Last year, BOTOX® Cosmetic celebrated its 20th anniversary as the first FDA-approved treatment for moderate to severe frown lines in adults.1 It was the first product of its kind to receive FDA approval for aesthetic use and has become the only neurotoxin with FDA approval for the temporary improvement in the appearance of three areas of the upper face: moderate to severe glabellar (frown) lines, forehead lines, and lateral canthal lines (crow’s feet) in adults.1-6 BOTOX® Cosmetic is the #1 selling product of its kind in the US.7 Today, BOTOX® Cosmetic is approved for use in 98 countries.8
Please see BOTOX® Cosmetic Important Safety Information below, including Boxed Warning.
For Seth L. Matarasso, MD, a board-certified dermatologist in San Francisco and Clinical Professor of Dermatology at University of California School of Medicine, in SF, CA, it’s the neurotoxin he recommends to his patients. “I choose BOTOX® Cosmetic because of its scientific innovation and 20-year legacy, along with the established safety profile,” he says.1,2
BOTOX® Cosmetic (onabotulinumtoxinA) is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow's feet, and frown lines between the eyebrows in adults.
Talk to your doctor about BOTOX® Cosmetic and whether it’s right for you. There are risks with this product—the effects of BOTOX® Cosmetic may spread hours to weeks after injection causing serious symptoms. Alert your doctor right away as difficulty swallowing, speaking, breathing, eye problems or muscle weakness can be a sign of a life-threatening condition. If this happens, do not drive a car, operate machinery, or do other dangerous activities. Patients with these conditions before injection are at the highest risk. Please see additional Important Safety Information below.
Here are four important reasons why Dr. Matarasso recommends BOTOX® Cosmetic.
1. SCIENCE AND RESEARCH
BOTOX® Cosmetic is the most studied neurotoxin, and there are more than 500 peer-reviewed articles discussing BOTOX® Cosmetic.9 “I suspect that physicians and the healthcare community take great comfort in knowing that there’s such extensive scientific research and rigor behind this product,” says Matarasso. “Patients want to know that the product they’re being treated with is clinically proven to be effective and established safety profile. The fact that BOTOX® Cosmetic has over 20 years of published research and safety data makes all the difference and really establishes trust.”1
2. PREDICTABLE RESULTS
Physicians like Matarasso choose BOTOX® Cosmetic for its consistent results.2 “I’ve been in practice for over 30 years and have been using BOTOX® Cosmetic since it was first FDA approved,” says Matarasso. “I’ve treated thousands of patients, and each time, I know the product will deliver predictable and subtle results.2 It’s a tried-and-true product and one that I recommend for my patients.”
3. BOTOX® COSMETIC IS FDA APPROVED FOR THREE AREAS
BOTOX® Cosmetic is the only neurotoxin that’s FDA approved to temporarily improve the appearance of three areas of the face: moderate to severe forehead lines, frown lines, and crow’s feet in adults.2-6 “Knowing that it is approved in these three areas is an important reason why BOTOX® Cosmetic is one of a kind,” says Matarasso.2 Patients feel the same kind of reassurance. Based on results from an online market research survey, 94% of neurotoxin patients deemed FDA approval as very important to them.10* The one and only BOTOX® Cosmetic brings you The Look of 3—a treatment of 3 areas, 64 Units, at least 3 times a year.2-6 Treatments should be spaced at least 90 days apart.2 Providers can assess their patients for treatment in 3 areas of the face with an FDA-approved treatment.2 Patients feel confident about their results after receiving BOTOX® Cosmetic.11† In clinical trials, full results of treatment were seen in 30 days.2
Swallowing problems may last for several months. Side effects may include allergic reactions, neck and injection-site pain, fatigue and headache. Allergic reactions can include rash, welts, asthma symptoms, and dizziness. Don’t receive BOTOX® Cosmetic if there’s a skin infection. Tell your doctor your medical history, muscle or nerve conditions (including ALS/Lou Gehrig's disease, myasthenia gravis, or Lambert-Eaton syndrome), and medications, including botulinum toxins, as these may increase the risk of serious side effects. Please see additional Important Safety Information below.
4. PATIENTS KNOW IT AND TRUST IT
After 20 years on the market, people know and trust the iconic BOTOX® Cosmetic brand.1 “Both new patients who are considering a treatment for the first time and my established patients ask for BOTOX® Cosmetic by name,” says Matarasso. “Being first to the market is one of the reasons why BOTOX® Cosmetic is in the vernacular now. In my experience, I often consider that BOTOX® Cosmetic is a reliable treatment option for appropriate patients who are new to aesthetic neurotoxin treatments. It remains one of the most popular treatments in my practice,” says Matarasso. “More and more of my patients—both women and men—are getting treatments with BOTOX® Cosmetic and look like themselves, just with fewer lines.”2
*Results from an online market research survey of patients who receive a neurotoxin at least once within the last 2 years.10
† In a 2022 online market research survey, 98% of patients (n = 129) treated for the temporary improvement of moderate to severe frown lines, crow's feet lines, and forehead lines reported they “Completely” or “Somewhat Agree” (top 2 of 5 responses) that they are confident about their results after receiving BOTOX® Cosmetic. In clinical trials, full results of treatment were seen at day 30.11
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
BOTOX® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:
- Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
- Moderate to severe lateral canthal lines associated with orbicularis oculi activity
- Moderate to severe forehead lines associated with frontalis activity
IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
WARNING: DISTANT SPREAD OF TOXIN EFFECT
Postmarketing reports indicate that the effects of BOTOX® Cosmetic 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, 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 an underlying condition that would predispose them to these symptoms. In unapproved usesand approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses.
BOTOX® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
WARNINGS AND PRECAUTIONS
Lack of Interchangeability Between Botulinum Toxin Products
The potency units of BOTOX® Cosmetic are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of BOTOX® Cosmetic cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method.
Spread of Toxin Effect
Please refer to Boxed Warning for Distant Spread of Toxin Effect.
No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines) have been reported. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory disorders occur.
Serious Adverse Reactions With Unapproved Use
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX® injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX® to the site of injection and/or adjacent structures. In several of the cases, patients had pre-existing dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of BOTOX®. The safety and effectiveness of BOTOX® for unapproved uses have not been established.
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such reactions occur, further injection of BOTOX® Cosmetic should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined.
There have been reports following administration of BOTOX® of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.
Increased Risk of Clinically Significant Effects With Pre-existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from onabotulinumtoxinA (see Warnings and Precautions).
Dysphagia and Breathing Difficulties
Treatment with BOTOX® 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. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning).
Pre-existing Conditions at the Injection Site
Caution should be used when BOTOX® Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).
Dry Eye in Patients Treated With BOTOX® Cosmetic
There have been reports of dry eye associated with BOTOX® Cosmetic injection in or near the orbicularis oculi muscle. If symptoms of dry eye (eg, eye irritation, photophobia, or visual changes) persist, consider referring patients to an ophthalmologist.
Human Albumin and Transmission of Viral Diseases
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.
The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for glabellar lines were eyelid ptosis (3%), facial pain (1%), facial paresis (1%), and muscular weakness (1%).
The most frequently reported adverse reaction following injection of BOTOX® Cosmetic for lateral canthal lines was eyelid edema (1%).
The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for forehead lines with glabellar lines were headache (9%), brow ptosis (2%), and eyelid ptosis (2%).
Co-administration of BOTOX® Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX® Cosmetic may potentiate systemic anticholinergic effects.
The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated byadministration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin,
Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX® Cosmetic.
USE IN SPECIFIC POPULATIONS
There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX® Cosmetic in pregnant women. There are no data on the presence of BOTOX® Cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production.