In the treatment of cervical dystonia, XEOMIN is injected into the sternocleidomastoid, levator scapulae, splenius capitis, scalenus, and/or the trapezius muscle(s). The dose and number of injection sites in each treated muscle should be individualized based on the number and location of the muscle(s) to be treated, the degree of dystonia, muscle mass, body weight, and response to any previous botulinum toxin injections.1
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In a placebo-controlled trial using initial XEOMIN doses of 120 and 240 units, both doses achieved greater improvement than placebo.1
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.
Chronic Sialorrhea: The most commonly observed adverse reactions (incidence ≥3% of patients and greater than placebo) for XEOMIN were tooth extraction (5%), dry mouth (4%), diarrhea (4%), hypertension (4%), fall (3%), bronchitis (3%), dysphonia (3%), back pain (3%) and dry eye (3%).
Upper Limb Spasticity: The most commonly observed adverse reactions (incidence ≥2% of patients and greater than placebo) for XEOMIN were seizure (3%), nasopharyngitis (2%), dry mouth (2%), and upper respiratory tract infection (2%).
Cervical Dystonia: The most commonly observed adverse reactions (incidence ≥5% of patients and greater than placebo) for XEOMIN 120 Units and XEOMIN 240 Units, respectively, were: dysphagia (13%, 18%), injection pain site (9%, 4%), neck pain (7%, 15%), muscle weakness (7%, 11%), and musculoskeletal pain (7%, 4%).
Blepharospasm: The most commonly observed adverse reactions (incidence ≥5% of patients and twice greater than placebo) for XEOMIN were eyelid ptosis (19%), dry mouth (16%), dry eye (16%), visual impairment (12%), diarrhea (8%), headache (7%), dyspnea (5%) and nasopharyngitis (5%).
Co-administration of XEOMIN and aminoglycoside antibiotics or other agents interfering with neuromuscular transmission, e.g., tubocurarine-type 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.
Please see accompanying full Prescribing Information, including BOXED WARNING.