Limited coverage drugs – rivaroxaban for VTE prophylaxis
|
Generic name |
rivaroxaban | |
|---|---|---|
|
Strength |
10 mg | |
| Form | tablet | |
| Special Authority criteria | Approval period |
|---|---|
| For prophylaxis of VTE following elective total hip replacement surgery or elective total knee replacement surgery.3,4 | Following elective total hip replacement: Up to a maximum of 35 days1,2
Following elective total knee replacement: Up to a maximum of 14 days1,2 |
Practitioner exemptions
- A Collaborative Prescribing Agreement (rivaroxaban 10 mg)(PDF) is available to a limited number of practitioners in the orthopaedic surgery specialty.
- PharmaCare coverage is subject to the patient's PharmaCare plan rules, including any annual deductible requirement.
Special notes
- The duration of therapy includes the period during which doses are administered post-operatively in an acute care (hospital) setting. The PharmaCare approval period is for the balance of the total duration after discharge.
- The first dose is typically administered 6 to 8 hours after surgery, assuming adequate hemostasis has been achieved.
- The RECORD clinical trial program did not evaluate the efficacy or safety of sequential use of a low molecular weight heparin followed by rivaroxaban for prophylaxis of VTE. Due to the current lack of evidence for sequential use, PharmaCare coverage is not intended for this practice.
- Clinical judgment is warranted to assess the increased risk for VTE and/or adverse effects in patients with a history of previous VTE, myocardial infarction, transient ischemic attack or ischemic stroke; a history of intraocular or intracerebral bleeding; a history of gastrointestinal disease with gastrointestinal bleeding; moderate or severe renal insufficiency; severe liver disease; concurrent use of other anticoagulants; or age greater than 75 years.
Special Authority requests
PharmaCare coverage of rivaroxaban for the post-operative prophylaxis of VTE is only available with a valid Collaborative Prescribing Agreement (rivaroxaban 10 mg)(PDF). Special Authority request forms are not needed and will not be accepted.
