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. Cases of PML have been reported in patients taking TYSABRI who were recently or concomitantly treated with immunomodulators or immunosuppressants, as well as in patients receiving TYSABRI as monotherapy [see Warnings and Precautions (5.1) ].
- Because of the risk of PML, TYSABRI is available only through a special restricted distribution program called the TOUCH™ Prescribing Program. Under the TOUCH™ Prescribing Program, only prescribers, infusion centers, and pharmacies associated with infusion centers registered with the program are able to prescribe, distribute, or infuse the product. In addition, TYSABRI must be administered only to patients who are enrolled in and meet all the conditions of the TOUCH™ Prescribing Program [see Warnings and Precautions (5.1, 5.2) ].
- 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) ].
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TYSABRI SUMMARY
TYSABRI (natalizumab) is a recombinant humanized IgG4κ monoclonal antibody produced in murine myeloma cells. Natalizumab contains human framework regions and the complementarity-determining regions of a murine antibody that binds to α4-integrin.
TYSABRI (natalizumab) is indicated for the following:
Multiple Sclerosis (MS)
TYSABRI is indicated 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. The safety and efficacy of TYSABRI beyond two years are unknown.
Because TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability, TYSABRI is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate multiple sclerosis therapies [see Boxed Warning, Warnings and Precautions (5.1) ].
Safety and efficacy in patients with chronic progressive multiple sclerosis have not been studied.
Crohn's Disease (CD)
TYSABRI is indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn's disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α. TYSABRI should not be used in combination with immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate) or inhibitors of TNF-α [see Boxed Warning, Warnings and Precautions (5.1) ].
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NEWS HIGHLIGHTSMedia Articles Related to Tysabri (Natalizumab)
Multiple Sclerosis More Common In Black Women Than White
Source: Multiple Sclerosis News From Medical News Today [2013.05.07]
Multiple sclerosis (MS) is more common in black women than in white women, according a new study. The research was conducted by Kaiser Permanente and was published in the journal Neurology. The results contradict the widely believed notion that black people are less vulnerable to the disease. The electronic health records of over 3...
Peli1 Identified As Pivotal Actor In Animal Model Of Multiple Sclerosis
Source: Multiple Sclerosis News From Medical News Today [2013.05.06]
Scientists have identified an influential link in a chain of events that leads to autoimmune inflammation of the central nervous system in a mouse model of multiple sclerosis (MS). An international team of researchers led by scientists in The University of Texas MD Anderson Cancer Center Department of Immunology reported their results in an advance online publication in Nature Medicine...
Atrophy In Key Region Of Brain Associated With Multiple Sclerosis
Source: Multiple Sclerosis News From Medical News Today [2013.04.25]
Magnetic resonance imaging (MRI) measurements of atrophy in an important area of the brain are an accurate predictor of multiple sclerosis (MS), according to a new study published online in the journal Radiology. According to the researchers, these atrophy measurements offer an improvement over current methods for evaluating patients at risk for MS...
Shrinkage of Brain Region May Signal Onset of Multiple Sclerosis
Source: MedicineNet Multiple Sclerosis Specialty [2013.04.23]
Title: Shrinkage of Brain Region May Signal Onset of Multiple Sclerosis
Category: Health News
Created: 4/23/2013 10:35:00 AM
Last Editorial Review: 4/23/2013 12:00:00 AM
Multiple Sclerosis
Source: MedicineNet Amyotrophic Lateral Sclerosis Specialty [2013.04.16]
Title: Multiple Sclerosis
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 4/16/2013 12:00:00 AM
Published Studies Related to Tysabri (Natalizumab)
Low-contrast acuity measures visual improvement in phase 3 trial of natalizumab
in relapsing MS. [2012]
prespecified tertiary outcome measure in AFFIRM... CONCLUSION: Low-contrast letter acuity detected treatment effects on sustained
Efficacy of natalizumab therapy in patients of African descent with relapsing multiple sclerosis: analysis of AFFIRM and SENTINEL data. [2011.04]
BACKGROUND: Patients with multiple sclerosis (MS) who are of African descent experience a more aggressive disease course than patients who are of white race/ethnicity. In phase 3 clinical trials (Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis [AFFIRM] and Safety and Efficacy of Natalizumab in Combination With Interferon Beta-1a in Patients With Relapsing Remitting Multiple Sclerosis [SENTINEL]), natalizumab use significantly improved clinical and magnetic resonance imaging outcomes over 2 years in patients with relapsing MS. Because patients of African descent may be less responsive to interferon beta treatment than patients of white race/ethnicity, the efficacy of natalizumab therapy in this population is clinically important. OBJECTIVE: To evaluate the efficacy of natalizumab use in patients of African descent with relapsing MS... CONCLUSION: Natalizumab therapy significantly improved the relapse rate and accumulation of brain lesions in patients of African descent with relapsing MS.
