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U.S. Department of Health and Human Services

Safety

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Prolia (denosumab)

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

 

September 2012

Summary View

MEDICATION GUIDE

  • information about the new indication in men with osteoporosis and the risk of atypical fracture

 

 

May 2012 

Summary View

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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