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Approved Risk Evaluation and Mitigation Strategies (REMS)

Bildyos (denosumab-nxxp)
BLA #761444
REMS last update: 08/29/2025



What is the purpose of the REMS?

The goal of the BILDYOS REMS is to mitigate the risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD), including dialysis-dependent patients, associated with BILDYOS.

Objective 1: Inform healthcare providers on:

  1. Risk of severe hypocalcemia in patients with advanced chronic kidney disease (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2)
  2. Need to assess for presence of chronic kidney disease-mineral bone disorder (CKD-MBD) before initiating BILDYOS in patients with advanced chronic kidney disease

What do participants need to know?

Healthcare providers should read the relevant Medication Guide or communication materials included in the product-specific approved REMS to learn about the risk(s). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Bildyos REMS, see the DailyMed link(s).
Material Name Material Name Link
Patient Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Bildyos_2025_08_29_ REMS_Patient_Guide.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Bildyos_2025_08_29_ REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Bildyos_2025_08_29_ REMS_Full.pdf
REMS Letter for Healthcare Providers (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Bildyos_2025_08_29_ REMS_Letter_for_Healthcare_Providers.pdf
REMS Letter for Professional Societies (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Bildyos_2025_08_29_ REMS_Letter_for_Professional_Societies.pdf
REMS Website (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Bildyos_2025_08_29_ REMS_Website.pdf
Assessment Plan
Bildyos REMS Assessment Plan

This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters, and posted here as they become available.

What updates have been made to the REMS?

Date Summary of change
08/29/2025 Approval of REMS

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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