The FDA approved the anticoagulant rivaroxaban (Xarelto, Janssen), to reduce the risk for stroke among patients with non-valvular atrial fibrillation (AF).

Approval comes after data from the ROCKET-AF trial showed a 20-mg dose of rivaroxaban was noninferior to warfarin in preventing stroke and systemic embolism in patients with non-valvular AF.

Although the two drugs demonstrated similar rates of major bleeding, patients taking rivaroxaban had significantly lower rates of intracranial hemorrhage.

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Rivaroxaban is the first oral factor Xa inhibitor approved with a stroke prevention indication. A 10 mg dose of the drug had already been approved to prevent deep-vein thrombosis (DVT) in patients undergoing joint replacement surgery.

For the new indication, rivaroxaban should be taken with the evening meal and dosing is dependent on the patient’s creatinine clearance. Patients with a clearance greater than 50 mL/min should take a 20-mg dose and those with a creatinine clearance of 15 to 50 mL/min should take a 15-mg dose, according to labeling information.

Patients with a creatinine clearance level below 15 mL/min should not take rivaroxaban.

If rivaroxaban is discontinued for any reason other than pathological bleeding, another anticoagulant should be considered, according to a boxed warning on the medication’s label. This warning has been added to existing information about risk for spinal and epidural hematomas in patients receiving neuraxial anesthesia or undergoing spinal puncture.

The FDA has required Janssen to submit a Risk Evaluation and Mitigation Strategy for rivaroxaban, which consists of a Medication Guide and communication plan, to communicate the increased risk for thrombotic events, including stroke, in the event that the drug is discontinued and not replaced with an adequate alternative, or not taken with the evening meal.

Two other oral direct factor Xa inhibitors, apixaban (Eliquis, Bristol-Myers Squibb) and edoxaban (Lixiana, Daiichi Sankyo), are currently under development for stroke prevention.