Natalizumab plus interferon beta-1a reduces lesion formation in relapsing multiple sclerosis. [2010.05.15]
The SENTINEL study showed that the addition of natalizumab improved outcomes for patients with relapsing multiple sclerosis (MS) who had experienced disease activity while receiving interferon beta-1a (IFNbeta-1a) alone... Natalizumab add-on therapy reduced gadolinium-enhancing, T1-hypointense, and T2 MRI lesion activity and slowed brain atrophy progression in patients with relapsing MS who experienced disease activity despite treatment with IFNbeta-1a alone.
Demographic and clinic characteristics of French patients treated with natalizumab in clinical practice. [2010.02]
Natalizumab is the first selective adhesion molecule inhibitor indicated for treatment of active relapsing-remitting multiple sclerosis (RRMS)... Tolerability was similar to that observed in AFFIRM.
Multiple sclerosis associated fatigue during natalizumab treatment. [2009.10.15]
OBJECTIVE: To assess multiple sclerosis (MS) associated fatigue after the first 6 months of natalizumab treatment... CONCLUSION: Fatigue and well-being improved after treatment initiation with natalizumab. A randomized controlled trial is necessary to come to definite conclusions as to a potential effect of natalizumab on fatigue in MS.
Clinical Trials Related to Tysabri (Natalizumab)
A Prospective, Open-label, Non-randomized, Clinical Trial to Determine if Natalizumab (Tysabri�) Improves Ambulatory Measures in Relapsing-remitting Multiple Sclerosis (RRMS) Patients "TIMER" Study [Recruiting]
The aim of this study is to evaluate the evolution of walking capacity as measured by T100T,
T25FW, MWD and EDSS during the first year of therapy with natalizumab.
A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS [Recruiting]
Phase 3b, multicenter, international, randomized, double-blind, placebo-controlled study to
assess the efficacy of natalizumab in approximately 856 SPMS subjects who are exhibiting
disease progression independent of relapses. Subjects will be randomized to receive either
natalizumab 300 mg or placebo intravenously (IV) every 4 weeks (q4wk) for 96 weeks. This
study will be conducted in subjects between the ages of 18 and 58, inclusive, with a
diagnosis of SPMS for at least 2 years, an EDSS score between 3. 0 and 6. 5, inclusive, and
documented evidence of disease progression independent of clinical relapses over the 1 year
prior to enrollment, and who are naïve to natalizumab.
Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis [Recruiting]
The long-term objective is to further establish the role of Tysabri in preventing
neurological degeneration in multiple sclerosis (MS) and to establish powerful and efficient
new markers for neurological degeneration in MS. The study intends to correlate cognition
with two instruments and their measurements-MRI and OCT (optical coherence tomography).
TOP: IMA-06-02 Tysabri Observational Program [Recruiting]
A long term, post-marketing, observational safety and treatment impact study of Tysabri in
patients with Relapsing Remitting Multiple Sclerosis
NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Multiple Sclerosis Experiencing Fatigue or Sleepiness [Recruiting]
Reports of Suspected Tysabri (Natalizumab) Side Effects
Fatigue (3044),
Multiple Sclerosis Relapse (2537),
Headache (1733),
Gait Disturbance (1328),
Fall (1320),
Progressive Multifocal Leukoencephalopathy (1184),
Asthenia (1179),
Urinary Tract Infection (1118),
Multiple Sclerosis (1056),
Malaise (1001), more >>
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Page last updated: 2013-05-07
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