Janssen Research & Development Submits Application to U.S. FDA for XARELTO® (rivaroxaban) to Reduce Secondary Cardiovascular Events in Patients with Acute Coronar... (t available. Rivaroxaban systemic exposu...)

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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

t available. Rivaroxaban systemic exposure is not further increased at single doses >50 mg due to limited absorption. Discontinue XARELTO^® and initiate appropriate therapy if bleeding complications associated with overdosage occur. The use of activated charcoal to reduce absorption in case of XARELTO^® overdose may be considered. Due to the high plasma protein binding, rivaroxaban is not expected to be dialyzable.

ADVERSE REACTIONS IN CLINICAL STUDIES

Hemorrhage: The most common adverse reactions with XARELTO^® were bleeding complications.
Nonvalvular Atrial Fibrillation: The most frequent adverse reactions associated with permanent drug discontinuation were bleeding events, with incidence rates of 4.3% for XARELTO^® versus 3.1% for warfarin. The incidence of discontinuations for nonbleeding adverse events was similar in both treatment groups. In XARELTO^®- versus warfarin-treated patients, respectively, major bleeding events were 5.6% versus 5.4%.
Prophylaxis of Deep Vein Thrombosis: In the RECORD clinical trials, the overall incidence rate of adverse reactions leading to permanent treatment discontinuation was 3.7% with XARELTO^®. In XARELTO^®- versus enoxaparin-treated patients, respectively, major bleeding event rates reported in hip surgery studies were 0.2% versus 0.1% and any bleeding events were 6.1% versus 5.8%; major bleeding events reported in the knee surgery study were 0.6% versus 0.5% and any bleeding events were 5.0% versus 4.9%. Other adverse drug reactions included wound secretion (2.8% vs 2.0%) and syncope (1.2% vs 0.7%) in XARELTO^®- versus enoxaparin-treated patients, respectively.
Other Clinical Trial Experience: In an investigational study of acute medically ill patients being
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SOURCE Janssen Research & Development, LLC
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