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Merz Pharmaceuticals Introduces Comprehensive Programs to Provide Patients With Financial Assistance for Xeomin® (incobotulinumtoxinA)
Date:3/8/2011

is available in 50-unit and 100-unit vials, which Merz believes may allow for more precise billing and reduce wastage.

IMPORTANT SAFETY INFORMATIONWARNING: Distant Spread of Toxin EffectPostmarketing reports indicate that 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 may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. 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 treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.CONTRAINDICATIONSXEOMIN is contraindicated in patients with a known hypersensitivity to the active substance botulinum toxin type A or to any of the components in the formulation and in the presence of infection at the proposed injection site(s).

WARNINGS AND PRECAUTIONS

  • The potency units of XEOMIN 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.
  • Hypersensitivity reactions 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
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  • SOURCE Merz Pharmaceuticals
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