Label Changes for:

Prolia (denosumab) 

May 2012

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – May 2012

 

8 USE IN SPECIAL POPULATIONS

8.1 Pregnancy
  • Category X to reflect the animal study findings of adverse neonatal outcomes in offspring exposed to denosumab in utero

MEDICATION GUIDE

“Who Should not Take Prolia”: 

  • addition: women who are or plan to become pregnant; hypersensitivity to denosumab.

 

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