Aquis Tablet 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 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 taken orally twice daily. The first dose should be administered 12 ~ 24 hours after surgery. The recommended duration of treatment in patients who have undergone hip replacement surgery is 32 ~ 38 days. The recommended duration of treatment in 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, the recommended dose for patients with nonvalvular atrial fibrillation who have at least 2 of the following characteristics 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 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 affecting 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 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 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 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 Administration of this medicine is not recommended because there is no clinical experience in patients on dialysis or in patients with creatinine clearance less than 15 mL/min. 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 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 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), but 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 greater than 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 who are 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 an anticoagulant that prevents blood clot formation by inhibiting coagulation. During treatment, the risk of bleeding may increase, so careful monitoring for symptoms of bleeding is necessary. If severe bleeding occurs, the use of this drug should be discontinued immediately, and appropriate treatment should be received if necessary. This medication should not be administered to patients with certain health conditions. For instance, it should not be used in patients with allergies to this drug or its components, active bleeding, severe blood coagulation disorders, or a recent history of gastrointestinal ulcers or intracranial hemorrhage. It should also be used with caution in patients taking other anticoagulants. This drug should be used cautiously in patients with significantly impaired renal function or liver dysfunction. In particular, for patients with mild to moderate liver impairment, liver function test results should be monitored carefully. This drug may interact with other medications, particularly those that may increase the risk of bleeding such as serotonin reuptake inhibitors, non-steroidal anti-inflammatory drugs, and acetylsalicylic acid. Elderly or underweight patients may also have an increased risk of bleeding and should take care when using it. Patients undergoing spinal or epidural anesthesia are at risk of serious neurological injury due to this medication, thus special attention must be given to drug administration and catheter management before and after anesthesia. The main side effects of this medication include bleeding, bruising, and nosebleeds. Since severe bleeding may occur, patients should consult with healthcare professionals immediately if any unusual symptoms arise. Prior to undergoing surgery or invasive procedures, this medication should be discontinued for a specified period, and after the procedure, resumption should be based on bleeding risks and the patient's condition. This medication is not recommended for pregnant or breastfeeding women. If breastfeeding, one should consult a doctor about whether to discontinue the drug or breastfeeding. Safety and efficacy in pediatric patients have not been established, thus it is advisable not to use this medication in children. This drug may interact with medications that inhibit or induce specific enzymes, so if patients are taking other medications, they must inform their healthcare provider. In the event of overdose, the risk of bleeding increases significantly, so adherence to the prescribed dose is crucial, and immediate emergency treatment should be sought if bleeding symptoms occur.

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

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. It is important to maintain a storage temperature between 1 to 30 degrees Celsius. This will help preserve the effectiveness of the medication over time.

Appearance

Pale yellow round film-coated tablet

Package unit

60 tablets/PTP[(10 tablets/PTP × 6)]