Apixaban 5 mg Tablets (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. 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 taken 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. 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, after completing at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching medications When switching from parenteral anticoagulant therapy 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, International Normalized Ratio) is below 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 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 on dialysis or in patients with creatinine clearance below 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 are 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 weigh ≤ 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 recurrent 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 are 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. For patients who cannot swallow tablets, immediately before use this medicine may be crushed and mixed with water or a beverage such as applesauce, then administered orally. This medicine may also be crushed, mixed with 60mL of water, and administered through a nasogastric tube.

This medication is an anticoagulant that prevents blood clotting. Careful monitoring for bleeding symptoms is required during use, and it should be administered cautiously to patients with a high risk of bleeding. This drug should not be administered to patients with clinically significant bleeding or blood coagulation disorders, nor to certain liver disease patients. Patients with a recent history of gastrointestinal ulcers, cerebrovascular hemorrhage, or surgeries of the brain or spinal cord, who are at high risk of bleeding, should also avoid using this medication. Additionally, caution is needed when used in combination with other anticoagulants, as the risk of bleeding may increase, and lactose-intolerant patients should not take this drug. For patients with severely impaired kidney or liver function, monitoring is necessary as the concentration of this medication in the blood may increase, and caution is required when used together with drugs that increase the risk of bleeding, such as nonsteroidal anti-inflammatory drugs (NSAIDs). Patients receiving spinal or epidural anesthesia are at risk of hematoma while taking this medication; therefore, strict adherence to catheter removal timing and dosing intervals is required, and frequent neurological evaluations should be conducted. Bleeding, bruising, nosebleeds, and hematomas are common side effects, and serious adverse reactions, including severe bleeding or liver dysfunction, may occur rarely. During the use of this drug, blood test results may change, so regular examinations as instructed by a physician are necessary. Use of this medication is not recommended for pregnant or breastfeeding women, and especially during breastfeeding, discontinuation of either the medication or breastfeeding should be considered due to the potential for drug excretion. It is advisable not to use this medication in children as safety and efficacy have not been established. For elderly patients, no special dosage adjustments are needed, but caution is necessary in those with a low body weight or renal impairment. This medication may interact with other drugs; therefore, caution is needed, especially when used with CYP3A4 and P-gp inhibitors or inducers, anticoagulants, antiplatelet agents, and NSAIDs, as the risk of bleeding may be increased. Before undergoing surgery or invasive procedures, this medication should be discontinued for a certain period, and in case of bleeding, the medication should be stopped immediately and healthcare providers consulted. In case of overdose, the risk of bleeding significantly increases; immediate medical attention is required for appropriate treatment as there is no antidote, thus treatment should focus on controlling the bleeding.

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

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The recommended storage temperature is between 1 to 30 degrees Celsius, which helps maintain the medication's effectiveness over time.

Appearance

Pink, oval, biconvex film-coated tablet

Package unit

10 tablets/PTP, 60 tablets/PTP [(10 tablets/PTP) X 6]