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)
European Drug Agency To Weigh Risks/Benefits Of Tysabri -- Cites 23 Cases Of PML
Source: Multiple Sclerosis News From Medical News Today [2009.10.27]
Today the EMEA, the European equivalent of the U.S. Food and Drug Administration, released a statement indicating that one of its advisory committees was launching a review of the risks and benefits of
Good News On Multiple Sclerosis And Pregnancy
Source: Clinical Trials / Drug Trials News From Medical News Today [2009.11.19]
There is good news for women with multiple sclerosis (MS) who are pregnant or thinking about becoming pregnant. A new study shows that pregnant women with multiple sclerosis are only slightly more likely to have cesarean deliveries and babies with a poor prenatal growth rate than women who do not have MS.
BrainStorm Stem Cell Therapy Technology Possesses Promising Potential For The Future Treatment Of Multiple Sclerosis
Source: Multiple Sclerosis News From Medical News Today [2009.11.18]
BrainStorm Cell Therapeutics Inc. (OTCBB:BCLI), a leading developer of adult stem cell technologies and therapeutics, is pleased to announce that the company's therapeutic approach for treating neurodegenerative diseases, particularly ALS and Parkinson's disease, was found to have a positive effect in a mouse model of multiple sclerosis (MS).
Mayo Clinic Neurologist Reports: "Thousands Of NMO Patients Are Misdiagnosed With Multiple Sclerosis"
Source: Multiple Sclerosis News From Medical News Today [2009.11.13]
Thousands of Neuromyelitis Optica (NMO) patients are potentially being misdiagnosed with Multiple Sclerosis (MS), according to Mayo Clinic Neurologist Sean Pittock, M.D., largely due to lack of awareness of NMO within the medical community. Dr. Pittock shared this finding with more than 50 of the world's leading doctors and medical researchers - from Harvard to Oxford - who gathered at the 2009 NMO Roundtable Conference, sponsored by the Guthy-Jackson Charitable Foundation.
Teen Obesity Linked to Later Multiple Sclerosis (CME/CE)
Source: MedPage Today Neurology [2009.11.10]
Women who were obese at age 18 faced a doubling in risk for developing multiple sclerosis in later adulthood, researchers said.
Published Studies Related to Tysabri (Natalizumab)
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.
The efficacy of natalizumab in patients with relapsing multiple sclerosis: subgroup analyses of AFFIRM and SENTINEL. [2009.03]
The AFFIRM and SENTINEL studies showed that natalizumab was effective both as monotherapy and in combination with interferon beta (IFNbeta)-1a in patients with relapsing multiple sclerosis (MS). Further analyses of AFFIRM and SENTINEL data were conducted to determine the efficacy of natalizumab in prespecified patient subgroups according to baseline characteristics: relapse history 1 year before randomization (1, 2, > or = 3), Expanded Disability Status Scale score (< or = 3.5, > 3.5), number of T2 lesions (< 9, > or = 9), presence of gadolinium-enhancing (Gd+) lesions (0, > or = 1), age (< 40, > or = 40) and gender (male, female).
Effect of natalizumab on clinical and radiological disease activity in multiple sclerosis: a retrospective analysis of the Natalizumab Safety and Efficacy in Relapsing-Remitting Multiple Sclerosis (AFFIRM) study. [2009.03]
BACKGROUND: The efficacy of natalizumab on clinical and radiological measures in the phase III Natalizumab Safety and Efficacy in Relapsing-Remitting Multiple Sclerosis (AFFIRM) study has prompted the investigation of whether natalizumab can increase the proportion of patients with relapsing-remitting multiple sclerosis who do not have disease activity... INTERPRETATION: Disease remission might become an increasingly attainable goal in multiple sclerosis treatment with the use of newer, more effective therapies.
Cost-Effectiveness Analyses of Natalizumab (Tysabri((R))) Compared with Other Disease-Modifying Therapies for People with Highly Active Relapsing-Remitting Multiple Sclerosis in the UK. [2008]
BACKGROUND: Natalizumab (Tysabri((R))) is a new disease-modifying therapy that has been shown to be clinically effective in patients with relapsing-remitting multiple sclerosis (RRMS) and has been licensed for use in patients with highly active RRMS (HARRMS). These patients are those who experience higher relapse rates and faster disability progression than the general RRMS population. OBJECTIVES: To estimate the cost effectiveness of natalizumab compared with interferon-beta, glatiramer acetate and best supportive care from various UK cost perspectives... CONCLUSION: If UK society is willing to pay more than pound8200 per QALY, or Health and Social Services are willing to pay more than pound26 000 per QALY, this analysis suggests that natalizumab is likely to be a cost-effective treatment for all patients with HARRMS.
Health-related quality of life during natalizumab maintenance therapy for Crohn's disease. [2007.12]
OBJECTIVES: We evaluated the effects of treatment on health-related quality of life (HRQoL) during a randomized controlled trial of natalizumab maintenance therapy (ENACT-2) using both disease-specific and generic measures... CONCLUSIONS: The substantial improvement in HRQoL experienced by patients who responded to natalizumab induction therapy was maintained during an additional 48 wk of maintenance therapy.
Clinical Trials Related to Tysabri (Natalizumab)
A Pharmacokinetic (PK) Study of Tysabri at Steady State [Not yet recruiting]
The pharmacokinetic (PK) profile of Tysabri in patients has been observed following 1 dose
and after 6 consecutive doses. The primary purpose of this study is to observe the PK
profile of Tysabri in patients who have been treated with Tysabri for at least 12 months
(i. e., after achievement of steady state). To support this investigation, the
pharmacodynamic (PD) profile will also be established in this population by assessing α4
integrin saturation.
The dosing regimen will be consistent with the current commercial prescribing information
(Tysabri 300 mg IV infusion once a month).
The following participant population will be enrolled:
- Have been treated monthly with Tysabri (natalizumab) for at least 12 months (with the 9
most recent doses received at uninterrupted intervals [i. e., every 28±7 days])
- Currently enrolled in the Tysabri Outreach: United Commitment to Health (TOUCH)
Prescribing Program
- Tested negative at any prior evaluation for anti-Tysabri antibodies
- Test negative for antibodies to Tysabri at the Screening Visit
Participants will be asked to provide blood samples over a 28-day period following a
scheduled infusion of Tysabri.
The primary objective is to assess the PK profile of Tysabri at steady state. The secondary
objective is to assess the PD profile (α4 integrin saturation) of Tysabri at steady state.
The Effects of TYSABRI Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis [Recruiting]
Although TYSABRI has been studied in clinical trials, and has been approved by the FDA for
the treatment of MS, no information is available on the effects of vaccination (immunization
against disease, such as measles or tetanus) in patients who receive TYSABRI. This study is
designed to determine the effects of TYSABRI treatment on vaccinations in people. In order
to do this, some people will receive 6 doses of TYSABRI before being vaccinated, and some
people will receive only the vaccinations (no treatment for MS will be given for
approximately 3 months).
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.
TOP: IMA-06-02 Tysabri Observational Program [Recruiting]
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.
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Page last updated: 2009-11-19
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