Recommended dosage: Prevention of VTE: elective hip or knee replacement surgery: The recommended dose of apixaban is 2.5 mg taken orally twice daily. The initial dose should be taken 12 to 24 hours after surgery.
In patients undergoing hip replacement surgery, the recommended duration of treatment is 32 to 38 days.
In patients undergoing knee replacement surgery, the recommended duration of treatment is 10 to 14 days.
Prevention of stroke and systemic embolism: NVAF: The recommended dose of Apixaban is 5 mg taken orally twice daily.
Age, body weight, serum creatinine: In patients with at least 2 of the following characteristics, age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL (133 micromole/L), the recommended dose of Apixaban is 2.5 mg twice daily.
Treatment of DVT and PE: The recommended dose of Apixaban is 10 mg taken orally twice daily for 7 days, followed by 5 mg taken orally twice daily.
Prevention of recurrent DVT and PE: The recommended dose of Apixaban is 2.5 mg taken orally twice daily after at least 6 months of treatment for DVT or PE.
Renal impairment: In patients with mild or moderate renal impairment, the following recommendations apply: for the treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTEt), no dose adjustment is necessary (see Pharmacology: Pharmacokinetics under Actions); for the prevention of stroke and systemic embolism in patients with NVAF and serum creatinine ≥1.5 mg/dL (133 micromole/L) associated with age ≥80 years or body weight ≤60 kg, a dose reduction is necessary and described previously. In the absence of other criteria for dose reduction (age, body weight), no dose adjustment is necessary (see Pharmacology: Pharmacokinetics under Actions).
In patients with severe renal impairment (creatinine clearance 15-29 mL/min) the following recommendations apply (see Precautions and Pharmacology: Pharmacokinetics under Actions): for the treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTEt) apixaban is to be used with caution; for the prevention of stroke and systemic embolism in patients with NVAF, patients should receive the lower dose of apixaban 2.5 mg twice daily.
In patients with creatinine clearance <15 mL/min, or in patients undergoing dialysis, there is no clinical experience therefore apixaban is not recommended (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: Apixaban may be used with caution in patients with mild or moderate hepatic impairment (Child Pugh A or B). No dose adjustment is required in patients with mild or moderate hepatic impairment (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Body weight: Prevention of VTE: elective hip or knee replacement surgery: No dose adjustment required (see Pharmacology: Pharmacokinetics under Actions).
Prevention of stroke and systemic embolism: NVAF: No dose adjustment required (see Pharmacology: Pharmacokinetics under Actions).
Treatment of VTE: No dose adjustment required (see Pharmacology: Pharmacokinetics under Actions).
Gender: No dose adjustment required (see Pharmacology: Pharmacokinetics under Actions).
Pediatric and adolescent: The efficacy and safety of Apixaban in children below age 18 have not been established. No data are available.
Elderly: Prevention of VTE: elective hip or knee replacement surgery: No dose adjustment required (see Pharmacology: Pharmacokinetics under Actions).
Prevention of stroke and systemic embolism: NVAF: See Recommended dosage as previously mentioned.
Treatment of VTE: No dose adjustment required (see Pharmacology: Pharmacokinetics under Actions).
Converting from or to parenteral anticoagulants: In general, switching treatment from parenteral anticoagulants to Apixaban (and vice versa) can be done at the next scheduled dose.
Converting from or to warfarin or other vitamin K antagonist (VKA): When converting patients from warfarin or other VKA therapy to apixaban, discontinued warfarin or other VKA therapy and start apixaban when the international normalized ratio (INR) is below 2.0.
When converting patients from apixaban to warfarin or other VKA therapy, continue Apixaban for 48 hour after the first dose of warfarin or other VKA therapy.
Surgery and invasive procedures: Apixaban should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. Apixaban should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be non-critical in location and easily controlled. If surgery or invasive procedures cannot be delayed, exercise appropriate caution taking into consideration an increased risk of bleeding. This risk of bleeding should be weighed against the urgency of intervention. In non-valvular atrial fibrillation patients, bridging anticoagulation during the 24 to 48 hours after stopping Apixaban and prior to the intervention is not generally required. Apixaban should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established.
Apixaban can be initiated or continued in NVAF patients who may require cardioversion.
For patients not previously treated with anticoagulants, at least 5 doses of Apixaban 5 mg twice daily [2.5 mg twice daily in patients who qualify for a dose reduction (see Recommended dosage as previously mentioned)] should be given before cardioversion to ensure adequate anticoagulation (see Pharmacology: Pharmacodynamics under Actions).
If cardioversion is required before 5 doses of apixaban can be administered, a 10 mg loading dose should be given, followed by 5 mg twice daily. The dosing regimen should be reduced to a 5 mg loading dose followed by 2.5 mg twice daily if the patient meets the criteria for dose reduction (see Renal impairment as previously mentioned). The administration of the loading dose should be given at least 2 hours before cardioversion (see Pharmacology: Pharmacodynamics under Actions).
Confirmation should be sought prior to cardioversion that the patient has taken apixaban as prescribed. Decisions on initiation and duration of treatment should take established guideline recommendations for anticoagulant treatment in patients undergoing cardioversion into account.
Method of administration: Oral use.
Apixaban should be swallowed with water, with or without food.
Missed dose: If a dose is missed, the patient should take apixaban immediately and then continue with twice daily administration as before.
For patients who are unable to swallow whole tablets, Apixaban tablets may be crushed and suspended in water, or 5% glucose in water (G5W), or apple juice or mixed with applesauce and immediately administered orally (see Pharmacology: Pharmacokinetics under Actions). Alternatively, Apixaban tablets may be crushed and suspended in 60 mL of water or D5W and immediately delivered through a nasogastric tube (see Pharmacology: Pharmacokinetics under Actions). Crushed Apixaban tablets are stable in water, D5W, apple juice, and applesauce for up to 4 hours.
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