FDA.reportPublic FDA data

TYRUKO - Sandoz Inc

Manufacturer
Sandoz Inc
Effective date
2025-10-30
Label type
RISK EVALUATION & MITIGATION STRATEGIES
Version
4
Source
full-release
Hydrated at
2026-06-04 22:50:43

Label at a glance#

ProductTYRUKO
Label structure6 sections

Label contents#

Full prescribing information#

I. Administrative Information

REMS Administrative Information

Risk: progressive multifocal leukoencephalopathy

Application Number: BLA 761322

Application Holder: Sandoz

REMS Approval: 08/2023

Most Recent REMS Update: 10/2025

II. REMS Goals

REMS Goals

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 progressive multifocal leukoencephalopathy 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 progressive multifocal leukoencephalopathy and timely discontinuation of TYRUKO in the event of suspected progressive multifocal leukoencephalopathy.

III. REMS Requirements

REMS Requirements

Sandoz must ensure that health care providers, patients, pharmacies, infusion sites, and wholesalers-distributors comply with the following requirements:

1. Health Care Providers who prescribe TYRUKO must:

REMS Participant Requirements

To become certified to prescribe

  1. Review the drug’s Prescribing Information.
  2. 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).
  3. Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS Program.

Before treatment initiation (first dose)

  1. 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.
  2. Enroll the patient by completing and submitting the Patient Enrollment Form – Multiple Sclerosis or Patient Enrollment Form – Crohn’s Disease to the REMS Program.
  3. Assess the patient’s risk factors that increase the risk of progressive multifocal leukoencephalopathy.

During treatment; 3 months after the first infusion

  1. 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

  1. 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

  1. 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

  1. 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

  1. Report cases of progressive multifocal leukoencephalopathy, hospitalizations due to opportunistic infection, or deaths to Sandoz.

2. Patients who are prescribed TYRUKO:

REMS Participant Requirements

Before treatment initiation

  1. Review the Medication Guide and the Patient Enrollment Form – Multiple Sclerosis or Patient Enrollment Form – Crohn’s Disease.
  2. 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.
  3. 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.
  4. Be monitored for risk factors that increase the risk of progressive multifocal leukoencephalopathy.

During treatment, before each infusion

  1. Review the Medication Guide.
  2. Have a list of medicines and treatments taken during the last month with you.
  3. 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

  1. 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

  1. Be monitored for signs and symptoms of progressive multifocal leukoencephalopathy.

At all times

  1. Notify the REMS Program if you switch physicians or infusion sites.
  2. 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.

3. Pharmacies that dispense TYRUKO must:

REMS Participant Requirements

To become certified to dispense

  1. Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS Program on behalf of the pharmacy.
  2. Have the authorized representative review the Educational Slide Set.
  3. Have the authorized representative enroll in the REMS Program by completing the Pharmacy Enrollment Form and submitting it to the REMS Program.
  4. Establish processes and procedures to verify that the infusion site is authorized.

Before dispensing

  1. Verify that the infusion site is authorized through the processes and procedures established as a requirement of the REMS Program.

At all times

  1. Maintain records of the pharmacy’s Site Authorization Confirmation.
  2. 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.

4. Infusion sites that dispense TYRUKO must:

REMS Participant Requirements

To become certified to dispense

  1. 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.
  2. Have the authorized representative review the Educational Slide Set.
  3. 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

  1. 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.
  2. Provide the patient with the Medication Guide.
  3. 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

  1. Submit the Pre-Infusion Patient Checklist to the REMS Program regardless of whether the patient receives the infusion.

At all times

  1. Maintain records of the infusion site’s Site Authorization Confirmation.
  2. 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.

5. Wholesalers-distributors that distribute TYRUKO must:

REMS Participant Requirements

To be able to distribute

  1. Establish processes and procedures to ensure that the drug is distributed only to certified pharmacies and infusion sites.
  2. Train all relevant staff involved in distributing on the REMS Program requirements.

At all times

  1. Distribute only to certified pharmacies and infusion sites.
  2. Maintain records to support that all processes and procedures are in place and being followed.
  3. 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.

 

REMS Applicant Requirements

Sandoz must provide training to health care providers who prescribe TYRUKO.

