Risk for recurrent venous thromboembolism reduced for patients with isolated distal DVT receiving six additional weeks of rivaroxaban
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Apixaban and rivaroxaban are both factor Xa inhibitors.
Among new users, rates of recurrent venous thromboembolism, GI and intracranial bleeding lower with apixaban than rivaroxaban
Compared with other DOACs, rivaroxaban linked to higher rates of GI bleeding overall and in an analysis restricted to patients with atrial fibrillation
The phase 3 UNIVERSE study evaluated rivaroxaban oral suspension in patients aged 2 to 8 years with single ventricle physiology who had the Fontan procedure.
The NDA submission is supported by data from the phase 3 EINSTEIN-Jr and UNIVERSE trials in pediatric patients, along with adequate and well-controlled studies in adults.
The application is supported by data from the double-blind, placebo-controlled phase 3 VOYAGER PAD trial.
Xarelto, a Factor Xa inhibitor, is currently indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
The FDA has approved the supplemental New Drug Application for Xarelto (rivaroxaban; Janssen) to include updated information for patients with prosthetic heart valves.
Lower rates seen for ischemic stroke or systemic embolism, GI bleeding or intracranial hemorrhage.