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FDA Date: 5/21/15
Prolia (denosumab) Injection REMS
Goal of the Prolia (denosumab) Injection REMS Program
The goal of the PROLIA REMS is to mitigate the risks of hypocalcemia, osteonecrosis of the jaw, atypical femoral fractures, serious infections, and dermatologic reactions by:
a. informing healthcare providers and patients about the risks of (1) hypocalcemia, (2) osteonecrosis of the jaw, (3) atypical femoral fractures, (4) serious infections, and (5) dermatologic reactions associated with PROLIA
b. informing healthcare providers they should counsel patients about the risks associated with PROLIA.
• Medication Guide
• Communication Plan