Yuhan Apixaban Tablet 5mg (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 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 orally twice daily. The initial 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 of this medicine 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 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 the 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 have acute coronary syndrome and/or have undergone 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 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 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 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 Use of this medicine is not recommended in patients on dialysis or in patients with a creatinine clearance of 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 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 ≤ 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 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 ≥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 who cannot swallow tablets For patients who cannot 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 the formation of blood clots by inhibiting blood clotting. While taking this medication, bleeding may occur, so it is important to carefully observe for signs of bleeding. If severe bleeding occurs, immediately stop taking this medication and consult a physician. This medication should not be administered to patients with certain diseases or conditions, such as those with active bleeding or severely impaired liver function, as well as specific postoperative patients. Furthermore, patients who are allergic to lactose, one of the ingredients of this medication, should not take it. Patients with impaired kidney or liver function, elderly patients, and underweight patients require special caution when taking this medication. Patients who have received spinal or epidural anesthesia should discuss with healthcare providers, as there is a risk of nerve damage associated with this medication. When taken with other anticoagulants or medications affecting blood coagulation, the risk of bleeding may increase, so it is essential to consult a doctor or pharmacist. Before undergoing surgery or invasive procedures, this medication may need to be stopped for a certain period, and after the procedure, it may be resumed based on the situation. Pregnant or breastfeeding women must consult a doctor regarding the use of this medication, and safety for children has not been established. This medication may cause side effects such as bleeding, bruising, nosebleeds, and hematomas, and in rare cases, liver dysfunction or severe bleeding may occur, so report any unusual symptoms to healthcare providers immediately. Excessive doses significantly increase the risk of bleeding; therefore, adhere to the prescribed dose and do not stop or change the dosage without a doctor’s direction.

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

This medication may be sensitive to air and light, so it should be stored in a tightly sealed container. Additionally, it is best stored at room temperature between 1°C and 30°C. Avoid exposing it to extreme heat or cold.

Appearance

Pink, oval-shaped, convex film-coated tablets

Package unit

60 tablets (10 tablets/PTP * 6)