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Prolia - AMGEN INC

Manufacturer
AMGEN INC
Effective date
2025-06-09
Label type
Risk Evaluation & Mitigation Strategies
Version
3
Source
full-release
Hydrated at
2026-06-04 22:50:43

Label at a glance#

ProductProlia
Label structure6 sections

Label contents#

Full prescribing information#

I. Administrative Information

REMS ADMINISTRATIVE INFORMATION

Risk: Severe hypocalcemia
Application Number: BLA 125320
Application Holder: Amgen Inc.
Initial REMS Approval: 06/2010
Most Recent REMS Updated: 06/2025

II. REMS Goal

REMS GOALS

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:

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

III. REMS Requirements

REMS REQUIREMENTS

To inform healthcare providers about the REMS and the risk and safe use of PROLIA, Amgen Inc. must disseminate REMS communication materials according to the table below:

REMS APPLICANT REQUIREMENTS

Target AudienceCommunication Materials & Dissemination Plans
Healthcare providers who are likely to prescribe PROLIA REMS Letters: REMS Letter for Healthcare Providers, REMS Letter for Professional Societies with attachment Prescribing Information.
  1. Mail REMS Letter for Healthcare Providers within 60 calendar days of this REMS modification and again 12 months later after the approval of this REMS modification.
    1. If returned, attempt to obtain updated address information and send a second letter by mail within 45 calendar days of the date the first letter is returned. If correct address cannot be obtained, the attempt will be documented.
  2. Email REMS Letter for Professional Societies within 60 calendar days of this REMS modification and again 12 months later after the approval of this REMS modification through the following professional societies and request the letter or content be provided to their members. If the first email is undeliverable, the REMS letter will be mailed within 30 calendar days. If the first email is marked as unopened, a second email will be sent within 7 calendar days. If the second email is undeliverable or marked as unopened, the REMS letter will be mailed within 30 calendar days.
    1. American Academy of Family Physicians
    2. American Association of Clinical Endocrinologists
    3. American College of Physicians
    4. American College of Rheumatology
    5. American Society of Bone Mineral Research
    6. American Society of Clinical Oncology
    7. Bone Health and Osteoporosis Foundation
    8. Endocrine Society
    9. North American Menopause Society
  3. Make available via a link from the PROLIA REMS Website.
  4. Disseminate through field-based sales and medical representatives from the date of this REMS modification for the duration of the REMS.
  5. Disseminate and prominently display at Professional Meetings where Amgen Inc. has a PROLIA commercial presence from the date of this REMS modification for the duration of the REMS.

Patient Guide and Prescribing Information

  1. Disseminate and prominently display at Professional Meetings where Amgen Inc. has a PROLIA commercial presence from the date of this REMS modification for the duration of the REMS.
  2. Disseminate through field-based sales and medical representatives during the initial and/or follow-up discussion with healthcare providers from the date of this REMS modification for the duration of the REMS. Field-based sales and/or medical representatives to verbally review the risk messages contained in the Patient Guide and Prescribing Information during the visit with the healthcare provider.

Website

  1. Make the REMS Website fully operational and all REMS materials available and updated through the website within 60 days post approval of this modification.
  2. Maintain the REMS Website from the date of this REMS modification for the duration of the REMS.
  3. Include a prominent REMS-specific link to the REMS Website on all product websites for consumers and healthcare providers. The REMS Website must not link back to the promotional product websites.

IV. REMS Assessment Timetable

REMS TIMETABLE FOR SUBMISSION ASSESSMENTS

Amgen Inc. must submit REMS Assessments at 18 months, 3 years, and 7 years from the date of the approval of this REMS modification (03/05/2024). To facilitate inclusion of as much information as possible while allowing reasonable time to prepare the submission, the reporting interval covered by each assessment should conclude no earlier than 60 calendar days before the submission date for that assessment. Amgen Inc. must submit each assessment so that it will be received by the FDA on or before the due date.

V. REMS Materials

REMS Material

The following materials are part of the PROLIA REMS:

Training and Educational Material

SPL UNCLASSIFIED SECTION

  • Patient:
    • Patient Guide

Communication Materials

SPL UNCLASSIFIED SECTION

    • REMS Letter for Healthcare Providers
    • REMS Letter for Professional Societies

VI. Statutory Elements

REMS ELEMENTS

This REMS is required under section 505-1 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355-1) and consists of the following elements:

    1. Communication Plan
    2. Timetable for Submission of Assessments

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
31f7a69c-73ae-42bf-97ee-e31040596ed6Product name120180423
b45e2e3f-1908-4144-8fa5-6f481dea7435Product name120170721

DailyMed REMS / Drug Safety Documents#

Labels related to this REMS document

DailyMed label, Relation, Version table
DailyMed labelRelationVersionEffectiveManufacturerSource
These highlights do not include all the information needed to use PROLIA safely and effectively. See full prescribing information for PROLIA. PROLIA ® (denosumab) injection, for subcutaneous use Initial U.S. Approval: 2010SPL related document2026-06-26Amgen, Inc | Amgen Manufacturing Limited LLC20251210_d3e48daf-c905-4a54-9ade-81586a05db38.zip!f61e141c-4a3d-4e01-ac55-54d4d183fbfc.xml

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProliaDENOSUMABAmgen, Inc49e5afe9-a0c7-40c4-af9f-f287a80c5c882026-06-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Prolia

Reported adverse events (FAERS/openFDA)#

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