FarmGen Apixaban Tablet 2.5 mg

Adult dose

This medicine should be taken with water, with or without food. If a patient misses a dose, they should take this medicine immediately 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 initial dose should be taken 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 of this medicine taken 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 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 concomitant administration of the recommended dose of this medicine with an antiplatelet agent, after hemostasis has been achieved, in patients with nonvalvular atrial fibrillation who also have acute coronary syndrome and/or have undergone percutaneous coronary intervention. (See “5. General Precautions, 1) Interactions with other medicines that affect hemostasis” under Precautions for Use and “12. Clinical Trial Information, 2) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, AUGUSTUS trial.”) 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 recurrent deep vein thrombosis and pulmonary embolism The recommended dose is 2.5mg of this medicine taken orally twice daily, to be administered after completion of at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching medicines When switching from a parenteral anticoagulant 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 another vitamin K antagonist 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 the 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 higher. 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 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 recurrent 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 patient groups; 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 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, 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 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 inhibiting blood coagulation. During treatment, patients should carefully monitor for signs of bleeding, especially if there is a high risk of bleeding. If severe bleeding occurs, discontinue use immediately and consult a healthcare professional. Routine monitoring with specific coagulation tests is not required for this medication, but checking blood concentration may be helpful in cases of overdose or urgent surgery. Patients with allergies to the active ingredient or other components, those with current severe bleeding, bleeding disorders, or severe liver disease are prohibited from using this medication. Patients with a recent history of gastrointestinal ulcers, intracranial hemorrhage, or vascular abnormalities, as well as those with high-risk malignant tumors, should also avoid using this medication. Unless in special circumstances, this medication should not be taken in conjunction with other anticoagulants. Patients with genetic issues such as lactose intolerance should not take this medication. Patients with severe renal impairment or decreased liver function should use this medication with caution, as blood concentration may increase. Additionally, when taken with certain antidepressants or anti-inflammatory medications, there may be an increased risk of bleeding. Elderly patients or those weighing less than 60 kg should take this medication carefully due to a higher risk of bleeding. Patients receiving spinal or epidural anesthesia need to be particularly cautious as this medication may increase the risk of hemorrhage leading to nerve paralysis. Side effects such as bleeding, bruising, nosebleeds, hematomas are common. In severe cases, intracranial bleeding, gastrointestinal bleeding, and ocular bleeding may occur, so report any unusual symptoms to a healthcare professional immediately. This medication may cause anemia due to bleeding, so regular monitoring is recommended. Before surgery or invasive procedures, this medication should be discontinued for a certain period based on bleeding risk, and it is essential to resume use as soon as bleeding risk stabilizes. Abrupt discontinuation may increase the risk of thrombosis, so do not stop without consulting healthcare personnel. The safety of this medication during pregnancy has not been established and is not recommended; if breastfeeding, either breastfeeding should be stopped or this medication should be discontinued. Safety and efficacy in children have not been confirmed yet. This medication may interact with drugs that inhibit or induce certain enzymes or protein carriers, potentially altering blood concentration, so inform healthcare professionals of all medications taken. Particularly pay attention when taken with strong CYP3A4 and P-gp inhibitors or inducers. There is minimal impact on driving or machine operation, but caution is advised due to bleeding risk. In case of overdose, the risk of bleeding increases, so discontinue immediately and consult healthcare personnel; there is no specific antidote, and appropriate treatment for bleeding is necessary.

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

This medication should be stored in a tightly sealed container to prevent air or moisture exposure. The recommended storage temperature is room temperature between 1 and 30 degrees Celsius. This helps maintain the efficacy of the medication for a longer duration.

Appearance

Pale yellow round film-coated tablet

Package unit

60 tablets/PTP [(10 tablets/PTP × 6)]