FDA.reportPublic FDA data

ELREXFIO - Pfizer Inc.

Manufacturer
Pfizer Inc.
Effective date
2025-07-10
Label type
Risk Evaluation & Mitigation Strategies
Version
5
Source
full-release
Hydrated at
2026-06-04 22:50:42

Label at a glance#

ProductELREXFIO
Label structure6 sections

Label contents#

Full prescribing information#

I. Administrative Information

REMS ADMINISTRATIVE INFORMATION

Risk: Cytokine Release Syndrome, neurologic toxicity including Immune Effector Cell-Associated Neurotoxicity Syndrome
Application Number: BLA 761345
Application Holder: Pfizer Inc.
Initial REMS Approval: 08/2023
Most Recent REMS Update: 07/2025

II. REMS Goal

REMS GOALS

The goal of the ELREXFIO REMS is to mitigate the risks of Cytokine Release Syndrome (CRS), and neurologic toxicity including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) by:

  • Ensuring prescribers are aware of the importance of monitoring for signs and symptoms of CRS and neurologic toxicity including ICANS in patients exposed to ELREXFIO

III. REMS Requirements

REMS REQUIREMENTS

REMS PARTICIPANT REQUIREMENTS

Pfizer Inc. must ensure that healthcare providers, patients, pharmacies, healthcare settings and wholesalers-distributors comply with the following requirements:

1. Healthcare providers who prescribe ELREXFIO must:
To become certified to prescribe1. Review the drug’s Prescribing Information.
2. Review the Prescriber Training Program and Adverse Reaction Management Guide.
3. Successfully complete the Knowledge Assessment and submit it to the REMS.
4. Enroll in the REMS by completing and submitting the Prescriber Enrollment Form to the REMS.
Before treatment initiation (first step-up dose)5. Counsel the patient on:
a) how to recognize and respond to signs and symptoms of CRS and neurologic toxicity including ICANS,
b) the need to report all symptoms suggestive of CRS and neurologic toxicity including ICANS to their healthcare provider or emergency room provider immediately,
c) the need to carry the Patient Wallet Card at all times.
6. Complete the Patient Wallet Card and provide the Patient Wallet Card to the patient.
At all times7. Report serious adverse events of CRS and neurologic toxicity including ICANS to the REMS.

REMS PARTICIPANT REQUIREMENTS

2. Patients who are prescribed ELREXFIO:
Before treatment1. Receive counseling from the prescriber using the Patient Wallet Card.
At all times2. Have the Patient Wallet Card with you and inform other healthcare providers about treatment with ELREXFIO.

REMS PARTICIPANT REQUIREMENTS

3. Pharmacies and healthcare settings that dispense ELREXFIO must:
To become certified to dispense1. Designate an Authorized Representative to carry out the certification process and oversee implementation and compliance with the REMS requirements on behalf of the pharmacy and/or healthcare setting.
2. Have the Authorized Representative review the Pharmacy and Healthcare Setting Training Program.
3. Have the Authorized Representative enroll in the REMS by completing and submitting the Pharmacy and Healthcare Setting Enrollment Form to the REMS.
4. Train all relevant staff involved in dispensing ELREXFIO on the REMS requirements using the Pharmacy and Healthcare Setting Training Program.
Before dispensing5. Obtain authorization to dispense each prescription by contacting the REMS to verify the prescriber is certified.
To maintain certification to dispense6. Have a new Authorized Representative enroll in the REMS by completing and submitting the Pharmacy and Healthcare Setting Enrollment Form to the REMS if the Authorized Representative changes.
At all times7. Report serious adverse events of CRS and neurologic toxicity including ICANS to the REMS.
8. Not distribute, transfer, loan or sell ELREXFIO except to certified pharmacies and healthcare settings.
9. Maintain records of staff training.
10. Maintain records that processes and procedures are in place and are being followed.
11. Maintain records of all ELREXFIO dispenses and provide data to the REMS and Wholesalers-Distributors, as requested.
12. Comply with audits carried out by Pfizer Inc. or a third party acting on behalf of Pfizer Inc. to ensure that all training, processes, and procedures are in place and are being followed.

