Enbiksag 2.5 mg (Apixaban)

Adult dose

This medicine should be taken with water, with or without food. If a patient misses a dose, they should take this medicine immediately 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 first dose should be administered 12 ~ 24 hours after surgery. The recommended duration of treatment is 32 ~ 38 days in patients who have undergone hip replacement surgery. The recommended duration of treatment is 10 ~ 14 days in 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 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 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. 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 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 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 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 Administration of this medicine is not recommended in dialysis patients or patients with creatinine clearance less than 15 mL/min because 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 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 aged ≥ 80 years or weighing ≤ 60kg who have serum creatinine ≥1.5 mg/dL (133 micromole/L) should receive this medicine at 2.5 mg twice daily. Patients with severe renal impairment (creatinine clearance 15-29 mL/min) should receive this medicine at 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 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 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 such patients. Liver function tests should be performed before starting treatment with this medicine. 5. Patients unable to swallow tablets For patients 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 used to prevent or treat the formation of blood clots by inhibiting blood coagulation. While taking this medication, there may be a risk of bleeding, so it is important to monitor for symptoms or signs of bleeding carefully. In the event of severe bleeding, the use of this medication should be discontinued immediately and medical advice should be sought. This medication should not be used in patients who have a high risk of significant bleeding, such as those with severe bleeding or very poor liver function, or those with a recent history of intracranial hemorrhage or gastrointestinal ulcers, as it may pose a risk. Additionally, when taken with other anticoagulants, the risk of bleeding may increase significantly, so concurrent use should be avoided. Patients with significantly impaired renal function or those with slightly compromised liver function should use this medication cautiously, especially when taken with other drugs that may increase the risk of bleeding. In particular, elderly patients or those with low body weight may be at an increased risk of bleeding, so it is important to take this medication as directed by healthcare providers. Patients receiving spinal or epidural anesthesia are at risk of nerve damage while taking this medication, so consultation with healthcare providers is necessary. Some other medications taken concurrently may increase or decrease the effect of this medication, so it is important to inform healthcare providers about all medications being taken. Women who are pregnant or breastfeeding should consult healthcare providers before taking this medication. The safety and effectiveness of this medication in children have not been established, so it is advisable not to use it in pediatric patients. Prior to any surgery or invasive procedures, this medication should be discontinued for a certain period, and after the procedure, the decision to resume its use will depend on the risk of bleeding and the need for treatment. In cases of overdose, the risk of bleeding may increase significantly, so it is important to adhere to the prescribed dosage and not to discontinue or change the dosage arbitrarily without a doctor's guidance. If any abnormal symptoms or signs of bleeding are suspected during treatment, it is crucial to seek medical attention immediately.

• Bleeding
• contusion
• 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 and moisture, and the storage temperature should be maintained between 1 degree and 30 degrees Celsius at room temperature. Proper storage will maintain the medication's effectiveness and safety.

Appearance

Light yellow round film-coated tablets

Package unit

60 tablets/PTP (10 tablets/PTP × 6)