Multiple Sclerosis Research Repository

FDA Tysabri label indications:

1. 1204s0576: date: revised 01/2012 (161061-14): indication:  “as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations.  Tysabri is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate MS therapy”

2.  1215104s959: date: revised 8-17; reference ID: 414-174; 161061-2x: indication: “as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis.  Tysabri increases the risk of PML.  When initiating and continuing treatment with Tysabri, physicians should consider whether the expected benefit of Tysabri is sufficient to offset this risk.  See important information regarding the risk of PML with Tysabri”

3.  125104s106: date: 08/08; 161061-5: indication: “as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations.  Tysabri is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate MS therapy”

4.  125104s283: date: 12/09; 161061-8; indication: “as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations.  Tysabri is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate MS therapy”

5.  125104s973s975: date: revised: 12-2021; reference ID: 4902920; indication: “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”

6.  125104: date: Nov 2004; 161061-1; indication: “for the treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations”

1. Indication listed on Tysabri website as of today (1-29-2025): “used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.  Tysabri increases the risk of progressive multifocal leukoencephalopathy (PML).  When starting and continuing treatment with Tysabri, it is important to discuss with your doctor whether the expected benefit of Tysabri is enough to outweigh this risk”