"Today, the U.S. Food and Drug Administration allowed marketing of the first test to help determine the risk for a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people using the drug Tysabri (natalizumab) to treat"...
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
NATALIZUMAB - INJECTION
COMMON 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.
USES: This medication is used to treat a type of multiple sclerosis that occurs when symptoms appear in cycles of worsening and improvement (relapsing/remitting multiple sclerosis-MS). It is not a cure for MS, but it is thought to help by preventing your immune system from attacking the nerves in your brain and spinal cord. It helps decrease the number of episodes of worsening and may prevent or delay disability.
Natalizumab is also used to treat a bowel condition called Crohn's disease (CD) when it is moderate to severe and/or keeps coming back. It is not a cure for CD, but it is thought to work by preventing your immune system from causing inflammation/swelling within your bowels.
Natalizumab is a protein called a monoclonal antibody.
HOW TO USE: This medicine comes with a Medication Guide. Read it carefully before you start using natalizumab and each time you receive another dose. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine.
This medication is given by a health care professional in an infusion center, usually every 4 weeks or as directed by your doctor. This medication is mixed in a solution and injected slowly into a vein, usually over 1 hour. It should not be given as a rapid injection. You will be monitored for 1 hour after your treatment is finished to make sure you do not have a serious reaction to the medication. (See also Side Effects section.)
It is important to use this medication regularly to get the most benefit from it. Do not miss any doses without your doctor's approval.
Tell your doctor if your condition worsens. When using this medication for Crohn's disease, if your condition does not improve after 12 weeks of treatment, your doctor will need to switch your treatment plan.
Additional Tysabri Information
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