Apixaban 5 mg Tablet (Apixaban)

Adult dose

This medicine should be taken with water, with or without food. If a patient forgets to take 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 surgery The recommended dose is 2.5 mg of this medicine taken orally twice daily. The initial dose should be administered 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, 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 twice daily orally. 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 treatment to this medicine or from this medicine to a parenteral anticoagulant, the switch can be made at the time of the next dose. 1) Switching from vitamin K antagonist treatment to this medicine When switching from vitamin K antagonist treatment to this medicine, discontinue warfarin or other vitamin K antagonist treatment and start this medicine when the International Normalized Ratio (INR, International Normalized Ratio) is less than 2.0. 2) Switching from this medicine to vitamin K antagonist treatment When switching from this medicine to vitamin K antagonist treatment, continue taking this medicine for 2 days after starting the vitamin K antagonist. After 2 days of combined treatment with this medicine and a vitamin K antagonist, measure the INR immediately before the scheduled dose of this medicine, and continue combined 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, 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 required 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 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 required 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 required 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 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 required 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 such patients. Liver function tests should be performed before starting treatment with this medicine. 5. 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.

While taking this medication, patients must carefully monitor for signs of bleeding. Special caution should be taken in situations with a high risk of bleeding, and if severe bleeding occurs, the use of this medication should be discontinued immediately. As this medication is an anticoagulant, there is a possibility of bleeding; thus, if bleeding symptoms appear, one should promptly consult a healthcare provider. This medication should not be administered to certain patients. For instance, it should not be used in patients with an allergy to this medication or its components, those with current severe bleeding, or patients with clotting issues or liver disease with a high risk of bleeding. Additionally, patients who have recently undergone gastrointestinal ulcers, intracranial hemorrhage, brain or spinal surgery, or have specific diseases with a high risk of bleeding should also refrain from using this medication. Patients with severely impaired renal function or slightly impaired liver function should use this medication with caution. Especially in elderly patients, patients with low body weight, or those taking anti-inflammatory medications like acetylsalicylic acid, the risk of bleeding may be heightened and caution is advised. Patients receiving spinal or epidural anesthesia or undergoing spinal puncture are at risk of nerve damage when taking this medication, necessitating strict monitoring by healthcare providers. The timing of catheter removal or insertion should be adjusted carefully before and after administration of this medication, and immediate treatment is required if neurological symptoms arise. Reports of side effects such as bleeding, bruising, nosebleeds, hematomas and others have been noted in clinical trials. Bleeding is the most common side effect while taking this medication; if there is severe or abnormal bleeding, healthcare providers should be notified without delay. The risk of bleeding may increase when this medication is taken with other anticoagulants; thus, particularly in conjunction with antiplatelet agents or non-steroidal anti-inflammatory drugs, a careful assessment of risks and benefits should be discussed with a healthcare provider. If surgery or invasive procedures are planned, discontinuation of this medication should occur at least 24 to 48 hours beforehand to reduce the risk of bleeding. After the procedure, it should not be resumed until the bleeding risk has subsided and hemostasis has been achieved. Women who are pregnant or breastfeeding are advised against taking this medication. This is especially concerning for breastfeeding women since this medication can be excreted in breast milk, potentially affecting the infant, and consultation with a healthcare provider is mandatory regarding its use. The safety and efficacy of this medication in children have not been sufficiently established; hence its use in the pediatric population is not recommended. This medication can interact with drugs that affect specific liver enzymes and proteins, so it is essential to inform healthcare providers of any concurrent medications for careful co-administration. In case of overdose, the risk of bleeding significantly increases, and it is crucial to immediately stop the medication and seek medical treatment. As there is no specific antidote, appropriate hemostatic treatment may be required in case of severe bleeding.

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

This medication may be sensitive to air or humidity; therefore, it should be stored in a tightly sealed container. It is advised to maintain a storage temperature in the range of 1 to 30 degrees Celsius. This helps safely preserve the effectiveness of the medication.

Appearance

Pink, oval-shaped, convex film-coated tablet

Package unit

60 tablets/PTP [10 tablets/PTP x 6]