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, 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.
Are there any treatments for PML?
- There is no known treatment, prevention, or cure for PML.
- Doctors may try to rapidly remove TYSABRI from a person's bloodstream through the use of plasma exchange (PLEX) to allow the immune system to re-establish itself. However, there is no evidence that plasma exchange has any benefit in the treatment of opportunistic infections such as PML.
- There are potential side effects of plasma exchange such as a drop in blood pressure or accumulation of fluid in the lungs. You should discuss plasma exchange with your prescriber if you have additional questions.
How many cases of PML have there been?
- In TYSABRI clinical trials, 3 cases of PML occurred (2 in MS trials, and 1 in Crohn's disease trials)
- The two MS patients who developed PML were taking TYSABRI and AVONEX at the same time. The one patient with Crohn's disease had a weakened immune system
- There have also been reports of PML in patients who have taken TYSABRI as a monotherapy since TYSABRI was reintroduced to the market in 2006
- An idependent committee reviewed over 3000 patients on TYSABRI in clinical trials for the possibility of PML
- These patients were on therapy for an average of 18 months
- While the risk was calculated to be 1/1000, it is believed to range from 0.2/1000 to 2.8/1000
- The absolute risk for PML in patients treated with TYSABRI cannot be precisely estimated
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