Beralapix 5 mg Tablet (Apixaban)

Adult dose

This medicine should be taken with water, regardless of food. If a patient forgets to take a dose, they should take this medicine as soon as possible and continue taking it twice daily as before. 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 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 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 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 antiplatelet agents after hemostasis has been achieved in patients with nonvalvular atrial fibrillation who have acute coronary syndrome and/or undergo 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 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 of this medicine orally twice daily, to 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 treatment 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 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 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 just 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 higher. 3. Renal impairment As there is no clinical experience in patients receiving dialysis or 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 were increased in these patient groups; 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 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 were increased in these patient groups; 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 such 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 immediately before use, mixed with water or a liquid 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 works by thinning the blood to prevent or treat the formation of clots. Careful monitoring for signs of bleeding is necessary during treatment since bleeding may occur. In the event of severe bleeding, the use of this medication should be discontinued immediately, and appropriate measures should be followed as instructed by a physician. Individuals with an allergy to this medication, those currently experiencing bleeding, or those with coagulation issues should not take this medication. Particularly, patients who have recently had gastrointestinal ulcers, brain hemorrhages, or surgeries involving the brain or spinal cord, as well as cancer patients with a high risk of bleeding, may be at risk if taking this medication. Consultation with a physician should be sought if taking other anticoagulants to account for an increased risk of bleeding. Patients with severely impaired kidney or liver function may have increased concentrations of this medication, thus it should be used cautiously. The risk of bleeding may also increase when taken with certain antidepressants or non-steroidal anti-inflammatory drugs (NSAIDs). Particularly, elderly patients or those with lower body weight may be at higher risk for bleeding and should take care while taking this medication. Patients receiving spinal or epidural anesthesia should inform healthcare professionals of the use of this medication, as there is a risk of serious nerve damage. This medication is not recommended for use during pregnancy or breastfeeding, and consultation with a physician is advised prior to use. This medication should be discontinued for a period before surgery or invasive procedures, and it should be resumed as soon as possible after discontinuation to mitigate the risk of clot formation. This medication may interact with certain antibiotics, antifungals, or antivirals, so it is important to inform a physician of any other medications being taken. Overdose can significantly increase the risk of bleeding, so it is crucial to adhere strictly to the prescribed dosage, and immediate medical attention is necessary if heavy bleeding occurs. While it does not significantly impact driving or machinery operation, use caution if experiencing symptoms of bleeding or dizziness.

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

This medication may be sensitive to air and moisture, thus it should be stored in a tightly closed container. It is best to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. This helps preserve the efficacy and safety of the medication for a longer period.

Appearance

Pink, egg-shaped, biconvex film-coated tablet

Package unit

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