SlideShare una empresa de Scribd logo
1 de 39
Leadership Through Innovation
in Facial Aesthetics
Allergan Programs Policy:
Off-Label Questions
 If a physician-speaker is asked an unsolicited question, he/she may
briefly answer that question even if the question involves information
inconsistent with Allergan’s approved product labeling
 Physician-speaker must adhere to the Programs Policy when
answering a question involving an off-label use of Allergan products
 The physician must:
– Indicate that the information under discussion is not consistent with the
FDA-approved labeling
– Note that the information being exchanged is based on his/her own
professional clinical experience as a physician, and
– If the physician believes, in the exercise of his/her medical and scientific
judgment, that the question should be answered, he/she may briefly
answer the question, but the speaker should then immediately return the
discussion to approved uses of Allergan products
The Allergan Medical Family of Products
The first and
only FDA-
approved product
indicated to treat
hypotrichosis of
the eyelashes by
increasing their
growth, including
length, thickness,
and darkness
The first and
only FDA-
approved product
indicated to treat
hypotrichosis of
the eyelashes by
increasing their
growth, including
length, thickness,
and darkness
The first treatment
approved by the
FDA for moderate
to severe glabellar
lines in patients
18 to 65 years of age
The first treatment
approved by the
FDA for moderate
to severe glabellar
lines in patients
18 to 65 years of age
The #1 selling dermal
filler in the US1
with:
Smooth Flow
Smooth Consistency
Provides a smooth,
natural look and feel
Smooth Outcomes
The #1 selling dermal
filler in the US1
with:
Smooth Flow
Smooth Consistency
Provides a smooth,
natural look and feel
Smooth Outcomes
Advances skin
care with GLX
Technology™
to help daily
rejuvenation
Advances skin
care with GLX
Technology™
to help daily
rejuvenation
Facial Aesthetics Portfolio
Please see BOTOX® Cosmetic Important Safety Information including Boxed Warning on slides 7-15, JUVEDERM ® Important Safety
Information on slide 16, and LATISSE®
Important Safety Information on slides 39-43.
1. Data on file, Allergan, Inc., November 2009; US Facial Injectables Market
Share Report; GuidePoint Global Filler Share Tracker.
Allergan Provides a Complete Array of Products for
Facial Aesthetics
Moderate to
severe glabellar
lines
Chin Wrinkles*
Nasolabial Folds*Perioral Lines*
Marionette Lines*
Hypotrichosis of
the Eyelashes
Skin Care
*When diagnosed as a moderate to severe wrinkle or fold.
Please see BOTOX®
Cosmetic Important
Safety Information
including Boxed
Warning on slides 7-15,
JUVEDERM ®
Important
Safety Information on
slide 16, and LATISSE®
Important Safety
Information on slides
39-43.
BOTOX®
Cosmetic
(onabotulinumtoxinA)
5
Please see BOTOX®
Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
History of Development, FDA Approvals, and
Clinical Trials
FDA approval for
cervical dystonia
FDA approval
for moderate to
severe glabellar lines
FDA approval
for hyperhidrosis
inadequately managed
with topical agents
BOTOX®
(onabotulinumtoxinA)
20th anniversary
Botulinum Toxin
Type A first isolated
1920s 1978 1989 2000 2002 2004 20091991
FDA = US Food and Drug Administration.
First therapeutic
testing in humans
with Oculinum
Dr. Allen Scott
FDA approval of
Oculinum for
blepharospasm,
strabismus
Allergan changes
product name
to BOTOX®
6
Indications
BOTOX®
is indicated for the treatment of cervical dystonia in adults to decrease the
severity of abnormal head position and neck pain associated with cervical dystonia.
BOTOX®
is indicated for the treatment of strabismus and blepharospasm associated with
dystonia, including benign essential blepharospasm or VII nerve disorders in patients
12 years of age and above.
The efficacy of BOTOX®
treatment in deviations over 50 prism diopters, in restrictive
strabismus, in Duane’s syndrome with lateral rectus weakness, and in secondary
strabismus caused by prior surgical over-recession of the antagonist has not been
established. BOTOX®
is ineffective in chronic paralytic strabismus except when used
in conjunction with surgical repair to reduce antagonist contracture.
BOTOX®
is indicated for the treatment of severe primary axillary hyperhidrosis that is
inadequately managed with topical agents.
BOTOX®
Cosmetic is indicated for the temporary improvement in the appearance of
moderate to severe glabellar lines associated with corrugator and/or procerus muscle
activity in patients 18 to 65 years of age.
BOTOX®
(onabotulinumtoxinA) & BOTOX®
Cosmetic
(onabotulinumtoxinA) Important Safety Information
7
IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING
Distant Spread of Toxin Effect
Postmarketing reports indicate that the effects of BOTOX®
or 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, blurred vision, 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
underlying conditions that would predispose them to these symptoms. In unapproved
uses, including spasticity in children and adults, and in approved indications, cases of
spread of effect have occurred at doses comparable to those used to treat cervical
dystonia and at lower doses.
