Axiaban Tablets 60mg (Edoxaban tosylate hydrate)

Adult dose

This medicine should 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 considered depending on age and condition. (See “9. Use in the Elderly” under Precautions for Use.) 2) Treatment of deep vein thrombosis and pulmonary embolism/reduction of 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 medication 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 a non-vitamin K antagonist oral anticoagulant (dabigatran, rivaroxaban, apixaban) to this medicine Discontinue oral anticoagulant therapy 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 medication 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 anticoagulation should be maintained continuously while switching to another anticoagulant. (1) Oral 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 the INR be measured at least 3 times. To minimize the effect of this medicine on INR measurements, these measurements should be taken before administration of this medicine. Once an 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 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 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 is required for patients with mild renal impairment (50 < CrCL ≤ 80mL/min). For patients with moderate to severe renal impairment (15 ≤ CrCL ≤ 50mL/min), the recommended dose of this medicine 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, depending on age and condition, in elderly patients at high risk of bleeding whose creatinine clearance is 15 ≤ CrCL < 30mL/min (see “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 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 may increase the risk of bleeding, so it should be used very carefully in conditions where bleeding easily occurs. If bleeding occurs, the cause should be investigated immediately and the medication should be discontinued if necessary. Patients with a high risk of bleeding should closely monitor for signs of bleeding or anemia after starting this medication. This medication should not be used in patients allergic to its components, those with severe bleeding, patients with severely impaired kidney function, and those with severely impaired liver function. Additionally, it should not be administered to patients with recent gastrointestinal ulcers or a history of intracranial hemorrhage, or in combination with other anticoagulants. This medication inhibits blood coagulation; therefore, using it with aspirin, non-steroidal anti-inflammatory drugs, platelet inhibitors, or some antidepressants may increase the risk of bleeding. Patients with weakened liver or kidney function should be more cautious when using this medication and should regularly receive tests of liver and kidney function. If undergoing surgery or invasive procedures, this medication should be discontinued for a certain period to reduce the risk of bleeding, and should be resumed once the condition stabilizes post-procedure. Women who are pregnant or breastfeeding should not use this medication, and women of childbearing age should consult a physician regarding pregnancy plans. Elderly patients or those with reduced kidney function should adjust the dosage and carefully evaluate the risk of bleeding. This medication is difficult to accurately monitor with general blood coagulation tests, so in cases of overdose, special tests or treatment may be necessary. In cases of excessive intake, the risk of bleeding increases, thus immediate medical intervention is required, and since there is no specific antidote, symptomatic treatment is instituted. Patients should inform medical professionals immediately if they experience dizziness, bleeding symptoms, or skin rashes while taking this medication.

• Hemorrhage
• soft tissue bleeding
• nasal bleeding
• vaginal bleeding
• anemia
• rash
• abnormal liver function test
• thrombocytopenia
• hypersensitivity
• anaphylactic reaction

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture, and should be kept at a temperature between 1 and 30 degrees Celsius. Proper storage will maintain the effectiveness and safety of the medication.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle