natalizumab

Brand name(s):

Tysabri

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

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.

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.

What is natalizumab?

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 should I discuss with my healthcare provider before receiving natalizumab?

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.

You should not receive natalizumab if you have ever had a brain infection called progressive multifocal leukoencephalopathy.

Before receiving natalizumab, tell your doctor if you have:

HIV or AIDS;
herpes or shingles;
leukemia, lymphoma;
if you have had a recent organ transplant;
if you are using any steroid medicines; or
if you are being treated with chemotherapy or radiation.

If you have any of these conditions, you may need a dose adjustment or special tests to safely receive this medication.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether natalizumab passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

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