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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

l. For patients with CrCl 15 to 50 mL/min, the recommended dose is 15 mg once daily with the evening meal.
  • Prophylaxis of Deep Vein Thrombosis: The recommended dose of XARELTO® is 10 mg taken orally once daily with or without food. The initial dose should be taken at least 6 to 10 hours after surgery once hemostasis has been established.
    • For patients undergoing hip replacement surgery, treatment duration of 35 days is recommended.
    • For patients undergoing knee replacement surgery, treatment duration of 12 days is recommended.
  • Missed Dose: If a dose of XARELTO® is not taken at the scheduled time, administer the dose as soon as possible on the same day.
  • Instructions for Patient Use
    • Remind patients to not discontinue XARELTO® without first talking to their healthcare professional to minimize the risk of post-discontinuation thrombotic events.
    • Advise patients with atrial fibrillation to take XARELTO® once daily with the evening meal.
  • DRUG INTERACTIONS

    • Drugs That Inhibit CYP3A4 Enzymes and Drug Transport Systems: Avoid concomitant administration of XARELTO® with combined P-gp and strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, lopinavir/ritonavir, ritonavir, indinavir/ritonavir, and conivaptan), which cause significant increases in rivaroxaban exposure that may increase bleeding risk.
    • Drugs That Induce CYP3A4 Enzymes and Drug Transport Systems: Avoid concomitant use of XARELTO® with drugs that are combined P-gp and strong CYP3A4 inducers (eg, carbamazepine, phenytoin, rifampin, St. John's wort) due to decreases in rivaroxaban exposure that may decrease efficacy.
    • NSAIDs/Aspi
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    SOURCE Janssen Research & Development, LLC
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