FDA.reportPublic FDA data

STOBOCLO - CELLTRION USA, Inc.

Manufacturer
CELLTRION USA, Inc.
Effective date
2025-09-10
Label type
Risk Evaluation & Mitigation Strategies
Version
4
Source
full-release
Hydrated at
2026-06-04 22:50:44

Label at a glance#

ProductSTOBOCLO
Label structure6 sections

Label contents#

Full prescribing information#

I. Administrative Information

REMS ADMINISTRATIVE INFORMATION

Risk: Severe hypocalcemia

Applicant Number: BLA 761404 (and Unbranded Biological Product)

Application Holder: CELLTRION, Inc.

Initial REMS Approval: 02/2025

Most recent REMS update: 09/2025

II. REMS Goal

REMS Goals

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

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 STOBOCLO 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 STOBOCLO, CELLTRION 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 STOBOCLOREMS 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 STOBOCLO 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 STOBOCLO 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 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 REMS Website.
  4. Disseminate through field-based sales and medical representatives from the date STOBOCLO is first commercially distributed for the duration of the REMS.
  5. Disseminate and prominently display at Professional Meetings where CELLTRION, Inc. has a STOBOCLO commercial presence from the date STOBOCLO is first commercially distributed for the duration of the REMS.

Patient Guide and Prescribing Information

  1. Disseminate and prominently display at Professional Meetings where CELLTRION, Inc. has a STOBOCLO commercial presence from the date STOBOCLO 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 STOBOCLO 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 Prescribing Information 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 STOBOCLO is first commercially distributed.
  2. Maintain the REMS Website from the date STOBOCLO 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 Assessment Timetable

REMS Timetable For Submission Assessments

CELLTRION, Inc. must submit REMS Assessments at 18 months, 3 years, and 7 years from the date of the initial REMS approval (02/28/2025). 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. CELLTRION, 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 STOBOCLO REMS:

Training and Educational Material

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 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 STOBOCLO safely and effectively. See full prescribing information for STOBOCLO. STOBOCLO ® (denosumab-bmwo) injection, for subcutaneous use Initial U.S. Approval: 2025 STOBOCLO ® (denosumab-bmwo) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences SPL related document2026-02-05CELLTRION USA, Inc.20260115_55abbae7-c8b6-4b28-8687-2ad65d2e7b42.zip!8b84a66e-df14-40e9-9b39-5eb4c3dfccf6.xml

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
StobocloDENOSUMAB-BMWOCELLTRION USA, Inc.10b9eea3-bf70-4ff3-a0b9-54248cbfd1562026-02-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Stoboclo

Reported adverse events (FAERS/openFDA)#

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