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STATE-OF-THE-ART MANUFACTURING PROCESS
Xeomin® is made through a unique precision manufacturing process that isolates the therapeutic component of the molecule and removes the complexing/unnecessary proteins that don’t play an active role in treatment. Xeomin® is a uniquely purified neurotoxin. Studies have not been performed to determine whether the presence or absence of complexing/unnecessary proteins has a long-term effect on safety or efficacy.
How does XEOMIN work?
When you squint or frown, the muscles between your eyebrows contract, causing the skin to furrow and fold. Over time, as your skin ages and loses some of its elasticity, these repeated contractions can cause persistent frown lines. Botulinum toxin type A – the active ingredient in Xeomin®– acts on nerve endings in muscles to prevent muscle fibers from contracting. By reducing these contractions, Xeomin® can temporarily reduce the lines between your eyebrows.
Injecting Xeomin® directly into the muscle relaxes the tension areas from wrinkles. As a result, the skin gets smoother and in most cases, wrinkles lessen and diminish. Several younger patients have used Xeomin® treatments as a preventative measure for wrinkles, providing a lift and glow simultaneously.
Don’t worry about the “unnatural” appearance. The team at Clear Aesthetics are expertly trained in applying precise dosages in exact locations for each and every patient, being mindful of their individual needs.
Who is XEOMIN for?
If you are an adult with moderate to severe glabellar lines, Xeomin® may be right for you. Talk to your doctor to discuss the benefits and risks of treatment. Do not use Xeomin® if you are allergic to botulinum toxin or any of the other ingredients in Xeomin®. You should also not use Xeomin® if you have had an allergic reaction to any other botulinum toxin product or have a skin infection at the planned injection site.
What is it like to get XEOMIN?
During treatment, which usually takes about 10-20 minutes, your doctor will inject Xeomin® into the muscles in your forehead that cause frown lines between your eyebrows. No anesthesia is required; however, your physician may use a topical anesthetic or cold pack to reduce any discomfort.
Please see accompanying XEOMIN® Fact Sheet
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
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.
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.
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• 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:
o avoid injection near the levator palpebrae superioris, particularly in patients with larger brow
depressor complexes;
o 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.
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