Rixiana 15 mg Tablets (Edoxaban Tosilate Hydrate)

Adult dose

This medicine should be taken with water, with or without food. 1. Adults 1) Reducing 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. (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 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 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 the next dose of the oral anticoagulant would have been due. 3) Switching from a parenteral anticoagulant to this medicine (1) Low-molecular-weight heparin (LMWH) Discontinue LMWH and start this medicine at the time the next dose of LMWH would have been due. (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 during the switch 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 receiving 60mg of this medicine, administer 30mg once daily together with an appropriate dose of a vitamin K antagonist. For patients receiving 30mg of this medicine, administer 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; measurements should be taken before administering this medicine to minimize its effect on 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 the next dose of this medicine would have been due. 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 the next dose of this medicine would have been due. 3) Switching from this medicine to a parenteral anticoagulant Discontinue this medicine and start the parenteral anticoagulant at the time the next dose of this medicine would have been due. 3. Patients with renal impairment No dose adjustment is required 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 reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation who are elderly and at high risk of bleeding, with creatinine clearance of 15 ≤ CrCL < 30mL/min, administration of 15mg once daily should be considered depending on age and condition (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 who cannot swallow tablets For patients who cannot swallow tablets, this medicine may be crushed immediately before use, mixed with water or a drink such as applesauce, and taken orally. Alternatively, this medicine may be crushed, suspended in a small amount of water, and administered through a nasogastric feeding tube, followed by flushing the tube with water. Crushed this medicine is stable for up to 4 hours in water and applesauce.

This medication is an anticoagulant that helps prevent blood clotting. However, taking this medication can increase the risk of bleeding, so patients with bleeding risks need to be particularly cautious. If any bleeding is suspected, medical personnel should be notified immediately, and if severe bleeding occurs, the medication should be discontinued and the bleeding site quickly checked. Patients with allergies to this medication or serious bleeding, those with severely impaired kidney or liver function, and those with certain bleeding risk conditions should not take this medication. Additionally, it should be avoided in combination with other anticoagulants, and patients with uncontrolled hypertension or specific heart diseases should also be cautious. During treatment, caution is also needed when using medications that may increase the bleeding risk such as acetylsalicylic acid, antiplatelet agents, or certain antidepressants. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing age should consult their physician regarding pregnancy plans. Elderly patients or those with poor kidney function may require dosage adjustments, so they should follow a physician's instructions. While on this medication, adverse reactions such as bleeding symptoms, dizziness, skin rashes, or abnormal liver function may occur, and if symptoms arise, medical personnel should be informed immediately. If undergoing surgery or an invasive procedure, the medication should be discontinued to reduce the risk of bleeding and can be resumed only after bleeding has completely stopped post-procedure. In cases of overdose, the risk of bleeding significantly increases; therefore, immediate medical assistance is necessary, and emergency interventions may be needed as there is no specific antidote. This medication is difficult to monitor accurately through routine blood coagulation tests; hence, regular medical check-ups and observations are required as per the physician's instructions.

• Hemorrhage
• 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 from air or moisture. Additionally, it is best to store the medication at a controlled room temperature, between 1 and 30 degrees Celsius.

Appearance

Orange round film-coated tablets

Package unit

14 tablets (14 tablets/PTP x 1)/carton