Safety

Firmagon (degarelix for injection)

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

February 2015

Summary View

WARNINGS AND PRECAUTIONS

Effect on QT/QTc Interval
  • Androgen deprivation therapy may prolong the QT 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.
     

 

August 2013

Summary View

ADVERSE REACTIONS

  • The safety of Firmagon administered monthly was evaluated further in an extension study in 385 patients who completed the above active-controlled trial…

 

March 2013

Summary View

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions
  • Hypersensitivity reactions, including anaphylaxis, urticaria and angioedema, have been reported post-marketing with Firmagon. In case of a serious hypersensitivity reaction, discontinue Firmagon immediately if the injection has not been completed, and manage as clinically indicated. Patients with a known history of serious hypersensitivity reactions to Firmagon should not be re-challenged with Firmagon.

 

Page Last Updated: 03/11/2015
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