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 purposes not listed in this medication guide.
What is the most important information I should know about natalizumab?
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 have 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 . 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, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the 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 should I discuss with my healthcare provider before receiving natalizumab?
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.
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.
You should not receive natalizumab if you are allergic to it, or if you have ever had a brain infection called progressive multifocal leukoencephalopathy.
To make sure you can safely use natalizumab, tell your doctor if you have any of these other conditions:
HIV or AIDS;
herpes or shingles;
leukemia, lymphoma;
if you have ever tested positive for anti-JC virus (human polyomavirus) antibodies;
if you have had a recent organ transplant; or
if you are being treated with chemotherapy or radiation.
FDA pregnancy category C. It is not known whether natalizumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
Natalizumab can pass into breast milk and may harm a nursing baby. You should not breast-feed while receiving natalizumab.