TYSABRI IV

TYSABRI IV Warning

Natalizumab increases your risk of getting a rare but very serious (sometimes fatal) brain infection (progressive multifocal leukoencephalopathy-PML). This risk may be higher if you are also using other medications that weaken the immune system, such as other MS treatments (e.g., interferon) or immunosuppressants (e.g., azathioprine). (See also Drug Interaction section.)

Natalizumab is available only to patients enrolled in the TOUCH Prescribing Program. Only physicians, infusion centers, and pharmacies enrolled in this program may prescribe, inject, or provide this medication to patients. Talk with your doctor about the risks and benefits of this medication and other treatment choices. If you and your doctor decide that this is the best treatment for you, your doctor can help you enroll in the TOUCH program. Your doctor will monitor you very closely while you are using this medication, usually at least 3 times during the first year and every 6 months from then on.

TYSABRI IV Side Effects

Headache, joint pain, redness/irritation at the IV site, swelling of the hands/feet/ankles, or changes in menstrual cycle may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Report to your doctor immediately any side effects that may occur while this drug is being given or shortly after your treatment is finished. Examples of these side effects (infusion reaction) may include chills, fever, flushing, nausea, dizziness, tiredness, and chest pain.

Tell your doctor immediately if any of these unlikely but serious side effects occur:

• severe headache
• fast/pounding heartbeat
• signs of infection (e.g., fever, persistent sore throat, breathing problems, unusual vaginal discharge, painful/frequent urination)
• mood changes (e.g., depression, suicidal thoughts)
• severe stomach/abdominal pain