Tysabri (Natalizumab) Patient Information: Side Effects and Drug Images at RxList

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May 27, 2012

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Tysabri Patient Information Including Side Effects

Brand Names: Tysabri

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

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 any of these serious side effects:

nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
signs of infection such as fever, chills, body aches, flu symptoms, sore throat, cough, redness, pain, swelling, or painful urination;
weakness on one side of the body, loss of balance or coordination;
change in your mental state, problems with speech or walking, decreased vision (these symptoms may start gradually and get worse quickly);
easy bruising or bleeding, unusual weakness;
white patches or sores inside 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;
joint or muscle pain;
stomach pain;
depression;
painful menstrual cramps; or
drowsiness, tiredness.

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 increases the risk of 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 have symptoms such as 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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