Natalizumab Injection

Conditions Treated

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; 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 and causing damage.

Possible Side Effects

What Side Effects Can This 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:

• 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 using 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].

Usage Instructions

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

What Dietary Instructions Should I Follow

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

Are There Any Special Instructions

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 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). do not have any vaccinations without talking to your doctor.