Jarexaban 10 mg (Rivaroxaban)

Adult dose

This 10 mg medication may be administered with or without food, while the 15 mg and 20 mg doses should be administered 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 medication 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 medication is 20 mg. There is limited experience with concomitant administration of rivaroxaban 15 mg once daily [10 mg 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 stenting. (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 medication 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 treatment of deep vein thrombosis and pulmonary embolism, and the recommended dose for reducing the risk of recurrence, is 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 10 mg once daily. The duration of treatment and dose should be determined after an individualized assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism relative to the risk of bleeding. Duration of administration / Frequency of administration / Daily dose Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence Days 1-21 / 15 mg twice daily / 30 mg From day 22 / 20 mg once daily / 20 mg Reduction of the risk of recurrence of deep vein thrombosis or pulmonary embolism After at least 6 months of treatment / 10 mg once daily / 10 mg The maximum daily dose of this medication is 30 mg during the first 3 weeks of treatment and 20 mg thereafter. 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 medication is 10 mg once daily. The initial dose should be started 6~10 hours after surgery, once hemostasis has been confirmed. The duration of treatment depends on each patient's risk of venous thromboembolism based on the type of surgery; 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 medication If you forget to take this medication, take the missed dose as follows. ① Patients taking 15 mg twice daily: Take this medication immediately; in this case, two 15 mg tablets may be taken at once. From the following day, continue taking 15 mg twice daily. ② Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. From the following day, continue taking one 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 medication ① Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Discontinue vitamin K antagonist treatment and start this medication when the International Normalized Ratio (INR) 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 treatment and start this medication when the INR is ≤ 2.5. Regardless of the dose, INR values will be falsely elevated after taking this medication. INR should not be used because it is not suitable for measuring the anticoagulant activity of this medication. 2) Switching from this medication to a vitamin K antagonist Inadequate anticoagulation may occur while switching from this medication to a vitamin K antagonist. Adequate anticoagulation should be maintained continuously while switching to another anticoagulant. Note that this medication may affect INR elevation. Patients switching from this medication to a vitamin K antagonist should receive the vitamin K antagonist concomitantly until the INR is ≥2.0. For the first 2 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 testing. However, in patients receiving this medication concomitantly with a vitamin K antagonist, INR should not be measured until 24 hours after taking this medication. Once this medication is discontinued, INR may be measured 24 hours after the last dose. 3) Switching from a parenteral anticoagulant to this medication In patients receiving a parenteral anticoagulant, start this medication 0~2 hours before the next scheduled dose of the parenteral agent (e.g., low-molecular-weight heparin), or when a continuously administered parenteral agent (e.g., intravenous unfractionated heparin) is discontinued. 4) Switching from this medication to a parenteral anticoagulant Discontinue this medication and start the parenteral anticoagulant at the time the next dose of this medication would have been due. 3. Patients with renal impairment No dose adjustment is required in patients with mild renal impairment (creatinine clearance 50-80 mL/min). Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that plasma concentrations of this medication increased significantly; therefore, this medication should be administered with caution. Administration of this medication is not recommended in patients with severe renal impairment and creatinine clearance below 15 mL/min because there is no clinical experience in this population. 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 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 who have undergone major orthopedic surgery of the lower limbs (knee or hip replacement) No dose adjustment is required in patients with moderate renal impairment (creatinine clearance 30-49 mL/min)

This medication is used to prevent or treat clot formation by inhibiting blood coagulation. However, the risk of bleeding may increase while taking this medication, so signs of bleeding should be monitored closely. If bleeding is severe, discontinue the medication immediately and seek appropriate treatment as directed by healthcare professionals. This medication should not be administered to patients with certain diseases or conditions. For example, patients with an allergy to this medication, those with severe bleeding, patients with significantly impaired liver function, and women who are pregnant or breastfeeding, as well as patients with lactose intolerance, should not take this medication. Furthermore, patients with recent gastrointestinal ulcers, a history of intracranial hemorrhage, or those with malignant tumors that pose a high bleeding risk should also not use this medication. Caution is required when used in combination with other anticoagulants or specific antifungal agents, as this may further increase the risk of bleeding. Patients with impaired renal function or those with diseases that increase the risk of bleeding should use this medication carefully, particularly if taking NSAIDs or antiplatelet agents that may elevate bleeding risks. Patients should consistently monitor for signs of bleeding or symptoms of anemia while on this medication and report any suspected symptoms to healthcare professionals immediately. Regular blood tests are not required to monitor drug concentration, but in cases of overdose or emergencies, specific tests may confirm levels. Before surgical or invasive procedures, this medication should be discontinued for a designated period, and after surgery, it should be resumed only after assessing bleeding risks and hemostatic status. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing potential must ensure adequate contraception while on this medication. Elderly patients may experience higher blood levels of this medication, though dose adjustment is generally not needed; however, the risk of bleeding may be increased. This medication is not recommended for children and adolescents under 18, as its safety and effectiveness have not been established. In cases of overdose, the bleeding risk can be significantly elevated, and immediate medical attention is required, as this medication is not removed by dialysis. This medication may affect driving or machinery operation; individuals should avoid such activities if experiencing drowsiness or fainting symptoms. It is necessary to consult with a physician or pharmacist to check for possible drug interactions during the course of this medication to manage and reduce bleeding risks.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, dyspepsia, 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 pseudoaneurysm, increased transaminases, elevated bilirubin levels, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, elevated transfer enzymes, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, cerebral and intracranial hemorrhage, syncope, genitourinary bleeding, renal impairment, nonspecific bleeding, hemoptysis, itching, rash, petechiae, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic reaction, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reactions accompanied by eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulation-related renal disease, severe uterine hemorrhage, syncope, drowsiness

Store this medication in a tightly sealed container to protect it from air and light. It is safe to store at room temperature, specifically between 1 to 30 degrees Celsius.

Appearance

Bright red round film-coated tablets

Package unit

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