REMS PARTICIPANT REQUIREMENTS

4. Wholesalers-distributors that distribute ELREXFIO must:
To be able to distribute1. Establish processes and procedures to ensure that ELREXFIO is distributed only to certified pharmacies and healthcare settings.
2. Train all relevant staff involved in distribution on the REMS requirements.
At all times3. Distribute only to certified pharmacies and healthcare settings.
4. Maintain records that all processes and procedures are in place and are being followed.
5. Maintain and submit records of drug distribution to the REMS at least on a monthly basis.
6. Comply with audits carried out by Pfizer Inc. or a third party acting on behalf of Pfizer Inc. to ensure that all processes and procedures are in place and are being followed.

REMS APPLICANT REQUIREMENTS

Pfizer Inc. must provide training to healthcare providers who prescribe ELREXFIO. The training includes the following educational materials: Prescriber Training Program, Adverse Reaction Management Guide, and Knowledge Assessment. The training must be available online.

Pfizer Inc. must provide training to pharmacies and healthcare settings that dispense ELREXFIO. The training includes the following educational material: Pharmacy and Healthcare Setting Training Program. The training must be available online.

To inform healthcare providers about the REMS and the risks and safe use of ELREXFIO, Pfizer Inc. must disseminate REMS communication materials according to the table below:

Target AudienceCommunication Materials & Dissemination Plans
Healthcare providers including oncologists, oncology physician assistants, oncology nurse practitioners, hematologists, and oncology nurses who are likely to prescribe and care for patients treated with ELREXFIO

REMS Letters:

Healthcare Provider REMS Letter, Professional Society REMS Letter with attachment REMS Fact Sheet

1. E-mail within 30 calendar days of the date ELREXFIO is first commercially distributed and again 12 months later.

a. Send by mail within 30 calendar days of the date the first e-mail was sent if a healthcare provider’s e-mail address is not available, or the e mail is undeliverable.

b. Send a second e-mail within 30 calendar days of the date the first e mail was sent if the first e-mail is marked unopened.

c. Send by mail within 30 calendar days of the date the second e-mail was sent if the second e-mail is marked as unopened.

2. Disseminate through field-based sales and medical representatives for 12 months from the date ELREXFIO is first commercially distributed.

3. Disseminate within 30 calendar days of the date ELREXFIO 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.

a. American Society of Clinical Oncology (ASCO); American Society of Hematology (ASH); Advanced Practitioner Society for Hematology and Oncology (APSHO); Oncology Nursing Society (ONS); National Comprehensive Cancer Network (NCCN); Society of Hematologic Oncology (SOHO); Hematology Oncology Pharmacy Association (HOPA); American Pharmacists Association (APhA); American Society of Health-System Pharmacists (ASHP)

4. Disseminate at Professional Meetings where Pfizer Inc. has a presence for 12 months from the date ELREXFIO is first commercially distributed.

REMS Fact Sheet

1. Disseminate at Professional Meetings where Pfizer Inc. has a presence for 12 months from the date ELREXFIO is first commercially distributed.

2. Disseminate through field-based sales and medical representatives during the initial and/or follow-up discussion with healthcare providers for 12 months after ELREXFIO is first commercially distributed. Field-based sales and/or medical representatives to orally review the key risk messages contained in the REMS Fact Sheet during the visit with the healthcare provider.

To support REMS operations, Pfizer Inc. must:

  1. Authorize dispensing for each prescription based on verifying the prescriber is certified.
  2. Establish and maintain the REMS Website, www.ELREXFIOREMS.com. The REMS Website must include the capability to enroll prescribers, pharmacies and healthcare settings, complete training online, maintain records of that training, and an 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 the website and the REMS Coordinating Center at the time ELREXFIO first becomes commercially available.
  4. Establish and maintain a REMS Coordinating Center for REMS participants at 1-844-923-7845.
  5. Establish and maintain a validated, secure database of all REMS participants who are enrolled and/or certified in the REMS.
  6. Ensure prescribers, pharmacies and healthcare settings can enroll in the REMS online, by fax and e-mail.
  7. Ensure pharmacies and healthcare settings are able to obtain authorization to dispense by phone and online.
  8. Notify prescribers, pharmacies and healthcare settings within 1 calendar day after they become certified in the REMS.
  9. Provide certified prescribers access to the database of certified pharmacies and healthcare settings.
  10. Provide certified pharmacies and healthcare settings access to the database of certified prescribers.
  11. Provide authorized wholesalers-distributors access to the list of certified pharmacies and healthcare settings.
  12. Report serious CRS and neurologic toxicity including ICANS as soon as possible to the FDA but no later than 15 calendar days from the initial receipt of the information by the applicant. This requirement does not affect the applicant’s other reporting and follow-up requirements under applicable FDA regulations.

