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What should I discuss with my healthcare provider before receiving 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.
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.
If you have any of these other conditions, you may need a dose adjustment or special tests:
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.
How is natalizumab given (Tysabri)?
Natalizumab is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting every 4 weeks. Natalizumab must be given slowly, and the IV infusion can take up to 1 hour to complete.
Before you receive your first dose of natalizumab, your doctor may want you to have an MRI to make sure you do not have any signs of a brain infection.
After you receive natalizumab, your caregivers may want to watch you for at least 1 hour in case you have any type of reaction to the medication. An allergic reaction can occur up to 2 hours after your infusion.
During your 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. Your doctor may also want to check you for several weeks after you stop using natalizumab. Do not miss any scheduled visits to your doctor.
Natalizumab can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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