WHAT IS BOTOX COSMETIC?
BOTOX® Cosmetic is the only approved treatment to temporarily improve the appearance of both moderate to severe frown lines between the brows and crow’s feet lines in adults.
A well-studied treatment
BOTOX® Cosmetic is one of the most extensively studied medical aesthetic treatments and is approved for cosmetic use in 78 countries.* BOTOX® Cosmetic has a record of experience that aesthetic specialists know and trust. And, the safety and efficacy of BOTOX® Cosmetic have been evaluated in both Allergan sponsored clinical trials as well as in 417 peer-reviewed articles in scientific and medical journals.
*VISTABEL® outside of North America.
Derived from sources that exist in nature
BOTOX® Cosmetic contains tiny amounts of a highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum. Formulations, potency, and approved doses vary among botulinum toxin products, which means that one product cannot take the place of another. Those are a few reasons why there is no such thing as a “generic” form of BOTOX® Cosmetic. There have been no studies to support that other products are Unit-to-Unit equivalent to BOTOX® Cosmetic.
A treatment experienced by millions of people
Approximately 10.9 million vials of BOTOX® Cosmetic have been sold in the United States since 2002, and millions of people have already made BOTOX® Cosmetic a part of what they do for themselves. Today, BOTOX® Cosmetic is the #1 selling product of its kind in the world.†
†Data collected through June 2014.
HOW DOES BOTOX COSMETIC WORK?
BOTOX® Cosmetic targets one of the underlying causes of frown lines and crow’s feet—the repeated muscle contractions from frowning and squinting over the years. Your specialist will inject these muscles with BOTOX® Cosmetic to temporarily reduce muscle activity. You will begin to notice a visible smoothing of your crow’s feet lines and frown lines between your brows.
Wrinkles result from a combination of many factors. It’s not just about cellular changes that can occur over time, reduction of collagen, or damage caused by free radicals in the sun and the environment. When you frown or concentrate, the muscles between your brows contract, causing your skin to furrow and fold. And when you squint, the muscles around your eyes contract and cause crow’s feet.
BOTOX® Cosmetic works beneath the skin’s surface and targets the underlying muscle activity that causes frown lines and crow’s feet.
For the crow’s feet area, your specialist will inject 3 areas of the orbicularis oculi, the muscle that frames the side of the eye. This will be repeated on the orbicularis oculi muscle on the other eye.
Injecting BOTOX® Cosmetic into the muscles that cause crow’s feet lines temporarily reduces the activity of those muscles. The result is a reduction in the appearance of those lines.
For the frown lines area, your specialist will administer 5 injections into muscles in your forehead—1 in the procerus muscle and 4 in the corrugator muscles.
Injecting BOTOX® Cosmetic into the muscles that cause frown lines temporarily reduces the activity of those muscles. The result is a reduction in the appearance of those lines.
WHAT SHOULD I EXPECT WITH TREATMENT?
Real, noticeable results
You may begin to notice results within 24 to 48 hours for moderate to severe frown lines, with results lasting up to 4 months.
Some patients report that being injected with BOTOX® Cosmetic feels like a pinch
Your specialist may use ice to numb the treatment area. If you are concerned about discomfort, your specialist may apply a topical numbing cream before administering your treatment.
The actual injection process takes about 10 minutes
Your specialist will discuss your treatment goals and perform a facial analysis to determine the appropriate treatment areas for you.
You’ll look like yourself—only with less noticeable frown lines and crow’s feet
BOTOX® Cosmetic is a technique-sensitive treatment. You should not lose the ability to show expression when you are treated by someone who is licensed, trained, and a medical expert in facial anatomy.
Return to your daily routine
Treatment requires minimal downtime or recovery; it’s often called a lunchtime procedure. You’ll be able to go about your normal routine immediately after you leave your specialist’s office.
Your cost not only includes the price of the product, but more importantly, the skill and expertise of the specialist or healthcare professional who is administering your treatment.
BOTOX® Cosmetic is a technique-sensitive treatment—look for someone who is licensed and trained and has experience treating patients with BOTOX® Cosmetic.
Be wary of discount products or “cheap” BOTOX® Cosmetic—if it sounds too good to be true, it probably is.
It is more important to find an experienced specialist who will take the time to understand your treatment goals and develop a treatment plan that is right for you.
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of both moderate to severe crow’s feet lines and frown lines between the eyebrows in adults
IMPORTANT SAFETY INFORMATION
BOTOX® Cosmetic may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic:
- Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months
- Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing
BOTOX® Cosmetic dosing units are not the same as, or comparable to, any other botulinum toxin product.
There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow’s feet lines, or both at the same time.
BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.
Do not take BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.
Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig’s disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX® Cosmetic.
Tell your doctor about all your medical conditions, including: plans to have surgery; had surgery on your face; weakness of forehead muscles: trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to (it is not known if BOTOX® Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® Cosmetic in the past.
Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.
Other side effects of BOTOX® Cosmetic include: discomfort or pain at the injection site; headache; and eye problems: double vision, blurred vision, drooping eyelids, and swelling of your eyelids.
For more information refer to the Medication Guide or talk with your doctor.
To report a side effect, please call Allergan at 1-800-433-8871.
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 uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and upper limb spasticity and at lower doses.
BOTOX® Cosmetic (onabotulinumtoxinA) for injection 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.
Lateral Canthal Lines
BOTOX® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe lateral canthal lines associated with orbicularis oculi activity in adult patients.
IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS
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), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines) have been reported.
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.
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).
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. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.
The most frequently reported adverse event following injection of BOTOX® Cosmetic for glabellar lines was eyelid ptosis (3%).
The most frequently reported adverse event following injection of BOTOX® Cosmetic for lateral canthal lines was eyelid edema (1%).
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 by administration 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
BOTOX® Cosmetic is not recommended for use in children or pregnant women. It is not known whether BOTOX® Cosmetic is excreted in human milk. Caution should be exercised when BOTOX® Cosmetic is administered to a nursing woman.