Label Changes for:

Votrient (pazopanib) tablets

June 2014

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

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

 June 2014

DRUG INTERACTIONS

Drugs That Raise Gastric pH
  • Avoid concomitant use of Votrient with drugs that raise gastric pH. Consider short-acting antacids in place of proton pump inhibitors (PPIs) and H2 receptor antagonists. Separate antacid and pazopanib dosing by several hours.  

November 2013

ADVERSE REACTIONS

Musculoskeletal and Connective Tissue Disorders
  • Arthralgia, muscle spasms 

 

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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