Ildong Edoxaban Tablets 15mg (Edoxaban besilate hydrate)

Adult dose

This medicine should be taken 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, a dose of 15mg once daily may be administered according to age and condition. 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 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 initiate this medicine when the International Normalized Ratio (INR) 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 initiate this medicine at the time of the next scheduled oral anticoagulant dose. 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 medicine 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 must be maintained continuously while switching to another anticoagulant. 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 administration of 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. 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 necessary 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 the reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, a dose of 15mg once daily should be considered according to age and condition in elderly patients at high risk of bleeding with creatinine clearance of 15 ≤ CrCL < 30mL/min (see section “9. Use in elderly patients” 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 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.

This medication prevents blood clots by inhibiting coagulation. However, it may increase the risk of bleeding, and caution should be exercised in patients prone to bleeding or in high-risk bleeding situations. If symptoms of bleeding are suspected or if there is an unexplained decrease in blood counts, immediate testing is required. In case of severe bleeding, this medication should be discontinued immediately, and the bleeding site should be quickly assessed and treated. This medication should not be administered to certain patients, such as those with severe renal or liver disease, pregnant or breastfeeding women, and patients at very high risk of bleeding. Caution is also needed when taken with other anticoagulants. During treatment with this medication, bleeding symptoms should be closely monitored, especially when combined with other drugs affecting hemostasis. This medication may be affected by liver and kidney functions, so tests of liver and kidney function should be performed before and during treatment. When planning surgery or invasive procedures, this medication may need to be withheld for a certain period to reduce the risk of bleeding. Generally, regular monitoring of coagulation status is not necessary; however, in cases of overdose or emergencies, professional testing may be needed to assess its effects. This medication is not to be used in pregnant or breastfeeding women, and women of childbearing age should discuss pregnancy plans with their doctor. Elderly patients or those with impaired renal function may require dosage adjustments. An overdose of this medication can significantly increase the risk of bleeding, so immediate consultation with medical personnel is necessary in case of overdose. Additionally, this medication may interact with other drugs, so be sure to inform medical staff of any other medications being taken. It has little impact on driving or operating machinery, but caution is advised if bleeding symptoms occur. Sudden discontinuation of this medication can increase the risk of thrombosis, so consultation with medical personnel is essential when discontinuing.

• Hemorrhage
• soft 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 and should be kept at room temperature between 1 to 30 degrees Celsius. Therefore, avoid excessively hot or cold places and store it in a cool, dry place.

Appearance

Orange round film-coated tablets

Package unit

30 tablets/bottle