Enbixazheng 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 orally twice daily. The first dose should be administered 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 orally twice daily. However, the recommended dose for patients with nonvalvular atrial fibrillation who have at least 2 of the following characteristics is 2.5 mg 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 and 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. (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’ in 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 orally twice daily for 7 days, followed by 5mg orally twice daily. 4) Reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism The recommended dose is 2.5mg orally twice daily, to be administered after completion of at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching therapy 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 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) 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 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 Since there is no clinical experience in patients on dialysis or in patients with creatinine clearance 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 the blood concentration of this medicine was 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 this medicine at a dose of 2.5 mg twice daily. Patients with severe renal impairment (creatinine clearance 15-29 mL/min) should receive this medicine at a dose of 2.5 mg 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 the blood concentration of this medicine was 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. Administration of this medicine is not recommended in patients with severe hepatic impairment. Patients with hepatic ALT/AST greater than 2 times the upper limit of normal or total bilirubin levels 1.5 times or greater than 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 treatment with this medicine. 5. Patients unable to swallow tablets For patients 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 blood clots by preventing blood coagulation. There may be a risk of bleeding during treatment, so patients should be closely monitored for signs of bleeding. If serious bleeding occurs, the medication should be immediately discontinued, and medical advice should be sought. This medication should not be used in patients with certain diseases or conditions, such as those with a high risk of bleeding, including a history of gastrointestinal ulcers or intracranial hemorrhage, or patients with coagulation disorders. Caution is also needed when used in combination with other anticoagulants, and some patients may be contraindicated due to the ingredients in this medication. Patients with severe renal or liver dysfunction may have increased drug levels, so it is crucial to consult with health professionals beforehand. The risk of bleeding may increase when taken with certain antidepressants or anti-inflammatory medications, so caution is warranted when used in combination with these drugs. Elderly patients or those with low body weight may be at a higher risk of bleeding and should take extra care while using this medication. Patients receiving spinal or epidural anesthesia should inform their healthcare provider, as this medication can increase the risk of serious neurological damage. This medication may cause various bleeding symptoms or other adverse reactions in some patients, so any unusual symptoms should be reported to medical staff immediately. Before any surgical or invasive procedure, this medication should be discontinued for a certain period to reduce the risk of bleeding, and it should be resumed after checking hemostatic status post-procedure. It is not recommended for use in pregnant or breastfeeding women, and any use should be discussed with a healthcare provider. The safety and efficacy of this medication have not been sufficiently established in children, so it should not be used in this population. This medication may interact with other drugs, so it is essential to inform healthcare providers of any other medications being taken. Overdose may significantly increase the risk of bleeding, so dosages must be adhered to precisely, and in the event of an overdose, emergency treatment should be sought immediately.

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

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is important to maintain a storage temperature of 1 to 30 degrees Celsius to preserve the drug's effectiveness and safety.

Appearance

Pink, oval-shaped, convex film-coated tablets

Package unit

60 tablets/PTP (10 tablets/PTP × 6)