TYRUKO
TYRUKO (natalizumab-sztn) is an integrin receptor antagonist indicated for the treatment of relapsing forms of multiple sclerosis (MS) and moderately to severely active Crohn’s disease in adults. In MS, the drug is used as monotherapy for clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, though clinicians must weigh its use against the risk of progressive multifocal leukoencephalopathy (PML). For Crohn’s disease, it is indicated for patients with evidence of inflammation who have had an inadequate response to or cannot tolerate conventional therapies and TNF-α inhibitors. When used for Crohn's disease, TYRUKO should not be administered in combination with other immunosuppressants or TNF-α inhibitors.
How TYRUKO Works
TYRUKO binds to the α4-subunit of α4β1 and α4β7 integrins expressed on the surface of most leukocytes, excluding neutrophils. This binding inhibits the adhesion of these leukocytes to their receptors, such as VCAM-1 on vascular endothelium and MAdCAM-1 in the gastrointestinal tract. By disrupting these molecular interactions, the drug prevents the migration of inflammatory cells across the endothelium into parenchymal tissues like the brain and gut. This blockade reduces the recruitment and inflammatory activity of activated immune cells in patients with multiple sclerosis and Crohn’s disease.
Details
- Status
- Prescription
- First Approved
- 2023-08-24
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
TYRUKO Approval History
What TYRUKO Treats
2 indicationsTYRUKO is approved for 2 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Sclerosis
- Crohn's Disease
TYRUKO Boxed Warning
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Natalizumab products increase 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 TYRUKO [se...
WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Natalizumab products increase 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 TYRUKO [see Warnings and Precautions ( 5.1 )] . - Healthcare professionals should monitor patients on TYRUKO for any new sign or symptom that may be suggestive of PML. TYRUKO 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, TYRUKO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TYRUKO REMS Program [see Warnings and Precautions ( 5.2 )] . WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning • Natalizumab products increase the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability ( 5.1 ). • 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 TYRUKO ( 5.1 ). • Monitor patients, and withhold TYRUKO immediately at the first sign or symptom suggestive of PML ( 4 , 5.1 ). • Because of the risk of PML, TYRUKO is available only through a
TYRUKO is a lower-cost alternative to Tysabri with no clinically meaningful differences. Requires prescriber approval to substitute.
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Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TYRUKO FDA Label Details
ProIndications & Usage
FDA Label (PDF)TYRUKO is an integrin receptor antagonist indicated for treatment of: Multiple Sclerosis (MS) TYRUKO 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. Natalizumab products increase the risk of PML [see Warnings and Precautions ] . When initiating and continuing treatment with TYRUKO, physicians should consider whether the expected benefit of TYRUKO is sufficient to offset this risk. Crohn's Disease (CD) • TYRUKO is indicated for induci...
WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Natalizumab products increase 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...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.