Accepted abstracts provide key updates on aesthetics products, including XEOMIN®, ULTHERAPY®, RADIESSE® and CELLFINA®
Merz Americas today announced the presentation of data, including one oral presentation, from studies of its aesthetics products, including Xeomin® (incobotulinumtoxinA), Ultherapy®, Radiesse® and the Cellfina® System, at the American Academy of Dermatology (AAD) annual meeting, March 1-5, in Washington, DC.
“The range of data that Merz is sharing at this year’s AAD annual meeting is aimed at informing aesthetic medicine practices and meeting patient needs,” said Terri Phillips, MD, FAAP, Vice President and Head of Global Medical Affairs at Merz. “We’re working hard to help practitioners help their patients live better, feel better and look better.”
Oral presentation
Ultherapy®
- Microfocused Ultrasound with Visualization: Treatment Plans and Comfort Management in Real-World Practice, Amanda K. Doyle, MD (Saturday, March 2: 9:25-9:30am, ePoster Presentation Center 2)
Poster presentations
Xeomin®
- Decrease in Therapeutic Effect Among Botulinum Toxin Type A Agents: Analysis of the FDA Adverse Event Reporting System Database, Rashid Kazerooni, Merz North America
Ultherapy®
- Differentiation of Microfocused Ultrasounds with Visualization Treatment Using a Customized Management Protocol of See-Plan-Treat, Julia Sevi, MD
Radiesse®
- Radiological Evaluation of Calcium Hydroxylapatite Implantation to Correct Volume Loss in the Dorsum of the Hand, Amir Moradi, MD
Cellfina®
- Multicenter Pivotal Study of the Safety and Effectiveness of a Tissue Stabilized-Guided Subcision Procedure for the Treatment of Cellulite – 5 Year Update, Michael S. Kaminer, MD, on behalf of the Cellfina 5-Year Study Group
- Validated Assessment Scales for Cellulite Dimples on the Buttocks and Thighs in Female Patients, Doris Hexsel, MD, on behalf of the Cellulite Dimple Grading Scale Study Group
- Validated Assessment Scales for Skin Laxity on the Posterior Thighs, Buttocks, Anterior Thighs, and Knees in Female Patients, Michael S. Kaminer, MD, on behalf of the Skin Laxity Grading Scale Study Group
DeScribe® PFD Patch
- Evaluation of a Perfluorodecalin Patch for Laser Tattoo Removal in a Pig Model to Assess Thermal Injury Protection and Plume, Wojciech Danysz, PhD, Merz Pharmaceuticals GmbH
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. |
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 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.
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 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.
PEDIATRIC USE
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®, CELLFINA®, and DESCRIBE® SAFETY INFORMATION
For full product and safety information, including possible mild side effects of Cellfina®, Ultherapy® and DeScribe®, visit www.cellfina.com, www.ultherapy.com and www.describepatch.com, respectively.
Corporate Contact:
Emily Browder
Communications & Public Affairs
Merz Americas
6501 Six Forks Road Raleigh, NC 27615
(984) 960-7201
Emily.Browder@merz.com
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.