FDA.reportPublic FDA data

LYNOZYFIC - Regeneron Pharmaceuticals, Inc.

Manufacturer
Regeneron Pharmaceuticals, Inc.
Effective date
2025-07-14
Label type
Risk Evaluation & Mitigation Strategies
Version
3
Source
full-release
Hydrated at
2026-06-04 22:50:41

Label at a glance#

ProductLYNOZYFIC
Label structure6 sections

Label contents#

Full prescribing information#

I. Administrative Information

REMS ADMINISTRATIVE INFORMATION

Risk: Cytokine Release Syndrome (CRS), and neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Application Number: BLA 761400
Application Holder: Regeneron Pharmaceuticals, Inc.
Initial REMS Approval: 07/2025
Most Recent REMS Update: 07/2025

II. REMS Goal

REMS GOALS

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

  1. Ensuring prescribers are aware of the importance of monitoring for signs and symptoms of CRS and neurologic toxicity, including ICANS in patients exposed to LYNOZYFIC

III. REMS Requirements

REMS REQUIREMENTS

REMS PARTICIPANT REQUIREMENTS

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

1. Healthcare providers who prescribe LYNOZYFIC 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 LYNOZYFIC:
Before treatment initiation1. 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 LYNOZYFIC.

REMS PARTICIPANT REQUIREMENTS

3. Pharmacies and healthcare settings that dispense LYNOZYFIC 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 LYNOZYFIC on the REMS requirements using the Pharmacy and Healthcare Setting Training Program.
5. Establish processes and procedures to verify the prescriber is certified for all dispenses after the first prescription.
Before dispensing, first prescription6. Obtain authorization to dispense by contacting the REMS to verify the prescriber is certified.
Before dispensing, all subsequent prescriptions7. Verify the prescriber is certified through the processes and procedures established as a requirement of the REMS.
To maintain certification to dispense8. 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 times9. Report serious adverse events of CRS and neurologic toxicity, including ICANS to the REMS.
10. Not distribute, transfer, loan or sell LYNOZYFIC except to certified pharmacies and healthcare settings.
11. Maintain records of staff training.
12. Maintain records that processes and procedures are in place and are being followed.
13. Maintain records of all LYNOZYFIC dispenses and provide data to the REMS, as requested.
14. Comply with audits carried out by Regeneron Pharmaceuticals, Inc. or a third party acting on behalf of Regeneron Pharmaceuticals, Inc. to ensure that all processes and procedures are in place and are being followed.

REMS PARTICIPANT REQUIREMENTS

4. Wholesalers-Distributors that distribute LYNOZYFIC must:
To be able to distribute1. Establish processes and procedures to ensure that LYNOZYFIC 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 weekly basis.
6. Comply with audits carried out by Regeneron Pharmaceuticals, Inc. or a third party acting on behalf of Regeneron Pharmaceuticals, Inc. to ensure that all processes and procedures are in place and are being followed.

REMS APPLICANT REQUIREMENTS

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

Regeneron Pharmaceuticals, Inc. must provide training to pharmacies and healthcare settings that dispense LYNOZYFIC. 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 LYNOZYFIC, Regeneron Pharmaceuticals, Inc. must disseminate REMS communication materials according to the table below:

