Label Changes for:

Xgeva (denosumab)

September 2012

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

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

 

 

September 2012

5 WARNINGS AND PRECAUTIONS

5.2 Osteonecrosis of the Jaw (ONJ)
  • In clinical trials in patients with osseous metastasis, 2.2% of patients receiving Xgeva developed ONJ after a median exposure of 13 doses; of these patients, ......

 

 

April 2012

 

WARNINGS AND PRECAUTIONS

Pregnancy
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