Antisaban 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 immediately and continue taking it twice daily as before. 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, 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 medicinal products affecting 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 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, 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 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, International Normalized Ratio) 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 this medicine for 2 days after starting the vitamin K antagonist. After 2 days of coadministration of this medicine and the vitamin K antagonist, measure the INR just before the scheduled dose of this medicine, and continue coadministration of this medicine and the vitamin K antagonist until the INR is 2.0 or higher. 3. Renal impairment Because there is no clinical experience in patients receiving 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 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 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 take 2.5 mg of this medicine twice daily. Patients with severe renal impairment (creatinine clearance 15-29 mL/min) should take 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 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 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 these 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 liquid 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 inhibiting clot formation. During the use of this medication, the possibility of bleeding may arise, so careful observation for signs of bleeding is necessary. If severe bleeding occurs, the use of this medication should be stopped immediately, and appropriate treatment should be administered if necessary. This medication should not be administered to patients with certain diseases or conditions, such as those with severe bleeding or very poor liver function, or those who have recently had a brain hemorrhage or gastrointestinal ulcer. Additionally, this medication should not be used in conjunction with other anticoagulants due to the significantly increased risk of bleeding. Caution should be exercised when using this medication in patients with severely impaired kidney function or slightly impaired liver function. This medication may increase the risk of bleeding when used together with certain antidepressants or non-steroidal anti-inflammatory drugs, so caution is needed. Particularly in the elderly or underweight patients, the risk of bleeding may be higher, so they should be careful. Patients undergoing spinal or epidural anesthesia should be extremely cautious as this medication can cause serious nerve damage. This medication is not recommended for pregnant or breastfeeding women, and its safety in children has not been established. If any surgical or invasive procedures are planned during the use of this medication, intake should be stopped for a certain period prior to reduce the risk of bleeding. The effect of this medication may increase or decrease depending on other medications taken alongside; therefore, patients should inform their healthcare provider of all medications they are taking. In case of overdose, there is a significantly increased risk of bleeding, and immediate consultation with healthcare providers and necessary measures should be taken. This medication does not significantly impact driving or operation of machinery, but caution should be exercised if any abnormal symptoms such as bleeding occur. Common adverse reactions during the use of this medication include bleeding, bruising, nosebleeds, hematomas, anemia, thrombocytopenia, hypersensitivity, allergic edema, nausea, skin rashes, muscle bleeding, hematuria, abnormal vaginal bleeding, genitourinary bleeding, injection site bleeding, positive fecal occult blood, post-procedural bleeding, traumatic bleeding, vomiting, colitis, diarrhea, esophagitis, benign gastrointestinal neoplasm, gastroesophageal reflux, gastritis, hemorrhoidal bleeding, gum bleeding, bloody stools, rectal bleeding, anal fissures, constipation.

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

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the medication's effectiveness for a long time.

Appearance

Pink, oval-shaped, biconvex film-coated tablets

Package unit

60 tablets/bottle, 30 tablets/bottle, 60 tablets/PTP [(10 tablets/PTP x 6)]