Prolia® REMS
A REMS (Risk Evaluation and Mitigation Strategy) is a program required by the Food and Drug Administration to manage known or potential serious risks associated with a drug product.
The purpose of the Prolia® REMS is to inform healthcare providers and patients about the following serious risk of:
Severe Hypocalcemia in Patients with Advanced Kidney Disease
The Prolia® REMS program materials are designed to inform healthcare providers and patients about this risk with Prolia®. The Prolia® REMS program materials include a REMS Letter for Healthcare Providers and a Patient Guide. It is important that you discuss with each patient the information included in the Patient Guide.
Materials for Healthcare Providers
REMS Letter for Healthcare Providers
Materials for Patients