Havixaban Tablet 2.5 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 then 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 taken 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 in 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 and an antiplatelet agent, after hemostasis has been achieved, in patients with nonvalvular atrial fibrillation accompanied by 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 in 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 in the risk of recurrence of deep vein thrombosis and pulmonary embolism The recommended dose is 2.5mg of this medicine taken orally twice daily, to 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 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 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 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 Administration of this medicine is not recommended in patients receiving dialysis or with a creatinine clearance of less than 15 mL/min, because there is no clinical experience in these patients. 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 in 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 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 in 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. 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 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 thrombus formation by inhibiting blood coagulation. During treatment, bleeding may occur, so careful monitoring for signs of bleeding is required. If severe bleeding occurs, discontinue the medication immediately and consult a doctor. Patients with an allergy to this medication, those currently experiencing severe bleeding, or patients with hepatic disorders that affect blood coagulation should not take this medication. Patients with a recent history of gastrointestinal ulcers, intracranial hemorrhage, spinal or brain surgery, brain or spinal injury, esophageal varices, vascular malformations, or those with a high risk of bleeding due to cancer should also avoid this medication. Additionally, caution is advised when taken with other anticoagulants as this may increase risks. Patients with genetic issues such as lactose intolerance should not take this medication. Patients with severe renal disease or compromised liver function may experience higher concentrations of this medication, so use with caution is advised. In particular, there is an increased risk of bleeding when taken with selective serotonin reuptake inhibitors, non-steroidal anti-inflammatory drugs, or acetylsalicylic acid. Elderly patients or those with low body weight also face a higher risk of bleeding, so caution is warranted. Patients undergoing spinal or epidural anesthesia may experience serious neurological damage from this medication and should always consult medical professionals prior to use. Common side effects include bleeding, bruising, nosebleeds, hematoma, anemia, thrombocytopenia, hypersensitivity, allergic edema, ocular hemorrhage, hypotension, epistaxis, hemoptysis, nausea, gastrointestinal bleeding, hemorrhoidal bleeding, bloody stools, rectal bleeding, gum bleeding, increased transaminases, skin rash, muscle bleeding, hematuria, abnormal vaginal bleeding, bleeding at the injection site, positive occult blood, visual disturbances, conjunctivitis, eating disorders, insomnia, drowsiness, headaches, dizziness, and pruritus. Before undergoing surgery or invasive procedures, this medication should be discontinued for a specific period, and after the procedure, it should be resumed considering the risk of bleeding and need for treatment. Use during pregnancy or breastfeeding is not recommended, and breastfeeding should be ceased or the medication discontinued during lactation. The safety and efficacy of this medication for children have not been sufficiently confirmed. There may be interactions with other medications, so if you are taking other medications, it is essential to inform your doctor or pharmacist. Overdose significantly increases the risk of bleeding, so immediate medical attention should be sought for appropriate treatment. There is no antidote for this medication, so professional treatment is necessary in cases of severe bleeding.

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

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture, and it is advisable to keep it at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness and prevent deterioration.

Appearance

Yellow round film-coated tablet

Package unit

60 tablets (10 tablets/PTPX6)