Apixaban 2.5 mg Tablet

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 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 taken orally twice daily. The first 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 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. There is limited experience with concomitant administration of the recommended dose of this medicine with an antiplatelet agent, after hemostasis has been achieved, in patients with nonvalvular atrial fibrillation who also have acute coronary syndrome and/or have undergone percutaneous coronary intervention. (Refer to ‘5. General precautions, 1) Interactions with other drugs that affect hemostasis’ under Precautions for Use and ‘12. Clinical Trial Information, 2) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, AUGUSTUS trial’.) 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, and it should be administered after completion of at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching medications When switching from a parenteral anticoagulant to this medicine or from this medicine to a parenteral anticoagulant, the switch may 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 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 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 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 Administration of this medicine is not recommended in patients on dialysis or in patients with a creatinine clearance of less than 15 mL/min because there is no clinical experience in these patients. 1) Prevention of venous thromboembolism in adult patients who have undergone hip or knee replacement surgery No dose adjustment is required 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 required 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 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 required 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 required in patients with mild or moderate hepatic impairment (Child Pugh A or B); however, 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 ≥1.5 times the upper limit of normal 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 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 apple sauce, 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 clots by stopping blood from clotting too much. During therapy, bleeding may occur, so it is important to closely monitor for signs of bleeding. If serious bleeding occurs, stop using this medication immediately and consult a healthcare professional. This medication should not be administered to patients at high risk of bleeding or those with coagulation disorders. Use with caution in patients with severe liver or kidney impairment, adjusting the dose as necessary according to a doctor’s instruction. When taken with other medications that affect blood clotting, the risk of bleeding may increase, so it is essential to consult a doctor. Before undergoing surgery or invasive procedures, it may be necessary to stop this medication for a certain period, and it can be resumed afterward depending on the situation. This medication is not recommended for use during pregnancy or breastfeeding, and consultation with a healthcare professional is necessary before use. Elderly patients or those underweight may have a higher risk of bleeding, so caution is needed during use. It does not significantly affect driving or operating machinery, but caution should be taken if bleeding symptoms or dizziness occur. In the case of overdose, the risk of bleeding is greatly increased, so the prescribed dosage must be strictly followed, and if bleeding is suspected, immediate medical assistance should be sought. This medication may interact with other drugs that inhibit or induce certain enzymes, so if taking other medications, be sure to inform a doctor or pharmacist.

• Bleeding
• contusion
• nosebleed
• hematoma
• anemia
• thrombocytopenia
• hypersensitivity
• allergic edema
• anaphylactic reaction
• cerebral hemorrhage

This medication should be stored in a tightly closed container as it may be sensitive to air or moisture. It is best to keep the storage temperature between 1 and 30 degrees Celsius.

Appearance

Pale yellow round film-coated tablet

Package unit

60 tablets/PTP (10 tablets/PTP x 6)