What is TYSABRI used for?

TYSABRI is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.1

Learn More About TYSABRI

What is natalizumab?

Natalizumab is the generic name for the FDA-approved monoclonal antibody marketed under the brand name TYSABRI.

Please see the full Prescribing Information, including Boxed Warning and Medication Guide.

Is there a REMS program for TYSABRI?

Because of the risk of progressive multifocal leukoencephalopathy (PML), TYSABRI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TOUCH® Prescribing Program.

Learn More About REMS: TOUCH Prescribing Program

How do patients take TYSABRI?

TYSABRI is a 1-hour IV infusion administered once every 4 weeks.1

  • Recommended dose: 300 mg infusion every 4 weeks
  • No premedication is required prior to infusion but may be administered based upon clinical judgment
  • Postinfusion observation: If no evidence of hypersensitivity reaction is observed after the first 12 infusions, a 1-hour postinfusion observation period is no longer required and is according to clinical judgment
    • If postinfusion observation is no longer required, total appointment time may be reduced by up to 50%
    • Total appointment time = infusion + observation

Remember: Only orders from infusion centers and certified pharmacies enrolled in and authorized by the TOUCH Prescribing Program will be processed. Contact Biogen at 1-800-456-2255.

Learn More About Dosing

What is the infusion protocol for TYSABRI?
  • Infuse TYSABRI 300 mg in 100 mL 0.9% Sodium Chloride Injection, USP, over ~1 hour (infusion rate ~5 mg/minute)1
    • Allow solution to warm to room temperature prior to infusion
    • Do not administer TYSABRI as an IV push or bolus injection
    • After the infusion is complete, flush with 0.9% Sodium Chloride Injection, USP
  • Observe patients during the infusion and for 1 hour after the infusion is complete for the first 12 infusions1
    • Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity-type reaction
    • For patients who have shown no evidence of a hypersensitivity reaction, postinfusion observation is according to clinical judgment after the first 12 infusions
  • Use of filtration devices during administration has not been evaluated. Other medications should not be injected into infusion set side ports or mixed with TYSABRI1
How do patients/prescribers locate infusion centers?
Where can I find information on TYSABRI's efficacy?
What is TYSABRI's safety profile?

Find Out More About the TOUCH Prescribing Program

What is the PML risk for TYSABRI?

The risk of developing progressive multifocal leukoencephalopathy (PML) while on treatment with TYSABRI is <1% regardless of JCV status.1

  • JCV infection is required for the development of PML1
  • Previous immunosuppressant use and treatment duration with TYSABRI are PML risk factors for JCV+ patients1
  • Biogen offers free anti-JCV antibody testing (the STRATIFY™ JCV Antibody assay) to support regular monitoring

JCV=John Cunningham virus.

Find Out More About PML Risk

Are there monitoring requirements for TYSABRI?
  • Healthcare professionals should monitor patients on TYSABRI for any new sign or symptom that may be suggestive of PML.1 Consider monitoring patients at high risk for PML more frequently
    • Patients should continue to be monitored for any new signs or symptoms that may be suggestive of PML for ~6 months after discontinuation of TYSABRI1
  • In TYSABRI-treated patients with PML, immune reconstitution inflammatory syndrome (IRIS) has been reported within days to several weeks after plasma exchange. Monitoring for development of IRIS and appropriate treatment of the associated inflammation should be undertaken1
  • Patients receiving TYSABRI should also be monitored for signs and symptoms of meningitis, encephalitis, acute retinal necrosis (ARN), hepatotoxicity, hypersensitivity reactions, and other infections, as well as JCV granule cell neuronopathy (GCN), that results in symptoms similar to PML and hemolytic anemia1
  • Biogen offers free anti-JCV antibody testing (the STRATIFY™ JCV Antibody assay) to support regular monitoring

JCV=John Cunningham virus; PML=progressive multifocal leukoencephalopathy.

Find Out More About PML Risk

Can patients take TYSABRI while pregnant or breastfeeding?

Before prescribing TYSABRI, ask your patients if they are pregnant or plan to become pregnant. It is not known if TYSABRI can harm fetal development; there are no adequate data on the risk associated with the use of TYSABRI in pregnant women. Natalizumab has been detected in human milk. There are no data on the effects of this exposure on the breastfed infant or the effects of the drug on milk production.1

Please see full Prescribing Information, including Boxed Warning.

What support can TYSABRI patients expect from a Nurse Educator?

Nurse Educators discuss treatment expectations, provide product and disease education, discuss infusion experience, and verify Risk Evaluation and Mitigation Strategy requirements.

Learn More About Nurse Educators

What financial assistance options are available for patients?

When cost may be a concern for your patients, Biogen is here to help them start and continue on TYSABRI.

We will work with your patients based on their individual needs. Biogen Support Services offers a variety of different financial and insurance resources, including:

  • Communicating with insurance companies to clarify and confirm coverage, including assistance with the Prior Authorization process and denied claims
  • Insurance counseling that educates uninsured and underinsured patients on government insurance programs
  • Financial assistance options, including:
    • The Biogen Copay Program, which may lower medication cost for eligible patients with commercial insuranceb
    • Other possible financial assistance, where applicable
  • Reimbursement services to provide coverage support in the administration of TYSABRI
  • An Infusion Copay Assistance Program for eligible patients

Help Your Patients Get Support
Your patients can call 1-800-456-2255 Monday-Friday from 8:30 AM to 8 PM ET. Hablamos español.

bEffective January 1, 2021, there is an annual cap on the amount of assistance that patients can receive over a one-year period. Federal and state laws and other factors may prevent or otherwise restrict eligibility. People covered by Medicare, Medicaid, the VA/DoD, or any other federal plans are not eligible to enroll. Patients are eligible to enroll in the Biogen Copay Program for as long as it is offered and they are treated with a Biogen relapsing MS medication. The Biogen Copay Program is no longer available for TECFIDERA patients in the states of Massachusetts and California.

Download the Access and Reimbursement Guide.