FDA.reportPublic FDA data

JUBBONTI - Sandoz Inc

Manufacturer
Sandoz Inc
Effective date
2025-10-29
Label type
RISK EVALUATION & MITIGATION STRATEGIES
Version
4
Source
full-release
Hydrated at
2026-06-04 22:50:44

Label at a glance#

ProductJUBBONTI
Label structure6 sections

Label contents#

Full prescribing information#

I. Administrative Information

REMS Administrative Information

Risks: Severe hypocalcemia

Application Number: BLA 761362 (and Unbranded Biological Product)

Application Holder: Sandoz Inc.

Initial REMS Approval: 03/2024

Most Recent REMS Update: 10/2025

II. REMS Goal

REMS Goals

The goal of the Jubbonti REMS is to mitigate the risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD) including dialysis-dependent patients associated with Jubbonti.

Objective 1: Inform healthcare providers on:

  • Risk of severe hypocalcemia 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 Jubbonti in patients with advanced chronic kidney disease

III. REMS Requirements

REMS Requirements

REMS Applicant Requirements

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

Target AudienceCommunication Materials & Dissemination Plans

Healthcare providers who are likely to prescribe Jubbonti

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 the date Jubbonti is first commercially distributed and again 12 months later.
    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 the date Jubbonti is first commercially distributed and again 12 months later 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 Society of Bone Mineral Research
    2. American College of Rheumatology
    3. American Association of Clinical Endocrinologists
    4. Endocrine Society
    5. American Society of Clinical Oncology
    6. Bone Health and Osteoporosis Foundation
    7. North American Menopause Society
    8. American Academy of Family Physicians
    9. American College of Physicians
  3. Make available via a link from the REMS Website.
  4. Disseminate through field-based sales and medical representatives from the date Jubbonti is first commercially distributed for the duration of the REMS.
  5. Disseminate and prominently display at Professional Meetings where Sandoz Inc. has a Jubbonti commercial presence from the date Jubbonti is first commercially distributed for the duration of the REMS.

Patient Guide and Prescribing Information (PI)

  1. Disseminate and prominently display at Professional Meetings where Sandoz Inc. has a Jubbonti commercial presence from the date Jubbonti is first commercially distributed 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 Jubbonti is first commercially distributed 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 PI during the visit with the healthcare provider.

Website

  1. Make the REMS Website fully operational and all REMS materials available through the website by the date Jubbonti is first commercially distributed.
  2. Maintain the REMS Website from the date Jubbonti is first commercially distributed 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 Assessments Timetable

REMS Timetable for Submission Assessments

Sandoz Inc. must submit REMS Assessments at 18 months, 3 years, and 7 years from the date of the initial REMS approval (03/05/2024). To facilitate inclusion of as much information as possible while allowing reasonable time to prepare the submission, the reporting internal covered by each assessment should conclude no earlier than 60 calendar days before the submission date for that assessment. Sandoz 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 Jubbonti REMS:

Training and Educational Materials

Patient:

  1. Patient Guide

Communication Materials

  1. REMS Letter for Healthcare Providers
  2. REMS Letter for Professional Societies

Other Materials

  1. REMS Website

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 JUBBONTI ® safely and effectively. See full prescribing information for JUBBONTI. JUBBONTI ® (denosumab-bbdz) injection, for subcutaneous use Initial U.S. Approval: 2024 JUBBONTI (denosumab-bbdz) is biosimilar* to PROLIA ® (denosumab).SPL related document2025-10-30Sandoz Inc20260329_97eda422-61a6-445a-bef4-1c95e75fe1a9.zip!bcedbfd3-5202-453f-aadf-81f7fa538518.xml

Products#

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DailyMed product names page 1 of 1 · 3 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JUBBONTIDENOSUMABSandoz Inc4bf239bb-c467-4add-b7cf-ea666e4fc6932025-10-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: JUBBONTI

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.