How is TYSABRI thought to work?
The specific mechanism(s) by which TYSABRI exerts its effects in relapsing MS have not been fully defined.1
In demyelinating diseases such as MS, evidence suggests α4-integrin may play a key role in inhibiting CNS migration of lymphocytes—a trigger in the inflammatory process in MS. TYSABRI is a monoclonal antibody that may help control inflammatory activity in MS through inhibition of α4-integrin.1,2
CNS = central nervous system.
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: Injection as 300 mg in 15 mL in a sterile, single-dose vial
- Colorless, clear to slightly opalescent solution for dilution prior to IV infusion
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.
How effective is TYSABRI?
In the AFFIRMa trial, a 2-year, multicenter, double-blind, placebo-controlled study in 942 patients with relapsing MS, TYSABRI significantly reduced1,3:
- Disability progressionb
- Annualized rate of relapse
- The number of new Gd+ and T2-hyperintense lesions
Gd+ = gadolinium-enhancing; EDSS = Expanded Disability Status Scale.
aNAtalizumab Safety and EFFIcacy in Relapsing-Remitting MS.
bDefined 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
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 reactions (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 vaginitis (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.
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.
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 forego 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.c
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.
cDepending 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.
What tools are available to help patients learn more?
Biogen, the company behind TYSABRI, has spent more than 15 years developing programs that support people with relapsing MS. For the most information, your patients can visit our patient-friendly website—TYSABRI.com.
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.