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Xeomin® (incobotulinumtoxinA) - a Botulinum Toxin Free From Accessory Proteins - Now Available in the U.S.
Date:10/5/2010

in injections.
  • Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of XEOMIN.

  • ADVERSE REACTIONS

    • Cervical Dystonia:  The most commonly observed adverse reactions (incidence greater than or equal to 10% of patients and twice the rate of placebo) for XEOMIN 120 Units and XEOMIN 240 Units, respectively, were: dysphagia (13%, 18%), neck pain (7%, 15%), muscle weakness (7%, 11%), and musculoskeletal pain (7%, 4%).
    • Blepharospasm: The most common adverse reactions (incidence greater than or equal to 10% of patients and twice the rate of placebo) for XEOMIN were eyelid ptosis (19%), dry mouth (16%), visual impairment (12%), diarrhea (8%), and headache (7%).

    DRUG INTERACTIONS

    Concomitant treatment of XEOMIN and aminoglycoside antibiotics, spectinomycin, or other agents that interfere with neuromuscular transmission (e.g., tubocurarine-like agents), or muscle relaxants, should be observed closely because the effect of XEOMIN may be potentiated.

    USE IN PREGNANCY

    Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. XEOMIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    Please see full prescribing information for XEOMIN, including Boxed WARNING, available at www.XEOMIN.com.

    About Merz

    Merz Pharmaceuticals, LLC is a part of the Merz Group of companies and was established in 1995 to develop and commercializ
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    SOURCE Merz Pharmaceuticals
    Copyright©2010 PR Newswire.
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