Rixaban 30 mg (Edoxaban Tosilate Hydrate)

Adult dose

This medicine should be taken 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 a P-gp inhibitor (cyclosporine, dronedarone, erythromycin, ketoconazole) For elderly patients at high risk of bleeding, 15mg once daily may be administered, depending on age and condition. 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 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 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 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 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 dose of LMWH. (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 while switching 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 administering this medicine to minimize its effect on the INR measurement. 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 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 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 whose creatinine clearance is 15 ≤ CrCL < 30mL/min. 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 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 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 can increase the risk of bleeding and may cause serious hemorrhages, so it should be used with caution in patients at high risk of bleeding. In case of severe bleeding, the medication should be stopped immediately, and the bleeding site should be identified and treated promptly. Patients at high risk of bleeding should be closely monitored for signs of bleeding or anemia after administration of this medication. This medication should not be administered to patients who have allergic reactions to its ingredients, currently have severe bleeding, have significantly impaired kidney function, or have severe liver disease. Patients with recent gastrointestinal ulcers, history of intracranial hemorrhage, or brain/spinal surgery should also not use this medication. Additionally, caution should be exercised when used in conjunction with other anticoagulants, as this can significantly increase the risk of bleeding. This medication may increase the risk of bleeding when used with acetylsalicylic acid, antiplatelet agents, non-steroidal anti-inflammatory drugs, and selective serotonin reuptake inhibitors, which affect hemostasis. Patients with reduced kidney function may experience elevated plasma levels of this medication, requiring dosage adjustments and regular renal function testing. Liver function tests should also be conducted prior to administration, and liver function should be monitored regularly during long-term use. Patients scheduled for surgery or invasive procedures should temporarily discontinue this medication to reduce the risk of bleeding, and should resume taking it after hemostasis is achieved. Special care is required during central nervous system anesthesia or spinal puncture due to the risk of hematoma. Pregnant or breastfeeding women should not use this medication, and women of childbearing age should consult their physician regarding pregnancy plans. Dosage should be adjusted for elderly patients or those with impaired kidney function. This medication is difficult to monitor accurately for anticoagulant effects with standard coagulation tests, so signs of bleeding or adverse reactions should be carefully observed. In case of overdose, the risk of bleeding increases, so contact medical personnel immediately, as no antidote is available, and emergency treatment may be required. It is important to consult healthcare professionals immediately if any unusual symptoms or bleeding occur while taking this medication.

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

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is best kept at room temperature between 1 to 30 degrees Celsius. This helps to maintain the effectiveness of the medication for a longer period.

Appearance

Pink round film-coated tablet

Package unit

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