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Approved Risk Evaluation and Mitigation Strategies (REMS)

REMS that have more than one drug product but are not Shared System REMS will not display the product name and ingredient properly on this website due to database limitations. Please refer to the REMS document for the correct product names.

Tysabri (natalizumab)
BLA #125104
REMS last update: 09/01/2023



What is the purpose of the REMS?

The goals of the Tysabri REMS are:

  1. 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.
  2. To warn against concurrent use with antineoplastic, immunosuppressant, or immunomodulating agents, and in patients who are immunocompromised.
  3. 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.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

What assessment is available to the REMS?

Assessment Plan
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:

  1. 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:__”.
  2. Removal of 12-Week Questionnaire for Crohn’s Disease from the REMS.
  3. 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.
  4. Minor formatting changes and editorial revisions.
10/14/2016 Revised to correct typographical error(s).
09/22/2016 Modified to:

  1. 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.
  2. Change the sponsor name change from Biogen Idec to Biogen in the REMS document and all REMS materials.
  3. Update the list of immunosuppressants, antineoplastics, and immunomodulators with a recently approved medication for multiple sclerosis (Zinbryta [daclizumab]) in the REMS materials.
  4. 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.
  5. Make format and editorial changes, typographical corrections, and update version and copyright dating throughout the REMS materials.
  6. Delete the REMS call center hours of availability from all REMS materials.
05/12/2015 Modified to:

  1. Be consistent with revisions to approved labeling in the Medication Guide and REMS forms and materials.
  2. Reflect your current trademark guidelines and the new version number in the appended REMS materials.
  3. 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.
  4. 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.

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