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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
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.
Successfully complete the Knowledge Assessment and submit it to the
REMS.
| Knowledge Assessment |
Enroll in the REMS by completing and submitting the Prescriber Enrollment
Form to the REMS.
| Prescriber Enrollment Form |
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.
| Patient Wallet Card |
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 ELREXFIO:
Before treatment
Receive counseling from the prescriber using the Patient Wallet Card.
| Patient Wallet Card |
At all times
Have the Patient Wallet Card with you and inform other healthcare providers
about treatment with ELREXFIO.
| Patient Wallet Card |
Pharmacies and healthcare settings that dispense ELREXFIO 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 enroll in the REMS by completing and
submitting the Pharmacy and Healthcare Setting Enrollment Form to the
REMS.
| Pharmacy and Healthcare Setting Enrollment Form |
Train all relevant staff involved in dispensing ELREXFIO on the REMS
requirements using the Pharmacy and Healthcare Setting Training Program.
Before dispensing
Obtain authorization to dispense each prescription by contacting the REMS to
verify the prescriber is certified.
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 ELREXFIO 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 ELREXFIO dispenses and provide data to the REMS
and Wholesalers-Distributors, as requested.
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.
Wholesalers-distributors that distribute ELREXFIO must:
To be able to
distribute
Establish processes and procedures to ensure that ELREXFIO 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
monthly basis.
Comply with audits carried out by Pfizer Inc. or a third party acting on behalf
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 Elrexfio REMS, see the DailyMed link(s).
REMS assessment plan unavailable for posting at this time.
What updates have been made to the REMS?
Date
Summary of change
12/13/2023
Modified to update the Healthcare
Provider REMS Letter to specify time periods when the prescriber knowledge, attitude,
and behavior (KAB) surveys will be conducted.
08/14/2023
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.
