Aquis Tablets 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 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 coadministration of the recommended dose of this medicine with an antiplatelet agent after hemostasis has been achieved in patients with nonvalvular atrial fibrillation undergoing treatment for acute coronary syndrome and/or 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 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, and it should be given after completion of at least 6 months of treatment with this medicine or another anticoagulant. When switching from parenteral anticoagulant therapy to this medicine or from this medicine to a parenteral anticoagulant, the switch may be made at the time of the next scheduled dose. 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. When switching 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 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. As there is no clinical experience in patients on dialysis or patients with creatinine clearance less than 15 mL/min, use of this medicine is not recommended. Prevention of venous thromboembolism in adult patients who have undergone hip or knee replacement surgery: No dose adjustment is required for 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 increased in these patients; therefore, this medicine should be used with caution in these patients. Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: No dose adjustment is required for 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. 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 for 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 increased in these patients; therefore, this medicine should be used with caution in these patients. 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 for 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 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, caution should be exercised when administering this medicine to these patients. Liver function tests should be performed before starting this medicine. For patients who cannot swallow tablets, this medicine may be crushed immediately before use and mixed with water or a beverage such as applesauce for oral administration. 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 excessive coagulation. During the use of this medication, there may be a risk of bleeding, so signs of bleeding such as nosebleeds, subcutaneous bleeding, hematuria, and melena should be closely monitored. If severe bleeding occurs, discontinue this medication immediately and consult medical personnel. It should not be administered to patients with certain liver diseases or blood coagulation disorders, patients who have had recent bleeding, or patients with certain conditions that have a high risk of bleeding. Also, caution should be taken when combined with other anticoagulants as it may increase the risk of bleeding. This medication should be used cautiously in patients with severely impaired kidney or liver function, the elderly, and underweight patients. Special care is needed for patients undergoing certain nerve block or lumbar puncture procedures due to the risk of significant nerve damage from bleeding. This medication may interact with other drugs, so it is important to consult healthcare providers when taking it with antiplatelet agents, non-steroidal anti-inflammatory drugs, certain antifungals, or antivirals. Pregnant or nursing women should consult a doctor before taking this medication, as it may be secreted in breast milk; it is recommended to either stop breastfeeding or discontinue the medication. Abrupt discontinuation of this medication can increase the risk of thrombosis; thus, any changes or discontinuation should be done under medical supervision. To reduce the risk of bleeding, this medication should be discontinued for a certain period before surgery or invasive procedures, and after bleeding has been controlled post-surgery, it is recommended to resume as soon as possible. If symptoms of bleeding or neurological abnormalities occur during the use of this medication, notify medical personnel immediately. In the case of overdose, the risk of bleeding significantly increases, so strictly adhere to the prescribed dosage, and consult medical personnel if overdose is suspected. This medication does not significantly affect driving or operating machinery; however, caution is advised if symptoms such as bleeding or dizziness occur.

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

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. The recommended storage temperature is room temperature between 1°C and 30°C.

Appearance

Yellow round film-coated tablet

Package unit

60 tablets - 10 tablets/PTP [60 tablets (10 tablets/PTP × 6)]