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Patient Medication Guide
Prescriber Information

What You Need to Know Before Taking TYSABRI

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, you can still get PML. Your chance of getting PML increases with a longer period of treatment or if you have received medicines that can weaken your immune system prior to starting TYSABRI.
  • 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.
  • If you get PML, your doctor will monitor you for certain new or worsening symptoms that can happen suddenly after you get PML. Contact your doctor right away if you think your general health status is getting worse.

How many cases of PML have there been?

  • For more information about the cases of PML, ask your healthcare provider.