U.S. Brand Names

Tysabri®

Canadian Brand Names

Tysabriâ„¢

Pharmacologic Category

Gastrointestinal Agent, Miscellaneous; Monoclonal Antibody, Selective Adhesion-Molecule Inhibitor

What key warnings should I know about before taking this medicine?

This medicine may rarely cause a severe brain infection called progressive multifocal leukoencephalopathy (PML). People with weakened immune systems are more at risk. Closely review the section in this leaflet which lists when to call your healthcare provider.

This medicine is only available to U.S. patients enrolled in the TOUCH prescribing Program. Canadian patients are encouraged to enroll in the Canadian Tysabri Care Programâ„¢ at 1-888-827-2827.

Please read the medication guide given to you.

Reasons not to take this medicine

• If you have an allergy to natalizumab or any other part of this medicine.

• If you are allergic to mouse proteins, talk with healthcare provider.

• Tell healthcare provider if you are allergic to any medicine. Make sure to tell about the allergy and how it affected you. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved.

• If you have had a brain infection called progressive multifocal leukoencephalopathy.

What is this medicine used for?

• This medicine is used to treat multiple sclerosis.

• This medicine is used to treat Crohn's disease.

How does it work?

• Natalizumab helps the body's immune system fight multiple sclerosis.

• It reduces irritation and inflammation.

How is it best taken?

• This medicine is given as an infusion into a vein over a period of time.

What do I do if I miss a dose? (does not apply to patients in the hospital)

• Call healthcare provider for instructions.

What are the precautions when taking this medicine?

• Serious infections have been reported with use of this medicine. If you have any infection, have many infections, or are taking antibiotics, talk with healthcare provider.

• If you have liver disease, talk with healthcare provider.

• If you have mental illness, talk with healthcare provider.

• Talk with healthcare provider before receiving any vaccinations. Use with this medicine may either increase the risk of serious infection or make the vaccination less effective.

• Tell dentists, surgeons, and other healthcare providers that you use this medicine.

• Check medicines with healthcare provider. This medicine may not mix well with other medicines.

• Tell healthcare provider if you are pregnant or plan on getting pregnant.

• Tell healthcare provider if you are breast-feeding.

What are some possible side effects of this medicine?

• Risk of infection. Avoid people with infections, colds, or flu.

• Depression.

• Headache.

• Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help.

• Belly pain.

• Diarrhea.

• Feeling tired or weak.

• Muscle weakness.

• Joint pain.

• Liver damage can rarely occur.

• Severe allergic reactions can rarely occur.

What should I monitor?

• You will be closely monitored by healthcare provider.

Reasons to call healthcare provider immediately

• If you suspect an overdose, call your local poison control center or emergency department immediately.

• Signs of a life-threatening reaction. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; or swelling of face, lips, tongue, or throat.

• Signs or symptoms of infection. These include a fever of 100.5 degrees or higher, chills, severe sore throat, ear or sinus pain, cough, increased sputum or change in color, painful urination, mouth sores, wound that will not heal, or anal itching or pain.

• If you are planning to harm yourself or the desire to harm yourself increases.

• Significant change in thinking clearly and logically.

• Sudden change in vision.

• Significant change in balance.

• Dark urine or yellow skin or eyes.

• Feeling extremely tired or weak.

• Severe muscle pain or weakness.

• Any rash.

• No improvement in condition or feeling worse.

How should I store this medicine?

• This medicine will be given to you in a healthcare setting. You will not store it at home.

General statements

• If you have a life-threatening allergy, wear allergy identification at all times.

• Do not share your medicine with others and do not take anyone else's medicine.

• Keep all medicine out of the reach of children and pets.

• Keep a list of all your medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant).

• Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Talk with healthcare provider before starting any new medicine, including over-the-counter, natural products, or vitamins.

Created: 2007-09-26 11:02:34.0

Modified: 2008-04-28 13:12:05.0

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