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Natalizumab (Injection)

Natalizumab (na-ta-LYE-zoo-mab)

Treats Crohn's disease (CD) and multiple sclerosis (MS) that has relapsed. This medicine is only used when other medicines do not work.

Brand Name(s):

Tysabri

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

You should not receive this medicine if you have had an allergic reaction to natalizumab. Do not use this medicine if you have or have had a brain infection called progressive multifocal leukoencephalopathy (PML).

How to Use This Medicine:

Injectable

  • Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
  • A nurse or other health provider will give you this medicine.
  • This medicine is injected slowly, and the needle will need to remain in place for about an hour. The medicine is usually given once every 4 weeks.
  • Your caregivers will observe you while you are receiving this medicine and for one hour afterward. This is to make sure you do not have any serious side effects from the medicine.
  • This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

If a dose is missed:

  • This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Make sure your doctor knows if you are using azathioprine (Imuran®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), interferon beta (Avonex®, Rebif®), 6-mercaptopurine (Purinethol®), or methotrexate (Rheumatrex®, Trexall®). Tell your doctor if you are also using other medicines to treat Crohn's disease (such as adalimumab, infliximab, Humira®, or Remicade®) or a steroid medicine (such as dexamethasone, prednisolone, prednisone, or Medrol®).

Warnings While Using This Medicine:

  • Make sure your doctor knows if you are pregnant or breastfeeding, or if you have liver disease, a fever, or any kind of infection. Tell your doctor if you have a condition that may weaken your immune system, such as HIV or AIDS, leukemia, lymphoma, or an organ transplant. Tell your doctor about any medicines you are taking that may weaken the immune system, such as cancer or steroid drugs.
  • This medicine is only given to patients who are enrolled in the TOUCH? prescribing program. Your doctor will explain the program and have you sign an enrollment form. Be sure to ask your doctor if you have any questions about the TOUCH? prescribing program. It is very important that you understand and follow all of the instructions for the program.
  • Your doctor may need to check your brain before you start using this medicine. To do this, you may need to have a test known as a Magnetic Resonance Imaging (MRI) scan.
  • This medicine may increase your risk of developing infections, including a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML). Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: back pain, blurred vision, confusion, convulsions, difficulty with walking or other movements, dizziness, drowsiness, fever, headache, problems with vision or speaking, or unusual tiredness or weakness.
  • This medicine may cause a rare condition called immune reconstitution inflammatory syndrome (IRIS). This may occur after a person who gets PML stops using the medicine. Tell your doctor right away if you have an inflammatory reaction to an infection that includes mild burning, stinging, or tingling of the skin, or a feeling of heat, redness, or swelling of the skin.
  • Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments. Blood tests may be needed to check for unwanted effects.
  • Tell your doctor right away if you start having dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellowing of your skin or the whites of your eyes. These could be symptoms of a serious liver problem.
  • This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; hives; itching; swelling of the face, tongue, and throat; trouble breathing; or chest pain after you receive this medicine.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Blurred vision or other changes in vision.
  • Burning pain on urination, or change in how much or how often you urinate.
  • Changes in your thinking, balance, or strength.
  • Chest pain or discomfort.
  • Dark-colored urine or pale stools.
  • Fast heartbeat.
  • Fever, chills, runny or stuffy nose, cough, sore throat, and body aches.
  • Headache, confusion, dizziness, or drowsiness.
  • Lightheadedness or fainting.
  • Nausea, vomiting, loss of appetite, or pain in your upper stomach.
  • Rapid weight gain.
  • Skin rash or itching.
  • Swelling in your hands, ankles, or feet.
  • Trouble breathing.
  • Unusual tiredness or weakness.
  • Warmth or redness in your face, neck, arms, or upper chest.
  • Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

  • Anxiety or depression.
  • Arm or leg pain.
  • Back pain.
  • Changes in weight.
  • Changes in your menstrual period.
  • Constipation, diarrhea, passing gas, or upset stomach.
  • Feeling of constant movement of self or surroundings.
  • Joint pain or swelling.
  • Muscle cramps or aches.
  • Pain, itching, burning, swelling, bleeding, or a lump under your skin where the needle is placed.
  • Sores or white patches on your lips, mouth, or throat.
  • Toothache.
  • Vaginal itching or discharge.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088


Last Updated: 4/4/2014

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