natalizumab - injection, Tysabri
GENERIC NAME: NATALIZUMAB - INJECTION (NA-ta-LIZ-ue-mab)
BRAND NAME(S): Tysabri
WARNING: Natalizumab increases your risk of getting a rare but very serious (sometimes fatal) brain infection (progressive multifocal leukoencephalopathy-PML). This risk may be higher the longer you use natalizumab and if you recently used or are currently using other medications that weaken the immune system/increase your risk of infection (such as immunosuppressants, cancer chemotherapy) or other medications that affect the immune system (immunomodulators). Ask your doctor or pharmacist for more information. See also Side Effects and Drug Interactions sections. The risk of PML may also be higher if you have been infected with the virus that causes this infection (JC virus). Your doctor may order a test to see if you have been infected with this virus. Because this medication increases the risk of PML, it is usually used alone and only when other treatments have not worked or you are unable to use them.
In the US, natalizumab is only available to patients enrolled in the TOUCH Prescribing Program. In Canada, a similar program is called the Tysabri Care Program. There are two different TOUCH prescribing programs: MS TOUCH for patients with multiple sclerosis, and CD TOUCH for patients with Crohn's disease. Only doctors, infusion centers, and pharmacies enrolled in these programs may prescribe, inject, or provide this medication to patients. Talk with your doctor about the risks and benefits of this medication and other treatment choices. If you and your doctor decide that this is the best treatment for you, your doctor can help you enroll in the TOUCH program. Your doctor will monitor you very closely while you are using this medication, usually at least 3 times during the first year and every 6 months from then on.
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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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