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Tysabri
Natalizumab
$7725.00
300mg/15ml · 3 × 1 vial · 3 months supply
BrandBranded medicine· By Biogen
$2575.00 per month
How long a supply?
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Annual cost
$30900a year at this pack size
Prescription required
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FDA boxed warningProgressive multifocal leukoencephalopathy
TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Risk factors for the development of PML include the presence of anti-JCV antibodies, duration of therapy, and prior use of immunosuppressants. These factors should be considered in the context of expected benefit when initiating and continuing treatment with TYSABRI.
Healthcare professionals should monitor patients on TYSABRI for any new sign or symptom that may be suggestive of PML. TYSABRI dosing should be withheld immediately at the first sign or symptom suggestive of PML. For diagnosis, an evaluation that includes a gadolinium-enhanced magnetic resonance imaging (MRI) scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended.
Because of the risk of PML, TYSABRI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TOUCH ® Prescribing Program.
Monitor patients, and withhold TYSABRI immediately at the first sign or symptom suggestive of PML
Because of the risk of PML, TYSABRI is available only through a restricted distribution program called the TOUCH
Prescribing Program
About Tysabri
Overview
Tysabri contains natalizumab, a monoclonal antibody given by intravenous infusion. It is used alone to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. It is also used to bring about and maintain improvement and remission in adults with moderately to severely active Crohn’s disease with evidence of inflammation when conventional treatments and TNF inhibitors have not worked adequately or cannot be tolerated. It works by blocking interactions that allow certain white blood cells to move into inflamed tissue, although its exact effects in these conditions are not fully understood.
What it treats
- Relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. Used as a single therapy. - Moderately to severely active Crohn’s disease in adults with evidence of inflammation who have not responded adequately to, or cannot tolerate, conventional treatments and TNF-alpha inhibitors. Used to induce and maintain clinical response and remission; it should not be combined with immunosuppressants or TNF-alpha inhibitors.
Safety information
Side effects
Common side effects in people treated for multiple sclerosis include headache, tiredness, joint pain, urinary tract infections, lower respiratory tract infections, stomach and intestinal infections, vaginal inflammation, depression, pain in the arms or legs, abdominal discomfort, diarrhea and rash. In people treated for Crohn’s disease, common side effects include headache, upper respiratory tract infections, nausea and tiredness. Serious side effects include progressive multifocal leukoencephalopathy (PML), severe herpes infections, liver injury, serious allergic reactions and low blood platelet counts. Herpes infections affecting the brain or its surrounding tissues have been life-threatening or fatal, and herpes-related damage to the retina has caused blindness. Liver injury can include liver failure requiring a transplant. Serious allergic reactions can include anaphylaxis. Tysabri may also increase the risk of certain infections. Contact a doctor promptly if you develop an infection or unusual bleeding. Seek immediate medical help for a suspected serious allergic reaction or other serious side effect. Low platelet counts and anemia have also occurred in newborns exposed to Tysabri during pregnancy; these babies need a complete blood count.
FDA boxed warning
Progressive multifocal leukoencephalopathy
TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Risk factors for the development of PML include the presence of anti-JCV antibodies, duration of therapy, and prior use of immunosuppressants. These factors should be considered in the context of expected benefit when initiating and continuing treatment with TYSABRI.
Healthcare professionals should monitor patients on TYSABRI for any new sign or symptom that may be suggestive of PML. TYSABRI dosing should be withheld immediately at the first sign or symptom suggestive of PML. For diagnosis, an evaluation that includes a gadolinium-enhanced magnetic resonance imaging (MRI) scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended.
Because of the risk of PML, TYSABRI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TOUCH ® Prescribing Program.
Monitor patients, and withhold TYSABRI immediately at the first sign or symptom suggestive of PML
Because of the risk of PML, TYSABRI is available only through a restricted distribution program called the TOUCH
Prescribing Program
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Do not use Tysabri (natalizumab) if you have or have ever had progressive multifocal leukoencephalopathy (PML), or if you have had an allergic reaction to Tysabri, including hives or anaphylaxis. Tysabri may increase the risk of certain infections, so monitoring is needed. Serious herpes infections affecting the brain or its lining can be life-threatening or fatal. Herpes-related damage to the retina can cause blindness. Treatment must be stopped if these infections occur. Significant liver injury, including liver failure requiring a transplant, has occurred. Treatment must be stopped if there is evidence of liver injury. Serious allergic reactions require permanent discontinuation. Tysabri may cause a low platelet count. Monitoring for abnormal bleeding is needed, and treatment must be stopped if a low platelet count develops. Tysabri can harm an unborn baby. Babies exposed during pregnancy may develop low platelet counts or anemia and should have a complete blood count after birth.
Interactions
Tysabri may increase the risk of progressive multifocal leukoencephalopathy (PML) and other infections when used with medicines that suppress or modify the immune system. For Crohn’s disease, Tysabri should not be used with immunosuppressants such as 6-mercaptopurine, azathioprine, cyclosporine or methotrexate, or with TNF-alpha inhibitors. If you take long-term corticosteroids, discuss this with your doctor, as these should be gradually reduced under medical supervision when starting Tysabri. For multiple sclerosis, people receiving long-term immunosuppressant or immunomodulatory treatment should generally not receive Tysabri. Tell your doctor about any such medicines you take.
Using Tysabri
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label TYSABRI (NATALIZUMAB) INJECTION [BIOGEN INC.] (DailyMed, retrieved 19 September 2026).
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