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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 progressive multifocal leukoencephalopathy 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 progressive multifocal leukoencephalopathy and timely
discontinuation of TYRUKO 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.
Review the following: Educational Slide Set, Overview and Helpful
Information for Evaluation of New Neurological Symptoms in
Patients Receiving TYRUKO (Multiple Sclerosis) or Understanding
PML for Gastroenterologists (Crohn’s Disease).
Enroll in the REMS by completing the Prescriber Enrollment Form
and submitting it to the REMS Program.
Before treatment initiation (first
dose)
Counsel the patient using the Medication Guide and the Patient
Enrollment Form – Multiple Sclerosis or Patient Enrollment Form –
Crohn’s Disease. Provide a copy of the materials to the patient.
Enroll the patient by completing and submitting the Patient
Enrollment Form – Multiple Sclerosis or Patient Enrollment Form –
Crohn’s Disease to the REMS Program.
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.
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.
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
Sandoz.
Patients who are prescribed TYRUKO:
Before treatment initiation
Review the Medication Guide and the Patient Enrollment Form –
Multiple Sclerosis or Patient Enrollment Form – Crohn’s Disease.
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.
Enroll in the REMS Program by completing the Patient Enrollment
Form – Multiple Sclerosis or Patient Enrollment Form – Crohn’s
Disease with the prescriber. Enrollment information will be
provided to the REMS Program.
Be monitored for risk factors that increase the risk of progressive
multifocal leukoencephalopathy.
During treatment, before each infusion
Review the Medication Guide.
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 TYRUKO.
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 TYRUKO 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.
Have the authorized representative review the Educational Slide
Set.
Have the authorized representative enroll in the REMS Program by
completing the Pharmacy Enrollment Form and submitting it to the
REMS Program.
Establish processes and procedures to verify that 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 Sandoz or a third party acting on
behalf of Sandoz to ensure that all processes and procedures are in
place and are being followed.
Infusion sites that dispense TYRUKO 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.
Have the authorized representative review the Educational Slide
Set.
Have the authorized representative enroll in the REMS Program by
completing the Infusion Site Enrollment Form and submitting it to
the REMS Program.
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.
Assess the patients’ health status for signs, symptoms and risk
factors of progressive multifocal leukoencephalopathy. Document
using the 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 of whether the patient receives the infusion.
At all times
Maintain records of the infusion site’s Site Authorization
Confirmation.
Comply with audits carried out by Sandoz or a third party acting on
behalf of Sandoz to ensure that all processes and procedures are in
place and are being followed.
Wholesalers-distributors that distribute TYRUKO 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 being followed.
Comply with audits carried out by Sandoz or a third party acting on
behalf of Sandoz to ensure that all processes and procedures are in
place and 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 Tyruko REMS, see the DailyMed link(s).
This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters,
and posted here as they become available.
What updates have been made to the REMS?
Date
Summary of change
02/02/2026
Modified to consist of updates to the website
screenshots that include the addition of separate links for the Multiple Sclerosis and
Crohn’s Disease Patient Enrollment Forms to be printed and submitted via fax, the
addition of pharmacy locator tools, and additional editorial changes.
10/30/2025
Modified to consist of editorial changes, updates to the
logo, and updates to REMS materials to align with revisions to the PI related to the risk
for hematological abnormalities.
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.
