Natalizumab injection

What is Natalizumab Injection?

NATALIZUMAB (Tysabri®) is used to help treat relapsing forms of multiple sclerosis. The medicine may help prevent relapses of multiple sclerosis, but the drug is not a cure. The medicine is only available through the TOUCH™ Prescribing Program. You must talk to your doctor, understand the risks and benefits of the medicine, and agree to all of the instructions in the program. If you have questions about this program, ask your health care provider, call 1—800—456—2255, or visit the Tysabri® website.

What should I tell my health care provider before I take this medicine?

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

• acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV) infection

• immune system problems

• leukemia or lymphoma

• organ transplant

• progressive multifocal leukoencephalopathy

• an unusual reaction to Natalizumab, murine proteins, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should this medicine be used?

The medicine will be given to you by slow intravenous infusion into a vein. Your infusions will be given by a health care professional. You will likely receive your infusions in a hospital, clinic, or office.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

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.

What if I miss a dose?

Follow the schedule for doses developed by your health care provider. You may want to use a calendar to help you know when your next dose is needed. If you cannot keep your appointment, call your health care provider.

What drug(s) may interact with Natalizumab?

• drugs that suppress your immune system

• medicines for cancer

• steroid medicines like prednisone or cortisone

• vaccines

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking Natalizumab?

Visit your doctor or health care professional for regular checks on your progress.

If you get a cold, other infection, or a persistent fever, call your doctor or health care professional for advice. Do not treat yourself. The medicine may decrease your body's ability to fight infections. The medicine may increase your chance of getting an unusual or serious infection.

Immediately report to your doctor any new or worsening symptoms such as a new or sudden change in your thinking, eyesight, balance, or strength that last several days.

Tell all of your doctors that you take this medicine.

You will need to see your doctor 3 months after the first dose of this medicine, 6 months after the first dose, and at least every 6 months thereafter.

Tell your doctor or health care professional if you had any reaction or unusual symptom to this medicine.

What side effects may I notice from receiving Natalizumab?

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

• any signs or symptoms of an infection such as a cough, fever or chills, runny nose, or sore throat

• changes in vision

• chest pain

• dark urine

• depression, feelings of sadness

• difficulty breathing, wheezing or shortness of breath

• dizziness

• irregular, missed, or painful menstrual periods

• light-colored stools

• loss of appetite, nausea

• muscle weakness

• problems with balance, talking, walking

• right upper belly pain

• unusually weak or tired

• yellowing of the eyes or skin

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

• headache

• nausea

Where can I keep my medicine?

This does not apply. This drug is usually given only in a hospital or in a clinic.