The results you expect backed by an extensive range of clinical studies

Actual patient treated for moderate to severe forehead, crow's feet
and glabellar lines. Results may vary.

Clinically proven, reliable
results
for forehead lines1

Primary efficacy end point: Composite investigator and subject
assessment of forehead lines severity at maximum eyebrow
elevation at Day 30–responder rates (% and number of subjects
achieving ≥2-grade improvement on FWS from baseline)1

Study BOTOX® Cosmetic 40 units(20 Units forehead lines and 20 Units glabellar lines) BOTOX® Cosmetic 64 units(20 Units forehead lines, 20 Units glabellar lines,
and 24 units lateral canthal lines)		 Placebo P Value
Study 1 61% (178/290) - 0% (0/101) P<0.0001
Study 2 46% (145/318) 53% (166/313) 1% (1/156) P<0.0001

Secondary efficacy end point: Investigator-assessed achievement
of none or mild from baseline on FWS at maximum eyebrow elevation
(treatment success)1

Study 1

Study 2

Two pivotal, multicenter, randomized, double-blind, placebo-controlled studies with 1178 patients (921 received BOTOX® Cosmetic) treated for moderate to severe forehead lines and glabellar lines simultaneously or moderate to severe forehead lines, glabellar lines, and lateral canthal lines simultaneously. The primary end point was investigator and patient assessment of forehead line severity at maximum eyebrow elevation using the 4-point Facial Wrinkle Scale with Photonumeric Guide (FWS) at day 30 following the first treatment.1

Similar results for
forehead lines1

  • Response rate for forehead lines across multiple treatment cycles is similar. A total of 165 and 197 patients received 3 cycles of BOTOX® Cosmetic over 1 year, 40 Units (20 Units for forehead lines with 20 Units for glabellar lines) and 64 Units (20 Units for forehead lines, 20 Units for glabellar lines, and 24 Units for lateral canthal lines), respectively.1

BOTOX® Cosmetic provides patient satisfaction1

Using the Facial Line Satisfaction Questionnaire, 90% of subjects in Study 1 and 82% in Study 2 reported being
“Mostly Satisfied” or “Very Satisfied” with BOTOX® Cosmetic 40 Units (20 Units FHL with 20 Units GL)
treatment
compared to subjects treated with placebo (1% in Study 1 and 3% in Study 2) at Day 60

Facial Lines Satisfaction Questionnaire Response Frequency at Day 60
(Percentage of Subjects)
STUDY 1 STUDY 2
Responses BOTOX Cosmetic
(20 Units FHL with 20 Units GL)
N=289		 Placebo
N=99		 BOTOX Cosmetic
(20 Units FHL with 20 Units GL)
N=317		 Placebo
N=155
“Very satisfied” 57% 1% 35% 0%
“Mostly satisfied” 33% 0% 47% 3%
“Neither dissatisfied or satisfied” 4% 22% 9% 23%
“Mostly dissatisfied” 4% 21% 7% 20%
“Very dissatisfied” 2% 56% 2% 54%
STUDY 1
Responses BOTOX Cosmetic
(20 Units FHL with 20 Units GL)
N=289		 Placebo
N=99
“Very satisfied” 57% 1%
“Mostly satisfied” 33% 0%
“Neither dissatisfied or satisfied” 4% 22%
“Mostly dissatisfied” 4% 21%
“Very dissatisfied” 2% 56%
STUDY
Responses BOTOX Cosmetic
(20 Units FHL with 20 Units GL)
N=317		 Placebo
N=155
“Very satisfied” 35% 0%
“Mostly satisfied” 47% 3%
“Neither dissatisfied or satisfied” 9% 23%
“Mostly dissatisfied” 7% 20%
“Very dissatisfied” 2% 54%

Adverse reactions seen in
clinical studies1,2

  • There were no additional adverse drug reactions reported with the simultaneous treatment of forehead lines, glabellar lines, and lateral canthal lines.1

Adverse reactions from BOTOX® Cosmetic forehead lines clinical studies1

Reactions BOTOX® Cosmetic Placebo
Headache 9% (58/665) 5% (17/315)
Eyelid ptosis 2% (12/665) 0% (0/315)
Brow ptosis 2% (13/665) 0% (0/315)
Skin tightness 2% (10/665) 0% (0/315)
FHL studies: Study 1 assessed BOTOX® Cosmetic treatment of FHL with GL; Study 2 assessed simultaneous treatment of FHL, GL, and LCL

References:

1. BOTOX® Cosmetic Prescribing Information, October 2017. 2. Data on file, Allergan; Clinical Study Report GMA-BTXC-12-001; March 11, 2014. 3. Data on file, Allergan; Clinical Study Report 191622-142; September 15, 2016. 4. Data on file, Allergan; Clinical Study Report 191622-143; September 19, 2016.

