Limited Coverage Drugs - Rivaroxaban for atrial fibrillation (AF)
|rivaroxaban for atrial fibrillation (AF)|
|15 mg and 20 mg|
|Special Authority Criteria||Approval Period|
At-risk patients with non-valvular AFi, for the prevention of stroke and systemic embolism AND:
1. anticoagulation is inadequateii following at least a 2-month trial of warfarin
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).
1. patients with impaired renal function (creatinine clearance or estimated glomerular filtration rate < 30 mL/min)
2. patients who are ≥ 75 years of age and who do not have documented stable renal functioniii
3. patients who have hemodynamically significant rheumatic valvular heart disease (especially mitral stenosis)
4. patients who have prosthetic heart valves.
- Since renal impairment can increase bleeding risk, it is important to monitor renal functioning regularly. Other factors that increase bleeding risk should also be assessed and monitored (see rivaroxaban product monograph).
- Patients starting rivaroxaban for AF should have ready access to appropriate medical services to manage a major bleeding event.
- There is currently no data to support that rivaroxaban for AF provides adequate anticoagulation in patients with rheumatic valvular disease or those with prosthetic heart valves. As a result, rivaroxaban for AF is not recommended for these patient populations.
- Information for Patients–Oral Anticoagulants in Atrial Fibrillation (PDF)
- Information for Prescribers–Rivaroxaban in Atrial Fibrillation (PDF)