Tysabri increases the risk of a certain type of viral brain infection (progressive multifocal leukoencephalopathy [PML]). PML may cause severe disability or death. Your risk of PML may be greater if you take other medicines that may weaken your immune system, such as immunosuppressants (eg, azathioprine) or immunomodulators (eg, interferon beta). Your risk for developing PML may also increase with the number of infusions of Tysabri you receive. Tell your doctor at once if you notice any new or worsening symptoms. These may include changes in thinking, eyesight, balance, or strength.
You can only get Tysabri through a special program called the TOUCH Prescribing Program. Talk with your health care provider if you have questions about this program.
Treating certain forms of multiple sclerosis (MS). It is used to slow the worsening of physical disability and to reduce the number of symptom flare-ups. It is usually given to patients who cannot use other MS treatments or for whom other MS treatments do not work. Tysabri is also used to treat moderate to severe Crohn disease in certain patients.
Tysabri is a monoclonal antibody. Exactly how Tysabri works is not known. It may block certain inflammatory cells from getting into the brain, which may help slow the progression of MS. Tysabri does not cure MS.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Tysabri . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Tysabri . Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Tysabri may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Tysabri as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Tysabri .
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; drowsiness; headache; joint pain; muscle cramps; nausea; pain in the arms or legs; tiredness.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in balance, eyesight, strength, or thinking; chest pain or discomfort; dark urine; depression; dizziness; fast heartbeat; feeling cold; fever, chills, or persistent sore throat; flushing; muscle pain; painful menstrual periods; painful urination or changes in the amount of urine; right-sided back, stomach, or side pain; severe or persistent headache or tiredness; severe or persistent nausea or vomiting; shortness of breath or wheezing; suicidal thoughts or attempts; swelling of the hands, ankles, or legs; tremor; vaginal discharge, itching, or odor; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.Proper storage of Tysabri :
Tysabri is usually handled and stored by a health care provider. Keep Tysabri out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Tysabri . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.