Accepted abstracts provide key updates on aesthetics products, including XEOMIN® (incobotulinumtoxinA), ULTHERAPY®, RADIESSE® and CELLFINA®
Merz Americas today announced the presentation of data from studies of its aesthetics products, including XEOMIN® (incobotulinumtoxinA), ULTHERAPY®, RADIESSE® and the CELLFINA® System, at The Aesthetic Meeting 2019, the annual global meeting of the American Society for Aesthetic Plastic Surgery (ASAPS) and the Aesthetic Surgery Education and Research Foundation (ASERF) which is taking placein New Orleans, L.A.
“This annual meeting is an important resource for all in the aesthetics industry, and we’re grateful to have a platform to share the latest data, which continues to showcase the products within our portfolio,” said Terri Phillips, MD, FAAP, Vice President and Head of Global Medical Affairs at Merz. “One of our company’s operating tenets is our commitment to healthcare providers, so we are also pleased to share data that helps providers address patient needs.”
- Closing the Loop in Blepharoplasty: Rejuvenation of the Lateral Periorbital Frame, Mohammed Alghoul, MD, FACS, Northwestern Plastic Surgery and Lauren Mioton, MD, Northwestern University (Sunday, May 19, 11:20 – 11:25 am, Scientific Paper Forum, Face and Rhinoplasty, Session Silver Rapid Fire)*
- Multicenter Pivotal Study of the Safety and Effectiveness of a Tissue Stabilized-Guided Subcision Procedure for the Treatment of Cellulite – 5 Year Update, Rachel Walker, MD, The Wall Center and Simeon H. Wall, Jr, MD, The Wall Center (Monday, May 20, 12:04 -12:09 pm, Scientific Paper Forum, Breast and Body 3, Session Silver Rapid Fire)
Practice Solution Sessions
- Using the BODY-Q to Evaluate Appearance and Quality of Life Following Treatment of Skin Laxity with Microfocused Ultrasound and Calcium Hydroxylapatite, Laurie A. Casas, MD University of Chicago Medicine, Jesse Smith, MD, University of Chicago Medicine and Michael Sheehan, PA-C, Casas Aesthetic Plastic Surgery (Saturday, May 18, 12:40 pm, Exhibit Hall, Practice Solutions Theater, Aisle 100)*
- Using the BODY-Q to Evaluate Appearance and Quality of Life Following Treatment of Skin Laxity of the Outer Thigh with Microfocused Ultrasound and Calcium Hydroxylapatite: Incorporating this Treatment into Your Practice, Laurie A. Casas, MD, University of Chicago Medicine (Sunday, May 19, 1:25 pm, Exhibit Hall, Practice Solutions Theater, Aisle 100)*
- Practical Guidance for Optimizing Patient Comfort During Microfocused Ultrasound with Visualization and Improving Patient Satisfaction, Shay Moinuddin, MHA, CANS, RN, The Few Institute (Sunday, May 19, 10 am, Exhibit Hall, Practice Solutions Theater, Aisle 100)
- Grid 21 Technique: A combined assessment and treatment scheme for predictable forehead and eyebrow shaping with Xeomin; Lara Devgan, MD, Private Practice, Sunday, May 19, 12:45 pm, Exhibit Hall, Practice Solutions Theater, Aisle 100)
- Radiological Evaluation of Calcium Hydroxylapatite Implantation to Correct Volume Loss in the Dorsum of the Hand, Amir Moradi, MD, Private Practice
- Decrease in therapeutic effect among botulinum toxin type A agents: analysis of the FDA adverse event reporting system database, Rashid Kazerooni, PharmD, MS, BCPS, Merz Americas
*Merz-supported investigator initiated study
PLEASE SEE BELOW FOR THE IMPORTANT SAFETY INFORMATION about XEOMIN, INCLUDING BOXED WARNING
IMPORTANT SAFETY INFORMATION
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
WARNING: DISTANT SPREAD OF TOXIN EFFECT
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.
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 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 Creutzfeldt-Jakob disease (CJD). No cases of transmission of viral diseases or CJD have ever been reported for albumin.
Glabellar Lines: The most commonly observed adverse reaction (incidence ≥ 2% of patients and greater than placebo) for XEOMIN was Headache (5.4%).
Co-administration of XEOMIN and aminoglycoside antibiotics or other agents interfering with neuromuscular transmission, e.g., tubocurarine-type 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.
Safety and effectiveness of XEOMIN in patients less than 18 years of age have not been established.
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.
IMPORTANT ULTHERAPY® AND CELLFINA® SAFETY INFORMATION
For full product and safety information, including possible mild side effects of Cellfina® and Ultherapy®, visit www.cellfina.com and www.ultherapy.com, respectively.
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Copyright © 2019 Merz North America, Inc. All rights reserved. MERZ®, the MERZ® logo and XEOMIN® are registered trademarks of Merz Pharma GmbH & Co. KGaA. Ultherapy® and Cellfina® are registered trademarks of Ulthera, Inc. Radiesse® is a registered trademark of Merz North America, Inc. DeScribe® is a registered trademark of ONLight Sciences, Inc.