Approved Risk Evaluation and Mitigation Strategies (REMS)

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Prolia (denosumab)

BLA #125320

REMS last update: 05/21/2015

View the Prolia Prescribing Information and Medication Guide at DailyMed.
View Prolia's Regulatory Information at Drugs@FDA

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

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:

Select to View Firm Press Release Download This List

Material Name
Journal Information Piece (PDF)
Patient Brochure (PDF)
Patient Counseling Chart for Healthcare Providers (PDF)
REMS document (PDF)
REMS full (PDF)
REMS Letter for Healthcare Providers (PDF)
REMS Letter for Professional Societies (PDF)
REMs Website (landing page) Screenshot (PDF)

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.

Prolia (denosumab) BLA #125320 REMS last update: 05/21/2015

What do participants need to know?

What materials are included in the REMS?

Prolia (denosumab)

BLA #125320

REMS last update: 05/21/2015