Medesthetics

NOV-DEC 2015

MedEsthetics—business education for medical practitioners—provides the latest noninvasive cosmetic procedures, treatment trends, product and equipment reviews, legal issues and medical aesthetics industry news.

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FROWN LINES CAN'T TELL THE DIFFERENCE. (But your accountant can.) * *Based on comparison of list prices for XEOMIN ($453) and BOTOX ($558) as of August 2015 (subject to change). Source: Medi-Span ® Price Rx ® . The price listings for XEOMIN and BOTOX are for therapeutic class acquisition cost purposes only and are not refl ective of any assumption of equivalence regarding the indications, effi cacy, safety profi les, or dosing regimens of the listed products. Referenced prices do not take into account any discounts, rebates, or other price incentives. 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. AT $453 PER VIAL, XEOMIN DELIVERS FOR YOUR PRACTICE XEOMIN was FDA approved for the treatment of adults with moderate to severe frown lines based on 2 clinical trials involving 547 patients where XEOMIN was clinically proven to temporarily improve the appearance of moderate to severe glabellar lines. Patients were classifi ed as responders only if they had a 2-grade improvement on a 4-point scale compared to baseline as assessed by both the investigator and subject. In a head to head prospective, multicenter, randomized, double blinded, parallel study of 250 patients, similar effi cacy (defi ned as * 1 point improvement one month after a single treatment) was demonstrated for XEOMIN (incobotulinumtoxinA) and Botox ® (onabotulinumtoxinA) as evaluated by the independent review panel. In addition, treating physicians reported similar effi cacy profi les during the four months post-treatment. There was no reported difference in patient satisfaction between XEOMIN and Botox at 1, 2, 3 or 4 months. Study Safety: 11.5% of subjects in the XEOMIN group and 14.1% of subjects in the Botox group reported at least one adverse event during the study. Two serious adverse events were reported, one in each treatment group. Both events were unrelated to study drug. The most common adverse events for both treatment groups were headache (5.7 / 3.9%), infection (2.5 / 3.1%), and facial asymmetry (1.6 / 2.3%) for XEOMIN and Botox respectively. WARNING: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of XEOMI 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 diffi culties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing diffi culties 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. IMPORT AFETY ORMA OXED WA AT XEOMIN ® (incobotulinumtoxinA) for injection, for intramuscular use is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.

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