Eliquis Tablet 2.5 mg (Apixaban)

Adult dose

This medicine should be taken with water, with or without food. If the 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. 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 have undergone 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 taken orally twice daily, and it should 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 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 initiate this medicine when the International Normalized Ratio (INR) is less than 2.0. 2) Switching from this medicine to vitamin K antagonist therapy To switch from this medicine to vitamin K antagonist therapy, continue this medicine for 2 days after starting the vitamin K antagonist. After 2 days of coadministration of this medicine and vitamin K antagonist therapy, measure the INR immediately before the scheduled dose of this medicine, and continue coadministration of this medicine and vitamin K antagonist therapy until the INR is 2.0 or greater. 3. Renal impairment Administration of this medicine is not recommended in patients on dialysis or in patients with creatinine clearance less than 15 mL/min because there is no clinical experience in these patients. 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 age ≥ 80 years or have 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. 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 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. Administration 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 the normal range or total bilirubin levels at least 1.5 times the upper limit of the normal range 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 cannot 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 an anticoagulant that prevents excessive blood clotting and is used in the prevention and treatment of thrombosis. During the use of this medication, careful monitoring for bleeding symptoms is required. If there is a high risk of bleeding or if bleeding has already occurred, the use of this drug should be discontinued. It should not be administered to patients with allergy reactions to this drug or current severe bleeding, patients with blood clotting disorders, or those with liver diseases that have a high risk of bleeding. Patients with a history of gastrointestinal ulcers, intracranial hemorrhage, brain or spinal surgery, esophageal varices, or vascular abnormalities should also avoid using this medication. Caution is necessary if used together with other anticoagulants, as this may increase the risk of bleeding, and it should not be administered to certain genetically lactose-intolerant patients. Caution is advised for patients with severely impaired kidney function or liver function, and when used concomitantly with certain antidepressants or anti-inflammatory drugs, as this may increase the risk of bleeding. Elderly patients or those with very low body weight, and patients receiving spinal or epidural anesthesia should be particularly careful as there is a risk of nerve damage when using this medication. For cancer patients, due to the higher risks of bleeding and thrombosis, a thorough assessment is required before using this drug. Varied bleeding-related side effects such as bleeding, bruising, nosebleeds, and hematomas are common, while severe bleeding or allergic reactions can occur in rare cases. Prior to undergoing surgery or invasive procedures, this medication should be discontinued for a certain period to reduce the risk of bleeding, and upon cessation, the risk of thrombosis may increase, so it should be resumed as soon as possible. There are many drugs that interact with this medication, so it is essential to consult with healthcare professionals about all medications taken together, especially if using strong CYP3A4 and P-gp inhibitors or inducers. The use of this drug is not recommended for pregnant or breastfeeding women, and safety and efficacy in pediatric patients have not been established. This medication does not significantly impact driving or machinery operation but caution is advisable in the presence of bleeding symptoms. In case of overdose, the risk of bleeding significantly increases, so it is necessary to stop taking it immediately and visit a medical facility; appropriate treatment may be required.

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

This medication can be sensitive to air or moisture, so it must be stored in a tightly closed container. It should be kept at room temperature between 1°C and 30°C, away from excessively cold or hot conditions.

Appearance

Light yellow round film-coated tablet

Package unit

60 tablets/PTP (10 tablets/PTP × 6)