Risk Evaluation and Mitigation Strategy for Prolia® (denosumab)

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration to ensure that the benefits of the drug outweigh its risks.

In order for Amgen to communicate certain risks about Prolia (denosumab), Amgen has worked with the FDA to develop materials to communicate the risks of:

  • Hypocalcemia
  • Serious infections
  • Dermatologic adverse reactions
  • Suppression of bone turnover, including osteonecrosis of the jaw and atypical femoral fractures

The REMS program materials are designed to inform healthcare providers (HCPs) and patients about the risks with Prolia and include a Dear Healthcare Professional Letter and Medication Guide. It is important that you discuss with your patients the information included in the Medication Guide.

To learn more about the serious risks of Prolia, read the Important Safety Information provided in this link and use the links below to access REMS supporting materials.