Approved Risk Evaluation and Mitigation Strategies (REMS)

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Tysabri (natalizumab)
BLA #125104
REMS last update: 10/14/2016

View the Tysabri Prescribing Information and Medication Guide at DailyMed.
View Tysabri's Regulatory Information at Drugs@FDA

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

Healthcare Providers who prescribe Tysabri must

To become certified to prescribe
  • Review the drug’s Prescribing Information.
  • Review the Educational Slide Set and Prescribing Program Enrollment Kit.
  • Enroll in the REMS by completing the appropriate Prescriber/Patient Enrollment Form and submitting it to the REMS Program.
Before treatment initiation
  • Counsel the patient on the benefits and risks of treatment using the Medication Guide and Prescriber/Patient Enrollment Form.
  • Counsel the patient on to promptly report any new or worsening symptoms that persist over several days, especially nervous system symptoms.
  • For patients with Crohn's Disease, counsel the patient on other Crohn’s Disease treatment options.
  • Provide the patient with the Medication Guide.
  • Enroll the patient by completing and submitting the appropriate Prescriber/Patient Enrollment Form to the REMS Program. Provide a completed copy of the form to the patient.
During treatment; at 3 and 6 months after the first infusion and every 6 months thereafter until treatment discontinuation
  • Assess the patient’s signs and symptoms for progressive multifocal leukoencephalopathy (PML).
During treatment; every 6 months
  • To authorize continued treatment, complete and submit the appropriate Patient Status Report and Reauthorization Questionnaire.
At treatment discontinuation
  • Complete and submit the Initial Discontinuation Questionnaire.
  • For at least six months, assesses the patient’s signs and symptoms for PML.
After treatment discontinuation; at 6 months
  • Complete and submit the 6-Month Discontinuation Questionnaire.
At all times
  • Report cases of PML, hospitalizations due to opportunistic infection, or deaths to sponsor.

Patients who are prescribed Tysabri

Before the first prescription
  • Review the Medication Guide and appropriate Prescriber/Patient Enrollment Form.
  • Enroll in the REMS Program by completing the appropriate Prescriber/Patient Enrollment Form with the prescriber. Enrollment information will be provided to the REMS Program.
  • Receive counseling from the prescriber on the benefits and risks of treatment.
  • For a patient with Crohn’s Disease, receive counseling from the prescriber on other Crohn’s Disease treatment options.
During treatment
  • Be monitored for signs and symptoms of progressive multifocal leukoencephalopathy (PML).
After treatment discontinuation
  • Be monitored for signs and symptoms of progressive multifocal leukoencephalopathy (PML).
At all times
  • Inform the prescriber if any new or worsening symptoms that persist over several days, especially nervous system symptoms.

Pharmacies that dispense Tysabri must

To become certified to dispense
  • Receive training provided by the sponsor.
  • Enroll in the REMS Program by completing the Certified Pharmacy Enrollment Form.
At all times
  • Comply with audits carried out by the sponsor or to ensure that all processes and procedures are in place and are being followed.

Infusion centers that dispense Tysabri must

To become certified to dispense
  • Receive training provided by the sponsor.
  • Enroll in the REMS Program by completing the Infusion Site Enrollment Form.
  • Complete and submit the Pre-infusion Patient Checklist.
  • Provide the patient with the Medication Guide.
At all times
  • Comply with audits carried out by the application holder or 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:


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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