BOTOX® Cosmetic (onabotulinumtoxinA) Indications
Glabellar Lines
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, 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 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.
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.
Hypersensitivity Reactions
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.
Cardiovascular System
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.
Please see additional Important Safety Information on following page.
© 2016 Allergan. All rights reserved. All trademarks are the property of their respective owners.
BotoxCosmetic.com 1-800-BOTOXMD APC66WR16 162035
BOTOX® Cosmetic (onabotulinumtoxinA) IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS (continued)
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.
ADVERSE REACTIONS
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%).
DRUG INTERACTIONS
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.
Please see accompanying BOTOX® Cosmetic full Prescribing Information including Boxed Warning and Medication Guide.
Approved Uses
BOTOX® Cosmetic (onabotulinumtoxinA) 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.
Please see additional Important Safety Information on following page.
© 2016 Allergan. All rights reserved. All trademarks are the property of their respective owners.
BotoxCosmetic.com 1-800-BOTOXMD APC66WR16 162035
Actual patient. Results may vary.
Photos taken at full smile before and after treatment with BOTOX® Cosmetic (onabotulinumtoxinA) at day 7. In two clinical studies, 26.1%
and 20.3% of people had ≥ 2-grade improvement at day 30. In one of these studies, 67.9% of people had mild or no crow’s feet at day 30
after treatment.
Side effects associated with the injection include localized pain, infection, inflammation, tenderness, swelling, redness, and/or
bleeding/bruising.
Before After (Day 7)
Moderate to severe crow’s feet lines
© 2016 Allergan. All rights reserved. All trademarks are the property of their respective owners.
BotoxCosmetic.com 1-800-BOTOXMD APC66WR16 162035
BOTOX® Cosmetic (onabotulinumtoxinA) IMPORTANT SAFETY INFORMATION (continued)
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.
Please see accompanying Summary of Information about BOTOX® Cosmetic.
Actual patient. Results may vary.
Photos taken at maximum frown before and after treatment with BOTOX® Cosmetic (onabotulinumtoxinA) at day 7. In clinical studies,
physicians assessed 80% of people had significant improvement at day 30.
Side effects associated with the injection include localized pain, infection, inflammation, tenderness, swelling, redness, and/or
bleeding/bruising.