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U.S. Department of Health and Human Services

Safety

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Trelstar (triptorelin pamoate for injectable suspension)

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

 

July 2014

Summary View

WARNINGS AND PRECAUTIONS

Effect on QT/QTc Interval
  • Androgen deprivation therapy may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.
     

 

March 2013

Summary View

ADVERSE REACTIONS

Post-marketing
  • convulsions