Megasaban 15 mg (Edoxaban Tosilate Hydrate)

Adult dose

This medicine should be taken with water, with or without food. 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) For elderly patients at high risk of bleeding, a dose of 15mg once daily may be administered depending on age and condition. 2) Treatment of deep vein thrombosis and pulmonary embolism/reduction in the risk of recurrent 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 treatment and initiate this medicine when the international normalized ratio (INR, International Normalized Ratio) is ≤ 2.5. 2) Switching from a non-vitamin K antagonist oral anticoagulant (dabigatran, rivaroxaban, apixaban) to this medicine Discontinue oral anticoagulant treatment and initiate 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 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 during the switch from this medicine to a vitamin K antagonist. Adequate anticoagulation should be maintained continuously when 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; 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 treatment. 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 treatment. 2) Switching from this medicine to a non-vitamin K antagonist oral anticoagulant (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 elderly patients at high risk of bleeding with a creatinine clearance of 15 ≤ CrCL < 30mL/min, a dose of 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. Administration to elderly patients” 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 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 is an anticoagulant that prevents the formation of blood clots. Taking this medicine may increase the risk of bleeding; hence special caution is necessary in conditions with a high risk of bleeding. Since fatal bleeding may occur, it is essential to check for bleeding sites if there is a decrease in blood count or drop in blood pressure of unknown origin. If bleeding is severe, stop taking this medication immediately and quickly assess the bleeding site. Patients at high risk of bleeding should closely monitor for bleeding symptoms and signs of anemia. This medication should not be administered to specific patients. For example, patients allergic to any component of this drug or those with severe bleeding, end-stage kidney disease, or severe liver disease should not use it. Moreover, it should not be given to patients with recent gastrointestinal ulcers or a history of intracerebral hemorrhage, uncontrolled hypertension, or women who are pregnant or breastfeeding. Patients with lactose intolerance should also avoid taking this medication. Concomitant use with certain drugs may increase the risk of bleeding, so caution is needed when taken with aspirin, antiplatelet agents, non-steroidal anti-inflammatory drugs, and specific antidepressants. In particular, concomitant use with P-gp inducers or inhibitors may change the effects or concentrations of this medication, following the physician's instructions is essential. During treatment with this medication, dizziness, headache, skin rash, bleeding symptoms, gastrointestinal bleeding, hematuria, or vaginal bleeding may occur, so it is important to inform healthcare providers immediately if any abnormal symptoms arise. Prompt diagnosis and treatment are necessary, especially if signs of bleeding appear. In cases of surgical or invasive procedures, this medication should be discontinued in advance to reduce the risk of bleeding, and treatment can resume once the risk of post-surgical bleeding has diminished. Patients undergoing central nervous system anesthesia need to be especially cautious as there is a risk of hematoma. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing age should consult a physician regarding their pregnancy plans. The safety and efficacy of this medication in pediatrics have not been established; thus, it should not be used in children. Elderly patients or those with reduced kidney function may require dose adjustments and should follow the healthcare provider’s directions. The risk of bleeding may significantly increase with overdose, so the dosage must be adhered to strictly, and if overdose occurs, seek medical attention immediately. This medication has no antidote, so reducing absorption with activated charcoal may be necessary in cases of overdose. Regular blood tests and liver function tests should be performed while taking this medication to closely evaluate the risk of bleeding and treatment efficacy. It does not significantly affect driving or machine operation, but care should be taken if symptoms like dizziness occur.

Bleeding, soft tissue bleeding, nasal bleeding, vaginal bleeding, anemia, rash, abnormal liver function tests, thrombocytopenia, hypersensitivity, anaphylactic reaction, allergic edema, dizziness, headache, intracranial hemorrhage, subarachnoid hemorrhage, conjunctival/scleral hemorrhage, intraocular hemorrhage, cardiac tamponade, other bleeding, hemoptysis, abdominal pain, lower gastrointestinal bleeding, upper gastrointestinal bleeding, oral/pharyngeal bleeding, nausea, retroperitoneal bleeding, increased serum bilirubin, increased gamma-glutamyltransferase, increased serum alkaline phosphatase, increased transaminases, increased aspartate aminotransferase, pruritus, urticaria, intramuscular bleeding, intraarticular bleeding, gross hematuria/urethral bleeding, bleeding at the puncture site, abnormal liver function tests, surgical site bleeding, subdural hemorrhage, procedural bleeding, interstitial lung disease, menstrual bleeding, bleeding complications, compartment syndrome, acute kidney injury due to reduced perfusion, anticoagulant-related nephropathy, increased risk of severe uterine bleeding

This medication should be stored in a tightly closed container to protect it from air and moisture, ideally at room temperature between 1°C and 30°C. Proper storage will help maintain the medication's efficacy for longer.

Appearance

Orange round film-coated tablet

Package unit

30 tablets/bottle