Label Changes for:

Prolia (denosumab)

July 2013

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

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

 

July 2013

CONTRAINDICATIONS

Hypersensitivity
  • Prolia is contraindicated in patients with a history of systemic hypersensitivity to any component of the product. Reactions have included anaphylaxis, facial swelling and urticaria

WARNINGS AND PRECAUTIONS

Hypersensitivity
  • Clinically significant hypersensitivity including anaphylaxis has been reported with Prolia. Symptoms have included hypotension, dyspnea, throat tightness, facial and upper airway edema, pruritis, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of Prolia 

 

September 2012

MEDICATION GUIDE

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

 

 

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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