Approved Risk Evaluation and Mitigation Strategies (REMS)
Prolia (denosumab)
BLA #125320
REMS last update: 04/09/2024
What is the purpose of the REMS?
The goal of the Prolia REMS is to mitigate the risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD), including dialysis-dependent patients, associated with Prolia.
Objective 1: Inform healthcare providers on:
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.
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 Prolia REMS, see the DailyMed link(s).Material Name | Material Name Link |
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Patient Guide (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2024_04_09_Patient_Guide.pdf |
REMS Document (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2024_04_09_REMS_Document.pdf |
REMS Full (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2024_04_09_REMS_Full.pdf |
REMS Letter for Healthcare Providers (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2024_04_09_REMS_Letter_for_Healthcare_Providers.pdf |
REMS Letter for Professional Societies (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2024_04_09_REMS_Letter_for_Professional_Societies.pdf |
REMS website (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2024_04_09_REMS_Website.pdf |
Assessment Plan |
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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 |
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04/09/2024 | Modified to: |
03/05/2024 | Modified to maintain the Medication Guide as part of the approved labeling, but not as an element of the approved REMS,along with other modifications outlined in our REMS Modification Notification letter. |
01/19/2024 | Modified to revise the Medication Guide to address the risk of severe hypocalcemia in patients with advanced chronic kidney disease including dialysis-dependent patients. |
05/19/2022 | Modified to revise the Medication Guide to clarify that Prolia is not approved for use in pediatric patients. |
10/01/2019 | Modified to revise the Medication Guide to include clarifying information for patients regarding the risk of multiple vertebral fractures following discontinuation of Prolia treatment. |
04/30/2019 | Modified to revise the Medication Guide to align with the revisions to the Prescribing Information. |
05/21/2015 | Modified to:
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02/26/2015 | Modified to delete language regarding amounts of Prolia (denosumab) that are present in the semen in the Medication Guide. |
06/16/2014 | Modified to reorder of the risks in Warnings and Precautions and the addition of a new warning of severe musculoskeletal pain in the Medication Guide. |
07/03/2013 | Modified to add the risk of hypersensitivity reactions in the Medication Guide. |
09/20/2012 | Modified to include information about the new indication in men with osteoporosis and the risk of atypical fracture in the REMS document, a revised Dear Healthcare Provider (DHCP) letter, revised REMS website as part of the REMS Communication Plan (CP), and a revised Medication Guide. |
06/07/2012 | Modified to:
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05/10/2012 | Modified to include information about contraindicating the use of denosumab in women who are pregnant or who plan to become pregnant in the Medication Guide |
09/16/2011 | Modified to:
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06/01/2010 | Approval of the 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.