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natalizumab

Pronunciation: nat ta LIZ yoo mab

Brand: Tysabri

What is the most important information I should know about natalizumab?

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Natalizumab may cause a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines. Call your doctor right away if you have any change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly.

Natalizumab is available only to select patients through a restricted-use program called . To receive this medication, you must be enrolled in this program and meet all requirements. You will be interviewed before receiving each dose of this medicine to make sure you still meet these requirements.

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During your natalizumab treatment, it is extremely important that your doctor check you every 3 to 6 months to make sure you are not developing any signs of serious infection. Do not miss any scheduled visits to your doctor.

Call your doctor at once if you develop any symptoms of liver damage, such as nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

You should also call your doctor right away if you develop any signs of infection such as fever, chills, sore throat, cough, stuffy nose, redness, pain, swelling, or painful urination.

What is natalizumab?

Natalizumab is a monoclonal antibody that affects the actions of the body's immune system. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

Natalizumab is used in to treat relapsing forms of multiple sclerosis.

Natalizumab is also used to treat moderate to severe Crohn's disease in adults. It is usually given after other Crohn's disease medications have been tried without successful treatment of this condition.

Natalizumab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving natalizumab?

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Natalizumab may cause a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines.

Natalizumab is available only to select patients through a restricted-use program called the TOUCH Prescribing Program. To receive this medication, you must be enrolled in this program and meet all requirements. You will be interviewed before receiving each dose of this medicine to make sure you still meet these requirements.

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You should not receive natalizumab if you are allergic to it, or if you have ever had a brain infection called progressive multifocal leukoencephalopathy.

To make sure you can safely use natalizumab, tell your doctor if you have any of these other conditions:

  • HIV or AIDS;
  • herpes or shingles;
  • leukemia, lymphoma;
  • if you have ever tested positive for anti-JC virus (human polyomavirus) antibodies;
  • if you have had a recent organ transplant; or
  • if you are being treated with chemotherapy or radiation.
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FDA pregnancy category C. It is not known whether natalizumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

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Natalizumab can pass into breast milk and may harm a nursing baby. You should not breast-feed while receiving natalizumab.

How is natalizumab given?

Natalizumab is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting every 4 weeks. Natalizumab must be given slowly, and the IV infusion can take up to 1 hour to complete.

Before you receive your first dose of natalizumab, your doctor may want you to have an MRI to make sure you do not have any signs of a brain infection.

After you receive natalizumab, your caregivers may want to watch you for at least 1 hour in case you have any type of reaction to the medication. An allergic reaction can occur up to 2 hours after your infusion.

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Natalizumab can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.

During your treatment, it is extremely important that your doctor check you every 3 to 6 months to make sure you are not developing any signs of serious infection. Your doctor may also want to check you for several weeks after you stop using natalizumab. Do not miss any scheduled visits to your doctor.

What happens if I miss a dose?

Contact your doctor if you miss an appointment for your natalizumab injection.

What happens if I overdose?

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Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving natalizumab?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

What are the possible side effects of natalizumab?

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Get emergency medical help if you have any of these signs of an allergic reaction: skin rash, hives, itching; dizziness, fever; nausea, vomiting; feeling flushed; chest pain, difficulty breathing; swelling of your face, lips, tongue, or throat; feeling light-headed or fainting.

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Call your doctor at once if you have a serious side effect such as:

  • change in your mental state, problems with speech or walking, decreased vision (these symptoms may start gradually and get worse quickly);
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • pain or burning when you urinate;
  • cough with yellow or green mucus, stabbing chest pain, feeling short of breath;
  • flu symptoms, sores or white patches in your mouth or on your lips;
  • vaginal itching or discharge;
  • tooth pain, gum pain or swelling; or
  • flare of herpes infection (cold sores, blisters or lesions of the genital or anal area).

Less serious side effects may include:

  • headache;
  • tired feeling;
  • joint or muscle pain;
  • stomach pain, diarrhea;
  • mild skin rash;
  • depression;
  • painful menstrual cramps; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect natalizumab?

Tell your doctor about all other medicines you use, especially drugs that may affect the immune system such as:

  • drugs that weaken your immune system (such as cancer medicine or steroids);
  • cyclosporine (Neoral, Sandimmune, Gengraf);
  • mercaptopurine (Purinethol);
  • methotrexate (Rheumatrex, Trexall);
  • mycophenolate mofetil (CellCept);
  • azathioprine (Imuran), leflunomide (Arava), etanercept (Enbrel);
  • basiliximab (Simulect), muromonab-CD3 (Orthoclone);
  • interferon (Roferon, Intron, Rebetron, Alferon, Avonex, Rebif, Betaseron, or Actimmune); or
  • sirolimus (Rapamune), tacrolimus (Prograf).

This list is not complete and other drugs may interact with natalizumab. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about natalizumab.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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