Elifixa Tablet 2.5mg (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 of this medicine taken orally twice daily. The first dose is 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 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 the 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 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, to be administered after completion of at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching between medicines 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 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 less than 2.0. 2) Switching from this medicine to vitamin K antagonist therapy When switching from this medicine to vitamin K antagonist therapy, continue taking 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 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 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 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 necessary 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 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 were increased in these patients; therefore, this medicine should be administered with caution in these patients. 4. Hepatic impairment This medicine must 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); however, 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 unable to swallow tablets, this medicine may be crushed and mixed with water or a drink such as applesauce for oral administration immediately before use. This medicine may also be crushed, mixed with 60mL of water, and administered through a nasogastric tube.

This drug is used to prevent or treat thrombus formation by inhibiting blood clotting. However, there is a risk of bleeding while taking this drug, so patients should be closely monitored for signs of bleeding. In case of severe bleeding, the medication should be stopped immediately and appropriate treatment sought. This drug should not be administered to certain patients. For example, it should not be used in patients who are allergic to this drug or its components, those with current severe bleeding, patients with coagulopathy or severe liver disease, or patients at high risk of bleeding such as those who have recently had gastrointestinal ulcers, intracranial hemorrhage, or surgeries on the brain or spinal cord. Additionally, caution is required when taking this drug with other anticoagulants, and patients with genetic issues such as lactose intolerance should not take this drug. Patients with severely impaired renal function or slightly impaired liver function should use this drug with caution. Also, the risk of bleeding may increase when taken with some antidepressants or non-steroidal anti-inflammatory drugs, requiring careful monitoring. Elderly patients or those with low body weight are also at higher risk for bleeding and need special attention. Patients undergoing spinal or epidural anesthesia may develop hematomas while taking this drug, leading to serious nerve damage, and thus require special caution. Common side effects of this drug include bleeding, bruises, nosebleeds, and hematomas. Bleeding can occur in various areas such as the gastrointestinal tract, eyes, or brain, and can be life-threatening in severe cases. Thus, if symptoms of bleeding or abnormal reactions occur, it is imperative to notify medical personnel immediately. Before undergoing surgery or invasive procedures, this medication should be discontinued for a specific period to reduce the risk of bleeding. However, stopping the medication may increase the risk of thrombosis, so it is crucial to resume treatment as soon as possible. This drug may interact with other medications, especially those that strongly inhibit enzymes (CYP3A4) and drug transport proteins (P-gp) involved in drug metabolism in the liver, which may increase the blood concentration of this drug and heighten the risk of bleeding. Conversely, taking this drug with medications that activate these enzymes can reduce its effectiveness, necessitating caution. Women who are pregnant or breastfeeding are advised not to take this medication. Particularly in breastfeeding women, this drug may be excreted in breast milk and pose a risk to neonates, necessitating either discontinuation of the drug or breastfeeding. The safety and efficacy of this drug in children have not been sufficiently confirmed. This drug does not significantly affect driving or machinery operation, but attention should be paid to the risk of bleeding. In case of overdose, there is no antidote for this drug, so if severe bleeding occurs, medical personnel should be notified immediately for appropriate treatment. Administering activated charcoal may help reduce absorption of this drug in emergency situations. During treatment with this drug, regular check-ups and careful monitoring are required to reduce the risk of bleeding, and consultation with a specialist is essential when used in conjunction with other medications.

• Hemorrhage
• Contusion
• Epistaxis
• Hematoma
• Anemia
• Thrombocytopenia
• Hypersensitivity
• Allergic Edema
• Anaphylactic Reaction
• Cerebral Hemorrhage

This drug should be stored in a tightly sealed container to avoid exposure to air or moisture. Additionally, it is recommended to store the drug at room temperature, between 1 to 30 degrees Celsius, avoiding excessive heat or cold.

Appearance

Yellow round film-coated tablet

Package unit

60 tablets (10 tablets/PTPX6)