Tysabri

What is the most important information I should know about Tysabri?
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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.
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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.
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During your Tysabri treatment, it is imperative 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.
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Call your doctor at once if you develop any signs of infection such as fever, chills, sore throat, cough, stuffy nose, redness, pain, swelling, or painful urination.
What is Tysabri?
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Tysabri is a monoclonal antibody that affects the actions of the body's immune system.
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Tysabri is used in to treat relapsing forms of multiple sclerosis.
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Tysabri may also be used for purposes other than those listed in this medication guide.
What should I discuss with my healthcare provider before receiving Tysabri?
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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.
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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.
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You should not receive Tysabri if you have ever had a brain infection called progressive multifocal leukoencephalopathy.
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Before receiving Tysabri, tell your doctor if you have:
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HIV or AIDS;
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herpes or shingles;
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leukemia, lymphoma; or
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if you have had a recent organ transplant;
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if you are using any steroid medicines; or
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if you are being treated with chemotherapy or radiation.
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If you have any of these conditions, you may not be able to receive Tysabri, or you may need a dosage adjustment or special tests during treatment.
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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.
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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?
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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.
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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.
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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.
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During your treatment, it is imperative 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?
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Contact your doctor if you miss a dose of Tysabri.
What happens if I overdose?
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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?
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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.
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Do not receive a vaccine or flu shot while you are being treated with Tysabri, unless your doctor has told you to.
What are the possible side effects of Tysabri?
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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 any of these serious side effects:
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signs of infection such as fever, chills, body aches, flu symptoms, sore throat, cough, redness, pain, swelling, or painful urination;
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sudden change in your vision, balance, strength, or mental state;
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easy bruising or bleeding, unusual weakness;
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white patches or sores inside your mouth or on your lips;
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vaginal itching or discharge;
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tooth pain, gum pain or swelling; or
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flare of herpes infection (cold sores, blisters or lesions of the genital or anal area).
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Other, less serious side effects are more likely to occur, such as:
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headache;
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joint or muscle pain;
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stomach pain;
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depression;
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painful menstrual cramps; or
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drowsiness, tiredness.
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Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
What other drugs will affect Tysabri?
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Before receiving Tysabri, tell your doctor if you are taking any other medicines, especially those that may affect the immune system such as:
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interferon (Roferon, Intron, Rebetron, Alferon, Avonex, Rebif, Betaseron, or Actimmune);
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cyclosporine (Neoral, Sandimmune, Gengraf);
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sirolimus (Rapamune), tacrolimus (Prograf);
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basiliximab (Simulect), efalizumab (Raptiva), muromonab-CD3 (Orthoclone);
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mycophenolate mofetil (CellCept);
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azathioprine (Imuran), leflunomide (Arava), etanercept (Enbrel); or
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if you are receiving chemotherapy or radiation treatments.
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If you are using any of these drugs, you may not be able to receive Tysabri, or you may need dosage adjustments or special tests during treatment.
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There may be other drugs not listed that can affect 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.