Generic Name: natalizumab (NA-ta-LIZ-ue-mab)
Brand Name: Tysabri
Tysabri increases the risk of a certain type of viral brain infection (progressive multifocal leukoencephalopathy [PML]). PML may cause severe disability or death. Your risk of PML may be greater if you take or have recently taken other medicines that may weaken your immune system, such as immunosuppressants (eg, 6-mercaptopurine, azathioprine, cyclosporine, methotrexate) or immunomodulators (eg, interferon beta). Your risk of developing PML may also increase if you have been exposed to JC virus or if you have used Tysabri for a long time, especially over 2 years. Tell your doctor at once if you notice any new or worsening symptoms while taking Tysabri or within 6 months after you stop taking it. These may include changes in thinking, eyesight, balance, memory, or strength; clumsiness; confusion; one-sided weakness; personality changes; or problems using your arms and legs.
You can only get Tysabri through a special program called the TOUCH Prescribing Program. Talk with your health care provider if you have questions about this program.
Tysabri is used for:
Treating certain forms of multiple sclerosis (MS) by slowing the worsening of physical disability and reducing the number of symptom flare-ups. It is usually given to patients who cannot use other MS treatments or for whom other MS treatments have not worked well enough. Tysabri is also used to treat moderate to severe Crohn disease in certain patients.
Tysabri is a monoclonal antibody. Exactly how it works is not known. It may work by blocking certain inflammatory cells from getting into the brain, which may help slow the progression of MS.
Do NOT use Tysabri if:
- you are allergic to any ingredient in Tysabri
- you have ever had PML
- you have Crohn disease and are also using an immunosuppressant (eg, 6-mercaptopurine, azathioprine, cyclosporine, methotrexate) or a tumor necrosis factor alpha (TNF-alpha) inhibitor (eg, adalimumab)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Tysabri:
Some medical conditions may interact with Tysabri. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have liver problems, immune system problems, a fever, herpes, shingles, or an infection
- if you have a condition that may weaken your immune system (eg, HIV infection, leukemia, lymphoma) or you have had an organ transplant
- if you are receiving chemotherapy or radiation treatments, or you are taking corticosteroids (eg, prednisone)
- if you have been tested and know whether or not you have anti-JC virus antibodies
Some MEDICINES MAY INTERACT with Tysabri. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Antineoplastics (eg, cisplatin), corticosteroids (eg, prednisone), immunomodulators (eg, interferon beta), immunosuppressants (eg, 6-mercaptopurine, azathioprine, cyclosporine, methotrexate), or TNF-alpha inhibitors (eg, adalimumab) because the risk of developing PML may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if Tysabri may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Tysabri:
Use Tysabri as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Tysabri comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Tysabri refilled.
- Tysabri is usually given as an injection at your doctor's office, hospital, or clinic.
- If you miss a dose of Tysabri, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Tysabri.
Important safety information:
- Tysabri may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Tysabri with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Tysabri is not a cure for MS or Crohn disease. Remain under the care of your doctor.
- Tysabri may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Serious and sometimes fatal infections of the brain or spinal cord caused by herpes viruses have been reported in patients using Tysabri. Call your doctor right away if you have a sudden fever or a severe headache or if you feel confused after receiving Tysabri.
- Tysabri may cause serious liver problems, including liver failure. Call your doctor right away if you experience nausea, vomiting, loss of appetite, yellowing of the skin or eyes, dark urine, pale stools, stomach pain, or unusual tiredness or weakness.
- Serious allergic reactions have occurred with the use of Tysabri. If a serious reaction occurs, it is usually within 2 hours after you receive Tysabri. However, a serious reaction may occur at any time. Contact your doctor at once if you develop hives, itching, trouble breathing, shortness of breath, wheezing, chest pain, dizziness, chills, fainting, fever, rash, nausea, or flushing.
- Tell your doctor or dentist that you use Tysabri before you receive any medical or dental care, emergency care, or surgery.
- Talk with your doctor before you receive any vaccine.
- Lab tests, including complete blood cell counts, liver function, anti-JC virus antibody, and magnetic resonance imaging (MRI) scans, may be performed while you use Tysabri. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- You will need to see your doctor 3 months and 6 months after your first dose of Tysabri. You will also need to see your doctor at least every 6 months after that. Be sure to keep all doctor and lab appointments.
- Safety and effectiveness of Tysabri in CHILDREN younger than 18 years old have not been confirmed. Tysabri is not approved for use in children.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tysabri while you are pregnant. Tysabri is found in breast milk. If you are or will be breast-feeding while you use Tysabri, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Tysabri:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Diarrhea; headache; joint pain; mild stomach pain; muscle cramps; nausea; pain in the arms or legs; tiredness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; changes in balance, eyesight, memory, strength, or thinking; chest pain or discomfort; clumsiness; confusion; depression; dizziness; fainting; fast heartbeat; feeling cold; fever, chills, cough, or persistent sore throat; flushing; muscle pain; one-sided weakness; painful menstrual periods; painful urination or changes in the amount of urine; personality changes; severe or persistent headache or tiredness; severe or persistent stomach or back pain; shortness of breath or wheezing; suicidal thoughts or attempts; swelling of the hands, ankles, or legs; tooth pain; tremor; vaginal discharge, itching, or odor.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Tysabri:
Tysabri is usually handled and stored by a health care provider. Keep Tysabri out of the reach of children and away from pets.
- If you have any questions about Tysabri, please talk with your doctor, pharmacist, or other health care provider.
- Tysabri is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Tysabri or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Tysabri. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Tysabri. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Tysabri.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.