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U.S. Department of Health and Human Services

Safety

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Nexavar (sorafenib tosylate) tablet

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2013

Summary View

 

ADVERSE REACTIONS

Adverse Reactions in HCC Study
  • Hypokalemia was reported in 9.4% of Nexavar - treated patients compared to 5.9% of placebo-treated patients. Most reports of hypokalemia were low grade (CTCAE Grade 1). CTCAE Grade 3 hypokalemia occurred in 0.3% of Nexavar-treated patients and 0.7% of placebo-treated patients. There were no reports of Grade 4 hypokalemia.
Adverse Reactions in RCC Study 1
  • Hypokalemia was reported in 5.4% of Nexavar -treated patients compared to 0.7% of placebo-treated patients. Most reports of hypokalemia were low grade (CTCAE Grade 1). CTCAE Grade 3 hypokalemia occurred in 1.3% of Nexavar -treated patients and 0.2% of placebo-treated patients. There were no reports of Grade 4 hypokalemia.
Additional Data from Multiple Clinical Trials
  • hypokalemia, proteinuria, and nephrotic syndrome
Postmarketing Experience
  • interstitial lung disease-like events