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To inform prescribers, infusion site healthcare providers, and patients about the risk of progressive multifocal leukoencephalopathy
(PML) associated with TYSABRI including the increased risk of PML with the presence of anti-JCV antibodies, longer treatment duration, and prior immunosuppressant use.
To warn against concurrent use with antineoplastic, immunosuppressant, or immunomodulating agents, and in patients who are immunocompromised.
To promote early diagnosis of PML and timely discontinuation of TYSABRI in the event of suspected PML.
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.
Assess the patient’s risk factors that increase the risk of progressive
multifocal leukoencephalopathy.
During treatment, 3
months after the first
infusion
Assess the patient’s signs, symptoms and risk factors for progressive
multifocal leukoencephalopathy.
During treatment, 6
months after the first
infusion and every 6
months thereafter
Assess the patient’s signs, symptoms and risk factors for progressive
multifocal leukoencephalopathy and whether the patient should continue
treatment. Document and submit the results to the REMS Program using
the Patient Status Report and Reauthorization Questionnaire.
| Patient Status Report and Reauthorization Questionnaire |
After treatment
discontinuation; initially
Assess the patient’s signs and symptoms for progressive multifocal
leukoencephalopathy. Document and submit to the REMS Program using
the Initial Discontinuation Questionnaire.
| Initial Discontinuation Questionnaire |
After treatment
discontinuation; 6
months later
Assess the patient’s signs and symptoms for progressive multifocal
leukoencephalopathy. Document and submit to the REMS Program using
the 6-Month Discontinuation Questionnaire.
At all times
Report cases of progressive multifocal leukoencephalopathy,
hospitalizations due to opportunistic infection, or deaths to the
Manufacturer.
Receive counseling from the prescriber on the benefits and risks of
treatment, and the need to promptly report any new or worsening
symptoms that persist over several days, especially nervous system
symptoms.
Have a list of medicines and treatments taken during the last month with
you.
Be monitored for signs, symptoms, and risk factors for progressive
multifocal leukoencephalopathy.
During treatment, 3
months and 6 months
after the first infusion,
and every 6 months
thereafter
Be monitored for signs, symptoms, and risk factors for progressive
multifocal leukoencephalopathy and the appropriateness of continuing
Tysabri.
After treatment
discontinuation; initially
and 6 months later
Be monitored for signs and symptoms of progressive multifocal
leukoencephalopathy.
At all times
Notify the REMS Program if you switch physicians or infusion sites.
Inform the prescriber of new or worsening symptoms that last several
days, especially nervous system symptoms including new or sudden
change in thinking, eyesight, balance, or strength, and other new or
worsening symptoms.
Pharmacies that dispense Tysabri must:
To become certified to
dispense
Designate an authorized representative to carry out the certification
process and oversee implementation and compliance with the REMS
Program on behalf of the pharmacy.
Take training provided by Biogen.
Have the authorized representative enroll in the REMS Program by
completing the Pharmacy Enrollment Form and submitting it to the REMS
Program.
| Pharmacy Enrollment Form |
Establish processes and procedures to verify the infusion site is
authorized.
Before dispensing
Verify that the infusion site is authorized through the processes and
procedures established as a requirement of the REMS Program.
At all times
Maintain records of the pharmacy’s Site Authorization Confirmation.
Comply with audits carried out by Biogen or a third party acting on behalf
of Biogen to ensure that all processes and procedures are in place and are
being followed.
Infusion sites that dispense Tysabri must:
To become certified to
dispense
Designate an authorized representative to carry out the certification
process and oversee implementation and compliance with the REMS
Program on behalf of the infusion site.
Take training provided by Biogen.
Have the authorized representative enroll in the REMS Program by
completing the Infusion Site Enrollment Form and submitting it to the
REMS Program.
| Infusion Site Enrollment Form |
Before administering
Obtain authorization to dispense each infusion for administration by
contacting the REMS Program or confirm receipt of a Notice of Patient
Authorization and no Notice of Patient Discontinuation to verify the patient
is authorized to receive the drug.
