XEOMIN 50 units demonstrated significant improvements when compared with placebo at week 6 (P=0.0004)1,2
*XEOMIN 25 units was not statistically significant when compared with placebo at week 6 (P=0.1452)1,2
XEOMIN demonstrated significant improvements in the Jankovic Rating Scale (JRS) Severity Subscore at week 6 compared with baseline and placebo3†
*Missing values replaced with last observation carried forward
Comparison of the XEOMIN group with the placebo group was statistically significant at P<0.001. Examination of age and gender subgroups did not identify substantial differences in response to XEOMIN among these subgroups. There were too few African-American patients to assess efficacy in that population.2
XEOMIN efficacy proven noninferior to the active comparator (Botox) in adults with blepharospasm
The potency units of XEOMIN are specific to the preparation and assay method used and are not interchangeable with other preparations of botulinum toxin products. Therefore, Units of biological activity of XEOMIN cannot be compared to or converted into Units of any other botulinum toxin products.
§Patient-reported outcome: onset and waning of effect were subjectively estimated by the patient at control and end of study visits.
¶In this non-inferiority study, duration of effect was calculated based on the time between the initial injection and the end of study visit (when the subject and the investigator agreed that a new injection was needed).
XEOMIN® (incobotulinumtoxinA) for injection, for intramuscular or intraglandular use, is a prescription medicine that is used to treat adults with:
See full prescribing information for complete BOXED WARNING.
The effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms.
The most commonly observed adverse reactions at rates specified below and greater than placebo are:
Chronic Sialorrhea: (≥4% of patients) tooth extraction, dry mouth, diarrhea, and hypertension.
Upper Limb Spasticity: (≥2% of patients) seizure, nasopharyngitis, dry mouth, upper respiratory tract infection.
Cervical Dystonia: (≥5% of patients) dysphagia, neck pain, muscle weakness, injection site pain, and musculoskeletal pain.
Blepharospasm: (≥10% of patients) eyelid ptosis, dry eye, visual impairment, and dry mouth.
Co-administration of XEOMIN and aminoglycoside or other agents interfering with neuromuscular transmission, (e.g., muscle relaxants), should only be performed with caution as these agents may potentiate the effect of the toxin.
Use of anticholinergic drugs after administration of XEOMIN may potentiate systemic anticholinergic effects.
The effect of administering different botulinum toxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.
There are no adequate data on the developmental risk associated with the use of XEOMIN in pregnant women. XEOMIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Safety and effectiveness of XEOMIN in patients less than 18 years of age have not been established.