Prescription medicine
Natalizumab Brand names: Tyruko, Tysabri
Natalizumab (Tysabri) is a prescription medicine with an FDA approval on record since 2004. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the natalizumab FDA label on DailyMed (effective March 21, 2025, Biogen Inc.); the BLA 125104 record on Drugs@FDA; every natalizumab label on DailyMed.
Highlights of the record
FDA label of March 21, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 [ see Warnings and Precautions ( 5.1 ) ]. 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 [ see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ) ]. 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 [ see Warnings and Precautions ( 5.2 ) ]. […]
Used for
From the label: indications and usageTYSABRI is an integrin receptor antagonist indicated for treatment of: Multiple Sclerosis (MS) TYSABRI is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Forms and strengths
- 300 mg/15ml
Injection.
On the market
- Earliest approval on file
- November 23, 2004 Tysabri, Biogen Idec; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 180,844 through July 30, 2026
What is natalizumab used for?
From the label: indications and usageTYSABRI is an integrin receptor antagonist indicated for treatment of: Multiple Sclerosis (MS) TYSABRI is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. TYSABRI increases the risk of PML [See Warnings and Precautions ( 5.1 ) ]. When initiating and continuing treatment with TYSABRI, physicians should consider whether the expected benefit of TYSABRI is sufficient to offset this risk. […]
Conditions named in the indications of natalizumab's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Integrin Receptor Antagonist.
Source: FDA drug label (TYSABRI), Biogen Inc., effective March 21, 2025 (SPL set c5fdde91-1989-4dd2-9129-4f3323ea2962), via openFDA; the full label on DailyMed
What does the patient leaflet for natalizumab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about TYSABRI?TYSABRI increases your chance (risk) of getting a rare brain infection that usually leads to death or severe disability. This infection is called progressive multifocal leukoencephalopathy (PML). If PML happens, it usually happens in people with weakened immune systems. There is no known treatment, prevention, or cure for PML. Your chance of getting PML may be higher if you are also being treated with other medicines that can weaken your immune system, including other treatments for Multiple Sclerosis (MS) and Crohn's disease (CD). You should not take certain medicines that weaken your immune system at the same time you are taking TYSABRI. Even if you use TYSABRI alone to treat your MS or CD, you can still get PML. Your risk of getting PML is higher if you: have been infected by the John Cunningham Virus (JCV). JCV is a common virus that is harmless in most people but can cause PML in people who have weakened immune systems, such as people taking TYSABRI. Most people who are infected by JCV do not know it or do not have any symptoms. This infection usually happens in childhood. Before you start receiving TYSABRI or during your treatment, your doctor may do a blood test to check if you have been infected by JCV. have received TYSABRI for a long time, especially longer than 2 years have received certain medicines that can weaken your immune system before you start receiving TYSABRI Your risk of getting PML is greatest if you have all 3 risk factors listed above. There may be other risk factors for getting PML during TYSABRI treatment that we do not know about yet. Your doctor should discuss the risks and benefits of TYSABRI treatment with you before you decide to receive TYSABRI. […]
Source: FDA drug label (TYSABRI), Biogen Inc., effective March 21, 2025 (SPL set c5fdde91-1989-4dd2-9129-4f3323ea2962), via openFDA; the full label on DailyMed
Is there a generic for natalizumab (Tysabri)?
No generic natalizumab is approved (Drugs@FDA, October 8, 2026).
- 2004 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the natalizumab label say about other medicines?
The natalizumab label names 7 other medicines in its interaction, contraindication or warning sections. The labels of 10 other medicines name natalizumab. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Azathioprine | drug interactions | DRUG INTERACTIONS Because of the potential for increased risk of PML and other infections, Crohn's disease patients receiving TYSABRI should not be treated with concomitant immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate) or inhibitors of TNF-α, and corticosteroids should be … |
| Cyclophosphamide | warnings and precautions | Prior treatment with an immunosuppressant (e.g., mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate mofetil). |
| Cyclosporine | drug interactions | DRUG INTERACTIONS Because of the potential for increased risk of PML and other infections, Crohn's disease patients receiving TYSABRI should not be treated with concomitant immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate) or inhibitors of TNF-α, and corticosteroids should be … |
| Mercaptopurine | drug interactions | DRUG INTERACTIONS Because of the potential for increased risk of PML and other infections, Crohn’s disease patients receiving natalizumab products should not be treated with concomitant immunosuppressants (e.g., 6‑ mercaptopurine, azathioprine, cyclosporine, or methotrexate) or inhibitors of TNF-α, and corticosteroids … |
| Methotrexate | drug interactions | DRUG INTERACTIONS Because of the potential for increased risk of PML and other infections, Crohn's disease patients receiving TYSABRI should not be treated with concomitant immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate) or inhibitors of TNF-α, and corticosteroids should be … |
| Mitoxantrone | warnings and precautions | Prior treatment with an immunosuppressant (e.g., mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate mofetil). |
| Mycophenolate mofetil | warnings and precautions | Prior treatment with an immunosuppressant (e.g., mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate mofetil). |
Other labels that name natalizumab
Source: FDA drug label (TYSABRI), Biogen Inc., effective March 21, 2025 (SPL set c5fdde91-1989-4dd2-9129-4f3323ea2962), via openFDA; the full label on DailyMed
What do FAERS reports show for natalizumab?
The FDA Adverse Event Reporting System holds 180,844 reports that list natalizumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,103 are coded as a death and 34,611 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as natalizumab?
2 other medicines are given the same way (intravenous) and in the same FDA class as natalizumab or labeled mainly for the same use (multiple sclerosis), the same class first. Multiple sclerosis lists all 23 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Alemtuzumab | Multiple sclerosis | none listed | n/a | No current entry |
| Ublituximab | Multiple sclerosis | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other integrin receptor antagonists
- the pharmacologic class, with prices and generics
- Natalizumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other