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.
BOTOX® Cosmetic is a nonsurgical, injectable treatment performed in one of our treatment rooms by a healthcare professional.
Other facts to know:
Approved in the United States for moderate to severe frown lines between
the brows in 2002, for moderate to severe crow’s feet in 2013, and is also approved in 79 countries2,†
Well studied with 442 articles published in scientific and medical journals3 l Millions of people have been treated, and here in our office we treat [insert
approximate number of patients treated daily] every day!
What BOTOX® Cosmetic is NOT:
It is NOT a surgical procedure
It is NOT a filler (a substance that is injected into certain areas of the face to “fill in” wrinkles)
It is NOT permanent †VISTABEL® outside of North America.
Please see full Indications and additional Important Safety Information about BOTOX® Cosmetic on following pages.
FREQUENTLY ASKED QUESTIONS
Q. How does BOTOX® Cosmetic work?
A. 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. BOTOX® Cosmetic is injected into these muscles to temporarily reduce muscle activity. After an injection, you will begin to notice a visible smoothing of your crow’s feet lines and frown lines between your brows.
Q. When will I see results?
A. You may begin to notice results within 24 to 48 hours for moderate to severe frown lines, with results lasting up to 4 months.
Q. Will BOTOX® Cosmetic make me look like I’ve had work done?
A. 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. It is important to talk to us about the results you want from treatment.
Q. Does BOTOX® Cosmetic treatment hurt?
A. Some patients report that being injected with BOTOX® Cosmetic feels like a pinch. We may use ice to numb the treatment area. If you are concerned about discomfort, we may apply a topical numbing cream before administering
Q. What are common side effects?
A. Three percent of patients experienced eyelid drooping in the frown lines studies and 1% of patients experienced eyelid swelling in the crow’s feet studies. Other possible side effects include: dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; eye problems: double vision, blurred vision, decreased eyesight and dry eyes; and allergic reactions.4 These are not all of the possible serious side effects of BOTOX® Cosmetic. Please see the Important Safety Information including Boxed Warning and Medication Guide.
Q. How long does the treatment take?
A. We will discuss your treatment goals and perform a facial analysis to determine the appropriate treatments for you. The actual injection process takes about 10 minutes.
Q. How can I save on treatments?
A. Enroll in the Brilliant Distinctions® Rewards Program to save money on BOTOX® Cosmetic treatments. You earn points on each BOTOX® Cosmetic treatment that you can redeem for savings on future treatments. You can also earn and redeem points on other selected treatments that your doctor may determine are right for you.
In addition, you can earn points when you shop online at your favorite retailers participating in the Brilliant Distinctions® Mall. As a member you will receive treatment reminders and information about your points balance.
Q. How many injections will I receive?
A. For the crow’s feet area, 3 areas of the muscle that frames the side of the eye (orbicularis oculi) will be injected. This will be repeated on the orbicularis oculi muscle on the side of the other eye. For the frown lines area, there are 5 injections into muscles in your forehead— 1 in the procerus muscle and 4 in the corrugator muscles.
Q. How long is the recovery time after treatment?
A. After your treatment, you can resume your day. There is minimal downtime and we may give you specific aftercare instructions.
Q. Do men receive BOTOX® Cosmetic treatment?
A. Yes. BOTOX® Cosmetic has also been clinically evaluated in male patients.In clinical studies for moderate to severe frown lines, 17.5% of patients treated with BOTOX® Cosmetic were men.5 In the clinical studies for moderate to severe crow’s feet, male patients comprised approximately 12% of patients treated with BOTOX® Cosmetic.6,7
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
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® Cosmeticisindicatedforthe temporary improvement in the appearance of moderate to severe lateral canthal lines associated with orbicularis oculi activity in adult patients.
IMPORTANT SAFETY INFORMATION (continued)
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
ThepotencyUnitsofBOTOX® 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® Cosmeticcannotbecompared 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.
Please see additional Important Safety Information on following pages.
BOTOX® Cosmetic (onabotulinumtoxinA) IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS (continued)
Spread of Toxin Effect (continued)
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 resultedfromtheadministrationofBOTOX® 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® forunapproveduseshavenot
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® Cosmeticshouldbediscontinued 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.
Please see additional Important Safety Information on following page.
BOTOX® Cosmetic (onabotulinumtoxinA) IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS (continued)
TherehavebeenreportsfollowingadministrationofBOTOX® ofadverseeventsinvolvingthecardiovascularsystem,includingarrhythmiaand 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
TreatmentwithBOTOX® andotherbotulinumtoxinproductscanresultinswallowingorbreathingdifficulties.Patientswithpre-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
CautionshouldbeusedwhenBOTOX® Cosmetictreatmentisusedinthepresenceofinflammationattheproposedinjectionsite(s)orwhen 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.
ThemostfrequentlyreportedadverseeventfollowinginjectionofBOTOX® Cosmeticforglabellarlineswaseyelidptosis(3%). ThemostfrequentlyreportedadverseeventfollowinginjectionofBOTOX® Cosmeticforlateralcanthallineswaseyelidedema(1%).
Co-administrationofBOTOX® Cosmeticandaminoglycosidesorotheragentsinterferingwithneuromusculartransmission(eg,curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administrationofBOTOX® Cosmeticmaypotentiatesystemicanticholinergiceffects.
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.
USE IN SPECIFIC POPULATIONS
BOTOX® Cosmeticisnotrecommendedforuseinchildrenorpregnantwomen.ItisnotknownwhetherBOTOX® Cosmeticisexcretedin humanmilk.CautionshouldbeexercisedwhenBOTOX® Cosmeticisadministeredtoanursingwoman.
Please see accompanying full Prescribing Information including Boxed Warning and Medication Guide.
1.Dataonfile,Allergan,Inc.,December2014.2.Dataonfile,Allergan,Inc.;May2015;BOTOX® andBOTOX® CosmeticCountryApprovals. 3.Dataonfile,Allergan,Inc.,June17,2015.4.BOTOX® CosmeticPrescribingInformation,August2015.5.CarruthersA,CarruthersJ,LoweNJ, etal;forBOTOX® GlabellarLinesI&IIStudyGroups.One-year,randomised,multicenter,two-periodstudyofthesafetyandefficacyofrepeated treatments with botulinum toxin type A in patients with glabellar lines. J Clin Res. 2004;7:1-20. 6. Data on file, Allergan, Inc.; Clinical Study Report 191622-098; March 28, 2012. 7. Data on file, Allergan, Inc.; Clinical Study Report 191622-099.
©2015 Allergan, Inc., Irvine, CA 92612 ® and TM marks owned by Allergan, Inc. BotoxCosmetic.com 1-800-BOTOXMD Re-order: APC58NH15 151958
Botox Before and After Photos by Raquel Wall, RN