tysabri

Tysabri (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.

Tysabri is used 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.

Important information

Tysabri 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 changes in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly.

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.

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.

Tysabri 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.

Before taking this medicine

Tysabri 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.

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 are allergic to natalizumab, or if you have ever had a brain infection called progressive multifocal leukoencephalopathy.

To make sure Tysabri 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 Tysabri will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

See also: Pregnancy and breastfeeding warnings (in more detail)

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

How is Tysabri given?

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

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.

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

After you receive your injection, 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.

Tysabri 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 Tysabri, 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 Tysabri. Do not miss any scheduled visits.

Tysabri dosing information

Usual Adult Dose for Multiple Sclerosis:

300 mg IV, infused over approximately 1 hour, every 4 weeks

Usual Adult Dose for Crohn"s Disease - Maintenance:

300 mg IV, infused over approximately 1 hour, every 4 weeks

If the patient with Crohn"s disease (CD) has not experienced therapeutic benefit by 12 weeks of induction therapy, Tysabri should be discontinued. For patients with CD that start Tysabri while on chronic oral corticosteroids, steroid tapering should commence as soon as a therapeutic benefit of Tysabri has occurred; if the patient cannot be tapered off of oral corticosteroids within 6 months of starting Tysabri, then it should be discontinued. Other than the initial 6-month taper, prescribers should consider discontinuing Tysabri for patients who require additional steroid use that exceeds 3 months in a calendar year to control their CD.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Tysabri 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 Tysabri?

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

Tysabri side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Tysabri: 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 Tysabri 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.

See also: Side effects (in more detail)

What other drugs will affect Tysabri?

Tell your doctor about all other medicines you use, especially:

• drugs that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection;

• other medicines to treat multiple sclerosis or Crohn"s disease;

• 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.