The training includes the following educational materials: Educational Slide Set, Overview, and either Helpful Information for Evaluation of New Neurological Symptoms in Patients Receiving TYRUKO (Multiple Sclerosis) or Understanding PML for Gastroenterologists (Crohn’s Disease). The training must be provided online or in hard copy format via fax or mail.

Sandoz must provide training to pharmacies and infusion sites that dispense TYRUKO.

The training includes the following educational materials: Educational Slide Set, Overview, and Pre‑Infusion Checklist. The training must be provided online or in hard copy format via fax or mail.

To support REMS Program operations, Sandoz must:

  1. Authorize dispensing for each patient based on receipt of the Patient Enrollment Form – Multiple Sclerosis or Patient Enrollment Form – Crohn’s Disease, and Patient Status Report and Reauthorization Questionnaire on the following schedule:

    Prior to initiation of treatment, authorize the first dispensing based on the receipt of the Patient Enrollment Form – Multiple Sclerosis or Patient Enrollment Form – Crohn’s Disease. If a completed Patient Enrollment Form – Multiple Sclerosis or Patient Enrollment Form – Crohn’s Disease is not received, the patient is not authorized to receive the drug.

    For subsequent dispensings, authorize dispensing based on receipt of a valid Patient Status Report and Reauthorization Questionnaire within 183 calendar days of the start of the authorization period indicated on the last Patient Status Report and Reauthorization Questionnaire If a valid Patient Status Report and Reauthorization Questionnaire is not received within 183 calendar days or prior to authorization expiration, the patient is not authorized to receive the drug until the completed form is received.

  2. Establish and maintain a REMS Program Website, www.TYRUKO-REMS.com. The REMS Program Website must include the capability to complete prescriber, pharmacy, and infusion site certification or enrollment online, the capability to enroll and manage patients online, and the option to print the Prescribing Information, Medication Guide, and REMS materials. All product websites for consumers and healthcare providers must include prominent REMS-specific links to the REMS Program Website. The REMS Program Website must not link back to the promotional product website(s).

  3. Ensure infusion sites are able to obtain patient authorization prior to each infusion online and by fax.
    1. For www.TYRUKO-REMS.com: obtain the patient authorization status online
    2. For paper-based/fax infusion sites: provide the current Notice of Patient Authorization or Notice of Patient Discontinuation
  5. Make the REMS Program Website fully operational and all REMS materials available through the website and REMS Program Contact Center within 30 calendar days of REMS approval (08/24/2023).

  6. Establish and maintain a REMS Program Contact Center for REMS participants at 1-855-489-7856.

  7. Establish and maintain a validated, secure database of all REMS participants who are enrolled and/or certified in the TYRUKO REMS Program. This database includes a reporting and collection system for all patients to provide information on progressive multifocal leukoencephalopathy.

  8. Share duration of natalizumab product exposure, presence of anti-JCV antibodies, prior treatment with immunosuppressants, and prior or current history of Progressive Multifocal Leukoencephalopathy with REMS programs for other natalizumab products for patients switched to or from another natalizumab product.

  9. Ensure health care providers, patients, pharmacies, and infusion sites are able to complete prescriber, patient, pharmacy, and infusion site certification or enrollment, complete pre-infusion checklists, report patient status, reauthorize patients, report patient discontinuation, or report a change in prescriber online or via a paper-based process.

  10. Ensure that a Medication Guide is made available for dispensing with each TYRUKO prescription.

  11. Notify prescribers after they become certified in the REMS Program.

  12. Notify pharmacies and infusion sites after they become certified in the REMS Program by providing a Site Authorization Confirmation.

  13. Provide certified prescribers access to the database of certified pharmacies, certified infusion sites, and enrolled patients.

  14. Provide certified pharmacies access to the database of certified infusion sites and enrolled patients.

  15. Provide certified infusion sites access to the database of enrolled patients.

  16. Provide authorized wholesaler-distributors access to the database of certified infusion sites and certified pharmacies.

To ensure REMS participants’ compliance with the REMS Program, Sandoz must:

  1. Ensure the Patient Status Report and Reauthorization Questionnaire is received for each patient. If the form is not received by the date the Patient Status Report and Reauthorization Questionnaire is due, Sandoz must contact the prescriber for the form. The patient is not authorized to receive the drug until the form is received.

