Rixiana Tablet 30 mg (Edoxaban Tosilate Hydrate)

Adult dose

This medicine should be administered with water, regardless of meals. 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 P-gp inhibitors (cyclosporine, dronedarone, erythromycin, ketoconazole) For elderly patients at high risk of bleeding, 15mg once daily may be administered depending on age and condition. (Refer to “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 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, International Normalized Ratio) 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 while switching from this medicine to a vitamin K antagonist. Adequate anticoagulant effects should be maintained continuously during the switch 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 the INR be measured at least 3 times; measurements should be taken before administering this medicine to minimize its effect on the INR measurement. 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, administration of 15mg once daily should be considered, depending on age and condition, for elderly patients at high risk of bleeding with a creatinine clearance of 15 ≤ CrCL < 30mL/min (refer to “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. Alternatively, this medicine may be crushed, suspended in a small amount of water, and administered through a nasogastric tube; flush the nasogastric tube with water afterward. Crushed this medicine is stable in water and applesauce for up to 4 hours.

This medication helps prevent blood clotting, which may increase the risk of bleeding. Extra caution should be exercised in conditions where bleeding is likely. During the use of this medication, bleeding can occur anywhere in the body, so if there is a decrease in blood counts or blood pressure for unknown reasons, bleeding sites must be checked. If serious bleeding occurs, discontinue the medication immediately and quickly assess the bleeding site. Patients with a high risk of bleeding should closely monitor for signs of bleeding or anemia after starting this medication. The medication should not be used by individuals allergic to its active ingredient or components, those with severe bleeding, end-stage renal disease, blood coagulation disorders, or severe liver dysfunction. Additionally, patients with recent gastrointestinal ulcers, malignancies, brain or spinal injuries, history of intracranial bleeding, those taking other anticoagulants simultaneously, uncontrolled hypertension, and pregnant or breastfeeding women should not use this medication. Patients taking medications that affect bleeding such as acetylsalicylic acid, antiplatelet drugs, non-steroidal anti-inflammatory drugs, or selective serotonin reuptake inhibitors should use this medication with caution, as should patients with mildly impaired liver function or conditions increasing bleeding risk. Side effects such as bleeding, anemia, skin rash, liver function abnormalities, etc. can occur commonly, and severe cases may lead to life-threatening hemorrhage, requiring careful monitoring for signs of bleeding during treatment. Patients undergoing surgery or invasive procedures should discontinue this medication beforehand to reduce bleeding risk and can resume after confirming hemostasis post-procedure. This medication should not be used concurrently with other anticoagulants. This medication may interact with specific drugs, so be sure to inform healthcare providers of any medications being taken together. Pregnant or breastfeeding women should not take this medication, and women of childbearing age should consult their doctor about pregnancy plans. Older adults or patients with reduced renal function may require dosage adjustments, and regular kidney and liver function tests during treatment are advisable. Overdosing can significantly increase the risk of bleeding, so strict adherence to dosing recommendations is essential, and any suspicion of overdose should prompt immediate consultation with healthcare professionals.

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. Additionally, it is best to keep the tablets at room temperature, between 1°C and 30°C, avoiding extreme temperatures.

Appearance

Pink round film-coated tablet

Package unit

28 tablets (14 tablets/PTP X 2)/carton