Natalizumab injection (patient information)

IMPORTANT WARNING

Using natalizumab 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).

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 syndrome (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 any other medications that affect the immune system such as azathioprine (Imuran); cyclosporine (Neoral, Sandimmune); medications for cancer; other medications for multiple sclerosis (MS, a disease in which the nerves do not function properly and patients may experience weakness, numbness, loss of muscle coordination and problems with vision, speech and bladder control) including cyclophosphamide (Cytoxan), interferon beta (Avonex, Betaseron, Rebif), glatiramer (Copaxone), and mitoxantrone (Novantrone); methotrexate (Rheumatrex); sirolimus (Rapamune); and tacrolimus (Prograf). Your doctor may tell you that you should not use natalizumab.

Talk to your doctor about the risks of using natalizumab. Tell your doctor about all the other treatments you have used to control your multiple sclerosis. Your doctor will probably not prescribe natalizumab unless you have not been helped enough by other treatments for multiple sclerosis or you cannot use other treatments.

You will probably need to have a magnetic resonance imaging scan (MRI; a scan that shows pictures of the inside of the body) before you begin treatment with natalizumab.

A program called the TOUCH program has been set up to help manage the risks of natalizumab treatment. You can only receive natalizumab 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.

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 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.

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

Call your doctor immediately if you develop any new or worsening medical problems during your treatment. Be especially sure to call your doctor if you experience any changes in your thinking, balance, eyesight, or strength that last several days.

Tell all the doctors who treat you that you are using natalizumab.

Why is this medication prescribed

Natalizumab is used to prevent episodes of symptoms and slow the worsening of disability in patients with relapsing forms (course of disease where symptoms flare up from time to time) of multiple sclerosis (MS). Natalizumab has not been studied in people with chronic progressive MS (a form of MS in which symptoms are always present and become more severe as time passes). Natalizumab is in a class of medications called immunomodulators. It works by stopping certain cells of the immune system from reaching the brain and spinal cord and causing damage.

How should this medicine be used

Natalizumab comes as a concentrated solution (liquid) to be diluted and infused (injected over a long time) into a vein by a doctor or nurse. It is usually given once every 4 weeks in a registered infusion center. It will take about 1 hour for you to receive your entire dose of natalizumab.

Natalizumab may cause serious allergic reactions that are most likely to happen within 2 hours after the beginning of an infusion, but may happen at any time during your treatment. You will have to stay at the infusion center for 1 hour after your infusion is finished. A doctor or nurse will monitor you during this time to see if you are having a serious reaction to the medication. Tell your doctor or nurse if you experience any unusual symptoms such as those listed in the SIDE EFFECTS section, especially if they occur within 2 hours after the start of your infusion.

Natalizumab controls the symptoms of MS, but does not cure the condition. Keep all appointments to receive natalizumab even if you feel well.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow

Before using natalizumab

• tell your doctor and pharmacist if you are allergic to natalizumab or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention the medications listed in the IMPORTANT WARNING section. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had liver or kidney disease.Before you receive each infusion of natalizumab, tell your doctor if you have a fever or any type of infection, including infections that last for a long time such as shingles (a rash that may occur from time to time in people who have had chicken pox in the past).
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using natalizumab, call your doctor.
• do not have any vaccinations without talking to your doctor.

What special dietary instructions should I follow

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose

If you miss an appointment to receive a natalizumab infusion, call your doctor as soon as possible.

Side effects

Mild side effects

Natalizumab may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• extreme tiredness
• joint pain or swelling
• pain in arms or legs
• swelling of the arms, hands, feet, ankles, or lower legs
• muscle cramps
• stomach pain
• diarrhea
• weight gain or loss
• depression
• night sweats
• painful, irregular, or missed menstruation (period)
• swelling, redness, burning, or itching of the vagina
• white vaginal discharge
• stuffed or runny nose or other cold symptoms
• frequent or painful urination
• sudden need to urinate right away
• difficulty controlling urination
• tooth pain
• cold sores

Severe side effects

Some side effects can be serious. If you experience any of the following symptoms or those mentioned in the IMPORTANT WARNING section, call your doctor immediately:

• sore throat, fever, cough or other signs of infection
• rash
• hives
• itching
• difficulty breathing
• chest pain
• dizziness
• chills
• flushing

Natalizumab may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

What storage conditions are needed for this medicine

The medication will be stored at the infusion center.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know

Keep all appointments with your doctor.

Brand names

• Tysabri®