REMS Safety Update on Prolia (denosumab)

May 3, 2024

The American Society of Clinical Oncology (ASCO) has been notified of a recent safety notice for the drug Prolia (denosumab) under the Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategy (REMS) program. A REMS Letter for Professional Societies has been released to address the potential risk for severe hypocalcemia in patients with advanced kidney disease following Prolia administration. More information for healthcare providers can be found on the Prolia REMS website for healthcare professionals.

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