DONGGU Apixaban Tablets 2.5 mg

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 they remember 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 first dose should be taken 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 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 undergo percutaneous coronary intervention. (See “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 recurrence of deep vein thrombosis and pulmonary embolism The recommended dose is 2.5mg of this medicine taken orally twice daily, after completing at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching between 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 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 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 To switch 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 taking this medicine together with the vitamin K antagonist, measure the INR immediately before the scheduled dose of this medicine, and continue taking this medicine together with 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 a creatinine clearance of less than 15 mL/min, use 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) has shown increased blood concentrations of this medicine 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 take 2.5 mg of this medicine twice daily. Patients with severe renal impairment (creatinine clearance 15-29 mL/min) should take 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) has shown increased blood concentrations of this medicine 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. 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 ≥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 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 drink such as applesauce, and taken orally. This medicine may also be crushed, mixed with 60mL of water, and administered through a nasogastric tube.

This medication is an anticoagulant that prevents blood clot formation. During treatment, bleeding may occur, and signs of bleeding should be observed carefully. If bleeding becomes severe, stop taking this medication immediately and consult a healthcare professional. This medication should not be administered to patients at high risk of bleeding, those with bleeding disorders, or those with severely impaired liver function. Furthermore, individuals who have allergic reactions to the active ingredient or any components of this medication should avoid its use. Patients with severely impaired kidney function or moderate or more severe liver function should use this medication cautiously. This medication may interact with other drugs, especially those affecting blood coagulation, certain antibiotics, antifungals, and antivirals, so caution is required when taken together. Pregnant or breastfeeding women are not recommended to use this medication; if breastfeeding, consult a healthcare provider. Safety and efficacy in children have not been established, so its use is not recommended. In elderly patients, special dose adjustment is not required; however, caution is necessary in those who are underweight or have impaired renal function. Prior to any surgical or invasive procedures, it's advisable to discontinue this medication for a certain period to reduce the risk of bleeding, and after surgery, it is recommended to resume the medication as soon as hemostasis is stable. There is an increased risk of bleeding while taking this medication, so if symptoms such as nosebleeds, hematuria, bruising, or bloody stools occur, alert a healthcare professional immediately. In case of overdose, the risk of bleeding increases; as there is no antidote for this medication, if bleeding occurs, stop taking it immediately and receive appropriate treatment. The effect on driving or operating machinery is minimal, but caution may be necessary due to symptoms from 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 avoid exposure to air and moisture, at temperatures between 1 and 30 degrees Celsius. Storing in this manner will help maintain the medication's effectiveness.

Appearance

Yellow round film-coated tablet

Package unit

10 tablets/box [10 tablets/PTT X 1], 60 tablets/box [10 tablets/PDT X 6]