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U.S. Department of Health and Human Services

Safety

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Firmagon (degarelix for injection)

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

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.