Significant improvement
in moderate
to severe
crow’s feet1

PRIMARY efficacy end point: composite investigator
and subject assessment of lateral canthal lines
severity at maximum smile at Day 30-Responder Rates
(% and Number of Subjects Achieving ≥2-grade
improvement on FWS from baseline)1

Study BOTOX® Cosmetic
(onabotulinumtoxinA) 24 units		 BOTOX® Cosmetic 44 units
(24 Units lateral canthal lines and 20 Units glabellar lines)		 Placebo
Study 1 26% (58/222) - 1.3% (3/223)
Study 2 20.3% (62/306) 21.3% (65/305) 0% (0/306)

Secondary efficacy end point: investigator-assessed
achievement of none or mild from baseline on FWS in
Study 1 (treatment success)1

Two pivotal, multicenter, randomized, double-blind, placebo-controlled studies with 1362 patients (833 received BOTOX® Cosmetic) treated for moderate to severe lateral canthal lines or simultaneously with glabellar lines–with 305 also injected for their moderate to severe glabellar lines. The primary end point was investigator and patient assessment of lateral canthal line severity at maximum smile using the 4-point Facial Wrinkle Scale with Photonumeric Guide (FWS) at day 30 following the first treatment.1

Adverse reactions seen in clinical studies1

Adverse reactions from BOTOX® Cosmetic lateral canthal lines clinical studies1

Event BOTOX® Cosmetic Placebo
Eyelid edema 1% (5/526) 0% (0/530)
LCL studies: Study 1 assessed BOTOX® Cosmetic treatment of LCL alone; Study 2 assessed simultaneous treatment of LCL and GL

Reference

1. BOTOX® Cosmetic Prescribing Information, October 2017.

Predictable outcomes for
glabellar lines–for up
to 4 months1

Co-primary efficacy end points: investigator’s rating of glabellar line severity at maximum frown (responder: severity grade of none or mild) and subject’s global assessment of change in appearance of glabellar lines (responder: grade of at least +2 [moderate improvement]), both at day 30 vs baseline1

Two pivotal, multicenter, randomized, double-blind, placebo-controlled studies with 537 patients (405 received BOTOX® Cosmetic) treated for moderate to severe glabellar lines. The co-primary end points were the investigator’s rating of glabellar line severity at maximum frown and the subject’s global assessment of change in appearance of glabellar lines, both at day 30 post injection.1

BOTOX COSMETIC PROVIDES PATIENT SATISFACTION1,2

82%of patients treated in a clinical study were satisfied with
their glabellar lines results after 60 days (n=60), compared with
0% for placebo (n=57)(p<0.001)1,2

A multicenter, randomized, double-blind, placebo-controlled, parallel-group, 120-day study of satisfaction with BOTOX® Cosmetic treatment in subjects with moderate or severe glabellar lines and lateral canthal lines. Primary end point was the between-group difference in the proportion of responders on the Facial Wrinkle Scale (per-protocol patient population). Response was defined as subjects answering “mostly satisfied” or “very satisfied” on item #5 of the Facial Line Satisfaction Questionnaire (FLSQ) at day 60 (GL only, follow-up version).2

Adverse reactions seen in clinical studies1

Adverse reactions from BOTOX® Cosmetic glabellar lines clinical studies1

Event BOTOX® Cosmetic Placebo
Eyelid ptosis 3% (13/405)) 0% (0/130)
Facial pain 1% (6/405) 0% (0/130)
Facial paresis 1% (5/405) 0% (0/130)
Muscular weakness 1% (6/405) 0% (0/130)
GL studies: Two phase III trials of identical design assessed treatment of GL alone

References:

1. BOTOX® Cosmetic Prescribing Information, October 2017. 2. Data on file, Allergan; Clinical Study Report GMA-BTXC-12-001; March 11, 2014.

BOTOX® Cosmetic (onabotulinumtoxinA) 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.

BOTOX® Cosmetic (onabotulinumtoxinA) 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 spasticity and at lower doses.

Important Information

Indications

BOTOX® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:

IMPORTANT SAFETY INFORMATION (continued)

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), 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.

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.

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).

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.

ADVERSE REACTIONS

The most frequently reported adverse reaction following injection of BOTOX® Cosmetic for glabellar lines was eyelid ptosis (3%).

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%).

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

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. 

Please see BOTOX® Cosmetic Full Prescribing Information including Boxed Warning and Medication Guide.