LEMTRADA REMS HEALTHCARE FACILITY ENROLLMENT FORM
Please enroll online at www.LemtradaREMS.com
or fax this completed form to the LEMTRADA REMS at 1-855-557-2478
For Healthcare
Facilities to Complete
*Indicates a mandatory field.
New Enrollment
Re-enrollment (every 2 years)
HEALTHCARE FACILITY AGREEMENT
I am the authorized representative designated by my healthcare facility to coordinate the activities of the LEMTRADA REMS. By signing
this form, I agree to comply with the following REMS requirements:
• I understand that my healthcare facility must be certified with the
LEMTRADA REMS to receive or administer LEMTRADA.
• I have completed the review of the LEMTRADA REMS Education
Program.
• I understand that my healthcare facility must confirm that
the patient is authorized to receive LEMTRADA by contacting
the LEMTRADA REMS or verifying online at
www.LemtradaREMS.com prior to initiation of each
treatment course.
• I understand the risk of serious infusion reactions during and
following the administration of LEMTRADA.
• I understand the risk of stroke during and following the
administration of LEMTRADA.
• I understand the need to monitor patients for infusion reactions
during and for at least 2 hours after each LEMTRADA infusion.
– To include the monitoring of patient vital signs before the
infusion and periodically during the infusion.
• I understand that my healthcare facility must be equipped with
the necessary on-site equipment and personnel to manage
anaphylaxis or serious infusion reactions.
• I understand that my healthcare facility must renew
enrollment in the LEMTRADA REMS every 2 years
from initial enrollment.
Please complete a separate Healthcare Facility Enrollment Form for each facility site, if applicable.
Name of Institution or Healthcare Facility* NPI Number*
Infusion Facility Address*
City* State* ZIP Code*
Ship-to Street Address (if different)*
City* State* ZIP Code*
Phone Number* Fax Number*
Email Address
Name of Authorized Healthcare Facility Representative* Title*
Site Affiliation
Academic
Government
Ambulatory/Freestanding
Hospital Based
Private Practice (in office)
HEALTHCARE FACILITY INFORMATION (PLEASE PRINT)
Please enroll online at www.LemtradaREMS.com or fax this completed form to the LEMTRADA REMS at 1-855-557-2478
If you have any questions regarding the LEMTRADA REMS, call 1-855-676-6326
HEALTHCARE FACILITY AGREEMENT (CONTINUED)
• This healthcare facility will establish procedures and protocols
that are subject to audit, to help ensure compliance with the
safe-use conditions required in the LEMTRADA REMS, including
the following:
– Ensure that a LEMTRADA REMS Patient Enrollment and
Prescription Ordering Form is received for each prescription.
– Ensure that the prescriber is certified and the patient is enrolled
and authorized by either calling the LEMTRADA REMS or
verifying this information via the LEMTRADA REMS website
prior to dispensing and administering LEMTRADA.
– Ensure that the infusion site is equipped to manage infusion
reactions.
– Ensure that LEMTRADA is not dispensed outside of the
authorized representative’s certified healthcare facility.
– Prior to the first day of each treatment course, counsel and
provide a copy of LEMTRADA Treatment and Infusion Reactions
Patient Guide to each patient to inform them about the risk of
serious infusion reactions.
– Observe each patient administered LEMTRADA at my
healthcare facility during and for at least 2 hours after each
LEMTRADA infusion, in order to provide appropriate medical
treatment in the event of serious infusion reactions following
LEMTRADA infusion.
– For each patient, complete and return the LEMTRADA REMS Infusion
Checklist to the LEMTRADA REMS Program within
5 business days from the patient’s last infusion of LEMTRADA
within a specific treatment course.
– Renew enrollment into the LEMTRADA REMS Program every
2 years from the initial enrollment.
• To make available to Genzyme documentation to verify
understanding of, and adherence to, the requirements of the
LEMTRADA REMS.
• To return to Genzyme any unused vials of LEMTRADA for patients
who will no longer receive infusions.
• To ensure that a LEMTRADA REMS Patient Authorization and
Baseline Lab Form is received for each prescription by either
calling the LEMTRADA REMS or verifying this information
via the LEMTRADA REMS website.
• To ensure that all non-prescribing HCPs who administer
LEMTRADA in my healthcare setting are trained using the
LEMTRADA REMS Education Program, and a record regarding
such training must be maintained.
©2022 Genzyme Corporation. All rights reserved.
Lemtrada and Sanofi are registered in U.S. Patent and Trademark Office.
US.MS.LEM.14.11.004-v6-07/2022
SIGNATURE
Authorized Healthcare Facility Representative Signature* Date*
Print Name* Title
