Jayelto 10 mg (Rivaroxaban)

Adult dose

This medicine 10 mg is administered regardless of meals, while 15 mg and 20 mg are administered with meals. 1. Adults 1) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation The recommended dose of this medicine is 20 mg once daily. The recommended dose for patients with moderate renal impairment (creatinine clearance 30-49 mL/min) is 15 mg once daily. The maximum daily dose of this medicine is 20 mg. There is limited experience with concomitant administration of rivaroxaban 15mg once daily [10mg once daily in patients with moderate renal impairment (creatinine clearance 30-49 mL/min)] and a P2Y12 inhibitor for up to 12 months in patients with nonvalvular atrial fibrillation who underwent percutaneous coronary intervention (PCI) with stent placement. (See '12. Clinical Trial Information') 2) Treatment of deep vein thrombosis and pulmonary embolism / Reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism The recommended initial dose of this medicine for the treatment of acute deep vein thrombosis and pulmonary embolism is 15 mg twice daily for the first 3 weeks. Thereafter, the recommended maintenance dose for the treatment of deep vein thrombosis and pulmonary embolism and the recommended dose for reducing the risk of recurrence are 20 mg once daily. After completing treatment (at least 6 months) for deep vein thrombosis or pulmonary embolism, the recommended dose for extended administration to reduce the risk of recurrence is 10mg once daily. The duration of treatment and dose should be determined after an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism versus the risk of bleeding. Treatment period Frequency of administration Daily dose Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence Days 1-21 15mg twice daily 30mg From day 22 20mg once daily 20mg Reduction of the risk of recurrence of deep vein thrombosis or pulmonary embolism After administration for 6 months or longer 10mg once daily 10mg The maximum daily dose of this medicine is 30 mg during the first 3 weeks of treatment and 20 mg thereafter during the treatment period. 3) Prevention of venous thromboembolism in adult patients undergoing major orthopedic surgery of the lower limbs (knee or hip replacement) The recommended dose of this medicine is 10 mg once daily. The first dose should be started 6~10 hours after surgery, once hemostasis has been confirmed. The duration of administration depends on each patient's risk of venous thromboembolism according to the type of surgery; however, a treatment duration of 5 weeks is recommended for patients undergoing hip replacement and 2 weeks for patients undergoing knee replacement. 4) If you forget to take this medicine If you forget to take this medicine, take the missed dose as follows. ① Patients taking 15 mg twice daily: Take this medicine immediately; in this case, 2 tablets of 15 mg may be taken at one time. From the next day, continue taking 15 mg twice daily. ② Patients taking 10, 15, 20 mg once daily: Take the missed dose immediately. From the next day, continue taking 1 tablet once daily. The daily dose must not be doubled to make up for a missed dose. 2. Switching medications 1) Switching from a vitamin K antagonist to this medicine ① Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Discontinue vitamin K antagonist therapy and start taking this medicine when the international normalized ratio (INR, International Normalized Ratio) is ≤ 3.0. ② Treatment of deep vein thrombosis and pulmonary embolism / Reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism Discontinue vitamin K antagonist therapy and start taking this medicine when the INR is ≤ 2.5. The INR value will be falsely elevated after taking this medicine, regardless of the dose. INR is not suitable for measuring the anticoagulant activity of this medicine and should not be used for this purpose. 2) 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. Note that this medicine may affect the increase in INR. Patients switching from this medicine to a vitamin K antagonist should receive the vitamin K antagonist concomitantly until the INR is ≥2.0. During the first 2 days after switching, administer the standard dose of the vitamin K antagonist, and thereafter administer a dose of the vitamin K antagonist based on INR testing. However, in patients receiving this medicine and a vitamin K antagonist concomitantly, INR should not be measured until 24 hours have elapsed after taking this medicine. Once this medicine is discontinued, INR may be measured 24 hours after the last dose. 3) Switching from a parenteral anticoagulant to this medicine In patients receiving a parenteral anticoagulant, start this medicine 0~2 hours before the next scheduled dose of the parenteral agent (e.g., low molecular weight heparin), or at the time of discontinuation of a continuously administered parenteral agent (e.g., intravenous unfractionated heparin). 4) Switching from this medicine to a parenteral anticoagulant Discontinue this medicine and start administration of 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 in patients with mild renal impairment with a creatinine clearance of 50-80 mL/min. Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), the plasma concentration of this medicine increased significantly; therefore, administer this medicine with caution. Administration of this medicine is not recommended in patients with severe renal impairment with a creatinine clearance below 15 mL/min, as there is no clinical experience in these patients. 1) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation The recommended dose in patients with moderate renal impairment (creatinine clearance 30-49 mL/min) and severe renal impairment (creatinine clearance 15-29 mL/min) is 15 mg once daily. 2) Treatment of deep vein thrombosis and pulmonary embolism / Reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism / Prevention of venous thromboembolism in adult patients undergoing major orthopedic surgery of the lower limbs (knee or hip replacement) No dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance 30-49 mL/min) 4. Patients with hepatic impairment Avoid administration of this medicine in patients with liver disease associated with coagulopathy and in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. Increased exposure to this medicine and increased risk of bleeding may occur in these patients. 5. For patients unable to swallow tablets, Immediately before use, this medicine may be crushed and mixed with water or a beverage such as applesauce for oral administration. This medicine may also be crushed and administered with a small amount of water through a gastrointestinal tube. Before administering this medicine through a gastrointestinal tube, confirm that the tube is correctly positioned, and flush the tube with water after administration.

This medication works by preventing the blood from clotting excessively, thereby preventing or treating thrombus formation. During treatment with this drug, there may be a risk of bleeding, so signs or symptoms of bleeding should be closely monitored. If serious bleeding occurs, discontinue the medication immediately and consult a physician. This drug should not be administered to patients with certain liver diseases, severe bleeding, pregnant or nursing women, or patients with lactose intolerance. Additionally, patients with recent gastrointestinal ulcers or a history of intracranial bleeding, and those with certain vascular abnormalities or tumors should not use this medication. Caution is needed when this drug is used with other anticoagulants or azole antifungals due to an increased risk of bleeding. Patients with impaired renal function or at high risk of bleeding should be administered this medication with care, and adjustments may be needed based on co-administered drugs affecting plasma concentrations. This drug may induce adverse reactions related to bleeding or anemia, and special caution is necessary in elderly patients or those at high risk of bleeding. Before undergoing surgery or invasive procedures, this medication should be stopped for a certain period, and the timing of re-administration should be determined considering the risk of bleeding post-procedure. Women who are pregnant or may become pregnant should practice contraception while taking this medication, and nursing mothers should avoid its use. Patients should be cautious of drowsiness or fainting when driving or operating machinery. In cases of overdose, the risk of bleeding significantly increases, and it is essential to inform medical personnel immediately. This drug is not removed by dialysis. Patients taking this medication should consult a physician immediately if they notice signs of bleeding, symptoms of anemia, skin rashes, or other adverse reactions.

• Bleeding
• anemia
• thrombocytosis
• tachycardia
• ocular bleeding
• gingival bleeding
• gastrointestinal bleeding
• stomach pain
• abdominal pain
• dyspepsia

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. The recommended storage temperature is room temperature between 1°C and 30°C.

Appearance

Bright red round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP x 3], 100 tablets/box [10 tablets/PTP x 10]