Provide the patient with the Medication Guide.
| Medication Guide |
Assess the patient’s health status for signs, symptoms and risk factors of
progressive multifocal leukoencephalopathy. Document using the Pre-
Infusion Patient Checklist.
| Pre-Infusion Patient Checklist |
During treatment,
within 1 business day of
the patient visit for
infusion
Submit the Pre-Infusion Patient Checklist to the REMS Program regardless
if the patient receives the infusion.
| Pre-Infusion Patient Checklist |
At all times
Maintain records of the infusion site’s Site Authorization Confirmation.
Comply with audits carried out by Biogen or a third party acting on behalf
of Biogen to ensure that all processes and procedures are in place and are
being followed.
Wholesaler-distributors that distribute Tysabri must:
To be able to distribute
Establish processes and procedures to ensure that the drug is distributed
only to certified pharmacies and infusion sites.
Train all relevant staff involved in distributing on the REMS Program
requirements.
At all times
Distribute only to certified pharmacies and infusion sites.
Maintain records to support that all processes and procedures are in place
and are being followed.
Comply with audits carried out by Biogen or a third party acting on behalf
of Biogen 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 Tysabri 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
09/01/2023
Editorial changes to update the approval dates in the recently approved REMS materials
08/24/2023
Modified to make change to the following materials:
REMS Document
Prescriber Enrollment Form
Patient Enrollment Form – Multiple Sclerosis
Patient Enrollment Form – Crohn’s Disease
Pharmacy Enrollment Form
Infusion Site Enrollment Form
Educational Slide Set
Overview
Understanding PML for Gastroenterologists – Crohn’s Disease
Pre-Infusion Patient Checklist
Patient Status Report and Reauthorization Questionnaire
Initial Discontinuation Questionnaire
6-Month Discontinuation Questionnaire
04/19/2023
Revised to make editorial changes to update the approval dates in the recently approved REMS materials.
04/11/2023
Modified the REMS document and materials to align with the labeling changes being approved to allow for in-home infusions and
additional changes to separate the joint Prescriber/Patient Enrollment Forms (MS) (CD)into a Prescriber Enrollment Form, Patient Enrollment Form (MS) and Patient
Enrollment Form (CD), as well as to streamline the materials. In addition, the scope of
the database requirement has been clarified.
12/10/2021
Modified to make:
Changes to the Tysabri Outreach: Unified Commitment to Health (TOUCH) Prescribing Program Educational Slide Set to align with the post-administration observation period revisions to the Tysabri prescribing information
Changes to the REMS document to update the format per the draft Format and Content of a REMS Document Guidance for Industry
Changes to update the list of products approved for Multiple Sclerosis (MS) in the following materials:
Patient Status Report and Reauthorization Questionnaire (MS)
Pre-Infusion Patient Checklist
Prescriber/Patient Enrollment Forms (MS)
Revised to reflect editorial changes to the following materials:
Prescriber/Patient Enrollment Forms (MS) (Crohn’s Disease)
Pharmacy Enrollment Form
Patient Status Report and Reauthorization Questionnaire (MS)
Pre-Infusion Patient Checklist
10/05/2020
Modified to remove the patient social security number field from the Patient/Prescriber Enrollment Forms.
07/07/2020
Revised to reflect editorial changes.
06/17/2020
Modified to make updates to the REMS document and materials to align with the labeling changes to the Tysabri prescribing information, and to streamline the Patient Status Report and Reauthorization Questionnaire – Crohn’s Disease and Initial Discontinuation Questionnaire – Crohn’s Disease by removing the section documenting ‘months of use’ of immunomodulatory/immunosuppressant therapies in the previous 6 months.
04/27/2020
Editorial changes to the REMS materials
04/21/2020
Modified to update the REMS document and REMS materials to align with updates to the Indications and Usage section. Updates to the Infusion
Site Enrollment Form and Certified Pharmacy Enrollment Form to include statements about the authorized representative and contact
information for certified infusion sites and pharmacies, respectively.
