Apixaban Tablets 2.5 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 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 surgery The recommended dose is 2.5 mg orally twice daily. The first dose should be administered 12 ~ 24 hours after surgery. The recommended duration of treatment is 32 ~ 38 days for patients who have undergone hip replacement surgery. The recommended duration of treatment is 10 ~ 14 days for patients who have undergone knee replacement surgery. 2) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation The recommended dose is 5 mg 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 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 and 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 orally twice daily, to be administered after completion of at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching 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 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 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 used 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 age ≥ 80 years or have body weight ≤ 60kg should receive this medicine at a dose of 2.5 mg twice daily. Patients with severe renal impairment (creatinine clearance 15-29 mL/min) should receive this medicine at a dose of 2.5 mg 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 used 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 used with caution. Use of this medicine is not recommended in patients with severe hepatic impairment. Patients with hepatic ALT/AST levels more than 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 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 drug is used to prevent or treat blood clots by preventing blood from clotting. During treatment, bleeding may occur, so careful observation for signs or symptoms of bleeding is necessary. If severe bleeding occurs, stop taking this medication immediately and consult healthcare professionals. This drug should not be administered to certain patients, such as those with an allergy to this drug or its components, current severe bleeding, bleeding disorders, or severe liver dysfunction. Additionally, patients who are at high risk of bleeding, such as those with recent gastrointestinal ulcers, cerebral hemorrhage, spinal surgery or injury, esophageal varices, should also avoid using this drug. When taken with other anticoagulants, the risk of bleeding may significantly increase, so combination therapy should be avoided or approached with caution. This medication contains lactose, so patients with lactose intolerance should not take it. Patients with severe renal impairment or liver dysfunction may have elevated blood levels of this drug and should use it with caution. Also, using this medication with certain antidepressants or non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of bleeding, so caution is advised. Elderly patients or those with low body weight may also have a higher risk of bleeding, so caution is needed when taking this medication. Patients receiving spinal or epidural anesthesia or punctures are at significant risk for serious nerve damage when taking this drug, so consultation with healthcare professionals is mandatory. This drug is not recommended in situations with a high risk of bleeding, especially in patients receiving thrombolytic therapy or undergoing treatment for pulmonary embolism, as safety has not been established. Cancer patients may also be at a higher risk of bleeding and thrombosis, so the risks and benefits should be carefully evaluated when using this drug. The most common side effect of this drug is bleeding, and symptoms such as nosebleeds, bruising, and hematomas may occur. If symptoms of bleeding appear, immediate notification to healthcare professionals is essential for appropriate management. This medication may interact with other drugs; therefore, caution is required, especially when taken with strong CYP3A4 and P-gp inhibitors or inducers, anticoagulants, antiplatelet agents, certain antidepressants, or non-steroidal anti-inflammatory medications. It is not recommended for pregnant women; if breastfeeding, consult a physician or discontinue breastfeeding when taking this drug. The safety and efficacy in pediatrics have not been established. Lastly, an overdose of this medication greatly increases the risk of bleeding; if an overdose is suspected, immediate contact with healthcare professionals is essential for appropriate treatment.

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

This medicine should be stored in a tightly sealed container to prevent exposure to air or moisture. It is safest to store at room temperature between 1°C and 30°C and avoid places that are too hot or too cold.

Appearance

Pale yellow round film-coated tablets

Package unit

60 tablets/PTP (10 tablets x 6 PTPs)