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Janssen Research & Development Submits Application to U.S. FDA for XARELTO® (rivaroxaban) to Reduce Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome
Date:12/29/2011

rin: NSAIDs/aspirin are known to increase bleeding; therefore, bleeding risk may be increased when these drugs are used concomitantly with XARELTO®. Promptly evaluate any signs or symptoms of blood loss if patients are treated concomitantly with aspirin, other platelet aggregation inhibitors, or NSAIDs.
  • Clopidogrel: Promptly evaluate any signs or symptoms of blood loss if patients are treated concomitantly with clopidogrel.
  • Drug-Disease Interactions With Drugs That Inhibit CYP3A4 Enzymes and Drug Transport Systems: Use in patients with CrCl 15 mL/min to 50 mL/min who are receiving concomitant combined  P-gp and weak or moderate CYP3A4 inhibitors only if the potential benefit justifies the potential risk (eg, amiodarone, diltiazem, verapamil, quinidine, ranolazine, dronedarone, felodipine, erythromycin, azithromycin, chloramphenicol, and cimetidine).
  • Prophylaxis of Deep Vein Thrombosis
    • Drugs That Inhibit CYP3A4 Enzymes and Drug Transport Systems: When clinical data suggest a change in exposure is unlikely to affect bleeding risk (eg, clarithromycin, erythromycin), no precautions are necessary during coadministration with drugs that are P-gp and CYP3A4 inhibitors.
    • Anticoagulants: Avoid concurrent use of XARELTO® with other anticoagulants due to the increased bleeding risk. Promptly evaluate any signs or symptoms of blood loss.
  • USE IN SPECIFIC POPULATIONS

    • Nursing Mothers: It is not known if rivaroxaban is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from rivaroxaban, a decision should be made whether to discontinue nursing or discontinue XARELTO®, taking into account the importance of the drug to the mother.
    • Geriatric Use: In clinical trials the
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    SOURCE Janssen Research & Development, LLC
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