Apixaban Tablets 5 mg (Apixaban)

Adult dose

Dosage: 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 they remember 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 The recommended dose is 2.5 mg of this medicine taken orally twice daily. The initial dose should be taken 12 ~ 24 hours after surgery. The recommended duration of treatment for patients who have undergone hip replacement is 32 ~ 38 days. The recommended duration of treatment for patients who have undergone knee replacement 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 antiplatelet agents in patients with nonvalvular atrial fibrillation accompanied by acute coronary syndrome and/or 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 taken orally twice daily, after completion of at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching therapy 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 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 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 Use of this medicine is not recommended in patients on dialysis or in patients with creatinine clearance less than 15 mL/min, as there is no clinical experience in these patients. 1) Prevention of venous thromboembolism in adult patients who have undergone hip or knee replacement 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 are 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 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. Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that blood concentrations of this medicine are 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 the normal range or total bilirubin levels at least 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 such 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, 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 thrombus formation by inhibiting blood coagulation. During treatment, signs of bleeding should be carefully monitored, and it should be used with particular caution in patients at high risk of bleeding. If serious bleeding occurs, the administration of this medication should be stopped immediately. It should not be administered to patients with known hypersensitivity to this medication, active bleeding, or specific conditions that put them at high risk of bleeding. Additionally, using it in combination with other anticoagulants is generally not recommended. Great caution is advised in patients with severe renal or liver dysfunction, as the risk of bleeding may increase when used with certain medications, thus consultation with a physician is necessary. Elderly or underweight patients may be at a higher risk of bleeding and should be monitored closely. Patients receiving spinal or epidural anesthesia face a risk of neurological damage, so special caution is needed during administration. The use of this medication is not recommended during pregnancy or breastfeeding; it is advisable to stop the medication during lactation. This medication may cause side effects such as bleeding, bruising, nosebleeds, and hematomas, so any abnormal symptoms should be reported to healthcare professionals immediately. Prior to surgery or invasive procedures, this medication should be discontinued for a certain period, and if treatment is stopped, the risk of thrombosis may increase, so it should be resumed as soon as possible. This medication may interact with other drugs; therefore, if you are taking other medications, be sure to inform your healthcare provider. Overdose significantly increases the risk of bleeding; hence, caution is warranted, and as there is no specific antidote, if severe bleeding occurs, you should seek medical attention immediately.

• Hemorrhage
• contusion
• nosebleed
• hematoma
• anemia
• thrombocytopenia
• hypersensitivity
• allergic edema
• anaphylactic reaction
• intracranial hemorrhage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is best kept at room temperature, between 1 to 30 degrees Celsius.

Appearance

Pink, egg-shaped, biconvex film-coated tablet

Package unit

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