Elivban 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 orally twice daily. The initial 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 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 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 the concomitant administration of the recommended dose of this medicine and an antiplatelet agent 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 that affect 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 orally twice daily, to 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 may be made at the time of the next scheduled dose. 1) Switching from vitamin K antagonist therapy to this medicine 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 below 2.0. 2) Switching from this medicine to vitamin K antagonist therapy 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, perform an INR test 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 receiving dialysis or in patients with creatinine clearance below 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 required in patients with mild or moderate renal impairment. Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), the blood concentration of this medicine was 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. Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), the blood concentration of this medicine was 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 levels exceeding 2 times the upper limit of the normal range or total bilirubin levels at least 1.5 times the upper limit of the normal range 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 treatment with 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 used to prevent or treat blood clots by inhibiting excessive blood coagulation. Patients should be closely monitored for signs of bleeding while taking this medication. Extra caution is advised in situations where the risk of bleeding is increased. If severe bleeding occurs, discontinue this medication immediately and consult a healthcare professional. While routine monitoring of blood concentration with specific blood tests is not required, measuring blood concentration may be helpful in emergencies. Patients who are allergic to this medication, have active bleeding, or suffer from blood coagulation disorders should not take this medication. Patients with a history of gastrointestinal ulcers, intracranial hemorrhage, or brain or spinal surgery should also avoid this medication. Combining this medication with other anticoagulants may significantly increase the risk of bleeding, so it is advised not to use them together. Patients with specific metabolic disorders like lactose intolerance may not be suitable for this medication. Patients with severely impaired kidney function or moderate to severe liver dysfunction should use this medication with caution. Care should be taken when using this medication with drugs that may increase bleeding risk, such as antidepressants or non-steroidal anti-inflammatory drugs (NSAIDs). Elderly patients or those with low body weight also face a higher risk of bleeding and need to be cautious. Patients undergoing spinal or epidural anesthesia are at risk of severe neurological injury from this medication, thus special caution is needed. The safety and efficacy of this medication have not been sufficiently established for patients requiring thrombolysis or pulmonary embolism removal procedures, so it is not recommended. When used in cancer patients, the risks of bleeding and thrombosis should be carefully assessed. Common side effects include bleeding, bruising, nosebleeds, and hematomas, while severe bleeding may occur rarely. As this medication may interact with other drugs, it is crucial to inform healthcare professionals about any other medications being taken. Before undergoing surgery or invasive procedures, this medication should be discontinued for a period of time, and after the procedure, refills should be resumed based on bleeding risk and treatment necessity. Pregnant or breastfeeding women are advised to avoid this medication and consult healthcare professionals if necessary. The safety and efficacy in children have not yet been established. In cases of overdose, the risk of bleeding increases, so patients should consult healthcare professionals immediately, as there is no antidote for this medication. Regular medical observation and caution are necessary when taking this medication to reduce the risk of bleeding.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. The appropriate storage temperature is room temperature between 1 degree and 30 degrees, avoiding too hot or too cold environments.

Appearance

Light yellow round film-coated tablet

Package unit

60 tablets (10 tablets/PTP×6)