EXCIVA Tablet 30 mg (Edoxaban Tosilate Hydrate)

Adult dose

This medicine should be taken with water, regardless of meals. 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 treatment 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 treatment 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 anticoagulant effects should be maintained continuously during the switch to another anticoagulant. 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; these measurements should be taken before administering this medicine to minimize its effect on INR measurements. Once INR ≥ 2.0 is achieved stably, 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 INR ≥ 2.0 is achieved stably, discontinue the parenteral anticoagulant and continue vitamin K antagonist treatment. 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 of this medicine is required 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 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 with a creatinine clearance of 15 ≤ CrCL < 30mL/min (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 it the next 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 is an anticoagulant that prevents blood clots by thinning the blood. The risk of bleeding may increase when taking this medication, so caution is especially needed in conditions with high bleeding risk. If symptoms of bleeding are suspected or there is a sudden unexplained decrease in blood counts, immediate testing is required. If serious bleeding occurs, discontinue taking this medication and quickly assess the bleeding site. Patients with hypersensitivity or severe bleeding, severe kidney or liver disease, those with certain bleeding risk diseases, pregnant women, and nursing mothers should not take this medication. When using this medication together with other drugs that affect blood coagulation, the risk of bleeding may increase, so it should be used cautiously as directed by a physician. This medication can be influenced by liver and kidney functions, so regular testing before and during treatment is necessary. Prior to surgery or invasive procedures, this medication may need to be discontinued for a certain period to reduce the risk of bleeding. In addition to bleeding, side effects such as anemia, rash, abnormal liver function tests may occur, so any unusual symptoms should be reported to a healthcare professional promptly. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing potential should consult their physician about pregnancy planning. Elderly patients or those with decreased kidney function may require dose adjustments and should be closely monitored for therapeutic effects and side effects. In cases of overdose, the risk of bleeding may significantly increase, and immediate medical attention is necessary. This medication is generally not monitored for effect with routine blood coagulation tests, but special tests can evaluate anticoagulation effects in emergency situations. This medication does not significantly affect driving or operating machinery, but caution is needed in the presence of bleeding symptoms.

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, epistaxis, hemoptysis, abdominal pain, lower gastrointestinal tract hemorrhage, upper gastrointestinal tract hemorrhage, oral/pharyngeal hemorrhage, nausea, retroperitoneal hemorrhage, increased serum bilirubin, increased gamma-glutamyl transferase, increased serum alkaline phosphatase, increased transaminases, increased aspartate aminotransferase, cutaneous soft tissue hemorrhage, pruritus, urticaria, intramuscular hemorrhage, intra-articular hemorrhage, gross hematuria/urethral hemorrhage, anticoagulant-related nephropathy, vaginal hemorrhage, puncture site hemorrhage, abnormal liver function tests, surgical site hemorrhage, subdural hemorrhage, procedural hemorrhage, interstitial lung disease, worsening or prolonged menstrual bleeding, weakness, pallor, unexplained edema, dyspnea, unexplained shock, compartment syndrome, renal failure due to decreased perfusion

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and it is recommended to store it at a temperature between 1 to 30 degrees Celsius. By storing it this way, the medication's effectiveness can be maintained and used safely.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle