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Tysabri (Natalizumab) - Summary

 
 



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) ].
 

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) ].


See all Tysabri indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Tysabri (Natalizumab)

Hot Topics: Role of MRI in Multiple Sclerosis Management
Source: MedPageToday.com - medical news plus CME for physicians [2014.12.12]
(MedPage Today) -- A revolution in diagnosis and subsequent monitoring.

Hot Topics: Vitamin D in Multiple Sclerosis
Source: MedPage Today Neurology [2014.12.11]
(MedPage Today) -- Vitamin D and MS are clearly connected, but do supplements help?

Toxin from tobacco smoke could increase pain in spinal cord injury and worsen multiple sclerosis
Source: Muscular Dystrophy / ALS News From Medical News Today [2014.12.08]
A neurotoxin called acrolein found in tobacco smoke that is thought to increase pain in people with spinal cord injury has now been shown to accumulate in mice exposed to the equivalent of 12...

Chemical compound identified that decreases effects of multiple sclerosis
Source: Endocrinology News From Medical News Today [2014.12.04]
UC Riverside-led mouse study shows the ligand indazole chloride improves motor function, imparting therapeutic benefits even when treatment is initiated at the peak of disease.

New research finds the first evidence of a rogue protein in multiple sclerosis
Source: Biology / Biochemistry News From Medical News Today [2014.12.03]
In a new study published in the journal Frontiers in Neurology, a team of researchers led by the University of Surrey, have identified a rogue protein in multiple sclerosis, which attacks the...

more news >>

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.

more studies >>

Clinical Trials Related to Tysabri (Natalizumab)

A Prospective, Open-label, Non-randomized, Clinical Trial to Determine if Natalizumab (Tysabri´┐Ż) 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.

NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Multiple Sclerosis Experiencing Fatigue or Sleepiness [Recruiting]

Natalizumab De-escalation With Interferon Beta-1b [Recruiting]
Multiple Sclerosis (MS) is the most common neurological disorder causing disability in young adults. The management of MS-patients requires treatment with disease-modifying agents, monoclonal antibodies such as natalizumab or immunosuppressants. Natalizumab showed good efficacy and is approved for treatment of relapsing MS with a number of restrictions due to safety issues. Cognitive data related to natalizumab treatment are still scarce. Interferon-beta-1b is approved for high-frequency, subcutaneous (sc) administration in the treatment of multiple sclerosis. It reduces the relapse rate, severity, hospitalisation and the disease activity as seen on MRI.

This is a pilot study to explore the concept of de-escalating natalizumab treatment to interferon-beta-1b e. o.d compared to continuous treatment with natalizumab in patients with relapsing-remitting multiple sclerosis previously treated with natalizumab for 12 months. The study is designed as prospective, controlled, randomized, rater-blinded, parallel-group, two arm, mono-centric including patients of the Ticino Cohort. One arm will be treated with Interferon-beta 1b 250mcg given subcutaneously every other day, the other with Natalizumab 300 mg given intravenously (i. v.), every four weeks. The treatment duration is 12 months, the follow-up period 12 months. The time to first on-study relapse will be compared between the to treatment arms (primary outcome). Other efficacy parameter include clinical and radiological parameters, patient reported outcome on quality of life and fatigue. Safety is assessed by reports of adverse events.

A Proof of Concept Study to Evaluate the Effectiveness of Tysabri in Relapsing Remitting Multiple Sclerosis (RRMS) Patient Bladder Function [Recruiting]
A recent report has demonstrated improvements in QoL parameters in patients receiving TYSABRI« (Rudick et al, 2007). This observation, coupled with anecdotal reports and our own experience, lead us to hypothesize that TYSABRI« will have a demonstrable beneficial effect on improving patient's bladder function as defined by changes in baseline to month 6 scores on the UDI-6 and also on patient reported incontinence episodes and micturitions per day.

more trials >>

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 >>


Page last updated: 2014-12-12

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