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| October 12, 2006 |
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| The physicians and staff of The Neuroscience Group are providing this physician and provider communication to help you stay abreast of issues and updates in the dynamic field of neurosciences, with the goal of helping you provide better overall healthcare services to your patients. |
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MS and TYSABRI Update
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The FDA has recently approved prescribing TYSABRI (natalizumab) for the treatment of worsening neurological symptoms in multiple sclerosis. As part of the reintroduction of this pharmaceutical, specific guidelines have been established for the use of TYSABRI. Only specific infusion sites, pharmacies and providers are enrolled in the TOUCH prescribing program.
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TYSABRI is indicated as monotherapy for the treatment of patients with relapsing forms of MS to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations. Safety and efficacy beyond 2 years has not been studied. The immunosuppressive effects of TYSABRI may increase a patient’s risk of serious infection. In the AFFIRM and SENTINEL studies, the rate of any type of infection was approximately 1.5 per patient-year in both TYSABRI-treated and placebo-treated patients. The infections were predominantly URI, UTI and influenza. TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection. Because of the risk of PML, TYSABRI is only available via this distribution program.
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TYSABRI should not be administered to patients with known hypersensitivity and is contraindicated in patients with PML (progressive multifocal leukoencephalopathy) that is a demyelinating disease that attacks the CNS. It is caused by a polyomavirus called the JC virus. The JC Virus is common and widespread in humans. There are no pathologic signs or symptoms that distinguish MS from PML.
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| Here are a few tips for primary care providers. TYSABRI should only be prescribed as monotherapy for relapsing forms of MS, based on clinical and radiological evidence. The patient must be educated on the benefits and risk of the treatment. The patient must be evaluated at 3 and 6 months following the first infusion and every 6 months after that. Opportunistic infections are a serious concern and must be evaluated and reported ASAP. |
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| The most frequently reported serious adverse events included: infections, pneumonia, and acute hypersensitivity reactions. An infusion-related reaction was defined as any adverse event occurring within 2 hours of start of the infusion. Approximately 24% of TYSABRI-treated MS patients experienced an infusion-related reaction compared with 18% of placebo-treated patients. Careful clinical assessment and follow-up is needed. If you have any questions on whether or not TYSABRI would be of use with MS patients, please contact Dr. Susan Hibbs. Susan.hibbs@neurosciencegroup.com |
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