MORE FROM ALLERGAN AESTHETICS X

THE ONLY ONE FDA APPROVED FOR

simultaneous treatment in 3 areas2,4-6

BOTOX® Cosmetic (onabotulinumtoxinA) has clinical data
reported in 528 aesthetic publications—that’s more than any other product of its kind.8

You can see our pivotal studies below.

CLINICALLY PROVEN, RELIABLE RESULTS FOR
FOREHEAD LINES2

PRIMARY EFFICACY END POINT: Composite investigator and subject assessment of forehead line severity at maximum eyebrow elevation at day 30-responder rates (% and number of subjects achieving a ≥ 2-grade improvement on Facial Wrinkle Scale [FWS] from baseline)2
Study BOTOX® Cosmetic (40 Units: 20U FHL + 20U GL) BOTOX® Cosmetic (64 Units: 20U FHL + 20U GL + 24U LCL) Placebo P-Value
Study 1 61% (178/290) - 0% (0/101) P < 0.0001
Study 2 46% (145/318) 53% (166/318) 1% (1/156) P < 0.0001
FHL = forehead lines; GL = glabellar lines; LCL = lateral canthal lines.
secondary EFFICACY END POINT: Investigator-assessed  achievement of none or mild from baseline on FWS at maximum eyebrow elevation (treatment success)2

Study 1

botox forehedline study1 table

Study 2

botox  forehedline study2 table
FHL = forehead lines; GL = glabellar lines; LCL = lateral canthal lines.
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 FWS with Photonumeric Guide at day 30 following the first treatment.2
SIMILAR RESULTS FOR FOREHEAD LINES2

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.2

BOTOX® COSMETIC PROVIDES PATIENT SATISFACTION2

90%

of subjects in Study 1 reported being "Very Satisfied" or "Mostly Satisfied" with BOTOX® Cosmetic compared to 1% with placebo at day 602

82%

of subjects in Study 2 reported being "Very Satisfied" or "Mostly Satisfied" with BOTOX® Cosmetic compared to 3% with placebo at day 602

FACIAL LINES SATISFACTION QUESTIONNAIRE RESPONSE FREQUENCY AT DAY 60 (% OF SUBJECTS)2
Study1 Study2
Responses BOTOX® Cosmetic (20U FHL + 20U GL; N = 289) Placebo(N = 99) BOTOX® Cosmetic (20U FHL + 20U GL; N = 317) Placebo(N = 155)
“Very Satisfied” 57% 90% 1% 35%82% 0%
“Mostly Satisfied” 33% 0% 47% 3%
“Neither Dissatisfied or Satisfied” 4% 22% 9% 23%
“Mostly Dissatisfied” 4% 21% 7% 20%
“Very Dissatitsfied” 2% 56% 2% 54%
FHL = forehead lines; GL = glabellar lines.
ADVERSE REACTIONS FROM BOTOX® COSMETIC FOREHEAD LINES CLINICAL STUDIES2
Reactions BOTOX® Cosmetic (N = 665) Placebo(N = 315)
Headache 9% (58/665) 5% (17/315)
Eyelid ptosis 2% (12/665) 0% (1/315)
Brow ptosis 2% (13/665) 0% (0/315)
Skin tightness 2% (10/665) 0% (0/315)

There were no additional adverse drug reactions reported with the simultaneous treatment of forehead lines, lateral canthal lines, and glabellar lines.2

Forehead lines studies: Study 1 assessed BOTOX® Cosmetic treatment of forehead lines with glabellar lines; Study 2 assessed simultaneous treatment of forehead lines, lateral canthal lines, and glabellar lines.2

SIGNIFICANT IMPROVEMENT IN MODERATE TO SEVERE LATERAL CANTHAL LINES2

PRIMARY EFFICACY END POINT: Composite investigator and subject assessment of lateral canthal line severity at maximum smile at day 30-responder rates (% and number of subjects achieving a ≥ 2-grade improvement on Facial Wrinkle Scale [FWS] from baseline)2
Study BOTOX® Cosmetic (24 Units LCL) BOTOX® Cosmetic (44 Units: 24U LCL + 20U GL) Placebo
Study 1 26.1% (58/222) - 1.3% (3/223)
Study 2 20.3% (62/306) 21.3% (65/305) 0% (0/306)
LCL = lateral canthal lines; GL = glabellar lines.
secondary EFFICACY END POINT: Investigator-assessed achievement of none or mild from baseline on FWS in Study 1 (treatment success)2

Study 1

botox cosmetic table
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 FWS with Photonumeric Guide at day 30 following the first treatment.2
ADVERSE REACTION FROM BOTOX® COSMETIC LATERAL CANTHAL LINES
CLINICAL STUDIES2
Event BOTOX® Cosmetic (N = 526) Placebo (N = 530)
Eyelid edema 1% (5/526) 0% (0/530)

