Huxifaban Tablet 5 mg (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 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 together with an antiplatelet agent after hemostasis has been achieved in patients with nonvalvular atrial fibrillation who also have acute coronary syndrome and/or undergo 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, 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 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 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 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 greater. 3. Renal impairment Because there is no clinical experience in patients receiving dialysis or in patients with creatinine clearance 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) indicates that blood concentrations of this medicine 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 age ≥ 80 years or have body weight ≤ 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 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 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 greater 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, this medicine should be administered with caution 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 and treat blood clots by inhibiting blood coagulation. Careful monitoring for signs of bleeding is necessary during treatment, and caution should be exercised, especially in cases of elevated bleeding risk. If severe bleeding occurs, stop taking this medication immediately and seek appropriate treatment to stop the bleeding. This medication should not be administered to certain patients, such as those who are allergic to this drug or its components, those currently experiencing severe bleeding, those with bleeding disorders, or those with significantly impaired liver function. Also, patients with recent gastrointestinal ulcers or intracranial hemorrhage history, those who have undergone certain neurological surgeries or experienced nervous system damage, or patients with malignancies at high risk for bleeding should not be treated with this medication. Caution is needed when taking this medication with other anticoagulants, as the risk of bleeding may increase. Concurrent use should be avoided unless in special cases. This medication contains lactose and should not be administered to patients with lactose intolerance. In patients with significantly impaired kidney function or mildly decreased liver function, the risk of bleeding may increase when taken with certain antidepressants or anti-inflammatory drugs, and caution should be exercised. Particularly in the elderly, underweight patients, or those undergoing spinal or epidural anesthesia, the risk of serious nerve damage from bleeding is higher, so it should be administered with extra caution. In cancer patients, the risk of both clotting and bleeding is simultaneously elevated, so the use of this medication should be carefully considered. When taking this medication, side effects such as bleeding, bruising, nosebleeds, and hematoma may commonly occur, and rarely, serious bleeding or allergic reactions may occur. Prior to surgeries or invasive procedures that carry a bleeding risk, discontinuation of this medication for a certain period is necessary, and after the surgery, resumption should be determined according to the bleeding risk and the patient’s condition. This medication may interact with other medications, especially when taken with certain antifungals, antivirals, anticoagulants, antidepressants, and anti-inflammatory drugs, caution is advised. Pregnant or breastfeeding women should avoid this medication due to unestablished safety profiles. In breastfeeding cases, it is recommended to discontinue breastfeeding when taking this medication. Safety and efficacy in pediatric patients have yet to be established. This medication does not significantly impact driving or machinery operation, but caution should be observed due to potential side effects such as bleeding. In cases of overdose, there is a significantly increased risk of bleeding, so taking the medication should be stopped immediately and appropriate treatment sought; there is no antidote for this medication. Severe bleeding may require additional treatment to stop the bleeding.

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

This medication must be stored in a tightly closed container to avoid exposure to air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature to safely preserve the medication's effectiveness.

Appearance

Pink, oval-shaped, convex film-coated tablets

Package unit

60 tablets (10 tablets/PTPX6)