In the 2-year AFFIRM pivotal trial:

83% of patients taking TYSABRI had no sustained physical disability progression for 12 weeks vs 71% with placebo (primary endpoint: percentage with sustained increase in disability was 17% vs 29%; p<0.001)1,2

View the complete AFFIRM study description.


How do patients take TYSABRI?

TYSABRI is a 1-hour IV infusion administered once every 28 days.1

  • Recommended dose: 300 mg every 28 days
  • How supplied: 300 mg in a 15 mL, sterile, single-dose vial
    • Colorless, clear to slightly opalescent solution for dilution prior to IV infusion
    • Observe patients during the 1-hour IV infusion and for 1 hour after the infusion is complete

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.

Find an Infusion Center Near Your Patient

How effective is TYSABRI?

In the AFFIRM trial, a 2-year, multicenter, double-blind, placebo-controlled study in 942 patients with relapsing MS, TYSABRI significantly reduced1,2:

  • Disability progressiona
  • Annualized rate of relapse
  • The number of new Gd+ and new or newly enlarging T2-hyperintense lesions

AFFIRM=NAtalizumab Safety and EFFIcacy in Relapsing-Remitting MS; Gd+=gadolinium-enhancing; EDSS=Expanded Disability Status Scale.

aDefined as an increase of ≥1.0 point on the EDSS from baseline EDSS ≥1.0 that was sustained for 12 weeks, or a ≥1.5-point increase on the EDSS from a baseline EDSS of 0 that was sustained for 12 weeks.1

See Results From the AFFIRM Trial

What should I know about the safety and tolerability of TYSABRI?
  • TYSABRI increases the risk of PML, an opportunistic viral infection of the brain that usually leads to death or severe disability1
  • TYSABRI carries a black box warning for PML. Because of the risk of PML, TYSABRI is available only through a restricted distribution program under a REMS called the TOUCH® Prescribing Program1
  • TYSABRI is contraindicated in patients who have or have had PML, and in patients who have had a hypersensitivity reaction to TYSABRI1
  • The most common adverse reactions reported at an incidence of ≥10% with TYSABRI and ≥2% difference with placebo were headache (38% vs 33%), fatigue (27% vs 21%), infusion reactionsb (24% vs 18%), urinary tract infections (21% vs 17%), arthralgia (19% vs 14%), depression (19% vs 16%), pain in extremity (16% vs 14%), rash (12% vs 9%), gastroenteritis (11% vs 9%), and vaginitisc (10% vs 6%)1
  • For full safety information, please view the full Prescribing Information, including Boxed Warning

PML=progressive multifocal leukoencephalopathy; REMS=Risk Evaluation and Mitigation Strategy.

bInfusion reactions were defined as any event that occurred within 2 hours after the start of the infusion.
cPercentage based on female patients only.

Find Out More About the TOUCH Prescribing Program

Are there monitoring requirements for TYSABRI?
  • Healthcare professionals should monitor patients on TYSABRI for any new sign or symptom that may be suggestive of PML1
    • Periodic monitoring for radiographic signs consistent with PML should be considered to allow for an early diagnosis of PML. 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 TYSABRI
  • 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

PML=progressive multifocal leukoencephalopathy.

Find Out More About PML Risk

What financial assistance options are available to help patients get started on and pay for TYSABRI?

The Above MS™ program from Biogen gives patients access to Support Coordinators who can help them understand their insurance coverage and try to identify the best financial assistance solution for them. Our goal is that no one has to forgo treatment based solely on financial limitations.

Financial and insurance services include a $0 Copay Program with no income requirements and no enrollment time limit for eligible patients.d

To learn more about the financial services offered, patients can call one of our Support Coordinators at 1-800-456-2255, Monday through Friday, 8:30 AM to 8:00 PM ET.

dDepending on patients’ income or, in some cases, if their medication is obtained from an out-of-network provider, there may be an annual cap that limits the amount of assistance that they can receive over one year. 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.

Download the Access and Reimbursement Guide

What tools are available to help patients learn more?

Biogen, the company behind TYSABRI, has spent more than 20 years developing treatments for people with relapsing MS. For the most information, your patients can visit our patient-friendly website—

Remind your patients that Biogen Support Coordinators are available to assist with any questions or concerns. Patients can call 1-800-456-2255, Monday through Friday from 8:30 AM to 8:00 PM ET.

Learn About Services to Support Your Patients on TYSABRI

AFFIRM=NAtalizumab Safety and EFFIcacy in Relapsing-Remitting MS.