Tysabri

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Tysabri


Generic Name: Natalizumab (nay-tal-IZ-oo-mab)
Brand Name: Tysabri

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). 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.


Tysabri is used for:

Treating relapsing forms of multiple sclerosis (MS). It is used to slow the worsening of physical disability and to reduce the number of symptom flare-ups. Tysabri is usually given to patients who cannot use other MS treatments or for whom other MS treatments do not work.

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

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 immune system problems, 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 for cancer

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), or immunosuppressants (eg, azathioprine) 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 this medicine 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 blood counts and magnetic resonance imaging (MRI) scans, may be performed while you use this medicine. These tests may be used to monitor your condition or check for side effects.
  • 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:

Diarrhea; headache; joint pain; muscle cramps; 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; chills; depression; dizziness; fast heartbeat; feeling cold; fever; flushing; muscle pain; nausea; painful menstrual periods; painful urination or changes in your amount of urine; right-sided back, stomach, or side pain; severe or persistent headache or tiredness; shortness of breath; sore throat; suicidal thoughts or attempts; swelling of the hands, ankles, or legs; tremor; vaginal discharge, itching, or odor; vomiting.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or 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/findyour.htm), or emergency room immediately.

Proper storage of Tysabri :

Tysabri is 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.

Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.




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