Edoxaban 30 mg Tablet (Edoxaban Tosilate Hydrate)

Adult dose

This medicine may be taken with water, with or without food. 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 a P-gp inhibitor (cyclosporine, dronedarone, erythromycin, ketoconazole) For elderly patients at high risk of bleeding, a dose of 15mg once daily may be used, depending on 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 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, International Normalized Ratio) is 2.5 or less. 2) Switching from a non-vitamin K antagonist oral anticoagulant (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 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 during the transition from this medicine to a vitamin K antagonist. Adequate anticoagulation should be maintained continuously while switching to another anticoagulant. Option For patients receiving this medicine at 60mg, administer this medicine at 30mg once daily together with an appropriate dose of a vitamin K antagonist. For patients receiving this medicine at 30mg, administer this medicine at 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 the INR be measured at least 3 times. To minimize the effect of this medicine on INR measurements, measure the INR before administering this medicine. Once an 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 an INR ≥ 2.0 is stably achieved, discontinue the parenteral anticoagulant and continue vitamin K antagonist therapy. 2) Switching from this medicine to a non-vitamin K antagonist oral anticoagulant (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 in patients with moderate to severe renal impairment (15 ≤ CrCL ≤ 50mL/min) is 30mg once daily. For elderly patients at high risk of bleeding with a creatinine clearance of 15 ≤ CrCL < 30mL/min, 15mg once daily should be considered, depending on age and condition, to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (see section “9. Use in the elderly” under Precautions for Use). 4. If you miss a dose of this medicine If you miss a dose of this medicine, take it as soon as possible 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.

This medication prevents blood from clotting and the formation of thrombi. However, it may increase the risk of bleeding, leading to serious hemorrhages, and should be used with caution. In conditions with a high risk of bleeding, this medication should be used cautiously, and if unexplained decreases in blood count or blood pressure occur during treatment, the sites of bleeding must be examined. If a serious bleeding event occurs, the medication should be stopped immediately, and rapid assessment and treatment of the bleeding site should follow. Patients at high risk of bleeding should be closely monitored for bleeding or anemia symptoms after starting this medication. This medication should not be used in patients with certain conditions, such as an allergy to any of the ingredients, severe bleeding, end-stage renal disease, blood clotting disorders, severe liver disease, or a recent history of gastrointestinal ulcers or brain injuries, as it may pose risks. Additionally, the risk of bleeding increases significantly if this medication is used in conjunction with other anticoagulants, so co-administration should be avoided. Women who are pregnant or breastfeeding, and patients with lactose intolerance should also not use this medication. When using this medication with aspirin, antiplatelet agents, non-steroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors, or other drugs that affect hemostasis, the risk of bleeding may further increase, requiring careful administration. Elderly patients and those with compromised kidney or liver function may need dosage adjustments, and renal and liver function tests should be conducted before therapy. If undergoing surgery or invasive procedures, this medication should be discontinued for a certain period to reduce the risk of bleeding, and subsequently restarted promptly once hemostatic stability is achieved. While taking this medication, symptoms of bleeding or anemia may occur, so patients should be closely monitored, and any unusual symptoms should be discussed with healthcare professionals. In cases of overdose, the risk of bleeding significantly increases, and since there is no specific antidote for this medication, measures to reduce absorption may be necessary in urgent situations. Women planning to become pregnant should consult a physician before taking this medication, and it should not be used during pregnancy or breastfeeding. The safety and efficacy of this medication have not been established in children, and it should not be used in this population.

Hemorrhage, anemia, rash, abnormal liver function tests, thrombocytopenia, hypersensitivity, anaphylactic reaction, allergic edema, dizziness, headache, intracranial hemorrhage, subarachnoid hemorrhage, conjunctival/scleral hemorrhage, intraocular hemorrhage, pericardial hemorrhage, other hemorrhage, nasal bleeding, hemoptysis, abdominal pain, lower gastrointestinal bleeding, upper gastrointestinal bleeding, oral/pharyngeal bleeding, nausea, retroperitoneal bleeding, increased serum bilirubin, increased gamma-glutamyl transferase, increased serum alkaline phosphatase, increased transaminases, increased aspartate aminotransferase, cutaneous soft tissue hemorrhage, pruritus, urticaria, intramuscular bleeding, intra-articular bleeding, gross hematuria/urethral bleeding, vaginal bleeding, puncture site bleeding, abnormal liver function tests, surgical site bleeding, subdural hemorrhage, bleeding during procedures, interstitial lung disease, worsening or prolonged menstrual bleeding

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. Furthermore, it is important to maintain the storage temperature in a range of room temperature, specifically between 1 to 30 degrees Celsius.

Appearance

Pink round film-coated tablets

Package unit

30 tablets/bottle