natalizumab

What is the most important information I should know about natalizumab?

Natalizumab may cause a serious brain infection that can lead to disability or death, especially if you use natalizumab longer than 2 years, if you've used an immunosuppressant drug before, or if you've been infected with John Cunningham Virus (JCV).

What is natalizumab?

Natalizumab is used to treat relapsing forms of multiple sclerosis in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease).

Natalizumab is also used to treat moderate to severe Crohn's disease in adults. It is usually given after other medicines did not work or have stopped working.

Natalizumab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving natalizumab?

Natalizumab is available only under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Tell your doctor if you have ever had:

• fever, or an active infection;
• herpes or shingles;
• leukemia or lymphoma;
• HIV, AIDS, or other condition that can weaken your immune system;
• liver disease;
• an organ transplant; or
• hives, itching, or trouble breathing after a dose of natalizumab.

Tell your doctor if you are pregnant or breastfeeding.

How is natalizumab given?

Before your first dose, your doctor may recommend an MRI to make sure you do not have any signs of a brain infection.

Natalizumab is given as an infusion into a vein, usually once every 4 weeks. A healthcare provider will give you this injection, usually once every 4 weeks.

Natalizumab must be given slowly and the IV infusion can take at least 1 hour to complete. You will be watched closely for at least 1 hour after receiving natalizumab, to make sure you do not have an allergic reaction to the medication. An allergic reaction can occur up to 2 hours or longer after your infusion.

It is extremely important that your doctor check you every 3 to 6 months for signs of serious infection. Your doctor may also want to check you for several weeks after you stop using natalizumab.

Tell any doctor who treats you that you are using natalizumab.

What happens if I miss a dose?

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving natalizumab?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

What are the possible side effects of natalizumab?

Some allergic reactions may occur during the injection. Tell your caregiver right away if you feel dizzy, nauseated, light-headed, itchy, cold, sweaty, or if you have chest pain, trouble breathing, or swelling in your face.

• sudden fever or severe headache;
• confusion, memory problems, or other changes in your mental state;
• weakness on one side of your body;
• vision changes, eye pain or redness;
• problems with speech or walking; or
• trouble using your arms and legs.

• fever, chills, cough with yellow or green mucus;
• easy bruising, unusual bleeding (nosebleeds, bleeding gums, heavy menstrual periods), purple or red spots under your skin;
• any bleeding that will not stop;
• pain or burning when you urinate; or
• liver problems --nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Common side effects may include:

• headache, tired feeling;
• nausea, diarrhea, stomach pain;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• joint pain, pain in your arms and legs; or
• vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect natalizumab?

Tell your doctor about all your current medicines and any you start or stop using, especially drugs that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection.

Other drugs may affect natalizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your doctor or pharmacist can provide more information about natalizumab.