Lateral canthal lines studies: Study 1 assessed BOTOX® Cosmetic treatment of LCL alone; Study 2 assessed simultaneous treatment of lateral canthal lines and glabellar lines.2

PREDICTABLE OUTCOMES FOR GLABELLAR LINES—
FOR UP TO 4 MONTHS2

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 a + 2 [moderate improvement]), both at day 30 vs baseline2
2 days(48 hours)
QUICK
RESPONSE2

Patients may begin to see results within 24 to 48 hours after injection in glabellar lines2

Day
7
REAL RESULTS AS EARLY AS DAY 72

Investigator: 74% (299/405)
vs 6% (8/132) for placebo2

Subject: 82% (334/405)
vs 9% (12/132) for placebo2

Day
30
SIGNIFICANT RESPONSE AT DAY 302

Investigator: 80% (325/405)
vs 3% (4/132) for placebo2

Subject: 89% (362/405)
vs 7% (9/132) for placebo2

Month
4
LONG-LASTING
RESULTS2

Investigator: 25% (102/403)
vs 2% (2/128) for placebo2

Subject: 39% (157/403)
vs 1% (1/128) for placebo2

mobile-predictable-outcome
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.2
BOTOX® COSMETIC PROVIDES PATIENT SATISFACTION9

82%

of subjects in a clinical study were Satisfied″ with their glabellar line results compared
to 0% placebo (P < 0.001)9

FACIAL LINES SATISFACTION QUESTIONNAIRE:
FOLLOW-UP VERSION (LCL AND GL) AT DAY 60 (% of subjects)
Responses BOTOX®  Cosmetic (44 Units: 24U LCL + 20U GL; N = 60) Placebo (N = 57)
“Satisfied” 82% 0%
“Not Satisfied” 18% 100%
LCL = lateral canthal lines; GL = glabellar lines.
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 (glabellar lines only, follow-up version).9
ADVERSE REACTIONS FROM BOTOX® COSMETIC GLABELLAR LINES CLINICAL STUDIES2
Event BOTOX® Cosmetic (N = 405) Placebo(N = 130)
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)

Glabellar lines studies: Two phase 3 trials of identical design assessed treatment of glabellar lines alone.2

The one like no other—
from process to patient2,10

There’s nothing else like BOTOX® Cosmetic (onabotulinumtoxinA); it’s impossible to exactly replicate. This is because critical quality attributes define the complex fingerprint of a biologic such as BOTOX®.2,10 Just as no two fingerprints are the same, no two neurotoxins are the same.10,11

Product Formula

THE PROCESS IS THE PRODUCT12

BOTOX® Cosmetic is the result of a unique and proprietary manufacturing process, where Allergan Aesthetics owns the entire development, production, and distribution system from start to finish.2,12-14

A ONE-OF-A-KIND FORMULATION2

Our unique manufacturing process means you can’t convert units from BOTOX® Cosmetic. There’s no dose ratio between neurotoxin products.2

Product Formula

REFERENCES: 1. BOTOX® Prescribing Information, September 2020. 2. BOTOX® Cosmetic Prescribing Information, July 2020. 3. Data on file, Allergan, FDA Product Approval Information. 4. Dysport® Prescribing Information, July 2020. 5. Xeomin® Prescribing Information, August 2020. 6. Jeuveau® Prescribing Information, January 2020. 7. Data on file, Allergan, February 21, 2019, Total Number of Vials Produced at Westport. 8. Data on file, Allergan, November 2018, Botulinum Toxin Peer-Reviewed Publications. 9. Data on file, Allergan; March 11, 2014; Clinical Study Report GMA-BTXC-12-001. 10. US Food and Drug Administration. Frequently asked questions about therapeutic biological products. US Food and Drug Administration website. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm113522.htm. Updated July 7, 2015. Accessed September 4, 2020. 11. Vulto AG, Jaquez OA. The process defines the product: what really matters in biosimilar design and production? Rheumatology (Oxford). 2017;56(suppl 4):iv14-iv29. 12. Brin MF, James C, Maltman J. Botulinum toxin type A products are not interchangeable: a review of the evidence. Biologics. 2014;8:227-241. 13. Samizadeh S, De Boulle K. Botulinum neurotoxin formulations: overcoming the confusion. Investig Dermatol. 2018;11:273-287. 14. Data on file, Allergan, October 16, 2020; Westport Manufacturing Process.

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 and 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:
  • - 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 (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. 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.

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).

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.

ADVERSE REACTIONS

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%).

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.