JERICRABAN 5mg (Apixaban)

Adult dose

This medicine may be taken with water, with or without food. If a 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 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 the concomitant administration of the recommended dose of this medicine and 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’ 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, and it should be administered after completion of at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching between 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 scheduled dose. 1) Switching from vitamin K antagonist treatment to this medicine To switch 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) is less than 2.0. 2) Switching from this medicine to vitamin K antagonist treatment To switch 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 concomitant treatment with this medicine and the vitamin K antagonist, perform an INR test immediately 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 a creatinine clearance of 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 surgery No dose adjustment is required 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 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 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. 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 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. 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 these patients. Liver function tests should be performed before starting treatment with this medicine. 5. Patients who cannot 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 used to prevent or treat thrombus formation by inhibiting blood coagulation. However, during the course of treatment, bleeding may occur, so it is important to closely monitor for signs of bleeding. If severe bleeding occurs, the medication should be stopped immediately and medical advice should be sought. This medication is not to be administered to patients at high risk of certain bleeding or those with blood coagulation disorders. Additionally, it should be used cautiously in patients with severe liver or kidney dysfunction, and caution is needed when combined with other medications that may increase bleeding risk. In particular, there may be an increased risk of bleeding when taken together with non-steroidal anti-inflammatory drugs, some antidepressants, or antiplatelet agents. If surgery or invasive procedures are to be performed, this medication should be stopped at least 24–48 hours prior to the procedure and resumed only after confirming the bleeding risk and hemostatic status following the procedure. The use of this medication is not recommended during pregnancy or breastfeeding, and safety in children has not been established. In case of overdose, the risk of bleeding can significantly increase, so the prescribed dosage must be strictly followed. Moreover, this medication may interact with other drugs that inhibit or induce specific enzymes, so patients should inform their healthcare provider of any other medications they are taking. Finally, while taking this medication, patients should carefully monitor for symptoms of bleeding or neurological abnormalities (e.g., tingling in the legs, muscle weakness, etc.), and seek immediate medical attention if such signs appear.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. It is best to store the medication at room temperature between 1°C and 30°C. This way, the efficacy of the medication can be maintained for a longer period.

Appearance

Pink, oval, film-coated tablets that are biconvex on both sides

Package unit

60 tablets (10 tablets/PTP x 6)