NPIXIS Tablet 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 orally twice daily. The initial dose should be administered 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 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 for a long term. There is limited experience with administering the recommended dose of this medicine together with antiplatelet agents after hemostasis has been achieved in patients with nonvalvular atrial fibrillation who also have acute coronary syndrome and/or have undergone percutaneous coronary intervention. 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, and treatment should be started after completion of at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching between medicines When switching from parenteral anticoagulant treatment 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 treatment to this medicine To switch from vitamin K antagonist treatment 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 treatment To switch from this medicine to vitamin K antagonist treatment, continue taking this medicine for 2 days after starting the vitamin K antagonist. After 2 days of combined treatment with this medicine and the vitamin K antagonist, measure the INR immediately before the scheduled dose of this medicine, and continue the combined treatment until the INR is 2.0 or higher. 3. Renal impairment As there is no clinical experience in patients undergoing dialysis or patients with a creatinine clearance of less than 15 mL/min, administration 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 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 age ≥ 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 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. Administration of this medicine is not recommended in patients with severe hepatic impairment. 5. Patients unable to swallow tablets For patients unable to swallow tablets, this medicine may be crushed immediately before use and mixed with water or a drink 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 blood coagulation. While taking this medication, bleeding may occur, so it is important to closely monitor for signs of bleeding such as nosebleeds, bruising, hematuria, and black stools. If severe bleeding occurs, this medication should be discontinued immediately, and medical advice should be sought. This medication is not used in patients with certain blood coagulation disorders or those at high risk of bleeding. Patients with severely impaired liver or kidney function, or those with a recent history of intracranial hemorrhage or gastrointestinal ulcers, should use this medication with caution. When taken with other anticoagulants or medications that affect blood coagulation, the risk of bleeding may increase, so it is essential to inform healthcare providers. Before undergoing surgery or invasive procedures, this medication should be discontinued for a certain period, and after surgery, it can be resumed after assessing bleeding risks and conditions. Pregnant or breastfeeding women should consult a physician before using this medication. Safety and efficacy in children have not been established, so it is not used in this population. Elderly patients may require dose adjustments based on weight and kidney function. An overdose of this medication increases the risk of bleeding, so the prescribed dosage must be strictly followed, and in case of overdose, immediate medical consultation is necessary. This medication may interact with other drugs, so patients should inform their healthcare providers about any other medications they are taking. While this medication does not significantly affect driving or machinery operation, caution should be exercised if symptoms of bleeding or dizziness occur. If neurological symptoms (e.g., numbness or weakness in the legs) arise while taking this medication, medical advice should be sought immediately.

• Hemorrhage
• contusion
• nosebleed
• hematoma
• anemia
• thrombocytopenia
• hypersensitivity
• allergic edema
• anaphylaxis
• intracerebral hemorrhage

This medication should be stored in a tightly closed container to prevent exposure to air and moisture. Additionally, avoid storing it in extremely hot or cold places, and it is best to store it at a typical room temperature between 1 to 30 degrees Celsius.

Appearance

Pale yellow round film-coated tablet

Package unit

60 tablets/PTP [(10 tablets/PTP × 6)]