Limited Use Note(s)

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APIXABAN5mg Tab
Reason For Use CodeClinical Criteria
448INCLUSION CRITERIA: At risk patients with non-valvular atrial fibrillation, for the prevention of stroke and systemic embolism AND in whom: 1. Anticoagulation is inadequate following at least a 2-month trial on warfarin; OR 2. Anticoagulation using warfarin is contraindicated or not possible due to inability to regularly monitor the patient via International Normalized Ratio (INR) testing (i.e. no access to INR testing services at a laboratory, clinic, pharmacy, and at home) EXCLUSION CRITERIA: 1. Patients with impaired renal function (creatinine clearance or estimated glomerular filtration rate less than 25mL per min); OR 2. Patients who are greater than or equal to 75 years of age and who do not have documented stable renal function; OR 3. Patients who have hemodynamically significant rheumatoid valvular heart disease (especially mitral stenosis); OR 4. Patients who have prosthetic heart valves. NOTES: At-risk patients with atrial fibrillation are defined as those with a CHADS2 score of greater than or equal to 1. Prescribers may consider an antiplatelet regimen or oral anticoagulation for patients with a CHADS2 score of 1. Inadequate anticoagulation is defined as INR testing results that are outside the desired INR range for at least 35% of the tests during the monitoring period (i.e., adequate anticoagulation is defined as INR test results that are within the desired INR range for at least 65% of the tests during the monitoring period). Documented stable renal function is defined as creatinine clearance or estimated glomerular filtration rate maintained for at least 3 months. DOSING: the usual recommended dose is 5mg twice daily; a reduced dose of apixaban 2.5mg twice daily is recommended for patients with at least two (2) of the following: age greater than or equal to 80 years old, body weight less than or equal to 60kg, or serum creatinine greater than or equal to 133 micromole per litre. Since renal impairment can increase bleeding risk, renal function should be regularly monitored. Other factors that increase bleeding risk should also be assessed and monitored (see apixaban product monograph). Patients starting apixaban should have ready access to appropriate medical services to manage a major bleeding event. There is currently no data to support that apixaban provides adequate anticoagulation in patients with rheumatic valvular disease or those with prosthetic heart valves. As a result, apixaban is not recommended for these patient populations.
LU Authorization Period: Indefinite.
444For the treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) for up to six (6) months.
LU Authorization Period: 6 Months.
NOTE: - The recommended dose of apixaban for patients initiating DVT or PE treatment is 10 mg twice daily for 7 days, followed by 5 mg twice daily. - ODB Program coverage for apixaban is an alternative to heparin/warfarin for up to 6 months. When used for greater than 6 months, apixaban is more costly than heparin/warfarin. As such, patients with an intended duration of therapy greater than 6 months should be considered for initiation on heparin/warfarin. - For clarity, coverage will not be provided for patients who have already received 6 months of treatment with rivaroxaban for the same DVT or PE. - Since renal impairment can increase bleeding risk, it is important to monitor renal function regularly. Other factors that increase bleeding risks should also be assessed and monitored (see product monograph).