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The goal of the LEMTRADA REMS is to mitigate the risks of autoimmune conditions, infusion reactions, stroke, and malignancies associated with LEMTRADA by:
Helping to ensure informed decisions about the safe use of LEMTRADA by:
Informing patients about the serious risks of autoimmune conditions, infusion reactions, stoke, and malignancies with LEMTRADA and the need for baseline and periodic monitoring; and
Informing healthcare providers about the serious risks of autoimmune conditions, infusion reactions, stroke, and malignancies with LEMTRADA, the need to counsel patients, and the need for baseline and periodic monitoring.
Helping to ensure the safe use of LEMTRADA by:
Ensuring that only certified prescribers prescribe LEMTRADA;
Ensuring that LEMTRADA is dispensed only in certain healthcare settings, by certified pharmacies, and certified healthcare facilities administering the infusion, which have on-site access to equipment and personnel trained to manage infusion reactions; and
Ensuring that only enrolled and authorized patients receive LEMTRADA;
Ensuring that certified prescribers submit documentation of periodic monitoring of patients who receive LEMTRADA to identify autoimmune conditions and malignancies.
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 Prescriber Knowledge
Assessment and submit it to the REMS.
Enroll in the REMS by completing the Prescriber
Enrollment Form and submitting it to the REMS.
Before treatment initiation
(first dose)
Counsel the patient on the risks associated with
LEMTRADA, including autoimmune conditions, infusion
reactions, stroke and malignancies, and the need for
baseline and periodic monitoring, using the LEMTRADA
Treatment and Infusion Reactions Patient Guide and the
Patient Safety Information Card. Provide a copy of the
materials to the patient.
Enroll the patient by completing and submitting the
Patient Enrollment and Prescription Ordering Form to
the REMS. Provide a completed copy to the patient and
retain a copy in the patient’s record.
Order the prescription using the Patient Enrollment and
Prescription Ordering Form and submit it to the REMS.
Before treatment initiation and
during treatment, within 30 days
prior to the first infusion date of
each treatment course
Assess the patient’s health status by completing the
laboratory testing and monitoring as described in the
Prescribing Information. Document and submit to the
REMS using Patient Authorization and Baseline Lab
Form.
During treatment, at periodic
intervals
Assess the patient’s health status by completing the
laboratory testing and monitoring as described in the
Prescribing Information.
Order the prescription using the Patient Enrollment and
Prescription Ordering Form and submit it to the REMS.
During treatment, every 6
months
Assess the patient for adverse events and completion of
laboratory testing and monitoring. Document and
submit to the REMS using the Patient Status Form.
After the last infusion, every 6
months for 48 months
Assess the patient for adverse events and completion of
laboratory testing and monitoring. Document and
submit to the REMS using the Patient Status Form.
At all times
Report any adverse events suggestive of autoimmune
conditions, infusion reactions, stroke, and malignancies
to Genzyme.
Report if an enrolled patient who has received
LEMTRADA within the last 48 months is no longer under
your care to Genzyme.
Document and submit to the REMS using the Patient
Transfer of Care Form, when transferring patients to a
new Healthcare Provider
Patients who are prescribed LEMTRADA:
Before treatment initiation
Receive counseling from the prescriber on the risks
associated with LEMTRADA, including autoimmune
conditions, infusion reactions, stroke and malignancies,
and the need for laboratory testing and monitoring,
using LEMTRADA Treatment and Infusion Reactions
Patient Guide and the Patient Safety Information Card.
Enroll in the REMS by completing the Patient
Enrollment and Prescription Ordering Form with the
prescriber. Enrollment information will be provided to
the REMS.
Get a skin exam.
Before treatment initiation, within
30 days prior to the first infusion
date of each treatment course
Be monitored for autoimmune conditions and/or
malignancies.
During treatment; after each
infusion for at least 2 hours
Be monitored for infusion reactions.
During treatment, at periodic
intervals
Be monitored for autoimmune conditions and/or
malignancies.
Inform the prescriber if you have had a stroke.
During treatment, yearly
Get a skin exam.
After last infusion, at periodic
intervals for 48 months
Be monitored for autoimmune conditions and/or
malignancies.
At all times
Inform the prescriber if any reactions or symptoms are
experienced after receiving LEMTRADA.
Have the Patient Safety Information Card with you.
Pharmacies that dispense LEMTRADA must:
To become certified to dispense
Designate an authorized representative to carry out
The certification process and oversee implementation
and compliance with the REMS on behalf of the
pharmacy.
Have the authorized representative review the REMS
Education Program.
Have the authorized representative enroll in the REMS
by completing the Pharmacy Enrollment Form and
submitting it to the REMS.
Train all relevant staff involved in dispensing
LEMTRADA using the REMS Education Program.
Establish processes and procedures to verify that the
Patient Enrollment and Prescription Ordering Form is
received for each prescription.
Before dispensing
Verify that the Patient Enrollment and Prescription
Ordering Form is received for each prescription
through the processes and procedures established as
a requirement of the REMS.
Obtain authorization to dispense each prescription by
contacting the REMS to verify that the prescriber is
certified, the healthcare facility administering the
infusion is certified, and the patient is enrolled and
authorized to receive LEMTRADA.
To maintain certification to
dispense, every 2 years
Have the authorized representative re-enroll in the
REMS by completing the Pharmacy Enrollment Form.
At all times
Maintain records of training.
Maintain records of all processes and procedures
including compliance with those processes and
procedures.
Comply with audits carried out by Genzyme to ensure
that all processes and procedures are in place and are
being followed.
