Alpix 5 mg Tablet (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 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 taken orally twice daily. The first dose should be administered 12 ~ 24 hours after surgery. The recommended duration of treatment is 32 ~ 38 days for patients who have undergone hip replacement surgery. The recommended duration of treatment is 10 ~ 14 days for patients who have undergone knee replacement surgery. 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 antiplatelet agents after hemostasis has been achieved in patients with nonvalvular atrial fibrillation who have acute coronary syndrome and/or have undergone 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, after completion of 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 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, International Normalized Ratio) 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 concurrent treatment with this medicine and the vitamin K antagonist, measure the INR immediately before the scheduled dose of this medicine and continue concurrent 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 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. 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 aged ≥ 80 years or have a 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 must 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 treatment with 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 drug is used to prevent or treat clots by stopping blood from clotting. During treatment with this medication, there may be a risk of bleeding, so it is essential to monitor carefully for any symptoms or signs of bleeding. If severe bleeding occurs, the use of this medication should be stopped immediately, and appropriate measures should be taken in consultation with a healthcare professional. This drug should not be administered to certain patients, for example, those allergic to this drug or its components, those with current serious bleeding, severe liver disease, or conditions with a high bleeding risk. Recent patients who have had gastrointestinal ulcers, intracranial bleeding, or spinal or brain surgery, as well as those with vascular abnormalities or malignant tumors, may also be at risk if they use this drug. It is generally not recommended to use this drug in conjunction with other anticoagulants, except under special circumstances with a healthcare provider's guidance. This medication contains lactose, so it should not be given to patients with lactose intolerance. Patients with severely impaired kidney function or liver impairment should use this medication cautiously, as its concentration may increase in those patients. Additionally, caution is required when taking this drug with medications such as selective serotonin reuptake inhibitors (SSRIs), non-steroidal anti-inflammatory drugs (NSAIDs), or acetylsalicylic acid, as the risk of bleeding may increase. Especially in elderly patients or those with low body weight, there is a higher risk of bleeding, and they should be advised to consult with a healthcare professional before usage. Patients receiving spinal or epidural anesthesia may face an increased risk of central nervous system bleeding when taking this drug, necessitating appropriate timing adjustments with anesthesia and medication. This drug is not recommended for patients who may require thrombolysis, such as in the case of pulmonary embolism, as its safety and efficacy have not been established. In cancer patients, there is an increased risk of bleeding and thrombosis, so it is essential to discuss the use of this drug thoroughly with a healthcare provider beforehand. Common side effects that may occur while using this drug include bleeding, bruising, nosebleeds, and hematomas, and if severe bleeding symptoms occur, they must inform healthcare professionals immediately. This drug may interact with other medications; thus, patients should inform healthcare professionals about any other medications they are taking. In particular, if taken with drugs that strongly inhibit CYP3A4 and P-gp, the concentrations of this drug can increase, leading to a higher bleeding risk. Conversely, if taken with drugs that strongly induce CYP3A4 and P-gp, the effects of this drug may be diminished, requiring caution. This drug is not recommended during pregnancy, and if breastfeeding, it may be secreted in breast milk, necessitating the stoppage of breastfeeding or discontinuing this medication. Safety and efficacy regarding children have not been established, so it is best not to use it in this population. This drug does not significantly affect driving or machine operation, but caution should be exercised considering the risk of bleeding. Before surgical or invasive procedures, it may be necessary to discontinue this medication for a certain period to reduce the risk of bleeding. After the procedure, resuming medication should be decided by a healthcare professional. In the case of overdose, the risk of bleeding increases significantly, and the prescribed usage and dosage must be strictly adhered to. In cases of severe bleeding, the administration of this drug should be stopped, and appropriate care should be sought, with specific coagulation product delivery possibly considered in emergency situations.

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

This medication should be stored in a tightly closed container to prevent air and moisture from entering. Additionally, it is advisable to store it at room temperature between 1 to 30 degrees Celsius. This storage maintains the drug's effectiveness.

Appearance

Pink oval biconvex film-coated tablet

Package unit

60 tablets/box [(10 tablets/PTP ×6)]