Edoxaban Tablets 60mg (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 used, depending on age and condition. (See Precautions for Use, Section 9, “Use in the Elderly.”) 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 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 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) 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 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 medication 1) Switching from this medicine to a vitamin K antagonist Inadequate anticoagulation may occur when switching from this medicine to a vitamin K antagonist. Adequate anticoagulation should be maintained continuously while switching 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, measure INR before administering this medicine. Once INR ≥ 2.0 is achieved stably, 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 achieved stably, 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 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. To reduce 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, for elderly patients at high risk of bleeding whose creatinine clearance is 15 ≤ CrCL < 30mL/min (see Precautions for Use, Section 9, “Use in the Elderly”). 4. If you forget to take this medicine If you forget to take this medicine, take it immediately on the same day, and take it 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 unable to 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. This medicine may also be crushed, suspended in a small amount of water, and administered through a nasogastric tube, followed by flushing the tube with water. Crushed this medicine is stable in water and applesauce for up to 4 hours.

This medication prevents blood clotting and the formation of thrombosis. However, it may increase the risk of bleeding; therefore, patients with a high risk of bleeding should exercise particular caution. If any symptoms of bleeding or unexplained changes in blood counts occur, immediate medical evaluation is necessary. In case of severe bleeding, the medication should be discontinued, and the bleeding site should be promptly investigated and treated. This medication should not be used if certain diseases or conditions exist, such as severe renal disease, liver disease, high risk of bleeding, or if a woman is pregnant or breastfeeding. Additionally, when used with other anticoagulants or medications affecting hemostasis, the bleeding risk may increase, thus cautious administration under a doctor's guidance is required. Regular liver and kidney function tests should be performed while taking this medication, and it should be discontinued before any surgical or invasive procedures. Special caution is needed during central nervous system anesthesia or spinal puncture due to the risk of hematoma formation. This medication is not recommended for pregnant or breastfeeding women, and women of childbearing age should consult their healthcare provider regarding pregnancy plans. Elderly patients and those with reduced renal function may require dosage adjustments, and sudden discontinuation of this medication may increase the risk of thrombosis, so it should be stopped in consultation with healthcare professionals. While this medication is not typically monitored through coagulation tests, care is needed as overdose may heighten the risk of bleeding. There is no specific antidote for overdose, so prompt medical attention is required.

Hemorrhage, soft tissue hemorrhage, nasal hemorrhage, vaginal 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, hemoptysis, abdominal pain, lower gastrointestinal hemorrhage, upper gastrointestinal hemorrhage, oral/pharyngeal hemorrhage, nausea, retroperitoneal hemorrhage, increased serum bilirubin, increased gamma-glutamyl transferase, increased serum alkaline phosphatase, increased transaminases, increased aspartate aminotransferase, pruritus, urticaria, intramuscular hemorrhage, intrachondral hemorrhage, gross hematuria/urethral hemorrhage, anticoagulant-related nephropathy, bleeding at the puncture site, abnormal liver function tests, bleeding at the surgical site, subdural hemorrhage, bleeding during procedures, interstitial lung disease, worsening or prolonged menstrual bleeding, increased risk of severe uterine hemorrhage

This medication should be stored in a tightly closed container to prevent air or moisture exposure, and it is recommended to keep it at room temperature between 1°C and 30°C. Storing it this way helps maintain the medication's efficacy for a longer period.

Appearance

Yellow round film-coated tablet

Package unit

28 tablets/box