  2. Maintain adequate records to demonstrate that REMS requirements have been met, including, but not limited to records of: drug distribution and dispensing; certification of prescribers, pharmacies, and infusion sites; enrolled patients; and audits of REMS participants. These records must be readily available for FDA inspections.

  3. Establish a plan for addressing non-compliance with REMS Program requirements.

  4. Monitor certified prescribers, pharmacies, infusion sites, and wholesalers-distributors on an ongoing basis to ensure the requirements of the REMS are being met. Take corrective action if non-compliance is identified, including de-certification.

  5. Audit certified infusion sites, certified pharmacies, specialty pharmacies, and the wholesaler-distributor(s) in accordance with the audit plan each year to ensure compliance with respective REMS requirements.

  6. Take reasonable steps to improve implementation of and compliance with the requirements in the TYRUKO REMS Program based on monitoring and evaluation of the TYRUKO REMS Program.

IV. REMS Assessment Timetable

REMS Timetable for Submission Assessments

Sandoz must submit REMS Assessments at 6 months and 12 months from the date of the initial approval of the REMS (08/24/2023) and annually thereafter. To facilitate inclusion of as much information as possible while allowing reasonable time to prepare the submission, the reporting interval covered by each assessment should conclude no earlier than 60 calendar days before the submission date for that assessment. Sandoz must submit each assessment so that it will be received by the FDA on or before the due date.

V. REMS Materials

REMS Material

The following materials are part of the TYRUKO REMS:

Enrollment Forms:

Prescriber:

  1. Prescriber Enrollment Form

Patient:

  1. Patient Enrollment Form (Multiple Sclerosis)
  2. Patient Enrollment Form (Crohn’s Disease)

Pharmacy:

  1. Pharmacy Enrollment Form

Infusion sites:

  1. Infusion Site Enrollment Form

Training and Educational Materials:

Prescriber:

  1. Educational Slide Set
  2. Overview
  3. Helpful Information for Evaluation of New Neurologic Symptoms in Patients Receiving TYRUKO (Multiple Sclerosis)
  4. Understanding PML for Gastroenterologists (Crohn’s Disease)

Patient:

  1. Medication Guide

Pharmacy:

  1. Educational Slide Set
  2. Overview

Infusion sites:

  1. Educational Slide Set
  2. Overview

Patient Care Form:

  1. Pre-Infusion Patient Checklist
  2. Patient Status Report and Reauthorization Questionnaire
  3. Initial Discontinuation Questionnaire
  4. 6-Month Discontinuation Questionnaire

Other Materials:

  1. REMS Program Website
  2. Change Prescriber Authorization Form

VI. Statutory Elements

REMS Elements

This REMS is required under section 505-1 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355-1) and consists of the following elements:

  1. Medication Guide
  2. Elements to Assure Safe Use (ETASU):
    1. Health care providers who prescribe TYRUKO are specially certified under 505-1(f)(3)(A)
    2. Pharmacies and health care settings that dispense TYRUKO are specially certified under 505-1(f)(3)(B)
    3. TYRUKO is dispensed to patients with evidence or other documentation of safe-use conditions under 505-1(f)(3)(D)
    4. Each patient using TYRUKO is subject to certain monitoring under 505-1(f)(3)(E)
  3. Implementation System
  4. Timetable for Submission of Assessments

DailyMed REMS / Drug Safety Documents#

Labels related to this REMS document

DailyMed label, Relation, Version table
DailyMed labelRelationVersionEffectiveManufacturerSource
These highlights do not include all the information needed to use TYRUKO ® safely and effectively. See full prescribing information for TYRUKO . TYRUKO (natalizumab-sztn) injection, for intravenous use Initial U.S. Approval: 2023 TYRUKO (natalizumab-sztn) is biosimilar* to TYSABRI ® (natalizumab).SPL related document2025-10-31Sandoz Inc20251223_f6b039fc-8333-4b4e-b7bd-869f0b207e44.zip!213ffc6b-f760-4eb6-a1c8-a3693896b1df.xml

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TYRUKONATALIZUMAB-SZTNSandoz Incef653c36-dd4b-4e71-9d2d-40b8fea24b672025-10-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TYRUKO

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