Eliquis 5 mg (Apixaban)

Adult dose

This medicine may 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 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, 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 have acute coronary syndrome and/or have undergone percutaneous coronary intervention. (Refer to ‘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 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 taken orally twice daily, and treatment should be started after completing at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching between medicines When switching from parenteral anticoagulant therapy to this medicine or from this medicine to a parenteral anticoagulant, the change can be made starting with 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 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 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 As there is no clinical experience in patients on dialysis or in patients with a creatinine clearance of 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 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 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 patients; therefore, this medicine should be administered with caution in these patients. 4. Hepatic impairment 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. 5. Patients who cannot swallow tablets For patients who cannot swallow tablets, this medicine may be crushed immediately before use and mixed with water or a beverage such as applesauce for oral administration. This medicine may also be crushed, mixed with 60mL of water, and administered through a nasogastric tube.

This medicine is used to prevent or treat thrombus formation by inhibiting blood coagulation. During the treatment with this medication, bleeding may occur, so signs of bleeding should be closely monitored. In particular, if severe bleeding occurs, the use of this medication should be immediately discontinued, and appropriate measures should be taken under the direction of a physician, if necessary. This medication should not be administered to patients with certain conditions, for example, to patients with ongoing bleeding, coagulation disorders, or severely impaired liver function. Additionally, caution should be exercised when using this medication in patients with a recent history of intracranial hemorrhage or gastrointestinal ulcers, as well as those who have undergone spinal or brain surgery, as these patients are at higher risk for bleeding. Concurrent use with other anticoagulants may increase the risk of bleeding; thus, combination therapy should be avoided unless specifically indicated. The blood concentration of this medication may increase in patients with severely impaired kidney function or mild impaired liver function, so it should be used with caution in these patients. Moreover, when taken with certain antidepressants, non-steroidal anti-inflammatory drugs (NSAIDs), or acetylsalicylic acid, there may be an increased risk of bleeding, so caution is advised. This medication should be stopped for a certain period before undergoing surgery or invasive procedures, and reinitiated after surgery considering bleeding risk and hemostatic status. Women who are pregnant or breastfeeding are advised not to take this medication; especially during breastfeeding, it may be excreted in breast milk and pose a risk to the infant, requiring either cessation of the drug or breastfeeding. The safety and efficacy of this medication have not been established in children, so it is not used in this population. In elderly patients, dose adjustment is generally not necessary; however, caution is needed in those who are of lower weight or have impaired kidney function. During the course of this medication, if bleeding symptoms (e.g. nosebleeds, gum bleeding, hematuria, black stools, etc.) occur, immediate notification of healthcare personnel is necessary. In case of overdose, there is an increased risk of bleeding. As there is no antidote for this medication, if there is severe bleeding, immediate medical attention is required. This medication may interact with other drugs that inhibit or induce certain enzymes; therefore, if taking other medications, inform your physician or pharmacist. It does not significantly affect driving or operation of machinery; however, care is needed due to the risk of bleeding. During the course of taking this medication, regular blood tests to check liver and kidney function are recommended. Lastly, this medication must be taken strictly according to a physician's prescription and instructions; do not arbitrarily stop taking it or change the dosage.

• Hemorrhage
• contusion
• epistaxis
• hematoma
• anemia
• thrombocytopenia
• hypersensitivity
• allergic edema
• anaphylaxis
• cerebral hemorrhage

This medication must be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain the storage temperature between 1 degree and 30 degrees Celsius to safely preserve the medication's effectiveness.

Appearance

Pink oval biconvex film-coated tablet

Package unit

60 tablets/PVP [10 tablets/PVP X 6]