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Abecma - Celgene Corporation

Manufacturer
Celgene Corporation
Effective date
2024-04-04
Label type
RISK EVALUATION & MITIGATION STRATEGIES
Version
4
Source
full-release
Hydrated at
2026-06-04 22:50:37

Label at a glance#

ProductAbecma
Label structure6 sections

Label contents#

Full prescribing information#

I. Administrative Information

REMS Administrative Information

Risk: cytokine release syndrome (CRS) and neurologic toxicities

Application Number: BLA 125736

Application Holder: Celgene Corporation, a Bristol-Myers Squibb Company

Initial REMS Approval: 03/2021

Most Recent REMS Update: 04/2024

II. REMS Goal

REMS Goals

The goal of the ABECMA REMS is to mitigate the risks of cytokine release syndrome (CRS) and neurologic toxicities by:

1. Ensuring that hospitals and their associated clinics that dispense ABECMA are specially certified and have on-site immediate access to tocilizumab.

III. REMS Requirements

REMS Requirements

Celgene Corporation must ensure that hospitals and their associated clinics comply with the following requirements:

REMS Participant Requirements

1. Hospitals and their associated clinics that dispense ABECMA must:

SPL UNCLASSIFIED SECTION

To become certified to dispense

  1. Have a minimum of two doses of tocilizumab available on-site for each patient for immediate administration (within 2 hours of infusion).
  2. Designate an Authorized Representative to carry out the certification process and oversee implementation and compliance with the REMS requirements on behalf of the hospital and associated clinic(s).
  3. Have the Authorized Representative enroll in the REMS by completing the Hospital Enrollment Form and submitting it to the REMS.
  4. Establish processes and procedures to verify that a minimum of two doses of tocilizumab are available on-site for each patient and are ready for immediate administration (within 2 hours of infusing) through the processes and procedures established as a requirement of the REMS.

Before infusion

  1. Verify that a minimum of two doses of tocilizumab are available on-site for each patient and are ready for immediate administration (within 2 hours of infusion) through the processes and procedures established as a requirement of the REMS.

To maintain certification to dispense if there is a change in authorized representative

  1. Have a new Authorized Representative enroll in the REMS Program by completing the Hospital Enrollment Form.

At all times

  1. Maintain records that processes and procedures are in place and are being followed.
  2. Comply with audits carried out by Celgene Corporation or a third party acting on behalf of Celgene Corporation to ensure that all training, processes, and procedures are in place and are being followed.

REMS Applicant Requirements

To support REMS operations, Celgene Corporation must:

  1. Ensure ABECMA is distributed only to certified hospitals or their associated clinics.
  2. Establish and maintain the REMS website, www.AbecmaREMS.com. The REMS website must include the option to print the Prescribing Information (PI), Medication Guide, and REMS materials. All product websites for consumers and healthcare providers must include prominent REMS-specific links to the REMS website.
  3. Make the REMS website fully operational and all REMS materials available through website and call center.
  4. Establish and maintain a REMS Call Center for REMS participants at 1-866-340-7332.
  5. Establish and maintain a validated, secure database of all REMS participants who are enrolled and/or have been certified in the ABECMA REMS.
  6. Ensure hospitals and their associated clinics are able to enroll in the REMS online via e-mail and fax.
  7. Notify hospitals and their associated clinics within 7 calendar days after they become certified in the REMS.

To ensure REMS participants’ compliance with the REMS, Celgene Corporation must:

  1. Verify annually that the designated Authorized Representative for certified hospitals and their associated clinics remains the same. If different, the hospital and their associated clinics must re-certify with a new Authorized Representative.
  2. Maintain adequate records to demonstrate that REMS requirements have been met, including, but not limited to records of: ABECMA distribution and dispensing; certification of hospitals and their associated clinics, and audits of REMS participants. These records must be readily available for FDA inspections.
  3. Monitor hospitals and their associated clinics on an ongoing basis to ensure the requirements of the REMS are being met. Take corrective action if non-compliance is identified, including de-certification.
  4. Maintain an ongoing annual audit plan of hospitals and their associated clinics.
  5. Audit all certified hospitals and their associated clinics no later than 180 calendar days after the hospital places its first order of ABECMA to ensure that all REMS processes and procedures are in place, functioning, and support the ABECMA REMS requirements. Certified hospitals and their associated clinics must also be included in Celgene Corporation’s ongoing annual audit plan.
  6. Take reasonable steps to improve implementation of and compliance with the requirements in the ABECMA REMS based on monitoring and evaluation of the ABECMA REMS.

IV. REMS Assessment Timetable

REMS Timetable for Submission Assessments

Celgene Corporation must submit REMS Assessments to the FDA at 6 months, 12 months, and annually thereafter from the date of the initial approval of the REMS (03/26/2021). 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. Celgene Corporation 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 ABECMA REMS:

Enrollment Form(s):

Health Care Setting:

  1. Hospital Enrollment Form

Other Material(s)

  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. Elements to Assure Safe Use:
    1. Health care settings that dispense ABECMA are specially certified under 505-1(f)(3)(B)
    2. ABECMA is dispensed to patients only in certain health care settings under 505-1(f)(3)(C)
  2. Implementation System
  3. 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 ABECMA safely and effectively. See full prescribing information for ABECMA. ABECMA ® (idecabtagene vicleucel), suspension for intravenous infusion Initial U.S. Approval: 2021SPL related document2025-11-25Celgene Corporation20240731_3e408665-319f-4ac0-afdc-2e5a6f2740db.zip!22dbd76a-02da-485d-bfda-64db495434f9.xml

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AbecmaIDECABTAGENE VICLEUCELCelgene Corporationb90c1fe7-f5cc-464e-958a-af36e9c26d7c2025-11-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Abecma

Reported adverse events (FAERS/openFDA)#

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