Jareva Tablet 13.5 mg (Rivaroxaban)

Adult dose

This medicine 10mg, 13.5mg, and 18mg may be administered with or without 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 18mg once daily. The recommended dose for patients with moderate renal impairment (creatinine clearance 30-49 mL/min) is 13.5mg once daily. The maximum daily dose of this medicine is 18mg. There is limited experience with concomitant administration of rivaroxaban 13.5mg 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 have undergone percutaneous coronary intervention (PCI) with stent placement. 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 13.5mg 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 18mg 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 the treatment dose should be determined following 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 13.5mg twice daily 27mg From day 22 18mg once daily 18mg Reduction of the risk of recurrence of deep vein thrombosis or pulmonary embolism After administration for 6 months or more 10mg once daily 10mg The maximum daily dose of this medicine is 27mg during the first 3 weeks of treatment and 18mg thereafter during the treatment period. 3) Prevention of venous thromboembolism in adult patients who have undergone major orthopedic surgery of the lower limbs (knee or hip replacement) The recommended dose of this medicine is 10 mg once daily. The initial 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 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. ①Patients taking 13.5mg twice daily: Take this medicine immediately; in this case, 2 tablets of 13.5mg may be taken at one time. From the following day, continue taking 13.5mg twice daily. ②Patients taking 10, 13.5mg, or 18mg once daily: Take the missed dose immediately. From the following day, continue taking 1 tablet once daily. The daily dose should not be doubled to make up for a missed dose. 2. Switching medications 1) Switching from a vitamin K antagonist to this medicine ①Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Discontinue vitamin K antagonist treatment and start taking this medicine when the international normalized ratio (INR, International Normalized Ratio) is ≤ 3.0. ②Treatment of deep vein thrombosis and pulmonary embolism/Reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism Discontinue vitamin K antagonist treatment and start taking this medicine when INR is ≤ 2.5. Regardless of the dose, the INR value will be falsely elevated after taking this medicine. INR is not suitable for measuring the anticoagulant activity of this medicine and should not be used. 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 elevation of INR. Patients switching from this medicine to a vitamin K antagonist should receive the vitamin K antagonist concomitantly until INR≥2.0. During the first2 days after switching, administer the standard dose of the vitamin K antagonist, and thereafter administer the dose of the vitamin K antagonist according to INR test results. Conversely, in patients receiving this medicine and a vitamin K antagonist concomitantly, INR should not be tested until 24 hours have elapsed after taking this medicine. Once this medicine is discontinued, INR may be tested 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 administration of the parenteral agent (e.g., low molecular weight heparin), or at the time a continuously administered parenteral agent (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 creatinine clearance 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. Administration of this medicine is not recommended in patients with severe renal impairment with creatinine clearance less than 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 for patients with moderate renal impairment (creatinine clearance 30-49 mL/min) and severe renal impairment (creatinine clearance 15-29 mL/min) is 13.5mg 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 who have undergone 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 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 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 administer after flushing the tube with water.

This drug is used to prevent or treat blood clots by inhibiting blood coagulation. Careful monitoring for bleeding symptoms should be observed during treatment, as bleeding may occur. If severe bleeding occurs, this drug should be discontinued immediately and a doctor should be consulted. This medication is contraindicated in patients with certain liver diseases, severe bleeding, women who are pregnant or breastfeeding, and patients with specific high bleeding risk conditions. Additionally, there may be an increased risk of bleeding when taken with other anticoagulants or certain antifungal medications, so concomitance should be avoided or used with caution. Caution should also be exercised when administering this drug to patients with impaired renal function or diseases at high risk of bleeding. Extreme caution is required when co-administering this drug with drugs that increase bleeding risk, such as non-steroidal anti-inflammatory drugs or platelet aggregation inhibitors. During treatment, symptoms of anemia as well as signs of bleeding should be closely monitored, and if unexplained hypotension or abnormal blood tests occur, the bleeding source should be located. Prior to surgery or invasive procedures, this medication should be discontinued for a certain period of time, and after the procedure, the timing for re-administration should be decided based on the risk of bleeding and hemostatic status. Special caution is necessary when placing a catheter near nerves or when undergoing a lumbar puncture due to the risk of bleeding-related nerve damage. This drug may pose risks to the fetus during pregnancy, so women who are pregnant or planning to become pregnant should consult a physician, and appropriate contraception should be practiced during treatment. Older adults may have increased blood concentration of this drug due to decreased renal function, but no dose adjustments are needed, although the risk of bleeding may increase. This drug is not recommended for children and adolescents as its safety and efficacy have not been established in this population. Overdose may increase the risk of bleeding, so dosages should be strictly adhered to, and if overdose is suspected, immediate consultation with healthcare professionals is required. Drowsiness or dizziness may occur due to this drug while driving or operating machinery, so caution is needed when symptoms arise.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, digestive disorders, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized weakness and energy loss, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound exudate, vascular pseudoneurysm, increased transaminases, elevated bilirubin levels, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased enzymes, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and cerebral hemorrhage, syncope, urogenital bleeding, renal dysfunction, epistaxis, hemoptysis, itching, rash, petechiae, skin and subcutaneous hemorrhage, urticaria, hypotension, hematoma, angioedema, allergic angioedema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, eosinophilia, drug reactions with systemic symptoms, eosinophilic pneumonia, anticoagulant-related renal disorders, reconsideration adverse events like arthralgia, unspecified bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, hematochezia, melena, deep vein thrombosis, joint dislocation, Pseudomonas wound infection, nasopharyngitis, myocardial infarction, cardiomyopathy, increased cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, severe uterine hemorrhage, oral mucosal ulcers due to agranulocytosis, high fever, severe dysphagia, angina, atrial fibrillation, heart failure, cardiac arrest, cerebral infarction, sputum disease, asthma, laryngitis, dysphagia, gastrointestinal motility disorders, fractures, arthritis, arthropathy, rhabdomyolysis, urinary tract infections, voiding disorders, kidney stones, bladder carcinoma, prostatic hyperplasia, influenza-like syndrome, drug hypersensitivity

This drug should be stored in a tightly closed container to protect it from air and moisture at a temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the drug's efficacy and safety.

Appearance

Pale yellow, round, film-coated tablet

Package unit

30 tablets/PTP [(10 tablets/PTP X 3)], 100 tablets/PTP [(10 tablets/PTP X 10)]