TOUCH Validation System
Biogen Idec and Elan Pharmaceuticals, Inc. are committed to patient safety. The TOUCH Prescribing Program has been developed in consultation with the FDA. This program represents our commitment to the responsible use of TYSABRI and was designed to:
- Promote informed benefit-risk decisions between prescribers and patients regarding the use of TYSABRI in relapsing MS
- Minimize morbidity and mortality due to PML through early detection with clinical vigilance
- Minimize the risk of PML by treating patients who are not immunocompromised
- Warn against concurrent use with antineoplastics, immunosuppressants or immunomodulators
- Determine the incidence and risk factors for PML and other serious opportunistic infections in patients treated with TYSABRI, as well as the overall safety of TYSABRI in the clinical practice setting
If you have any questions about TYSABRI or the TOUCH Prescribing Program, please call our toll-free number
WARNING
TYSABRI® increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Although the cases of PML were limited to patients with recent or concomitant exposure to immunomodulators or immunosuppressants, there were too few cases to rule out the possibility that PML may occur with TYSABRI® monotherapy.
- 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, Progressive Multifocal Leukoencephalopathy; and WARNINGS, Prescribing, Distribution, and Administration Program for TYSABRI®).
- 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 and WARNINGS, Progressive Multifocal Leukoencephalopathy).
INDICATIONS AND USAGE
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 (see BOXED WARNING and WARNINGS, Progressive Multifocal Leukoencephalopathy), TYSABRI® is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate multiple sclerosis therapies.
Safety and efficacy in patients with chronic progressive multiple sclerosis have not been studied.
CONTRAINDICATIONS
TYSABRI® should not be administered to patients with known hypersensitivity to TYSABRI® or any of its components.
TYSABRI® is contraindicated in patients who have or have had progressive multifocal leukoencephalopathy (PML) (see BOXED WARNING and WARNINGS).
