Important information you should know about TYSABRI
- TYSABRI increases your chance of getting a rare brain infection that
usually causes death or severe disability. This infection is called progressive
multifocal leukoencephalopathy (PML). PML usually happens in people with
weakened immune
systems
- No one can predict who will get PML
- There is no known treatment, prevention, or cure for PML
- Your chance of getting PML may be higher if you are also being treated with
other medicines that can weaken your immune system, including other MS
treatments
- Even if you use TYSABRI alone to treat your MS, it is not known if your
chance of getting PML will be lower. It is also not known if treatment for a
long period of time with TYSABRI can increase your chance of getting PML
- TYSABRI is available only through a restricted distribution program called
the TOUCH™ Prescribing Program. In order to receive TYSABRI, you must talk to
your doctor and understand the benefits and risks of TYSABRI and agree to all
of the instructions in the TOUCH Prescribing Program.
- If you take TYSABRI, it is important that you call your doctor right away
if you get any new or worsening medical problems (such as a new or sudden
change in your thinking, eyesight, balance, or strength or other problems) that
have lasted over several days. Tell all of your doctors that you are getting
treatment with TYSABRI.
TYSABRI is a prescription medicine approved for patients with relapsing
forms of MS to:
— Slow the worsening of disability that is common in patients with
MS
— Decrease the number of flare-ups (relapses)
- Because of the chance of getting PML, TYSABRI is generally recommended for
patients that have not been helped enough by, or cannot tolerate other
treatments for MS.
- TYSABRI does not cure MS.
- TYSABRI has not been studied for use longer than 2 years. Also, TYSABRI has
not been studied in patients with chronic progressive MS, or in children.
- It is not known if patients older than 65 years have a different response
to TYSABRI.
