TYSABRI Indication and
Important Safety Information
TYSABRI is a prescription medicine approved for adult patients with relapsing forms of MS to slow the worsening of disability and decrease the number of flare-ups (relapses). Because TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection that usually causes death or severe disability, TYSABRI is generally recommended for patients that have not been helped enough by, or cannot tolerate, another treatment for MS. TYSABRI does not cure MS and has not been studied for longer than two years or in patients with chronic progressive MS.
Important Safety Information
- TYSABRI increases your chance of getting a rare brain infection that usually causes death or severe disability called 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 may be higher if you are also being treated with other medicines that can weaken your immune system, including other MS treatments. Therefore, you should not take certain medicines that weaken the immune system at the same time you are taking TYSABRI. Even if you use TYSABRI alone to treat your MS, you can still get PML.
- Your chance of getting PML increases if you have been exposed to JCV, the virus that causes PML. Your doctor may do a blood test to check if you have been exposed to JCV.
If you have been exposed to JCV, your chance of getting PML increases even more if:
- – You have received TYSABRI for a long time, especially longer than 2 years.
- – You have received certain medicines that can weaken your immune system before you start receiving TYSABRI.
Your risk of PML is greatest if you have all 3 risk factors listed above. If you haven't been exposed to JCV, you could still be at risk of getting PML due to the possibility of a false negative result or future exposure to JCV. Because of this risk, you may want to be retested periodically. Your doctor should discuss the risks and benefits of TYSABRI treatment with you before you decide to take TYSABRI.
- If you take TYSABRI, it is important to call your doctor right away if you have 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 available only through the TOUCH® Prescribing Program (TOUCH), which is a restricted distribution program. Only prescribers, patients, and infusion centers enrolled in TOUCH can prescribe, receive, and infuse TYSABRI. In order to receive TYSABRI, you must talk to your doctor and agree to all of the instructions in TOUCH.
- You should not receive TYSABRI if you have PML or are allergic to TYSABRI or any of its ingredients.
- TYSABRI is not recommended if you have a medical condition that can weaken your immune system, such as HIV infection or AIDS, leukemia or lymphoma, organ transplant, or others, or if you are taking medicines that weaken your immune system.
- Tell your doctor about all of the medicines you take or have taken.
- Tell your doctor if you are pregnant or are trying to become pregnant or if you are breastfeeding or plan to breastfeed. TYSABRI can pass into your breast milk. It is not known if the TYSABRI that passes into breast milk can harm your baby.
- Serious side effects with TYSABRI include an increase in your chance of getting an unusual or serious infection, because it can weaken your immune system.
- Other serious side effects with TYSABRI include allergic reactions (e.g., hives, itching, trouble breathing, chest pain, dizziness, wheezing, chills, rash, nausea, flushing of skin, low blood pressure), including serious allergic reactions (e.g., anaphylaxis) and infections. Serious allergic reactions usually happen within 2 hours of the start of the infusion, but can happen any time after receiving TYSABRI. Tell your doctor or nurse right away if you have any symptom of an allergic reaction. You may need treatment if you are having an allergic reaction.
- TYSABRI may cause liver damage. Symptoms of liver damage include yellowing of the skin and eyes (jaundice), unusual darkening of the urine, nausea, feeling tired or weak, or vomiting. Blood tests can be done to check for liver damage. Call your doctor right away if you experience any symptoms of liver damage.
- Common side effects include headache, urinary tract infection, lung infection, pain in your arms and legs, vaginitis, stomach area pain, feeling tired, joint pain, depression, diarrhea, and rash. Tell your doctor about any side effect that bothers you or does not go away.