XALIQUIS can be taken with or without food.
if a dose is missed, the patient should take XALIQUIS immediately and then continue with twice daily intake as before.
Posology: Prevention of VTE: elective hip or knee replacement surgery: The recommended dose of Xaliquis 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 in patients with NVAF: The recommended dose of XALIQUIS is 5 mg taken orally twice daily.
Dose reduction: The recommended dose of XALIQUIS is 2.5 mg taken orally twice daily in patients with NVAF and at least two of the following characteristics: age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL (133 micromole/L).
Therapy should be continued long-term.
Treatment of DVT and PE: The recommended dose of XALIQUIS is 10 mg (2 x 5 mg) taken orally twice daily for 7 days, followed by 5 mg taken orally twice daily for a maximum of 6 months.
Prevention of recurrent DVT and PE: The recommended dose of XALIQUIS is 2.5 mg taken orally twice daily. When prevention of recurrent DVT and PE is indicated, the 2.5 mg twice daily dose should be initiated following completion of 6 months of treatment for DVT or PE. The maximum duration of prevention of recurrent DVT and/or PE is 12 months.
Renal impairment: Prevention of VTE: elective hip or knee replacement surgery: No dose adjustment is necessary in patients with mild, moderate or severe (creatinine clearance 15-29 mL/min) renal impairment (see Pharmacology: Pharmacodynamics under Actions). Because there is limited clinical experience in patients with creatinine clearance <15 mL/min and no data in patients undergoing dialysis, apixaban is not recommended in these patients.
Prevention of stroke: NVAF: No dose adjustment is necessary in patients with mild or moderate renal impairment (see Pharmacology: Pharmacodynamics under Actions).
In patients with severe renal impairment (creatinine clearance 15-29 mL/min) the following recommendations apply (see Precautions and Pharmacology: Pharmacodynamics under Actions): Patients should receive the lower dose of apixaban 2.5 mg twice daily.
Patients with serum creatinine ≥1.5 mg/dL (133 micromole/L) associated with age ≥80 years or body weight ≤60 kg should also 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: Pharmacodynamics under Actions).
Treatment of VTE: No dose adjustment is necessary in patients with mild, moderate, or severe (creatinine clearance 15-29 mL/min) renal impairment (see Pharmacology: Pharmacodynamics under Actions). Because there is limited clinical experience in patients with creatinine clearance <15 mL/min and no data in patients undergoing dialysis, apixaban is not recommended in these patients.
Hepatic impairment: No dose adjustment is required in patients with mild or moderate hepatic impairment.
XALIQUIS is not recommended in patients with severe hepatic impairment.
Body weight: Prevention of VTE: elective hip or knee replacement surgery: No dose adjustment required.
Treatment of VTE: No dose adjustment required.
Prevention of stroke: NVAF: No dose adjustment required, unless criteria for dose reduction are met (see Dose reduction as previously mentioned).
Gender: No dose adjustment required.
Paediatric and adolescent: The safety and efficacy of XALIQUIS in children below age 18 have not yet been established. No data are available.
Elderly: Prevention of VTE: elective hip or knee replacement surgery: No dose adjustment required.
Prevention of stroke NVAF: No dose adjustment required, unless criteria for dose reduction are met (see Dose reduction as previously mentioned).
Cardioversion (NVAF): XALIQUIS 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 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 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.
Treatment of VTE: No dose adjustment required.
Converting from or to parental anticoagulants: In general, switching treatment from parenteral anticoagulants to XALIQUIS (and vice versa) can be done at the next scheduled dose.
Converting from or to warfarin or other vitamin K antagonists (VKA): When converting patients from warfarin or other VKA therapy to XALIQUIS, discontinue warfarin or other VKA therapy and start XALIQUIS when the international normalized ratio (INR) is below 2.0.
When converting from XALIQUIS to warfarin or other VKA therapy, continue XALIQUIS for 48 hours after the first dose of warfarin or other VKA therapy.
Surgery and invasive procedures: XALIQUIS 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. XALIQUIS 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 XALIQUIS and prior to the intervention is not generally required. XALIQUIS should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established.
Patients can continue taking XALIQUIS while being cardioverted.
For patients who are unable to swallow whole tablets, XALIQUIS tablets may be crushed and suspended in water and promptly administered orally. Alternatively, XALIQUIS tablets may be crushed and suspended in 60 mL of water promptly delivered through a nasogastric tube (see Pharmacology: Pharmacodynamics under Actions).
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