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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:
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
What do participants need to know?
Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.
Healthcare providers who prescribe LYNOZYFIC must:
To become certified to prescribe
Review the drug’s Prescribing Information.
Review the Prescriber Training Program and Adverse Reaction
Management Guide.
Successfully complete the Knowledge Assessment and submit it
to the REMS.
Enroll in the REMS by completing and submitting the
Prescriber Enrollment Form to the REMS.
Before treatment initiation (first step-up dose)
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.
Complete the Patient Wallet Card and provide the Patient Wallet
Card to the patient.
At all times
Report serious adverse events of CRS and neurologic toxicity,
including ICANS to the REMS.
Patients who are prescribed LYNOZYFIC:
Before treatment initiation
Receive counseling from the prescriber using the Patient Wallet
Card.
At all times
Have the Patient Wallet Card with you and inform other
healthcare providers about treatment with LYNOZYFIC.
Pharmacies and healthcare settings that dispense LYNOZYFIC must:
To become certified to dispense
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.
Have the Authorized Representative review the Pharmacy and
Healthcare Setting Training Program.
Have the Authorized Representative enroll in the REMS by
completing and submitting the Pharmacy and Healthcare Setting
Enrollment Form to the REMS.
Train all relevant staff involved in dispensing LYNOZYFIC on the
REMS requirements using the Pharmacy and Healthcare Setting
Training Program.
Establish processes and procedures to verify the prescriber is
certified for all dispenses after the first prescription.
Before dispensing, first
prescription
Obtain authorization to dispense by contacting the REMS to
verify the prescriber is certified.
Before dispensing, all subsequent
prescriptions
Verify the prescriber is certified through the processes and
procedures established as a requirement of the REMS.
To maintain certification to
dispense
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 times
Report serious adverse events of CRS and neurologic toxicity,
including ICANS to the REMS.
Not distribute, transfer, loan or sell LYNOZYFIC except to
certified pharmacies and healthcare settings.
Maintain records of staff training.
Maintain records that processes and procedures are in place and
are being followed.
Maintain records of all LYNOZYFIC dispenses and provide data to
the REMS, as requested.
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.
Wholesalers-Distributors that distribute LYNOZYFIC must:
To be able to distribute
Establish processes and procedures to ensure that LYNOZYFIC is
distributed only to certified pharmacies and healthcare settings.
Train all relevant staff involved in distribution on the REMS
requirements.
At all times
Distribute only to certified pharmacies and healthcare settings.
Maintain records that all processes and procedures are in place
and are being followed.
Maintain and submit records of drug distribution to the REMS at
least on a weekly basis.
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.
What materials are included in the REMS?
The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Lynozyfic REMS, see the DailyMed link(s).
This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters,
and posted here as they become available.
What updates have been made to the REMS?
Date
Summary of change
07/14/2025
Revised to make editorial changes
07/02/2025
Approval of the REMS.
Disclaimer: This webpage provides general information about REMS programs
to various REMS participants (e.g., patients, pharmacies, and healthcare providers).
The summary information provided herein is not comprehensive and may not include
all of the information relevant to REMS participants. This webpage does not
constitute a replacement, modification, or revision of the approved REMS document,
including any appended REMS materials. Refer to the approved REMS document
for complete information on the REMS requirements for each approved application.