Updates to the list of other therapies for multiple sclerosis that should be avoided for use with Tysabri.
In addition, revision of the 6-Month Discontinuation Form – Crohn’s Disease (CD) to align it
with the multiple sclerosis (MS) version of this form and revision of "Full Prescribing Information" and “Boxed Warning” throughout all
appended REMS materials to "Prescribing Information" and “BOXED WARNING.
04/30/2018
Editorial revisions.
04/18/2018
Modified to:
Change selected REMS materials to reflect the addition of information noting that the risk
of developing PML may be associated with relative levels of serum anti-JCV antibody
compared to a calibrator as measured by ELISA (often described as an anti-JCV antibody
index value). This information has been included in the TOUCH Prescribing Program
Educational Slide Deck, and the following statement has been added to selected REMS
forms (the Prescriber/Patient Enrollment Forms, the Patient Status Report and
Reauthorization Questionnaires, the Initial Discontinuation Questionnaires, and the 6-
Month Discontinuation Questionnaire [MS]): “If an anti-JCV antibody index value is
available, please record it here:__”.
Removal of 12-Week Questionnaire for Crohn’s Disease from the REMS.
Changes to REMS educational materials to align with labeling changes approved on
August 16, 2017, pertaining to JCV granule cell neuronopathy, MRI monitoring for PML,
anti-JCV antibody testing following use of intravenous immunoglobulin, and acute
retinal necrosis caused by herpes viruses.
Minor formatting changes and editorial revisions.
10/14/2016
Revised to correct typographical error(s).
09/22/2016
Modified to:
Change the REMS to be consistent with safety labeling changes approved on May 18, 2016. The approved safety labeling change included the addition of “Periodic monitoring for radiographic signs consistent with PML should be considered to allow for an early diagnosis of PML. Lower PML-related mortality and morbidity have been reported following Tysabri discontinuation in patients with PML who were initially asymptomatic compared to patients with PML who had characteristic clinical signs and symptoms at diagnosis” within Section 5.1—Progressive Multifocal Leukoencephalopathy of the prescribing information.
Change the sponsor name change from Biogen Idec to Biogen in the REMS document and all REMS materials.
Update the list of immunosuppressants, antineoplastics, and immunomodulators with a recently approved medication for multiple sclerosis (Zinbryta [daclizumab]) in the REMS materials.
Change the signature statements to enable certified prescribers to delegate the completion of the forms to individuals within their office who are not certified prescribers in the reauthorization and discontinuation status forms.
Make format and editorial changes, typographical corrections, and update version and copyright dating throughout the REMS materials.
Delete the REMS call center hours of availability from all REMS materials.
05/12/2015
Modified to:
Be consistent with revisions to approved labeling in the Medication Guide and REMS forms and materials.
Reflect your current trademark guidelines and the new version number in the appended REMS materials.
Include products approved for multiple sclerosis and Crohn’s disease since the last REMS modification in the Prescriber-Patient Enrollment Forms and Pre-Infusion Patient Checklists.
Include new products in the lists of immunomodulatory or immunosuppressant products the patient currently receives or has received in the previous 6 months in the Patient Status Report and Reauthorization Questionnaires and the Patient Initial Discontinuation Questionnaire—CD.
12/15/2013
Modified to reflect the revision to the indication statement language and the new risk information regarding hepatotoxicity, meningitis, and encephalitis being approved with these supplements in the REMS document, multiple REMS forms and materials, and the Medication Guide.
05/24/2013
Modified to include information about monitoring of PML after discontinuation of Tysabri (natalizumab) in the Medication Guide, REMS document and the REMS materials (e.g., Prescriber/Patient Enrollment Forms and Reauthorization and Discontinuation Questionnaires for Multiple Sclerosis and Crohn’s Disease patients and the Understanding PML for Gastroenterologists document).
01/20/2012
Modified to include information about PML risk stratification in the Medication Guide, REMS document and REMS materials.
10/07/2011
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.
