Elix 2.5mg Tablet (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 then 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 antiplatelet agents after hemostasis has been achieved in patients with nonvalvular atrial fibrillation accompanied by acute coronary syndrome and/or 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 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 administered after completion of at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching therapy 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. 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, International Normalized Ratio) 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 As there is no clinical experience in patients on dialysis or in patients with creatinine clearance 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 increased in these patient populations; therefore, this medicine should be administered with caution to 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 increased in these patient populations; therefore, this medicine should be administered with caution to 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. Administration 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. 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 preventing blood from clotting. While taking this medication, bleeding may occur, so close observation for signs of bleeding is necessary. If serious bleeding occurs, this medication should be discontinued immediately, and appropriate treatment should be obtained as directed by a physician if necessary. This medication should not be administered to certain patients, for example, those who are allergic to this drug or its components, those with active bleeding, patients with blood coagulation disorders, patients with liver disease at high risk for bleeding, or those with a history of recent gastrointestinal ulcers or intracranial hemorrhage. Additionally, the risk of bleeding may significantly increase when used in combination with other anticoagulants, hence concurrent use should be avoided. Since this medication contains lactose, it should not be taken by patients with lactose intolerance or related genetic disorders. Caution should be exercised when administering to patients with severe renal impairment or liver dysfunction, and the risk of bleeding may increase when used with certain medications, so consultation with a doctor is advised. Particularly in the elderly, underweight patients, or patients undergoing neuraxial anesthesia, there is a higher risk of bleeding, requiring increased vigilance. This medication is not recommended for use during pregnancy or breastfeeding, and its safety and efficacy in pediatric patients have not been established. If undergoing surgery or invasive procedures, this medication should be discontinued for a certain period prior to the procedure to reduce bleeding risk, and resumption should be based on circumstances post-procedure. This medication may interact with other drugs, so it is essential to inform healthcare providers about all other medications being taken. In cases of overdose, the risk of bleeding increases; therefore, strict adherence to the prescribed dosage and regimen is crucial, and medical advice should be sought immediately in such instances. While this medication does not significantly impact driving or machinery operation, caution is required if bleeding symptoms or dizziness occur. While taking this medication, if bleeding symptoms (e.g., nosebleeds, gum bleeding, hematuria, melena, etc.) develop, healthcare professionals should be notified immediately.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. It is crucial to maintain the storage temperature between 1 degree and 30 degrees Celsius to ensure the prolonged efficacy and safety of the medication.

Appearance

Light yellow, round film-coated tablets

Package unit

60 tablets/PTP (10 tablets/PTP × 6)