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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) 

 

June 2014

Summary View 

WARNINGS AND PRECAUTIONS
(note: The re-ordering of risks in Warnings and Precautions)

Hypocalcemia and Mineral Metabolism
 
  • Hypocalcemia following Prolia administration is a significant risk in patients with severe renal impairment [creatinine clearance < 30 mL/min] or receiving dialysis. These patients may also develop marked elevations of serum parathyroid hormone (PTH).
Musculoskeletal Pain
 
  • In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking Prolia. The time to onset of symptoms varied from one day to several months after starting Prolia. Consider discontinuing use if severe symptoms develop

ADVERSE REACTIONS
 

Postmarketing Experience
 
  • Parathyroid Hormone (PTH): Marked elevation in serum PTH in patients with severe renal impairment (creatinine clearance < 30 mL/min) or receiving dialysis.

 

July 2013

Summary View

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

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.