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.
