Rivara 5 mg Tablets (Apixaban)

Adult dose

This medicine may be taken with water, with or without food. If a patient forgets to take a dose, they should take this medicine as soon as possible and continue taking it twice daily as before. 1) Prevention of venous thromboembolism in adult patients who have undergone hip or knee replacement surgery The recommended dose is 2.5 mg of this medicine orally twice daily. The first dose should be administered 12 ~ 24 hours after surgery. The recommended duration of treatment for patients who have undergone hip replacement surgery is 32 ~ 38 days. The recommended duration of treatment for patients who have undergone knee replacement surgery is 10 ~ 14 days. 2) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation The recommended dose is 5 mg of this medicine orally twice daily. However, for patients with nonvalvular atrial fibrillation who have at least 2 of the following characteristics, the recommended dose is 2.5 mg of this medicine orally twice daily; age ≥80 years, body weight ≤60kg, or serum creatinine ≥1.5 mg/dL (133 micromole/L). Treatment should be continued long term. There is limited experience with administering the recommended dose of this medicine together with antiplatelet agents after hemostasis has been achieved in patients with nonvalvular atrial fibrillation who have acute coronary syndrome and/or undergo percutaneous coronary intervention. (Refer to ‘5. General Precautions, 1) Interactions with Other Drugs That Affect Hemostasis’ and ‘12. Clinical Trial Information, 2) Reduction of the Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation, AUGUSTUS Trial’ under Precautions for Use.) 3) Treatment of deep vein thrombosis and pulmonary embolism The recommended dose of this medicine for the treatment of acute deep vein thrombosis and pulmonary embolism is 10mg orally twice daily for 7 days, followed by 5mg orally twice daily. 4) Reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism The recommended dose is 2.5mg of this medicine orally twice daily, and it should be administered after completing at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching between medications When switching from parenteral anticoagulant therapy to this medicine or from this medicine to a parenteral anticoagulant, the switch can be made at the time of the next scheduled dose. 1) Switching from vitamin K antagonist therapy to this medicine To switch from vitamin K antagonist therapy to this medicine, discontinue warfarin or another vitamin K antagonist and start this medicine when the international normalized ratio (INR, International Normalized Ratio) is below 2.0. 2) Switching from this medicine to vitamin K antagonist therapy To switch from this medicine to vitamin K antagonist therapy, continue taking this medicine for 2 days after starting the vitamin K antagonist. After 2 days of concomitant treatment with this medicine and a vitamin K antagonist, measure the INR immediately before the scheduled dose of this medicine, and continue concomitant treatment with this medicine and the vitamin K antagonist until the INR is 2.0 or higher. 3. Renal impairment Administration of this medicine is not recommended because there is no clinical experience in patients on dialysis or in patients with a creatinine clearance of less than 15 mL/min. 1) Prevention of venous thromboembolism in adult patients who have undergone hip or knee replacement surgery No dose adjustment is necessary in patients with mild or moderate renal impairment. Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), blood concentrations of this medicine were increased in these patients; therefore, this medicine should be administered with caution in these patients. 2) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation No dose adjustment is necessary in patients with mild or moderate renal impairment. However, patients with serum creatinine ≥1.5 mg/dL (133 micromole/L) who are aged ≥ 80 years or have a body weight ≤ 60kg should receive 2.5 mg of this medicine twice daily. Patients with severe renal impairment (creatinine clearance 15-29 mL/min) should receive 2.5 mg of this medicine twice daily, regardless of age or body weight. 3) Treatment of deep vein thrombosis and pulmonary embolism/ Reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism No dose adjustment is necessary in patients with mild or moderate renal impairment. Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), blood concentrations of this medicine were increased in these patients; therefore, this medicine should be administered with caution in these patients. 4. Hepatic impairment This medicine should not be administered to patients with liver disease associated with coagulopathy and a clinically significant risk of bleeding. No dose adjustment is necessary in patients with mild or moderate hepatic impairment (Child Pugh A or B), but this medicine should be administered with caution. Administration of this medicine is not recommended in patients with severe hepatic impairment. Patients with hepatic ALT/AST levels exceeding 2 times the upper limit of the normal range or total bilirubin levels ≥1.5 times the upper limit of the normal range were excluded from clinical trials; therefore, caution should be exercised when administering this medicine to these patients. Liver function tests should be performed before starting treatment with this medicine. 5. Patients unable to swallow tablets For patients unable to swallow tablets, this medicine may be crushed immediately before use and mixed with water or a beverage such as applesauce for oral administration. This medicine may also be crushed, mixed with 60mL of water, and administered through a nasogastric tube.

This medication is used to prevent or treat thrombosis by inhibiting blood clotting. While taking it, patients must be observed closely for bleeding symptoms, and it should be used cautiously when the risk of bleeding is high. If severe bleeding occurs, discontinue this medication immediately. It should not be administered to patients with specific blood coagulation disorders, current bleeding, severe liver disease, or those with a recent history of intracranial hemorrhage or gastrointestinal ulcers. Use with other anticoagulants may increase risk, warranting caution. Special attention is required for patients with significantly impaired kidney function, liver dysfunction, underweight individuals, elderly patients, and those undergoing spinal anesthesia. Common side effects include bleeding, bruising, nosebleeds, hematomas, and in severe cases, life-threatening bleeding such as intracranial hemorrhage or gastrointestinal bleeding. Interactions with other medications should also be watched, especially with certain antifungals, HIV treatments, some analgesics, and antidepressants, as they can increase bleeding risk. Before undergoing surgery or invasive procedures, this medication should be stopped for a certain period, and after the procedure, it should be resumed with consideration of bleeding risk. Use during pregnancy or lactation is not recommended, and safety in pediatric patients has not been established. This medication does not significantly affect driving or operating machinery, but caution is advised due to bleeding risks. In cases of overdose, the risk of bleeding increases significantly, so patients should contact a healthcare provider immediately, and appropriate treatment based on symptoms is necessary as there is no specific antidote.

• Hemorrhage
• contusion
• epistaxis
• hematoma
• anemia
• thrombocytopenia
• hypersensitivity
• allergic edema
• anaphylactic reaction
• cerebral hemorrhage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius. Storing it this way will help preserve the medication's effectiveness over time.

Appearance

Pink, egg-shaped, film-coated tablets that are convex on both sides

Package unit

60 tablets/box [(10 tablets/PTP x 6)]