Healthcare facilities that dispense and administer LEMTRADA must:
To become certified to dispense and
administer
Have the necessary on-site equipment and
personnel available to appropriately manage serious
infusion reactions (including anaphylaxis, cardiac
and respiratory emergencies).
Designate an authorized representative to carry out
the certification process and oversee implementation
and compliance with the REMS on behalf of the
healthcare facility.
Have the authorized representative review the REMS
Education Program.
Have the authorized representative enroll in the
REMS by completing the Healthcare Facility
Enrollment Form and submitting it to the REMS.
Train all relevant staff involved in the dispensing
and administration of LEMTRADA using the REMS
Education Program.
Establish processes and procedures to verify that (1)
the Patient Enrollment and Prescription Ordering
Form is received for each prescription, (2) patients
are counseled, (3) the patient is monitored for
infusion reactions during and for at least 2 hours
after each infusion, (4) the Infusion Checklist is
completed and submitted for each patient, and (5)
LEMTRADA is not dispensed outside of the certified
healthcare facility administering the infusion.
Before administering
Verify that the Patient Enrollment and Prescription
Ordering Form is received for each prescription
through the processes and procedures established
as a requirement of the REMS.
Obtain authorization to dispense each prescription
by contacting the REMS to verify that the prescriber
is certified and the patient is enrolled and authorized
to receive LEMTRADA.
Counsel the patient about the risk for infusion
During and after administering for at
least 2 hours
Assess the patient for infusion reactions.
After the last infusion, within 5
Complete the Infusion Checklist for each patient and
submit it to the REMS.
To maintain certification to dispense
and administer every 2 years
Have the authorized representative enroll in the
REMS by completing the Healthcare Facility
Enrollment Form and submitting it to the REMS.
At all times, within 75-business days
of submission of the Patient
Authorization and Baseline Lab Form
Return unused product to the distributor.
At all times
Not distribute, transfer, loan, or sell LEMTRADA.
Maintain records of training.
Maintain records of all processes and procedures
including compliance with those processes and
procedures.
Comply with audits carried out by Genzyme to
ensure that all training, processes and procedures
are in place and are being followed.
Wholesalers-distributors that distribute LEMTRADA must:
To be able to distribute
Establish processes and procedures to ensure that
the drug is distributed only to certified pharmacies
and certified healthcare facilities.
Train all relevant staff involved in distributing
LEMTRADA on the REMS requirements.
At all times
Distribute only to certified pharmacies and certified
healthcare facilities.
Maintain and submit patient level distribution
records of all shipments of LEMTRADA to the REMS.
Maintain records of all processes and procedures
including compliance with those processes and
procedures.
C Maintain records of all processes and procedures
including compliance with those processes and
procedures.
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 Lemtrada 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
03/27/2026
Revised to update the LemtradaREMS.com website to include a scheduled site maintenance page to alert users when the website is down as well as small edits to dates and version numbers
03/04/2024
Modified to make updates to the REMS website to replace static screenshots with links to the most recently approved US Prescribing Information (USPI) and REMS Education Program; updates to
the Patient Reminder Letter to reflect that email and phone patient reminder options are removed and patient reminders are only sent by post-mail; and changes to the audit
requirement to audit a representative sample of healthcare facilities.
12/15/2023
Revised to add a privacy cookie opt-out banner to the REMS website.
09/02/2022
Revised to make an editorial change.
03/12/2021
Modified to include the following:
Changes to the REMS materials to align with the labeling changes in supplements 5177 and 5179, which were approved on September 25, 2020
Changes to enable online enrollment of patients (and to enable an online digital
signature for LEMTRADA REMS patient enrollment forms)
Changes to allow pharmacies to obtain authorization to ship product
online via www.lemtradarems.com
Incorporation of formatting, layout, and wording changes to the Infusion Checklist to provide clarity and consistency with LEMTRADA REMS materials
Consolidation of selected REMS materials in order to eliminate redundancy
Change in the timeframe to return unused Lemtrada vials from 50 business days to 75 business days
Addition of a Patient Transfer of Care Form as a new REMS material
10/29/2019
Modified to make revisions to the REMS materials to reflect the revised Indications
and Usage statement and to incorporate myocardial ischemia as a potential
manifestation of infusion reactions associated with Lemtrada. In addition, the REMS
materials were revised to reflect the labeling revision advising prescribers to educate
patients that serious infusion reactions can occur at the time of infusion or within 48
hours after the last infusion.
04/23/2019
Modified to change the goals of the REMS from “to mitigate the risks of autoimmune conditions, infusion reactions, and malignancies associated with LEMTRADA” to “to mitigate the risks of
autoimmune conditions, infusion reactions, stroke, and malignancies associated with LEMTRADA.” Revisions to the appended materials to incorporate information about the risk of autoimmune
hepatitis, reflecting labeling changes approved on January 16, 2019.
11/28/2018
Modified to:
update the REMS document to the new format
change the REMS document and REMS materials to conform to labeling changes being approved with supplement 5160
reflect editorial changes to the REMS document and materials
04/05/2016
Modified to:
Make administrative and typographic changes to two Lemtrada REMS materials (the REMS Letter for Healthcare Providers and the Lemtrada REMS Infusion Checklist).
Make administrative and typographic changes, along with an update, to the Lemtrada REMS website.
09/18/2015
Modified to:
Update the Lemtrada logo throughout the REMS document and materials.
Add an option to complete and submit most of the required REMS forms online (with the exception of the Lemtrada REMS Patient Enrollment Form and the Lemtrada REMS Prescription Ordering Form).
Revise the REMS website that provide the ability to search for certified prescribers and healthcare facilities within the US and its territories.
11/14/2014
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.
