Tysabri

Tysabri is used for:

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.

Do NOT use Tysabri if:

• you are allergic to any ingredient in Tysabri
• you have ever had PML
• you have Crohn disease and are also using an immunosuppressant (eg, azathioprine) or a tumor necrosis factor (TNF) inhibitor (eg, adalimumab)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tysabri :

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:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have liver problems, immune system problems, a fever, herpes, shingles, or an infection
• if you have a condition that may weaken your immune system (eg, HIV infection, leukemia, lymphoma) or you have had an organ transplant
• if you are receiving chemotherapy or radiation treatments, or you are taking corticosteroids (eg, prednisone)

Some MEDICINES MAY INTERACT with Tysabri . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Antineoplastics (eg, cisplatin), corticosteroids (eg, prednisone), immunomodulators (eg, interferon beta), immunosuppressants (eg, azathioprine), or TNF inhibitors (eg, adalimumab) because the risk of developing PML may be increased

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.

How to use Tysabri :

Use Tysabri as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Tysabri comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Tysabri refilled.
• Tysabri is usually given as an injection at your doctor's office, hospital, or clinic.
• If you miss a dose of Tysabri , contact your doctor right away.

Ask your health care provider any questions you may have about how to use Tysabri .

Important safety information:

• Tysabri may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Tysabri with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Tysabri may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• Serious allergic reactions have occurred with the use of Tysabri . If a serious reaction occurs, it is usually within 2 hours after you receive Tysabri . However, a serious reaction may occur at any time. Contact your doctor at once if you develop hives, itching, trouble breathing, chest pain, dizziness, chills, rash, nausea, or flushing.
• Tell your doctor or dentist that you use Tysabri before you receive any medical or dental care, emergency care, or surgery.
• Talk with your doctor before you receive any vaccine.
• Lab tests, including complete blood cell counts, liver function, and magnetic resonance imaging (MRI) scans, may be performed while you use Tysabri . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• You will need to see your doctor 3 months and 6 months after your first dose of Tysabri . You will also need to see your doctor at least every 6 months after that. Be sure to keep all doctor and lab appointments.
• Tysabri should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tysabri while you are pregnant. It is not known if Tysabri is found in breast milk. Do not breast-feed while you are using Tysabri .

Possible side effects of 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:

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.

If OVERDOSE is suspected:

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.

Tysabri is usually handled and stored by a health care provider. Keep Tysabri out of the reach of children and away from pets.

General information:

• If you have any questions about Tysabri , please talk with your doctor, pharmacist, or other health care provider.
• Tysabri is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

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.