Jarelbi Tablet 15 mg (Rivaroxaban)

Adult dose

This medicine 10 mg may be taken with or without food, while 15 mg and 20 mg should be taken with food. 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 for 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 have undergone 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 recurrent 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 treatment 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 recurrent deep vein thrombosis and pulmonary embolism versus the risk of bleeding. Treatment period / Frequency of administration / Total 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 recurrent deep vein thrombosis or pulmonary embolism After at least 6 months of treatment: 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. 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 administered 6~10 hours after surgery, once hemostasis has been confirmed. The duration of treatment 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 once. From the next day, continue taking 15 mg twice daily. ② Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. From the next day, continue taking 1 tablet once daily. Do not take twice the recommended daily dose 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 treatment and start this medicine when the International Normalized Ratio (INR) is ≤ 3.0. ② Treatment of deep vein thrombosis and pulmonary embolism / Reduction of the risk of recurrent deep vein thrombosis and pulmonary embolism Discontinue vitamin K antagonist treatment and start this medicine when the INR is ≤ 2.5. Regardless of the dose, the INR value will be falsely elevated after taking this medicine. INR should not be used because it is not suitable for measuring the anticoagulant activity of this medicine. 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 INR elevation. Patients switching from this medicine to a vitamin K antagonist should receive both medicines until the INR is ≥2.0. For the first 2 days after switching, administer the standard dose of the vitamin K antagonist; thereafter, administer a dose of the vitamin K antagonist based on INR testing. However, in patients receiving this medicine concomitantly with a vitamin K antagonist, INR should not be tested until 24 hours after taking this medicine. Once this medicine is discontinued, INR testing may be performed 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 medicine (e.g., low molecular weight heparin), or when a continuously administered parenteral medicine (e.g., intravenous unfractionated heparin) is discontinued. 4) 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 in patients with mild renal impairment with a creatinine clearance of 50-80 mL/min. Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that the blood concentration of this medicine increased significantly; therefore, this medicine should be administered with caution. Use 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 recurrent 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 administering this medicine to patients with liver disease associated with coagulopathy and to patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. Increased exposure to this medicine and an increased risk of bleeding may occur in these patients. 5. For patients who cannot swallow tablets, Immediately before use, this medicine may be crushed, mixed with water or a beverage such as applesauce, and administered orally. 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 medicine prevents blood clotting to avert thrombus formation. However, bleeding may occur during its use, so symptoms or signs of bleeding should be carefully monitored. If severe bleeding occurs, the use of this medicine must be stopped immediately, and medical advice should be sought. This medicine should not be administered to patients with certain diseases or conditions, such as those experiencing severe bleeding, patients with severely impaired liver function, pregnant or nursing women, and patients with specific genetic lactose intolerance. Additionally, patients with recent gastrointestinal ulcers or a history of intracranial bleeding, vascular abnormalities, or tumors with a high risk of bleeding should not use this medicine. Caution is needed when used with other anticoagulants or azole antifungals due to increased bleeding risk, and especially certain antifungals should be avoided in combination. This medicine should be administered cautiously in patients with impaired renal function or those with high bleeding risk, as well as in patients taking medications such as non-steroidal anti-inflammatory drugs or platelet inhibitors that affect hemostasis. This medicine may cause various adverse reactions like bleeding, anemia, skin rash, liver dysfunction, and others, so any unusual symptoms should be reported to a healthcare provider immediately. Older adults and patients with decreased kidney function should be especially careful due to an increased risk of bleeding. Pregnant or nursing women should not take this medicine, and women who may become pregnant should use effective contraception during treatment. If surgery or invasive procedures are to be performed, this medicine should be discontinued for a certain period, and bleeding risk management around the procedure is necessary. In case of overdose, the risk of bleeding may significantly increase, so immediate medical attention should be sought if an overdose occurs. Caution should be exercised when driving or operating machinery due to the potential for drowsiness or fainting. Regular blood tests and clinical assessments to check for bleeding are recommended during treatment.

Hemorrhage, anemia, thrombocytosis, tachycardia, eye hemorrhage, gingival bleeding, gastrointestinal bleeding, stomach pain, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, overall muscle and energy reduction, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, discharge from wound sites, vascular pseudoaneurysm, increased transaminases, increased serum bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transfer enzymes, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and cerebral hemorrhage, syncope, urogenital bleeding, renal dysfunction, non-hemorrhage, hemoptysis, itching, rash, petechiae, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, drug reaction accompanied by eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related kidney disease, severe uterine hemorrhage, syncope, drowsiness

This medicine should be stored in a tightly closed container to protect it from air and moisture, and at a temperature between 1 to 30 degrees Celsius at room temperature. Proper storage will maintain the drug's effectiveness for a longer period.

Appearance

Red circular film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP packaging x 3]