Approved Risk Evaluation and Mitigation Strategies (REMS)
Tysabri (natalizumab)
BLA #125104
REMS last update: 10/05/2020
What is the purpose of the REMS?
The goals of the Tysabri REMS are:
- To inform prescribers, infusion center healthcare providers, and patients about the risk of progressive multifocal leukoencephalopathy (PML) associated with TYSABRI including the increased risk of PML with longer treatment duration, prior immunosuppressant use and the presence of anti-JCV antibodies.
- 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.
View application holder(s) REMS Website
Healthcare Providers who prescribe Tysabri must
To become certified to prescribe |
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Before treatment initiation |
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During treatment; at 3 and 6 months after the first infusion and every 6 months thereafter until treatment discontinuation |
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During treatment; every 6 months |
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At treatment discontinuation |
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After treatment discontinuation; at 6 months |
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At all times |
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Pharmacies that dispense Tysabri must
To become certified to dispense |
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At all times |
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Infusion centers that dispense Tysabri must
To become certified to dispense |
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At all times |
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Patients who are prescribed Tysabri
Before the first prescription |
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During treatment |
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After treatment discontinuation |
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At all times |
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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).Material Name | Material Name Link |
---|---|
6-Month Discontinuation Questionnaire (CD) (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_6-Month_Discontinuation_Questionnaire_CD.pdf |
6-Month Discontinuation Questionnaire (MS) (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_6-Month_Discontinuation_Questionnaire_MS.pdf |
Change Prescriber Authorization Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_Change_Prescriber_Authorization_Form.pdf |
Helpful Information for Evaluation of New Neurologic Symptoms in Patients Receiving Tysabri (MS) (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_Helpful_Information_for_Evaluation_of_New_ Neurologic_Symptoms_in_Patients_Receiving_Tysabri.pdf |
Infusion Site Enrollment Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_Infusion_Site_Enrollment_Form.pdf |
Initial Discontinuation Questionnaire (CD) (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_Initial_Discontinuation_Questionnaire_CD.pdf |
Initial Discontinuation Questionnaire (MS) (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_Initial_Discontinuation_Questionnaire_MS.pdf |
Patient Status Report and Reauthorization Questionnaire (CD) (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_Patient_Status_Report_and_Reauthorization_Questionnaire_CD.pdf |
Patient Status Report and Reauthorization Questionnaire (MS) (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_Patient_Status_Report_and_Reauthorization_Questionnaire_MS.pdf |
Pharmacy Enrollment Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_Certified_Pharmacy_Enrollment_Form.pdf |
Pre-Infusion Patient Checklist (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_Pre-Infusion_Patient_Checklist.pdf |
Prescriber/Patient Enrollment Form (CD) (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_Prescriber_Patient_Enrollment_Form_CD.pdf |
Prescriber/Patient Enrollment Form (MS) (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_Prescriber_Patient_Enrollment_Form_MS.pdf |
REMS Document (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_REMS_Document.pdf |
REMS Full (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_REMS_Full.pdf |
REMS Website Screenshots (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_REMS_Website_Screenshots.pdf |
TOUCH Prescribing Program Educational Slide Set (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_TOUCH_Prescribing_Program_Educational_Slide_Set.pdf |
TOUCH Prescribing Program Overview (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_TOUCH_Prescribing_Program_Overview .pdf |
Understanding PML for Gastroenterologists (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tysabri_2020_10_05_Understanding_PML_for_Gastroenterologists.pdf |
What updates have been made to the REMS?
Date | Summary of change |
---|---|
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. |
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:
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10/14/2016 | Revised to correct typographical error(s). |
09/22/2016 | Modified to:
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05/12/2015 | Modified to:
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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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