Lixiana 60mg (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) In elderly patients at high risk of bleeding, a dose of 15mg once daily may be used 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 a P-gp inhibitor (cyclosporine, dronedarone, erythromycin, ketoconazole) 2. Switching between medicines 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 lower. 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 medicine 1) Switching from this medicine to a vitamin K antagonist Inadequate anticoagulation may occur during the transition 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 taking 60mg of this medicine, administer 30mg of this medicine once daily together with an appropriate dose of a vitamin K antagonist. For patients taking 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. To minimize the effect of this medicine on INR measurements, measurements should be taken 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 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, a dose 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 immediately on the same day and take the next day's dose 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 feeding tube, followed by flushing the tube with water. The crushed medicine is stable in water and applesauce for up to 4 hours.

This medication is an anticoagulant that prevents blood clotting. However, it may increase the risk of bleeding; therefore, caution should be used in patients at risk of bleeding. If bleeding is suspected or if unexplained anemia or low blood pressure occurs, the site of bleeding should be checked immediately. In the case of severe bleeding, discontinue this medication and promptly inspect and treat the bleeding site. Patients at high risk of bleeding should be closely monitored for symptoms of bleeding or anemia after starting treatment. This medication should not be administered to patients with an allergy to it, those who have serious bleeding, significantly impaired kidney or liver function, or certain bleeding risk disorders. Caution is also required when used in combination with other anticoagulants, and it should not be administered to patients with uncontrolled hypertension, pregnant women, or breastfeeding mothers. When taken with drugs that increase bleeding risk, careful administration is mandatory, and caution is needed in patients with slightly impaired liver function or blood clotting issues. This medication may cause side effects such as bleeding, anemia, skin rashes, liver function abnormalities, etc. Bleeding is the most common side effect, and menstruation may become heavier or prolonged. Symptoms of bleeding include paleness, dizziness, headache, and shortness of breath; if these symptoms occur, consult healthcare professionals immediately. Interstitial lung disease may occasionally develop during therapy, so symptoms such as shortness of breath, cough, and fever should be carefully monitored. Before surgery or invasive procedures, this medication should be discontinued to reduce the bleeding risk, and it should be re-administered only when the bleeding risk is eliminated. The effectiveness of this medication cannot be accurately measured with standard blood coagulation tests; special tests may be required. In case of overdose, the risk of bleeding increases significantly, so it is essential to adhere strictly to the prescribed dosage, and emergency treatments like activated charcoal may be necessary in cases of overdose. Women who are pregnant or breastfeeding should not use this medication, and women of childbearing potential should consult their doctor regarding pregnancy plans. Elderly patients or those with reduced kidney function may require dose adjustments, and particularly for frail elderly patients at high risk of bleeding, a lower dose should be given. Care should be taken with combinations of this medication and certain antibiotics, antifungals, antiarrhythmics, etc., as blood concentration may increase. Additionally, when used with drugs that increase bleeding risk such as non-steroidal anti-inflammatory drugs, antiplatelet agents, and selective serotonin reuptake inhibitors, adherence to medical advice is essential. When discontinuing this medication, consult healthcare professionals to receive appropriate alternative treatment, as there may be an increased risk of thrombosis.

• 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 prevent effects from air or moisture. The storage temperature should be kept between 1 to 30 degrees Celsius.

Appearance

Yellow round film-coated tablet

Package unit

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