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FDA Approves Merz Pharmaceuticals' Xeomin® (incobotulinumtoxinA) for the Treatment of Cervical Dystonia and Blepharospasm
Date:8/2/2010

tions have been reported with botulinum toxin products (anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea). If serious and/or immediate hypersensitivity reactions occur, further injection of XEOMIN should be discontinued and appropriate medical therapy immediately instituted.
  • Cervical Dystonia: Patients with smaller neck muscle mass and patients who require bilateral injections into the sternocleidomastoid muscles are at greater risk of dysphagia. Limiting the dose injected into the sternocleidomastoid muscle may decrease the occurrence of dysphagia.
  • Blepharospasm:  Injection of XEOMIN into the orbicularis oculi muscle may lead to reduced blinking and corneal exposure with possible ulceration or perforation. Lower lid injections should not be repeated if diplopia occurred with previous botulinum toxin injections.

  • ADVERSE REACTIONS

    Cervical Dystonia:  The most commonly observed adverse reactions (greater than or equal to 5% of patients and > placebo) were: dysphagia, neck pain, muscle weakness, injection site pain, and musculoskeletal pain.

    Blepharospasm: The most commonly observed adverse reactions (greater than or equal to 5% of patients and > placebo) were: eyelid ptosis, dry eye, dry mouth, diarrhea, headache, visual impairment, dyspnea, nasopharyngitis, and respiratory tract infection.

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

    About Merz

    Merz Pharmaceuticals, LLC is a part of Merz, Inc.
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    SOURCE Merz Pharmaceuticals, LLC
    Copyright©2010 PR Newswire.
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