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Label Changes for:

Votrient (pazopanib) Tablets

April 2015

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

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

April 2015

WARNINGS AND PRECAUTIONS

Hepatic Toxicity and Hepatic Impairment
  • Patients older than 65 years are at greater risk for hepatotoxicity

ADVERSE REACTIONS

Postmarketing Experience
  • Eye Disorders: Retinal detachment/tear.

 

March 2015

WARNINGS AND PRECAUTIONS

Hepatic Toxicity and Hepatic Impairment
  • added...Patients older than 65 years are at greater risk for hepatotoxicity [see Use in Specific Populations (8.5)].

ADVERSE REACTIONS

Postmarketing Experience
  • added...Eye Disorders: Retinal detachment/tear

 

November 2014

WARNINGS AND PRECAUTIONS

Cardiac Dysfunction
  • In clinical trials with VOTRIENT, events of cardiac dysfunction such as decreased left ventricular ejection fraction (LVEF) and congestive heart failure have occurred. In the overall safety population for RCC (N = 586), cardiac dysfunction was observed in 0.6% (4/586) of patients without routine on-study LVEF monitoring. In a randomized RCC trial of VOTRIENT compared with sunitinib, myocardial dysfunction was defined 114 as symptoms of cardiac dysfunction or =15% absolute decline in LVEF compared with baseline or a decline in LVEF of =10% compared with baseline that is also below the lower limit of normal. … 

 

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… 

ADVERSE REACTIONS

Clinical Trials Experience
Potential serious adverse reactions with Votrient included:
(web2)