Merz Showcases Data across Multiple Injectable and Device Products at American Academy of Dermatology Annual Meeting

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Merz Showcases Data across Multiple Injectable and Device Products at American Academy of Dermatology Annual Meeting


RALEIGH, N.C.–(BUSINESS WIRE)–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

Merz in the Americas

Merz has a direct presence in six countries in the Americas, as well as
a network of selected professional distribution partners in South and
Central America and the Caribbean. Merz in the Americas is headquartered
in Raleigh, North Carolina, and has facilities in Mesa, Arizona,
Franksville, Wisconsin, as well as offices in Toronto, Canada, Mexico
City, Bogotá, Colombia, São Paolo, Brazil and Buenos Aires, Argentina.
For more information, visit www.merzusa.com.

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

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 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.

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.



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