Tysabri



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Generic Name: natalizumab
(nat ta LIZ yoo mab)

What is Tysabri?

Tysabri 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.

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

Tysabri 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.

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

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

Tysabri increases the risk of 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 symptoms such as change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly.

Tysabri 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.

During your Tysabri 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, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, or jaundice (yellowing of your 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 should I discuss with my healthcare provider before receiving Tysabri?

Tysabri increases the risk of 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.

Tysabri 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 Tysabri if you have ever had a brain infection called progressive multifocal leukoencephalopathy.

Before receiving Tysabri, tell your doctor if you have:

  • HIV or AIDS
  • herpes or shingles
  • leukemia, lymphoma;
  • if you have had a recent organ transplant
  • if you are using any steroid medicines; or
  • if you are being treated with chemotherapy or radiation.

If you have any of these conditions, you may need a dose adjustment or special tests to safely receive this medication.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether Tysabri passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

How is Tysabri given?

Tysabri is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting every 4 weeks. The medicine must be given slowly through an IV infusion, and can take up to 1 hour to complete.

Before you receive your first dose of Tysabri, 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 Tysabri, 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.

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. 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 Tysabri injection.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine. Symptoms of a Tysabri overdose are unknown.

What should I avoid while receiving Tysabri?

Tysabri can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection.

What are the possible side effects of Tysabri?

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.

Call your doctor at once if you have any of these serious side effects:

  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes)
  • signs of infection such as fever, chills, body aches, flu symptoms, sore throat, cough, redness, pain, swelling, or painful urination
  • weakness on one side of the body, loss of balance or coordination
  • change in your mental state, problems with speech or walking, decreased vision (these symptoms may start gradually and get worse quickly)
  • easy bruising or bleeding, unusual weakness
  • white patches or sores inside 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
  • joint or muscle pain
  • stomach pain
  • depression
  • painful menstrual cramps; or
  • drowsiness, tiredness.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Tysabri?

Before receiving Tysabri, tell your doctor if you are taking any other medicines, especially those that may affect the immune system such as:

  • interferon (Roferon, Intron, Rebetron, Alferon, Avonex, Rebif, Betaseron, or Actimmune)
  • cyclosporine (Neoral, Sandimmune, Gengraf)
  • sirolimus (Rapamune), tacrolimus (Prograf)
  • basiliximab (Simulect), efalizumab (Raptiva), muromonab-CD3 (Orthoclone)
  • mycophenolate mofetil (CellCept)
  • azathioprine (Imuran), leflunomide (Arava), etanercept (Enbrel); or
  • if you are receiving chemotherapy or radiation treatments.

This list is not complete and there may be other drugs that can interact with Tysabri. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about Tysabri.


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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.