Pronunciation: nat ta LIZ yoo mab

Brand: Tysabri

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

Natalizumab may cause a serious viral infection of the brain that can lead to disability or death.

Call your doctor right away if you have any change in your mental state, decreased vision, weakness on one side of your body, or problems with speech or walking. These symptoms may start gradually and get worse quickly.

Natalizumab is available only to select patients through a restricted-use program. You must be registered in the program and understand the risks of taking this medicine.

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 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?

Natalizumab may cause a serious viral infection of the brain that can lead to disability or death, especially if you use this medicine long-term, or if you have used an immunosuppressant drug in the past.

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.

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 natalizumab is safe for you, tell your doctor if you have:

  • 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.

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 medicine.

Natalizumab can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How is natalizumab given?

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.

Natalizumab is injected into a vein through an IV. A healthcare provider will give you this injection.

Natalizumab is usually given once every 4 weeks. Follow your doctor's dosing instructions very carefully.

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.

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.

While using natalizumab, you may need frequent blood tests. You may also need a brain scan or spinal tap (lumbar puncture) if you develop signs of a brain infection.

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.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your natalizumab injection.

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

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?

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

Call your doctor at once if you have:

  • change in your mental state, weakness on one side of your body, problems with speech or walking, trouble using your arms and legs, decreased vision (these symptoms may start gradually and get worse quickly);
  • pain, itching, numbness, tingling, burning pain, red or blistering skin rash (especially on one side of the body);
  • fever, chills, headache, upset stomach;
  • sudden fever with neck stiffness and increased sensitivity to light; or
  • nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • headache, tired feeling;
  • nausea, diarrhea, stomach pain;
  • fever, chills, cough with yellow or green mucus;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • pain or burning when you urinate;
  • joint pain, pain in your arms and legs; or
  • vaginal itching or discharge.

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 medicines you use, and those you start or stop using during your treatment with natalizumab, especially:

  • other medicines to treat multiple sclerosis or Crohn's disease; or
  • drugs that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection.

This list is not complete. Other drugs may interact with natalizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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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