Medications and Drugs

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Brand Names: Tysabri

Generic Name: natalizumab (Pronunciation: nat ta LIZ yoo mab)

• What is natalizumab (Tysabri)?
• What are the possible side effects of natalizumab (Tysabri)?
• What is the most important information I should know about natalizumab (Tysabri)?
• What should I discuss with my healthcare provider before receiving natalizumab (Tysabri)?
• How is natalizumab given (Tysabri)?
• What happens if I miss a dose (Tysabri)?
• What happens if I overdose (Tysabri)?
• What should I avoid while receiving natalizumab (Tysabri)?
• What other drugs will affect natalizumab (Tysabri)?
• Where can I get more information?

What is natalizumab (Tysabri)?

Natalizumab is a monoclonal antibody that affects the actions of the body's immune system. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

Natalizumab is used in to treat relapsing forms of multiple sclerosis.

Natalizumab is also used to treat moderate to severe Crohn's disease in adults. It is usually given after other Crohn's disease medications have been tried without successful treatment of this condition.

Natalizumab may also be used for other purposes not listed in this medication guide.

What are the possible side effects of natalizumab (Tysabri)?

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash, hives, itching; dizziness, fever; nausea, vomiting; feeling flushed; chest pain, difficulty breathing; swelling of your face, lips, tongue, or throat; feeling light-headed or fainting.

Call your doctor at once if you have a serious side effect such as:

• change in your mental state, problems with speech or walking, decreased vision (these symptoms may start gradually and get worse quickly);
• upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• pain or burning when you urinate;
• cough with yellow or green mucus, stabbing chest pain, feeling short of breath;
• flu symptoms, sores or white patches in your mouth or on your lips;
• vaginal itching or discharge;
• tooth pain, gum pain or swelling; or
• flare of herpes infection (cold sores, blisters or lesions of the genital or anal area).

Less serious side effects may include:

• headache;
• tired feeling;
• joint or muscle pain;
• stomach pain, diarrhea;
• mild skin rash;
• depression;
• painful menstrual cramps; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about natalizumab (Tysabri)?

Natalizumab may cause a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines. Call your doctor right away if you any change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly.

Natalizumab is available only to select patients through a restricted-use program called the TOUCH Prescribing Program. To receive this medication, you must be enrolled in this program and meet all requirements. You will be interviewed before receiving each dose of this medicine to make sure you still meet these requirements.

During your natalizumab treatment, it is extremely important that your doctor check you every 3 to 6 months to make sure you are not developing any signs of serious infection. Do not miss any scheduled visits to your doctor.

Call your doctor at once if you develop any symptoms of liver damage, such as nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

You should also call your doctor right away if you develop any signs of infection such as fever, chills, sore throat, cough, stuffy nose, redness, pain, swelling, or painful urination.

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