Alfix Tablet 2.5 mg (Apixaban)

Adult dose

Take this medicine with water, with or without food. If a patient forgets to take a dose, they should take this medicine as soon as possible 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 first 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 coadministration 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. (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 study’ 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 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 completion of at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching medications When switching from a parenteral anticoagulant 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) 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 coadministration of this medicine and the vitamin K antagonist, measure the INR immediately before the scheduled dose of this medicine, and continue coadministration of 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, 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. Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), 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 age ≥ 80 years or have a body weight ≤ 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. Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), 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 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 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 unable to swallow tablets, this medicine may be crushed and mixed with water or a beverage such as applesauce for oral administration immediately before use. 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 clots by inhibiting blood coagulation. During the use of this drug, bleeding may occur, so signs of bleeding should be carefully monitored. If bleeding worsens, the use of this medication should be stopped immediately and consultation with a healthcare professional should be sought. This drug should not be administered to patients with certain conditions, such as those with severe bleeding or significantly impaired liver function. Additionally, patients with allergies to any of the components in this medication should avoid taking it. Patients with impaired renal or liver function should use this medication with caution, and dose adjustment may be necessary if required. This drug can interact with other medications, so care should be taken when used with drugs that increase the risk of bleeding. Before undergoing surgery or invasive procedures, this medication should be discontinued for a certain period, and it should be resumed once the post-operative condition stabilizes. Women who are pregnant or breastfeeding should avoid using this drug, and if use is necessary, it should be discussed with a healthcare provider. This drug has not been established to be safe and effective in children, thus should not be used in pediatric patients. In general, elderly patients do not usually require dose adjustments unless specific situations arise. Overdosing with this medication can significantly increase the risk of bleeding, so the prescribed dosage should be strictly adhered to. In case of overdose, immediate medical attention should be sought, and as there is no antidote for this medication, treatment to control bleeding may be necessary. If unusual symptoms or bleeding symptoms occur during use, healthcare professionals should be informed immediately.

• Bleeding
• contusion
• nosebleed
• hematoma
• anemia
• thrombocytopenia
• hypersensitivity
• allergic edema
• anaphylactic reaction
• cerebral hemorrhage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 degree Celsius to 30 degrees Celsius to ensure the drug's effectiveness and safety over time.

Appearance

Pale yellow round coated tablet

Package unit

60 tablets/box [(10 tablets/PTP x 6)]