Onepixaban 2.5 mg (Apixaban)

Adult dose

This medicine should 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 2 times 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 taken orally 2 times daily. The initial dose should be taken 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 taken orally 2 times 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 2 times 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 concomitant administration of the recommended dose of this medicine 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. (See “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 taken orally 2 times daily for 7 days, followed by 5mg taken orally 2 times 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 2 times daily, and it should be administered after completion of 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) is less than 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 the vitamin K antagonist, measure the INR just 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 receiving dialysis or in patients with creatinine clearance below 15 mL/min, administration 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 weigh ≤ 60kg should take 2.5 mg of this medicine 2 times daily. Patients with severe renal impairment (creatinine clearance 15-29 mL/min) should take 2.5 mg of this medicine 2 times 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. 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 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. Patients unable to swallow tablets For patients unable to swallow tablets, this medicine may be crushed immediately before use, mixed with water or a beverage such as applesauce, and administered orally. 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 blood clots by preventing blood from clotting. When taking this medication, it is important to carefully observe for signs of bleeding, as bleeding can occur. If severe bleeding occurs, the use of this medication must be stopped immediately. This medication should not be administered to patients with a high risk of bleeding, such as those with bleeding disorders or those who have recently experienced hemorrhagic stroke or gastrointestinal ulcers. Additionally, concomitant use with other anticoagulants may increase the risk of bleeding and should be avoided. Patients with severely impaired kidney or liver function may have increased drug concentrations, so caution is advised. This medication may also increase bleeding risks when taken with certain antidepressants or anti-inflammatory pain relievers, requiring caution. Elderly patients, especially those who are underweight or have reduced kidney function, may have a higher risk of bleeding. Patients undergoing spinal or epidural anesthesia are at risk of nerve damage when using this medication, so special care is needed. During treatment with this medication, abnormal symptoms such as bleeding, bruising, nosebleeds, or hematuria may occur, and if these symptoms arise, immediate consultation with a healthcare professional is required. During surgical or invasive procedures, it may be necessary to discontinue this medication for a period of time to reduce bleeding risk. Pregnant or breastfeeding women are advised to avoid this medication and consult a specialist if necessary. Safety and efficacy in children have not been established, therefore it should not be administered to them. This medication can interact with many other drugs, so it is essential to inform healthcare professionals about other medications being used. In cases of overdose, the risk of bleeding significantly increases, thus the recommended dosage must be strictly followed. This medication does not significantly affect driving or operating machinery, but caution should be exercised if symptoms like bleeding or dizziness occur.

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

This medication may be sensitive to air or moisture, so it must be stored in a tightly closed container. Additionally, to maintain the drug's effectiveness, it is important to store it at room temperature, specifically between 1 and 30 degrees Celsius.

Appearance

Yellow round film-coated tablet

Package unit

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