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:

  1. 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
  2. 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.

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.

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:

  1. Change the REMS goal statement.
  2. Change the Communication Plan including:
    1. Replacing the Dear Healthcare Provider letter with a REMS Letter for Healthcare Providers and a REMS Letter for Professional Societies.
    2. Adding a Patient Counseling Toolkit which contains a Patient Counseling Tool for Healthcare Providers, a Patient Brochure, and copies of the product labeling and Medication Guide.
    3. Adding a Journal Information Piece, disseminate Prolia REMS-related information at scientific Meetings.
    4. Changing the Prolia REMS website to reflect the aforementioned modifications.
  3. Change the timetable for submission of REMS assessments.
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:

  1. Include the serious risks of hypocalcemia REMS document goals and the DHCP letter.
  2. Increase provider’s awareness of the importance of the Medication Guide and inform the providers of the survey results in the Dear Healthcare Professional Letter.
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:

  1. Describe the amended communication plan, updated communication materials reflecting the newly approved indications in the REMS document.
  2. Update the Medication Guide to be consistent with the prescribing information.
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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