Natalizumab Injection

Receiving natalizumab injection may increase the risk that you will develop progressive multifocal leukoencephalopathy (PML; a rare infection of the brain that cannot be treated, prevented, or cured and that usually causes death or severe disability). The chance that you will develop PML during your treatment with natalizumab is higher if you have one or more of the following risk factors.

• A blood test shows that you have been exposed to John Cunningham virus (JCV; a virus that many people are exposed to during childhood that usually causes no symptoms but may cause PML in people with weakened immune systems).
• You have received many doses of natalizumab, especially if you have received treatment for longer than 2 years.
• You have ever been treated with medications that weaken the immune system, including azathioprine (Azasan, Imuran), cyclophosphamide (Cytoxan), methotrexate (Otrexup, Rasuvo, Reditrex, Trexall, Xatmep), mitoxantrone, and mycophenolate (CellCept, Myfortic).

Your doctor will probably order a blood test before or during your treatment with natalizumab injection to see if you have been exposed to JCV. If the test shows that you have been exposed to JCV, you and your doctor may decide that you should not receive natalizumab injection, especially if you also have one or both of the other risk factors listed above. If the test does not show that you have been exposed to JCV, your doctor may repeat the test from time to time during your treatment with natalizumab injection. You should not be tested if you have had a plasma exchange (treatment in which the liquid part of the blood is removed from the body and replaced with other fluids) during the past 2 weeks because test results will not be accurate.

There are other factors that may also increase the risk that you will develop PML. Tell your doctor if you have or have ever had PML, an organ transplant, or another condition that affects your immune system such as human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), leukemia (cancer that causes too many blood cells to be produced and released into the bloodstream), or lymphoma (cancer that develops in the cells of the immune system). Also tell your doctor if you are taking or if you have ever taken any other medications that affect the immune system such as adalimumab (Humira); cyclosporine (Gengraf, Neoral, Sandimmune); etanercept (Enbrel); glatiramer (Copaxone, Glatopa); infliximab (Remicade); interferon beta (Avonex, Betaseron, Extavia, Rebif); medications for cancer; mercaptopurine (Purinethol, Purixan); oral steroids such as dexamethasone, methylprednisolone (Depo-medrol, Medrol, Solu-medrol), prednisolone (Prelone), and prednisone (Rayos); sirolimus (Rapamune); and tacrolimus (Astagraf, Envarsus XR, Prograf). Your doctor may tell you that you should not receive natalizumab injection.

A program called the TOUCH program has been set up to help manage the risks of natalizumab treatment. You can only receive natalizumab injection if you are registered with the TOUCH program, if natalizumab is prescribed for you by a doctor who is registered with the program, and if you receive the medication at an infusion center that is registered with the program. Your doctor will give you more information about the program, will have you sign an enrollment form, and will answer any questions you have about the program and your treatment with natalizumab injection.

As part of the TOUCH program, your doctor or nurse will give you a copy of the Medication Guide before you begin treatment with natalizumab injection and before you receive each infusion. Read this information very carefully each time you receive it and ask your doctor or nurse if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

Also as part of the TOUCH program, your doctor will need to see you every 3 months at the beginning of your treatment, then every 6 months during your treatment to decide whether you should continue using natalizumab, and then at least 6 months after treatment is stopped. You will also need to answer some questions before you receive each infusion to be sure that natalizumab is still right for you and other questions after treatment is stopped.

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Call your doctor immediately if you develop any new or worsening medical problems during your treatment, and for 6 months after your final dose. Be especially sure to call your doctor if you experience any of the following symptoms: weakness on one side of the body that worsens over time; clumsiness of the arms or legs; changes in your thinking, memory, walking, balance, eyesight, or strength that last several days; confusion; or personality changes.

If your treatment with natalizumab injection is stopped because you have PML, you may develop another condition called immune reconstitution inflammatory syndrome (IRIS; swelling and worsening of symptoms that may occur as the immune system begins to work again after certain medications that affect it are started or stopped), especially if you receive a treatment to remove natalizumab from your blood more quickly. Your doctor will watch you carefully for signs of IRIS and will treat these symptoms if they occur.

Tell all the doctors who treat you that you are receiving natalizumab injection.

Talk to your doctor about the risks of receiving natalizumab injection.