Medication Monitor



Generic Name (Trade Name—Company)
Notes
October 31, 2019

Rivaroxaban

(Xarelto—Janssen)
Rivaroxaban approved to prevent VTE in acutely ill medical patients

FDA has approved rivaroxaban to prevent venous thromboembolism (VTE), or blood clots, in hospitalized, acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding.

The recommended dosage for this indication is 10 mg once daily, with or without food, in the hospital and after hospital discharge, for a total recommended duration of 31 to 39 days. 

The prescribing information includes a boxed warning that premature discontinuation of any oral anticoagulant, including rivaroxaban, increases the risk of thrombotic events. To reduce this risk, consider coverage with another anticoagulant if rivaroxaban is discontinued for a reason other than pathological bleeding or completion of a course of therapy. Epidural or spinal hematomas have occurred in patients treated with rivaroxaban who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Monitor patients frequently for signs and symptoms of neurological impairment, and if observed, treat urgently. Consider the benefits and risks before neuraxial intervention in patients who are or who need to be anticoagulated.

Bleeding is the most common adverse reaction of rivaroxaban.

To date, FDA has granted rivaroxaban eight indications, six of which are specifically for the treatment, prevention, and reduction in the risk of recurrence of VTE across a wide range of patient populations.