziness, etc., so if any unusual symptoms occur, patients should inform their doctor. In cases of overdose, the risk of bleeding increases significantly, and if overdose is suspected, immediate consultation with healthcare professionals is necessary. This medication is difficult to monitor accurately using routine blood coagulation tests, so regular evaluations should be performed according to healthcare professional recommendations.

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

This medication must be stored in an airtight container to protect it from air or moisture. The storage temperature should be maintained between 1 degree to 30 degrees Celsius at room temperature.

Appearance

Yellow round film-coated tablet

Package unit

PTP - 30 tablets/box [10 tablets/PTP x 3]