Label Changes for:

Votrient (Pazopanib) Tablets

August 2013

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

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

August 2013

 

WARNINGS AND PRECAUTIONS

  • Thrombotic Microangiopathy  - Thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS) has been reported in clinical trials of Votrient as monotherapy, in combination with bevacizumab, and in combination with topotecan…
 
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