Merz Aesthetics, the world’s largest dedicated medical aesthetics business, today announced the presentation of data from its extensive medical aesthetics portfolio, including Xeomin® (incobotulinumtoxinA), Ultherapy® and Radiesse®, at The Aesthetic Meeting 2021, the annual global meeting of the American Society for Aesthetic Plastic Surgery (ASAPS) and the Aesthetic Surgery Education and Research Foundation (ASERF). The meeting is taking place in Miami, FL, from April 29 to May 3; virtual access is also available for attendees.
“This meeting provides a platform for Merz Aesthetics to present our latest data and showcase important developments on our comprehensive product portfolio,” said Terri Phillips, M.D., Chief Medical Affairs Officer, Merz Aesthetics. “We look forward to participating and having the opportunity to connect with our industry peers in attendance.”
The following abstracts have been accepted for presentation at The Aesthetic Meeting 2021 and are intended to enhance the exchange of scientific information.
PRESENTATIONS
- Efficacy and Safety of Calcium Hydroxylapatite with Lidocaine for Improving Jawline Contour, Dr. Amir Moradi
May 2 2021, 12:21 PM - Management of Skin Contour Irregularities using Dilute and Hyperdilute CaHA, Dr. Babis Rammos
May 2, 2021, 1:15 PM - Optimizing Patient Outcomes by Customizing Treatment With Microfocused Ultrasound With Visualization: Gold Standard Consensus Guidelines from an Expert Panel, Dr. John Joseph
May 2, 2021, 1:15 PM - IncobotulinumtoxinA Demonstrates Safety and Prolonged Duration of Effect in a Dose-Ranging Study for Glabellar Lines, Dr. John Joseph
May 2, 2021, 1:33 PM
About Merz Aesthetics
Merz Aesthetics is a medical aesthetics business with a long history of empowering healthcare professionals, patients and employees to live every day with confidence. We aim to help people around the world look, feel and live like the best versions of themselves — however they define it. Clinically proven, our product portfolio includes injectables, devices and skin care treatments designed to meet each patient’s needs with the highest standards of safety and efficacy. We are known for building unique connections with customers who feel like family. Our global headquarters is in Raleigh, N.C., USA, with locations in 32 countries worldwide. Merz Aesthetics is part of Merz Group, a family owned company founded in 1908 and based in Frankfurt, Germany. Learn more at merzaesthetics.com.
PLEASE SEE BELOW FOR IMPORTANT SAFETY INFORMATION ABOUT XEOMIN®, INCLUDING BOXED WARNING, AND FULL PRESCRIBING INFORMATION AT XEOMINAESTHETIC.COM.
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INDICATIONS AND USAGE
XEOMIN® (incobotulinumtoxinA) for injection, for intramuscular use is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines with corrugator and/or procerus muscle activity in adult patients.
IMPORTANT SAFETY INFORMATION
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WARNING: DISTANT SPREAD OF TOXIN EFFECT 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. |
CONTRAINDICATIONS
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 XEOMIN should be discontinued and appropriate medical therapy immediately instituted. XEOMIN is contraindicated in patients with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
Use in patients with an infection at the injection site could lead to severe local or disseminated infection. XEOMIN is contraindicated in the presence of infection at the proposed injection site(s).
WARNINGS AND PRECAUTIONS
- The potency units of XEOMIN are specific to the preparation and assay method used and 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 units of any other botulinum toxin products.
- Treatment with XEOMIN and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. When distant effects occur, additional respiratory muscles may be involved. Patients may require immediate medical attention should they develop problems with swallowing, speech, or respiratory disorders. Dysphagia may persist for several months, which may require use of a feeding tube. Aspiration may result from severe dysphagia [See BOXED WARNING].
- 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.
- Glabellar Lines: Do not exceed the recommended dosage and frequency of administration of XEOMIN. In order to reduce the complication of ptosis the following steps should be taken:
- avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes;
- corrugator injections should be placed at least 1 cm above the bony supraorbital ridge.
- XEOMIN contains human serum albumin. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD or vCJD have ever been reported for albumin.
ADVERSE REACTIONS
Glabellar Lines: The most commonly observed adverse reaction (incidence ≥ 2% of patients and greater than placebo) for XEOMIN was Headache (5.4%).
DRUG INTERACTIONS
Co-administration of XEOMIN and aminoglycoside or other agents interfering with neuromuscular transmission, (e.g., 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.
USE IN PREGNANCY
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.
PEDIATRIC USE
Safety and effectiveness of XEOMIN in patients less than 18 years of age have not been established.
Copyright © 2019 Merz North America, Inc. All rights reserved.
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IMPORTANT RADIESSE® SAFETY INFORMATION
RADIESSE Injectable Implant is FDA-approved for hand augmentation to correct volume loss in the dorsum of the hands.
RADIESSE is contraindicated for patients with severe allergies, known hypersensitivity to any of the components of RADIESSE®, and patients with bleeding disorders. Introduction of the product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction.
Common adverse events observed in the clinical study of RADIESSE® injected into the dorsum of the hand include bruising, redness, swelling, pain, itching, nodule or bumps/ lumps, difficulty performing activities, loss of sensation and other local side effects.
For complete RADIESSE safety information, including information on adverse events from post-market surveillance of RADIESSE, please refer to the Instructions for Use at Radiesse.com. To report a problem with RADIESSE, please call MyMerz Solutions at 1-844-469-6379.
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IMPORTANT ULTHERAPY® SAFETY INFORMATION
For full product and safety information, including possible mild side effects of Ultherapy®, visit www.ultherapy.com.
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Corporate Contact:
Alison Brown
Director, Global Corporate Communications
Merz Aesthetics
6501 Six Forks Road, Raleigh, NC 27615
(919) 302-3296
media@merz.com
Copyright © 2021 Merz Pharmaceuticals, LLC. All rights reserved.
MERZ AESTHETICS and XEOMIN are registered trademarks of Merz Pharma GmbH & Co. KGaA.