Approved Risk Evaluation and Mitigation Strategies (REMS)
Prolia (denosumab)
BLA #125320
REMS last update: 10/01/2019
What is the purpose of the REMS?
The goal of the PROLIA REMS is to mitigate the risks of hypocalcemia, osteonecrosis of the jaw, atypical femoral fractures, serious infections, and dermatologic reactions by:
- informing healthcare providers and patients about the risks of (1) hypocalcemia, (2) osteonecrosis of the jaw, (3) atypical femoral fractures, (4) serious infections, and (5) dermatologic reactions associated with PROLIA
- informing healthcare providers they should counsel patients about the risks associated with PROLIA.
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.
Material Name | Material Name Link |
---|---|
Journal Information Piece (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2019_10_01_Journal_Information_Piece.pdf |
Patient Brochure (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2019_10_01_Patient_Brochure.pdf |
Patient Counseling Chart for Healthcare Providers (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2019_10_01_Patient_Counseling_Chart_for_Healthcare_Providers.pdf |
REMS Document (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2019_10_01_REMS_Document.pdf |
REMS Full (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2019_10_01_REMS_Full.pdf |
REMS Letter for Healthcare Providers (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2019_10_01_REMS_Letter_for_Healthcare_Providers.pdf |
REMS Letter for Professional Societies (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2019_10_01_REMS_Letter_for_Professional_Societies.pdf |
REMS Website (landing page) Screenshot (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Prolia_2019_10_01_REMS_Website_(landing_page)_Screenshot.pdf |
What updates have been made to the REMS?
Date | Summary of change |
---|---|
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:
|
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:
|
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:
|
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.
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