To ensure REMS participants’ compliance with the REMS, Pfizer Inc. must:

  1. Verify annually that the designated authorized representative for certified pharmacies and healthcare settings remains the same. If different, the pharmacy/healthcare setting 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: ELREXFIO distribution and dispensing; certification of pharmacies and healthcare settings; authorized wholesalers-distributors; and audits of REMS participants. These records must be readily available for FDA inspections.
  3. Monitor pharmacies, healthcare settings, and wholesalers-distributors on an ongoing basis to ensure the requirements of the REMS are being met. Take corrective action if noncompliance is identified, including decertification or deauthorization.
  4. Establish and maintain a plan for addressing noncompliance with REMS requirements.
  5. Audit all certified pharmacies and healthcare settings within 180 calendar days after the pharmacy or healthcare setting receives their first shipment of ELREXFIO and annually thereafter to ensure that all REMS processes and procedures are in place, functioning, and support the REMS requirements.
  6. Audit wholesalers-distributors that have distributed ELREXFIO within 180 calendar days of being authorized to distribute ELREXFIO and annually thereafter to ensure that all REMS processes and procedures are in place, functioning, and support the REMS requirements. Take corrective action if noncompliance is identified.
  7. Take reasonable steps to improve operations of and compliance with the requirements in the ELREXFIO REMS based on monitoring and evaluation of the ELREXFIO REMS.

IV. REMS Assessment Timetable

REMS TIMETABLE FOR SUBMISSION ASSESSMENTS

Pfizer Inc. must submit REMS Assessments to the FDA annually from the date of the initial approval of the REMS (08/14/2023). 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. Pfizer 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 ELREXFIO REMS:

Enrollment Forms

Prescriber:

  1. Prescriber Enrollment Form

Pharmacy and Healthcare Setting:

  1. Pharmacy and Healthcare Setting Enrollment Form

Training and Educational Materials

Prescriber:

  1. Prescriber Training Program
  2. Adverse Reaction Management Guide
  3. Knowledge Assessment

Patient:

  1. Patient Wallet Card

Pharmacy and Healthcare Setting:

  1. Pharmacy and Healthcare Setting Training Program

Communication Materials

  1. Healthcare Provider REMS Letter
  2. Professional Society REMS Letter
  3. REMS Fact Sheet

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 (FDC Act) (21 U.S.C. 355-1) and consists of the following elements:

  1. Communication Plan
  2. Elements to Assure Safe Use
    • Health care providers who prescribe ELREXFIO are specially certified under 505-1(f)(3)(A)
    • Pharmacies and health care settings that dispense ELREXFIO are specially certified under 505-1(f)(3)(B)
  3. Implementation System
  4. Timetable for Submission of Assessments

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf04f12d-3435-41d4-973b-e759446596f3Product name120241008

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 ELREXFIO safely and effectively. See full prescribing information for ELREXFIO. ELREXFIO ® (elranatamab-bcmm) injection, for subcutaneous use Initial U.S. Approval: 2023SPL related document2026-09-14Pfizer Laboratories Div Pfizer Inc | Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | Pharmacia & Upjohn Company LLC | PPD Development, L.P.20250907_a7f58a60-c6d4-417c-89d4-243b0aeb92d6.zip!5e1906a5-c29e-4d36-b6f7-7d2034f50003.xml

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ElrexfioELRANATAMAB-BCMMU.S. Pharmaceuticalsaa044060-5b4b-4692-bf0f-9a50e140b10e2026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Elrexfio

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