XEOMIN at Grafton Dermatology
Improve the appearance of moderate to severe frown lines between the eyebrows.
Xeomin Injections – The Newest Botox Alternative
With the new cosmetic approval, Xeomin now joins the ranks of Botox and Dysport. The Food and Drug Administration (FDA) approved Xeomin in July 2011 for the treatment of severe frown lines or "11's" between the eyes.
Worldwide, more than 84,000 people have been treated with Xeomin injections. The U.S. is actually the 20th country to approve this new drug. And, It usually takes only 10-20 minutes. Come in today and ask more about Xeomin!
XEOMIN® (incobotulinumtoxinA) is a prescription medication used to temporarily improve the appearance of moderate to severe frown lines between the eyebrows (glabellar lines) in adults. XEOMIN® contains botulinum toxin type A, a protein purified from the bacterium Clostridium botulinum. Botulinum toxin type A acts on nerve endings in muscles to prevent muscle fibers from contracting. By reducing these contractions, XEOMIN® can temporarily reduce the lines on your forehead between your brows. XEOMIN® was approved by the US Food and Drug Administration (FDA) in July 2011. It is now widely available to patients across the US.
WHAT IS XEOMIN®?
XEOMIN® (incobotulinumtoxinA) is a prescription medication used to temporarily improve the appearance of moderate to severe frown lines between the eyebrows (glabellar lines) in adults. XEOMIN® contains botulinum toxin type A, a protein purified from the bacterium Clostridium botulinum.
HOW DOES XEOMIN® WORK?
When you squint or frown, the muscles between your brows 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 on your forehead between your brows.
Learn more about two patients, Claudia and Elizabeth, and follow their experiences with Xeomin®.
IS XEOMIN® PROVEN?
XEOMIN® was proven effective in two randomized, double-blind, multicenter, placebo-controlled clinical trials of 547 healthy, adult patients. The average age of patients in the study was 46 years. Patients received 20 Units of XEOMIN® and were classified as responders if they had a 2-grade improvement on a 4-point scale as assessed by the physician and patient. Using these criteria, treatment success was higher with XEOMIN® than placebo on Day 30 in both studies (60% and 48% vs. 0% for placebo in both studies). Based on these trials, XEOMIN® received FDA approval for aesthetic use in 2011.
HOW DO I KNOW IF XEOMIN® IS RIGHT FOR ME?
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 take XEOMIN® if you are allergic to botulinum toxin or any of the other ingredients in XEOMIN®. You should also not take 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 SHOULD I TELL MY DOCTOR BEFORE TREATMENT?
Before receiving treatment with XEOMIN® you should tell your doctor about all of your medical conditions, including whether you have a disease that affects your muscles and nerves, have allergies to any botulinum toxin product, or have experienced any side effect from any other botulinum toxin in the past. In addition, tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you have received any other botulinum toxin product in the last four months or in the past. Be sure your doctor knows exactly which product(s) you received and when you received them.
WHAT CAN I EXPECT DURING TREATMENT?
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 brows. No anesthesia is required; however, your physician may use a topical anesthetic or cold pack to reduce any discomfort.
WHEN CAN I EXPECT TO SEE RESULTS?
In clinical trials, some patients observed visible smoothing as early as 3-4 days after injection. The median first onset of effect was less than a week. The maximum effect typically occurs at 30 days. The typical duration of effect is up to 3 months, but may last significantly longer or shorter in individual patients.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF XEOMIN®?
XEOMIN® may cause serious side effects, including allergic reactions. Symptoms of an allergic reaction to XEOMIN® may include: itching, rash, redness, swelling, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or seek medical help right away if you have wheezing, experience other asthma symptoms, or if you become dizzy or faint.
In clinical trials of XEOMIN® for the treatment of frown lines between the brows, headache was the most common side effect.
XEOMIN® may cause loss of strength or general muscle weakness, blurred vision, or drooping eyelids within hours to weeks of taking XEOMIN®. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
Tell your doctor if you have any side effect that bothers you or that does not subside. These are not all of the possible side effects of XEOMIN®. For more information, see the Important Safety Information on the back cover, Medication Guide and Full Prescribing Information, or ask your doctor.
IMPORTANT SAFETY INFORMATION
WARNING: DISTANT SPREAD OF TOXIN EFFECT: Postmarketing reports indicate that 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 may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. 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.
Additional Important Safety Information
INDICATION AND USAGE
XEOMIN (incobotulinumtoxinA) for injection, for intramuscular use is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.
IMPORTANT SAFETY INFORMATION (CONTINUED)
WARNING: DISTANT SPREAD OF TOXIN EFFECT
Postmarketing reports indicate that 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 may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. 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 treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.
XEOMIN is contraindicated in patients with a known hypersensitivity to the active substance botulinum toxin type A or to any of the components in the formulation and in the presence of infection at the proposed injection site(s), as injection could lead to severe local or disseminated infection.
WARNINGS AND PRECAUTIONS
- The potency units of XEOMIN 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.
- 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.
- 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 and aspiration may result from severe dysphagia [See Boxed Warning].
- 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.
- 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.
- 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%).
Concomitant treatment of XEOMIN and aminoglycoside antibiotics, spectinomycin, or other agents that interfere with neuromuscular transmission (e.g., tubocurarine-like agents), or muscle relaxants, should be observed closely because the effect of XEOMIN may be potentiated. 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
Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. XEOMIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
The safety and effectiveness of XEOMIN in patients less than 18 years of age have not been established.
Please click here for Xeomin full Prescribing Information, including Boxed WARNING.
Under the direction of Dr. Lee Grafton, Dr. Tamela Charbonnet and Dr. Kristal Guidroz, Tricia Petrella, board certified esthetician, and Taylor Zeringue, board certified cosmetologist will provide a complete skin care program consisting of in-office Medical Facials, HydraFacial, Micro Peels, Laser Hair Removal, IPL Treatments, make-up consultations using Glo Mineral Cosmetics.