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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.

Tyruko (natalizumab-sztn)
BLA #761322
REMS last update: 08/24/2023



What is the purpose of the REMS?

The goals of the TYRUKO REMS are:

  1. To inform prescribers, infusion site healthcare providers, and patients about the risk of progressive multifocal leukoencephalopathy (PML) associated with TYRUKO including the increased risk of PML with the presence of anti-JCV antibodies, longer treatment duration, 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 progressive multifocal leukoencephalopathy and timely discontinuation of TYURKO in the event of suspected progressive multifocal leukoencephalopathy.

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
08/24/2023 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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