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U.S. Department of Health and Human Services

Safety

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Votrient (pazopanib hydrochloride) Tablets

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

 

March 2012

Summary View

WARNINGS AND PRECAUTIONS

Hepatic Effects
  • Concomitant use of VOTRIENT and simvastatin increases the risk of ALT elevations and should be undertaken with caution and close monitoring [see Drug Interactions (7.3)].
  • Insufficient data are available to assess the risk of concomitant administration of alternative statins and VOTRIENT

ADVERSE REACTIONS

DRUG INTERACTIONS

Effect of Concomitant use of VOTRIENT and Simvastatin
  • Concomitant use of Votrient and simvastatin increases the incidence of ALT elevations. Across monotherapy studies with Votrient, ALT >3 X ULN was reported in 126/895 (14%) of patients who did not use statins, compared with 11/41 (27%) of patients who had concomitant use of simvastatin. If a patient receiving concomitant simvastatin develops ALT elevations, follow dosing guidelines for Votrient or consider alternatives to Votrient. Alternatively, consider discontinuing simvastatin. Insufficient data are available to assess the risk of concomitant administration of alternative statins and Votrient.

 

October 2011 

Summary View

 

WARNINGS AND PRECAUTIONS

Hypertension
  • In clinical studies, events of hypertension including hypertensive crisis have occurred... Votrient should be discontinued if there is evidence of hypertensive crisis or if hypertension is severe and persistent despite antihypertensive therapy and dose reduction of Votrient.

 

ADVERSE REACTIONS

Clinical Trials Experience
  • Potentially serious adverse reactions with Votrient included hepatotoxicity, QT prolongation and torsades de pointes, hemorrhagic events, arterial thrombotic events, gastrointestinal perforation, and fistula, and hypertensive crisis [see Warnings and Precautions (5.1-5.6)].
  • Cardiac Dysfunction - Pazopanib has been associated with cardiac dysfunction (such as....)

 

MEDICATION GUIDE

  • see document for details