Natalizumab injection

What is this medication?

NATALIZUMAB (na ta LIZ you mab) is used to treat relapsing multiple sclerosis. This drug is not a cure. It is also used to treat Crohn's disease.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Tysabri

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• immune system problems
• progressive multifocal leukoencephalopathy (PML)
• an unusual or allergic reaction to natalizumab, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• biologic medicines such as adalimumab, certolizumab, etanercept, golimumab, infliximab

This medicine may also interact with the following medications:

• azathioprine
• cyclosporine
• interferons
• 6-mercaptopurine
• methotrexate
• other medicines that lower your chance of fighting an infection
• steroid medicines like prednisone or cortisone
• vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medicine. Visit your doctor for regular check ups. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

Stay away from people who are sick. Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself.

In some patients, this medicine may cause a serious brain infection that may cause death. If you have any problems seeing, thinking, speaking, walking, or standing, tell your doctor right away. If you cannot reach your doctor, get urgent medical care.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• changes in vision
• chest pain
• confusion
• depressed mood
• dizziness
• feeling faint; lightheaded; falls
• general ill feeling or flu-like symptoms
• loss of memory
• missed menstrual periods
• muscle weakness
• problems with balance, talking, or walking
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• suicidal thoughts, mood changes
• unusual bruising or bleeding
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• headache
• joint pain
• muscle cramps
• muscle pain
• nausea, vomiting
• pain, redness, or irritation at site where injected
• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.