Generic name: rimabotulinumtoxinB 2500[USP'U] in 0.5mL
Dosage form: injection, solution
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The recommended initial dose of MYOBLOC for patients with a prior history of tolerating botulinum toxin injections is 2,500 to 5,000 Units divided among affected muscles (see CLINICAL STUDIES). Patients without a prior history of tolerating botulinum toxin injections should receive a lower initial dose. Subsequent dosing should be optimized according to the patient's individual response. MYOBLOC should be administered by physicians familiar and experienced in the assessment and management of patients with CD.
The method described for performing the potency assay is specific to Solstice Neurosciences' manufacture of MYOBLOC. Due to differences in the specific details of this assay such as the vehicle, dilution scheme and laboratory protocols for various potency assays, Units of biological activity of MYOBLOC cannot be compared to or converted into units of any other botulinum toxin or any toxin assessed with any other specific assay method. Therefore, differences in species' sensitivities to different botulinum neurotoxin serotypes preclude extrapolation of animal dose-activity relationships to human dose estimates.
The duration of effect in patients responding to MYOBLOC treatment has been observed in studies to be between 12 and 16 weeks at doses of 5,000 Units or 10,000 Units (see CLINICAL STUDIES).