Ocosaban 5 mg (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. Adults 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 taken orally twice daily. The first dose should be taken 12 ~ 24 hours after surgery. The recommended duration of treatment in patients who have undergone hip replacement surgery is 32 ~ 38 days. The recommended duration of treatment in 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 taken 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 taken 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. 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 taken orally twice daily for 7 days, followed by 5mg taken 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 taken orally twice daily, after completion of at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching between medicines 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 When switching from vitamin K antagonist therapy to this medicine, discontinue warfarin or other vitamin K antagonist therapy and start this medicine when the International Normalized Ratio (INR) is less than 2.0. 2) Switching from this medicine to vitamin K antagonist therapy When switching 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 the 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 As there is no clinical experience in patients on dialysis or in patients with creatinine clearance less than 15 mL/min, use of this medicine is not recommended. 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. Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that 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 of ≤ 60kg should take 2.5 mg of this medicine twice daily. Patients with severe renal impairment (creatinine clearance 15-29 mL/min) should take 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. Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that 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. Use 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 normal or total bilirubin levels at least 1.5 times the upper limit of normal were excluded from clinical trials; therefore, this medicine should be administered with caution to these patients. Liver function tests should be performed before starting this medicine. 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, mixed with 60mL of water, and administered through a nasogastric tube.

This drug is used to prevent or treat thrombus formation by preventing blood from coagulating. Careful observation for signs of bleeding should be conducted during treatment, and caution should be exercised when administering to patients at high risk of bleeding. In case of severe bleeding, this medication should be discontinued immediately. While regular blood concentration monitoring is not required, it may be helpful in emergencies. It should not be administered to patients who have allergies to this medication, those with severe bleeding, those with severely impaired liver function, or to patients with certain diseases that increase the risk of bleeding. Co-administration with other anticoagulants significantly increases the risk of bleeding and should be avoided. It should also not be administered to patients with genetic issues such as lactose intolerance. Special care should be taken with patients with very poor kidney function, slightly impaired liver function, elderly patients at high risk of bleeding, or underweight patients. Patients receiving spinal or epidural anesthesia may be at risk for developing hematomas during treatment with this medication and should be cautious; dosage should be halted for a period of time upon catheter removal. This medication has not been established as safe for patients undergoing thrombolysis or pulmonary embolism removal and is not recommended. Common side effects may include bleeding, bruising, nosebleeds, and hematomas, and severe bleeding may occur, so caution is advised. When taken with other medications that increase bleeding risks, consultation with a physician is necessary. Prior to surgery or invasive procedures, this medication should be discontinued for a period to reduce the risk of bleeding, and after the procedure has stabilized, it should be resumed. It is not recommended for pregnant women due to established safety concerns, and nursing mothers should either stop the medication or cease breastfeeding. The safety and efficacy for children have not been established. While it may not significantly affect driving or machine operation, caution may be needed based on individual conditions. This medication may interact with drugs that inhibit or induce specific enzymes, making it essential to discuss all medications with a healthcare provider. In case of suspected overdose, immediate cessation of use and consultation with healthcare professionals are necessary, as additional emergency treatment may be required if bleeding cannot be controlled.

• Hemorrhage
• bruise
• nosebleed
• hematoma
• anemia
• thrombocytopenia
• hypersensitivity
• allergic edema
• anaphylactic reaction
• cerebral hemorrhage

This medication should be stored in a tightly closed container to protect it from air and moisture. The recommended storage temperature is between 1°C and 30°C at room temperature. This helps maintain the drug's efficacy and safety for an extended period.

Appearance

Pink egg-shaped film-coated tablet with a biconvex shape on both sides

Package unit

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