Apixaban 2.5 mg (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 is 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. There is limited experience with coadministration 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 undergo percutaneous coronary intervention. (See “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 completing at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching treatment 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 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 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, 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. Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), the blood concentration of this medicine was 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 age ≥ 80 years or weigh ≤ 60kg should receive this medicine at a dose of 2.5 mg twice daily. Patients with severe renal impairment (creatinine clearance 15-29 mL/min) should receive this medicine at a dose of 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. Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), the blood concentration of this medicine was 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 greater than 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. 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 drink such as applesauce, and administered orally. 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 blood clots by preventing excessive blood coagulation. While taking this drug, one should monitor for signs of bleeding carefully, as bleeding can occur. If severe bleeding occurs, this medicine should be discontinued immediately, and appropriate measures should be taken in consultation with healthcare professionals. It is not safe to administer this drug to patients with certain diseases or conditions. For example, patients with severe bleeding, issues with blood coagulation, severely impaired liver function, or a recent history of intracranial hemorrhage or gastrointestinal ulcers may be at risk with its use. In addition, the risk of bleeding may increase when this drug is used in combination with other anticoagulants, so co-administration should be avoided. Caution should be exercised when using this medicine in patients with very poor renal function or slightly impaired liver function. Particularly in the elderly or those with low body weight, and when taken together with certain antidepressants or nonsteroidal anti-inflammatory drugs (NSAIDs), the risk of bleeding may increase. Patients receiving spinal or epidural anesthesia should consult healthcare professionals because there is a risk of developing an epidural or spinal hematoma while taking this medication. Careful evaluation is needed for the use of this medicine in cancer patients or those with certain thrombosis. This drug may have various side effects, the most common being bleeding, bruising, nosebleeds, and hematomas. If symptoms of bleeding or adverse reactions occur, notify healthcare professionals immediately. Interactions with other medications may occur, so all medications being taken should be disclosed to healthcare professionals, and the medicine should be taken according to their advice. Special caution is needed when taking this medicine with certain antifungal agents, antiviral agents, anticoagulants, antiplatelet agents, and NSAIDs. It is recommended that women who are pregnant or breastfeeding should not take this medicine, and breastfeeding should be discontinued if taken. Safety in pediatric patients has not been established, therefore it should not be used in children. The use of this drug should be discontinued before surgery or invasive procedures for a certain period and resumed only when the risk of bleeding post-surgery decreases. Overdosage significantly increases the risk of bleeding, so the dosage should be adhered to precisely, and in case of overdose, healthcare providers should be contacted immediately. This drug does not significantly affect driving or operating machinery; however, caution is necessary due to the risk of bleeding.

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

This medicine should be stored in a tightly closed container protected from air and moisture, and it is best to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness for a longer period.

Appearance

Yellow round film-coated tablet

Package unit

60 tablets/box [10 tablets/PTP × 6]