Target AudienceCommunication Materials & Dissemination Plan
Healthcare providers, including oncologists, oncology physician assistants, oncology nurse practitioners, hematologists/oncologists, and oncology nurses who are likely to prescribe and care for patients treated with LYNOZYFIC.REMS Letters: Healthcare Provider REMS Letter, Professional Society REMS Letter with attachment REMS Fact Sheet
1. Email within 30 calendar days of the date LYNOZYFIC is first commercially distributed and again 12 months later.
a. Send by mail within 30 calendar days of the date the first email was sent if a healthcare provider’s email address is not available, or the email is undeliverable.
b. Send a second email within 30 calendar days of the date the first email was sent if the first email is marked unopened.
c. Send by mail within 30 calendar days of the date the second email was sent if the second email is marked as unopened.
2. Disseminate through field-based sales and medical representatives for 12 months from the date LYNOZYFIC is first commercially distributed.
3. Disseminate within 30 calendar days of the date LYNOZYFIC 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. Advanced Practitioner Society for Hematology and Oncology (APSHO); American Geriatrics Society (AGS); American Pharmacists Association (APhA); American Society of Clinical Oncology (ASCO); American Society of Health-System Pharmacists (ASHP); American Society of Hematology (ASH); American Society for Transplantation and Cellular Therapy (ASTCT); Association of VA Hematology/Oncology (AVAHO); Eastern Cooperative Oncology Group and American College of Radiology Imaging Network (ECOG-ACRIN) Cancer Research group; HealthTree Foundation; Hematology Oncology Pharmacy Association (HOPA); International Myeloma Foundation (IMF); International Myeloma Society (IMS); International Society for Experimental Hematology (ISEH); Leukemia and Lymphoma Society (LLS); Michigan Society of Hematology and Oncology (MSHO); Multiple Myeloma Research Foundation (MMRF); National Comprehensive Cancer Network (NCCN); North American Immuno-Hematology Clinical Education and Research Consortium (NICER Consortium); Ohio Hematology Oncology Society (OHOS); Oncology Nursing Society (ONS); Society for Immunotherapy of Cancer (SITC); Society of Hematologic Oncology (SOHO); Southwest Oncology Group Cancer Research Network (SWOG CRN)
4. Disseminate at Professional Meetings where Regeneron Pharmaceuticals, Inc. has a presence for 12 months from the date LYNOZYFIC is first commercially distributed.
REMS Fact Sheet:
1. Disseminate at Professional Meetings where Regeneron Pharmaceuticals, Inc. has a presence for 12 months from the date LYNOZYFIC 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 LYNOZYFIC 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, Regeneron Pharmaceuticals, Inc. must:
1. Authorize dispensing for each patient’s first prescription based on verifying the prescriber is certified.
2. Establish and maintain the REMS Website, www.Lynozyficrems.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 LYNOZYFIC first becomes commercially available.
4. Establish and maintain a REMS Coordinating Center for REMS participants at 1-855-212-6391.
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 email.
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 database of certified pharmacies and healthcare settings.
12. Report serious adverse events of 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, Regeneron Pharmaceuticals, Inc. must:
13. Verify annually that the designated Authorized Representative for certified pharmacies and healthcare settings remains the same. If different, the pharmacy and healthcare setting must recertify with a new Authorized Representative.
14. Maintain adequate records to demonstrate that REMS requirements have been met, including, but not limited to records of: LYNOZYFIC distribution and dispensing; certification of prescribers; pharmacies and healthcare settings; authorized wholesalers-distributors; and audits of REMS participants. These records must be readily available for FDA inspections.
15. Monitor prescribers, pharmacies and 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.
16. Establish and maintain a plan for addressing noncompliance with REMS requirements.
17. Audit all certified pharmacies and healthcare settings no later than 180 calendar days after the pharmacy or healthcare setting receives their first shipment of LYNOZYFIC and annually thereafter to ensure that all REMS processes and procedures are in place, functioning, and support the REMS requirements.
18. Audit all wholesalers-distributors that have distributed LYNOZYFIC no later than 180 calendar days of being authorized to distribute LYNOZYFIC and annually thereafter to ensure that all REMS processes and procedures are in place, functioning, and support the REMS requirements.
19. Take reasonable steps to improve operations of and compliance with the requirements in the LYNOZYFIC REMS based on monitoring and evaluation of the LYNOZYFIC REMS.

IV. REMS Assessment Timetable

REMS TIMETABLE FOR SUBMISSION ASSESSMENTS

Regeneron Pharmaceuticals, Inc. must submit REMS Assessments 12 months from the date of the initial approval of the REMS (07/02/2025) and annually thereafter. 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. Regeneron Pharmaceuticals, 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 LYNOZYFIC REMS:

Enrollment Forms

Prescriber:

1. Prescriber Enrollment Form

Pharmacy and Healthcare Setting:

2. Pharmacy and Healthcare Setting Enrollment Form

Training and Educational Materials

Prescriber:

3. Prescriber Training Program
4. Adverse Reaction Management Guide
5. Knowledge Assessment

Patient:

6. Patient Wallet Card

Pharmacy and Healthcare Setting:

7. Pharmacy and Healthcare Setting Training Program

Communication Materials

8. Healthcare Provider REMS Letter
9. Professional Society REMS Letter
10. REMS Fact Sheet

Other Materials

11. 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. Elements to Assure Safe Use (ETASU)
    • Healthcare providers who prescribe LYNOZYFIC are specially certified under 505-1(f)(3)(A)
    • Pharmacies and healthcare settings that dispense LYNOZYFIC are specially certified under 505-1(f)(3)(B)
  3. Implementation System
  4. Timetable for Submission of Assessments

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Labels related to this REMS document

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DailyMed labelRelationVersionEffectiveManufacturerSource
These highlights do not include all the information needed to use LYNOZYFIC safely and effectively. See full prescribing information for LYNOZYFIC. LYNOZYFIC™ (linvoseltamab-gcpt) injection, for intravenous use Initial U.S. Approval: 2025SPL related document2025-07-02Regeneron Pharmaceuticals, Inc.20250907_8425ddd3-28d0-421c-bb57-bdabde2bd7ff.zip!ed438285-5806-4240-8019-9cbda319d96a.xml

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