The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Xarelto (rivaroxaban; Janssen) to include updated information for patients with prosthetic heart valves.
The Warnings & Precautions section now includes information from the multicenter, open-label, active-controlled, phase 3 GALILEO study that compared a Xarelto-based anticoagulation strategy with an antiplatelet-based strategy following successful transcatheter aortic valve replacement (TAVR). The co-primary end points were the number of patients with death or first thromboembolic event, as well as primary bleeding event.
Findings from the study showed that patients treated with Xarelto experienced higher rates of death and bleeding compared with those randomized to an antiplatelet regimen. The safety and efficacy of Xarelto have not been studied in patients with other prosthetic heart valves or other valve procedures. The use of Xarelto is not recommended in patients with prosthetic heart valves.
Xarelto, a Factor Xa inhibitor, is currently indicated to treat deep vein thrombosis (DVT) and pulmonary embolism (PE), for the reduction of the risk of recurrent DVT/PE, and for primary prevention of DVT, which may lead to PE, in patients who have just had hip or knee replacement. It is also approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, and for use in combination with aspirin, to reduce the risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke) in patients with chronic coronary artery disease or peripheral artery disease.
Xarelto is also approved for the prophylaxis of venous thromboembolism (VTE) and VTE-related death during hospitalization and post hospital discharge in adult patients admitted for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE and not at high risk of bleeding.
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