Elquisaban Tablets 5mg (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. 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 taken 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 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 administering the recommended dose of this medicine in combination 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. (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 taken orally twice daily for 7 days, followed by 5mg taken orally twice daily. 4) Reduction of the risk of recurrent 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 completing at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching between drugs 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 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, 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 combined treatment with this medicine and a vitamin K antagonist, measure the INR immediately before the scheduled dose of this medicine, and continue combined treatment with this medicine and the vitamin K antagonist until the INR is 2.0 or higher. 3. Renal impairment Use of this medicine is not recommended in patients on dialysis or in patients with a creatinine clearance of less than 15 mL/min, as 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 required 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 used 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 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 recurrent deep vein thrombosis and pulmonary embolism No dose adjustment is required 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 used 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. Use 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 helps prevent excessive blood clotting. However, the risk of bleeding increases during treatment with this medication, so signs of bleeding should be closely monitored. If severe bleeding occurs, the administration of this medication should be stopped immediately. Patients with an allergic reaction to this medication, active bleeding, severe liver dysfunction, or a history of recent intracranial hemorrhage or gastrointestinal ulcers should not take this medication. Additionally, caution is advised when using this medication in conjunction with other anticoagulants as it may greatly increase the risk of bleeding. Patients with compromised renal or hepatic function, the elderly, and those with low body weight should be more cautious when using this medication. Patients undergoing spinal or epidural anesthesia may be at risk for severe neurological damage from this medication, therefore special caution is required. The safety and effectiveness of this medication have not been fully established in cancer patients or those with pulmonary embolism, so it should be used with caution. This medication may interact with other drugs, particularly antibiotics, antifungals, antidepressants, and non-steroidal anti-inflammatory drugs, so consultation with a doctor or pharmacist is necessary when taking them together. If a patient is to undergo surgery or invasive procedures, this medication may need to be stopped a certain amount of time prior due to the risk of bleeding. Pregnant or breastfeeding women are not recommended to use this medication, and breastfeeding should be discontinued if this medication is taken. The safety in children has not been sufficiently established. In the case of overdose, the risk of bleeding increases, and immediate consultation with a healthcare professional is advised as there are no antidotes for this medication; proper treatment is required for severe bleeding. Symptoms of bleeding such as nosebleeds, gum bleeding, bruising, hematuria, or black stools should be reported immediately to a healthcare institution for treatment. This medication does not significantly affect the ability to drive or operate machinery, but caution is required considering the risk of bleeding.

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature to ensure the effectiveness of the medication.

Appearance

Pink, oval-shaped, convex film-coated tablet

Package unit

60 tablets/PTP (10 tablets/PTP x 6)