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U.S. Department of Health and Human Services

Safety

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Nexavar (sorafenib tosylate) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) –

 

March 2011

Summary View

ADVERSE REACTIONS

Postmarketing Experience
  • angioedema and drug-induced hepatitis

 

October 2010

Summary View

 

WARNINGS AND PRECAUTIONS

Use of Nexavar in combination with Carboplatin and Paclitaxel in Non-small Cell Lung Cancer
  • A randomized controlled trial in chemo-naive patients with Stage IIIB-IV Non-small Cell Lung Cancer, performed to compare the safety and efficacy of carboplatin and paclitaxel with or without sorafenib, was stopped early because overall survival was not improved with the addition of sorafenib. In the analysis of the subset of patients with squamous cell carcinoma (prospectively stratified), higher mortality was observed with the addition of sorafenib compared to those treated with carboplatin and paclitaxel alone (HR 1.81, 95% CI 1.19-2.74). No definitive cause was identified for this finding
Neomycin
  • Co-administration of oral neomycin causes a decrease in sorafenib exposure

ADVERSE REACTIONS

Additional Data from Multiple Clinical Trials
  • Reclassification of congestive heart failure as a common adverse reaction
  • Addition of Stevens-Johnson Syndrome, hyperthyroidism, and interstitial lung disease-like events as uncommon adverse reactions

 

DRUG INTERACTIONS

 

  • Addition of information on neomycin