AhnGuk Edoxaban Tablets 30 mg (Edoxaban Tosilate Hydrate)

Adult dose

This medicine should be administered 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 P-gp inhibitors (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 in the risk of recurrent deep vein thrombosis and pulmonary embolism Administer this medicine after at least 5 days of treatment with a parenteral anticoagulant. • 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 medications 2.1 Switching from another medication to this medicine 1) Switching from a vitamin K antagonist to this medicine Discontinue treatment with the vitamin K antagonist 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 treatment with the oral anticoagulant and start this medicine at the time the next dose of the oral anticoagulant would have been due. 3) Switching from a parenteral anticoagulant to this medicine (1) Low-molecular-weight heparin (LMWH) Discontinue LMWH and start this medicine at the time the next dose of LMWH would have been due. (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 while switching from this medicine to a vitamin K antagonist. Adequate anticoagulant effect must 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, measure the INR before administering this medicine. Once an INR ≥ 2.0 is stably achieved, discontinue this medicine and continue treatment with the vitamin K antagonist. (2) Parenteral option Discontinue this medicine and administer a parenteral anticoagulant and a vitamin K antagonist at the time the next dose of this medicine would have been due. Once an INR ≥ 2.0 is stably achieved, discontinue the parenteral anticoagulant and continue treatment with the vitamin K antagonist. 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 the next dose of this medicine would have been due. 3) Switching from this medicine to a parenteral anticoagulant Discontinue this medicine and start the parenteral anticoagulant at the time the next dose of this medicine would have been due. 3. Patients with renal impairment No dose adjustment is necessary for patients with mild renal impairment (50 < CrCL ≤ 80mL/min). The recommended dose of this medicine for 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, for reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. 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 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. 5. Patients who cannot swallow tablets For patients who cannot swallow tablets, this medicine may be crushed immediately before use, mixed with a liquid such as water or applesauce, and administered orally. It 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 works by thinning the blood to prevent clots from forming. Caution is required as the risk of bleeding may increase when taking this medication, especially in states where there is a risk of bleeding. If bleeding is suspected or there is a decrease in blood counts of unknown cause or drop in blood pressure, bleeding sites should be checked immediately. If severe bleeding occurs, the use of this medication should be discontinued and bleeding sites should be examined promptly. Patients at higher risk of bleeding should be closely monitored for symptoms of bleeding and anemia after taking this medication. This medication should not be used in patients with allergies to it or those with severe bleeding, end-stage renal disease, or severe liver disease. Caution is also needed when taking it with other anticoagulants, especially in patients with severe hypertension or certain heart diseases. When taken with acetylsalicylic acid, antiplatelet agents, or non-steroidal anti-inflammatory drugs, the risk of bleeding may increase, so it should be used cautiously. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing age should discuss pregnancy plans with their doctor. Elderly patients or those with reduced renal function may need dose adjustments. To reduce the risk of bleeding, this medication should be discontinued prior to surgery or invasive procedures, and can be resumed once the condition stabilizes post-procedure. This medication may affect the results of blood coagulation tests, and its effects may be difficult to monitor accurately with standard coagulation tests. Due to increased risk of bleeding with overdose, it must be taken as directed by a doctor, and any overdose should be consulted with medical personnel immediately.

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 hemorrhage, hemoptysis, abdominal pain, lower gastrointestinal hemorrhage, upper gastrointestinal hemorrhage, oral/pharyngeal hemorrhage, nausea, retroperitoneal hemorrhage, elevated serum bilirubin, increased gamma-glutamyl transferase, increased serum alkaline phosphatase, increased transaminases, increased aspartate aminotransferase, skin soft tissue hemorrhage, pruritus, urticaria, intramuscular hemorrhage, cartilage hemorrhage, macroscopic hematuria/urethral hemorrhage, anticoagulant-related nephropathy, vaginal hemorrhage, hemorrhage at puncture site, abnormal liver function tests, surgical site hemorrhage, subdural hemorrhage, hemorrhage during procedures, interstitial lung disease, menstrual hemorrhage, hemorrhagic complications, compartment syndrome, renal failure due to reduced perfusion, anticoagulant-related nephropathy, interstitial lung disease, severe uterine hemorrhage

This medication should be stored in a tightly sealed container to keep it away from air and moisture. It is also recommended to store it at room temperature, between 1 to 30 degrees Celsius.

Appearance

Pink round film-coated tablet

Package unit

10 tablets/box [10 tablets/PTP]