Approved Risk Evaluation and Mitigation Strategies (REMS)

Contact Us | REMS Basics | Gov Delivery Get REMS Email Alerts | Data Files

Tysabri (natalizumab)
BLA #125104
REMS last update: 05/12/2015

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

To be able to prescribe Tysabri
  • Review the prescribing information for Tysabri.
  • Review the educational materials for prescribers, including: Prescribing Program Educational Slide Set and Prescribing Program Enrollment Kits specific to Multiple Sclerosis (MS) or Crohn’s Disease (CD).
  • Enroll in the REMS by completing and submitting the Prescriber/Patient Enrollment Form (specific to MS or CD).
Before writing the first prescription for a patient
  • Counsel the patient on risks and benefits of Tysabri and to promptly report any new or worsening symptoms that persist over several days, especially nervous system symptoms.
  • For patients with CD, counsel the patient on other treatment options.
  • Provide the patient with a copy of the Medication Guide.
  • Assess the patient’s medical history for known contraindications to Tysabri.
  • Enroll the patient by completing and submitting the Prescriber/Patient Enrollment Form. Provide a completed copy of the form to the patient.
While patient is being treated with Tysabri
  • Evaluate the patient 3 months after the first infusion, and assess patient’s health status every 6 months by completing a Patient Status Report and Reauthorization Questionnaire (specific to MS and CD).
After a patient’s treatment has been discontinued
  • Immediately, assess patient’s health status by completing and submitting the Initial Discontinuation Questionnaire.
  • At six months, assess patient’s health status by completing and submitting the 6-Month Discontinuation Questionnaire.
Ongoing
  • Report cases of Progressive Multifocal Leukoencephalopathy (PML), hospitalizations due to opportunistic infection, or deaths to the sponsor as soon as possible.
  • Cooperate with periodic data collection.

Patients who receive Tysabri

To be able to receive Tysabri
  • Enroll in the REMS by completing the Prescriber/Patient Enrollment Form with the prescriber.
Before receiving the initial Tysabri prescription
  • Receive counseling from the prescriber about the risks and benefits of Tysabri using the Medication Guide.
While taking Tysabri
  • Adhere to the safe use conditions described in the Prescriber/Patient Enrollment Form specific to Multiple Sclerosis (MS) or Crohn’s Disease (CD).
Ongoing
  • Inform the prescriber if new or worsening symptoms that last several days. Some of these symptoms include a new or sudden change in my thinking, eyesight, balance, or strength, but I should also report other new or worsening symptoms.

Pharmacies that dispense Tysabri

To be able to dispense Tysabri
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
  • Train all relevant staff involved in the dispensing of Tysabri.
  • Enroll in the REMS by completing and submitting the Certified Pharmacy Enrollment Form.
Ongoing
  • Cooperate with audits carried out by the sponsor to ensure that all processes and procedures are in place and are being followed.

Infusion sites that dispense and administer Tysabri

To be able to dispense and administer Tysabri
  • Designate an authorized representative to carry out the certification process on behalf of the infusion site.
  • Train all relevant staff involved in dispensing and administering Tysabri.
  • Enroll in the REMS by completing and submitting the Infusion Site Enrollment Form.
Before each administration of Tysabri
  • Provide the patient with a copy of the Medication Guide.
  • Obtain authorization to dispense by contacting the TOUCH Prescribing Program.
  • Complete the Pre-Infusion Patient Checklist.
Ongoing
  • Cooperate with audits carried out by the sponsor 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.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.