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Phase 3 MISSION trial of Nexavar (sorafenib) in Patients with Non-Small Cell Lung Cancer Did Not Meet Primary Endpoint of Improving Overall Survival
Date:5/22/2012

considered in patients who develop cardiac ischemia and/or myocardial infarction.

Gastrointestinal perforation was an uncommon adverse reaction and has been reported in less than 1% of patients taking Nexavar.

Uncommon but serious adverse reactions, including keratoacanthomas/squamous cell cancer of the skin and Stevens-Johnson Syndrome, have been reported in clinical trials.

An increased risk of bleeding may occur following Nexavar administration. If bleeding necessitates medical intervention, consider discontinuation of Nexavar.

Hypertension may occur early in the course of treatment.  Monitor blood pressure weekly during the first 6 weeks and periodically thereafter and treat, as required.

Hand-foot skin reaction and rash are common and management may include topical therapies for symptomatic relief. In cases of any severe or persistent adverse reactions, temporary treatment interruption, dose modification, or permanent discontinuation of Nexavar should be considered. Temporary interruption of Nexavar therapy is recommended in patients undergoing major surgical procedures.

Nexavar can prolong the QT/QTc interval and increase the risk for ventricular arrhythmias.  Avoid use in patients with congenital long QT syndrome and monitor patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities.

Elevations in serum lipase and reductions in serum phosphate of unknown etiology have been associated with Nexavar.  Monitor patients taking concomitant warfarin regularly for changes in prothrombin time, INR, or clinical bleeding episodes.  Avoid concomitant use of strong CYP3A4 inducers, when possible, because inducers can decrease the systemic exposure of sorafenib.  Nexavar exposure decreases when co-administered with oral neomycin.  Effects of other antibiotics on Nexavar pharmacokinetics have not been studied.

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SOURCE Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc.
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