Aquis Tablet 5 mg (Apixaban)

Adult dose

This medicine should be taken with water, with or without food. If a patient misses a dose, they should take this medicine as soon as possible 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 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 is 32 ~ 38 days. The recommended duration of treatment for patients who have undergone knee replacement 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 concomitant administration of the recommended dose of this medicine with an antiplatelet agent after hemostasis has been achieved in patients with nonvalvular atrial fibrillation undergoing treatment for acute coronary syndrome and/or 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 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, 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 parenteral anticoagulant therapy, the switch may 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 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 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 less than 15 mL/min, administration of this medicine is not recommended. 1) Prevention of venous thromboembolism in adult patients who have undergone hip or knee replacement 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 this medicine at 2.5 mg twice daily. Patients with severe renal impairment (creatinine clearance 15-29 mL/min) should receive this medicine at 2.5 mg 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 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 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 such patients. Liver function tests should be performed before starting 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 medication is used to prevent or treat excessive blood clotting. During treatment, bleeding may occur, so careful observation for signs of bleeding is necessary. Particularly in patients at high risk for bleeding, it should be administered with caution. If severe bleeding occurs, administration of this drug should be discontinued immediately, and appropriate treatment should be provided if necessary. This medication should not be given to certain patients. For example, patients with hypersensitivity to this medication, those with active bleeding, or patients with bleeding disorders or high-risk liver disease should not use this drug. Additionally, patients with a history of gastrointestinal ulcers or intracranial hemorrhage, those who have undergone spinal or brain surgery, or patients with malignancies high in bleeding risk may also be at risk if they take this medication. Except in special cases, it should not be used in combination with other anticoagulants. Because this medication contains lactose, it is not prescribed to patients with lactose intolerance or related genetic disorders. In patients with significantly impaired renal function or mild hepatic impairment, the blood concentration of this medication may increase, so caution should be exercised in administration. Additionally, caution should be taken when used with certain antidepressants, NSAIDs, or acetylsalicylic acid, as the risk of bleeding may increase. Elderly patients or those with low body weight may also be at increased risk of bleeding, so it should be used with caution. Patients undergoing spinal or epidural anesthesia or spinal puncture are at risk of serious neurological injury associated with this medication's administration, so special caution is needed. The safety and efficacy of this drug have not been established in patients requiring thrombolysis or pulmonary embolism removal, so it is not recommended. In cancer patients, both bleeding and thrombotic risks are elevated; thus, the risks and benefits of this medication should be carefully evaluated before use. The most common side effect of this drug is bleeding, which may include nosebleeds, bruising, and hematomas. Rarely, other side effects such as abnormal liver function, allergic reactions, or neurological issues may occur, so immediate consultation with healthcare professionals is necessary if unusual symptoms arise. This drug may interact with other medications; therefore, caution is needed, especially when used with strong CYP3A4 and P-gp inhibitors or inducers, anticoagulants, antiplatelet agents, certain antidepressants, and NSAIDs. Use of this drug is not recommended in pregnant or nursing women, and breastfeeding should be discontinued if this medication is used. Safety and efficacy in pediatric patients have not been established, so it should not be used in children. Before undergoing surgery or invasive procedures, this medication should be discontinued for a certain period to reduce bleeding risk, and after the procedure, it should be resumed as soon as the patient's condition stabilizes. In cases of overdose, the risk of bleeding significantly increases, so immediate notification to healthcare professionals is required, and because there is no antidote for this medication, appropriate hemostatic treatment may be necessary. Regular monitoring and symptom observation are important during treatment to reduce the risk of bleeding.

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

This medication should be stored in a sealed container as it may be sensitive to air and moisture. It is important to store it at room temperature, between 1 to 30 degrees Celsius, to maintain its effectiveness.

Appearance

Pink, egg-shaped, biconvex film-coated tablet

Package unit

60 tablets/PTP [10 tablets/PTP × 6]