IMPORTANT WARNING
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.
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 (Imuran), cyclophosphamide (Cytoxan), methotrexate (Rheumatrex, Trexall), mitoxantrone, and mycophenolate mofetil (CellCept).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).
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Why is this medication prescribed?
Natalizumab is used to prevent episodes of symptoms and slow the worsening of disability in people who have relapsing forms (course of disease where symptoms flare up from time to time) of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control). Natalizumab is usually used by people who were not helped by other medications for MS or who cannot take these medications. Natalizumab is also used to treat and prevent episodes of symptoms in people who have Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) who have not been helped by other medications or who cannot take other medications. 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 or digestive tract and causing damage.
How should this medicine be used?
Natalizumab comes as a concentrated solution (liquid) to be diluted and injected slowly 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.
If you are receiving natalizumab injection to treat Crohn's disease, your symptoms should improve during the first few months of your treatment. Tell your doctor if your symptoms have not improved after 12 weeks of treatment. Your doctor may stop treating you with natalizumab injection.
Natalizumab may help control your symptoms, but will not cure your condition. Keep all appointments to receive natalizumab injection 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 receiving natalizumab injection,
tell your doctor and pharmacist if you are allergic to natalizumab, any other medications, or any of the ingredients in natalizumab injection. Ask your doctor or pharmacist for a list of the ingredients.
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 ever received natalizumab injection before and if you have or have ever had any of the conditions listed in the IMPORTANT WARNING section. 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 chickenpox in the past).
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving natalizumab injection, 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.
What side effects can this medication cause?
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
heartburn
constipation
gas
weight gain or loss
depression
night sweats
painful, irregular, or missed menstruation (period)
swelling, redness, burning, or itching of the vagina
white vaginal discharge
frequent or painful urination
sudden need to urinate right away
difficulty controlling urination
tooth pain
cold sores
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 or get emergency medical treatment:
sore throat, fever, cough or other signs of infection
rash
hives
itching
difficulty breathing
chest pain
dizziness
chills
flushing
yellowing of the skin or eyes
nausea
vomiting
unusual darkening of the urine
Natalizumab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
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 and the laboratory. Your doctor may order certain lab tests to check your body's response to natalizumab injection.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
