Elquisaban 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 they remember and then 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 taken 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 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 concomitant administration of the recommended dose of this medicine with 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. (See “5. General Precautions, 1) Interactions with Other Drugs That Affect Hemostasis” under Precautions for Use and “12. Clinical Trial Information, 2) Reduction of the Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation, AUGUSTUS Trial.”) 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, 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 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 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 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 the 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 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), 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 more than 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 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 the formation of blood clots by inhibiting blood coagulation. It is important to closely monitor for signs of bleeding during treatment, especially in patients with a high risk of bleeding. If severe bleeding occurs, the medication should be discontinued immediately. This medication should not be taken by patients with allergy to it, active bleeding, severely impaired liver function, or those who have recently undergone surgery or suffered trauma with a high risk of bleeding. Additionally, concurrent use with other anticoagulants may significantly increase the risk of bleeding and should be avoided. Caution should be exercised in patients with severe renal dysfunction or slightly impaired liver function, as well as when using specific psychiatric medications or anti-inflammatory analgesics, due to the potential increased risk of bleeding. Older adults or underweight patients may also have an increased risk of bleeding, so dosage adjustments and caution are necessary. Patients receiving spinal or epidural anesthesia may be at risk of nerve damage while taking this medication, so special management is required. This medication is not recommended for pregnant or breastfeeding women, and its safety in children has not been established. While taking this medication, various adverse reactions such as bleeding, nosebleeds, bruising, etc., may occur, and if any abnormal symptoms arise, it is essential to consult with healthcare professionals immediately. For surgical or invasive procedures, this medication should be discontinued for a specified period to reduce the risk of bleeding, and it should be resumed as soon as possible to avoid increased thromboembolic risk. This medication has many interactions with other drugs, so it is crucial to discuss with a doctor or pharmacist about other medications being taken. In case of an overdose, the risk of bleeding is significantly increased, and it is essential to visit a medical institution immediately for appropriate treatment.

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

This medication should be stored in a tightly sealed container to protect it from exposure to air and moisture, and it should be kept at room temperature between 1°C and 30°C. Proper storage can maintain the efficacy of the medication for a long time.

Appearance

Pale yellow, round film-coated tablet

Package unit

60 tablets/PTP (10 tablets/PTP × 6)