BOTOX®
(onabotulinumtoxinA) & BOTOX®
Cosmetic
(onabotulinumtoxinA) Important Safety Information
(continued)
8
CONTRAINDICATIONS
BOTOX®
and BOTOX®
Cosmetic are 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
The recommended dosage and frequency of administration for BOTOX®
or
BOTOX®
Cosmetic should not be exceeded. Risks resulting from administration
at higher dosages are not known.
Lack of Interchangeability Between Botulinum Toxin Products
The potency Units of BOTOX®
and 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®
and
BOTOX®
Cosmetic cannot be compared to or converted into Units of any other
botulinum toxin products assessed with any other specific assay method.
9
BOTOX®
(onabotulinumtoxinA) & BOTOX®
Cosmetic
(onabotulinumtoxinA) Important Safety Information
(continued)
WARNINGS (continued)
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®
/BOTOX®
Cosmetic at the labeled dose of 20 Units
(for glabellar lines) or 100 Units (for severe primary axillary hyperhidrosis) have
been reported.
No definitive, serious adverse event reports of distant spread of toxin effect associated
with BOTOX®
for blepharospasm at the recommended dose (30 Units and below) or
for strabismus at the labeled doses have been reported.
Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported. These reactions
include anaphylaxis, urticaria, soft-tissue edema, and dyspnea. If such reactions
occur, further injection of BOTOX®
or 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.
10
BOTOX®
(onabotulinumtoxinA) & BOTOX®
Cosmetic
(onabotulinumtoxinA) Important Safety Information
(continued)
WARNINGS (continued)
Pre-existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or
neuromuscular junctional disorders (eg, myasthenia gravis or Lambert-Eaton
syndrome) should be monitored particularly closely when given botulinum toxin.
Patients with neuromuscular disorders may be at increased risk of clinically significant
effects including severe dysphagia and respiratory compromise from typical doses of
BOTOX®
or BOTOX®
Cosmetic.
11
BOTOX®
(onabotulinumtoxinA) & BOTOX®
Cosmetic
(onabotulinumtoxinA) Important Safety Information
(continued)
PRECAUTIONS
Caution should be used when BOTOX®
or BOTOX®
Cosmetic treatment is used in patients
who have an inflammatory skin problem at the injection site, marked facial asymmetry,
ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or the
inability to substantially lessen glabellar lines by physically spreading them apart.
Information for Patients
Patients should be counseled that if loss of strength, muscle weakness, or impaired
vision occur, they should avoid driving a car or engaging in other potentially
hazardous activities.
Pregnancy
Administration of BOTOX®
or BOTOX®
Cosmetic is not recommended during
pregnancy. There are no adequate and well-controlled studies of BOTOX®
or
BOTOX®
Cosmetic in pregnant women.
Nursing Mothers
It is not known whether BOTOX®
or BOTOX®
Cosmetic are excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when
BOTOX®
or BOTOX®
Cosmetic are administered to a nursing woman.
12
BOTOX®
(onabotulinumtoxinA) & BOTOX®
Cosmetic
(onabotulinumtoxinA) Important Safety Information
(continued)
ADVERSE REACTIONS
General
The most serious adverse events reported after treatment with botulinum toxin include
spontaneous reports of death, sometimes associated with anaphylaxis, dysphagia,
pneumonia, and/or other significant debility.
There have also been reports 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.
Cervical Dystonia
The most frequently reported adverse reactions following injection of BOTOX®
for cervical
dystonia include dysphagia (19%), upper respiratory infection (12%), neck pain
(11%), and headache (11%).
13
BOTOX®
(onabotulinumtoxinA) & BOTOX®
Cosmetic
(onabotulinumtoxinA) Important Safety Information
(continued)
ADVERSE REACTIONS (continued)
Blepharospasm
The most frequently reported treatment-related adverse reactions following injection of
BOTOX®
for blepharospasm include ptosis (20.8%), superficial punctate keratitis
(6.3%), and eye dryness (6.3%).
Strabismus
The most frequently reported adverse events following injection of BOTOX®
for
strabismus include ptosis (15.7%) and vertical deviation (16.9%).
Primary Axillary Hyperhidrosis
The most frequently reported adverse events (3% to 10% of patients) following injection
of BOTOX®
for severe primary axillary hyperhidrosis include injection-site pain and
hemorrhage, non-axillary sweating, infection, pharyngitis, flu syndrome, headache,
fever, neck or back pain, pruritus, and anxiety.
Glabellar Lines
The most frequently reported adverse events following injection of BOTOX®
Cosmetic
include blepharoptosis and nausea.
14
BOTOX®
(onabotulinumtoxinA) & BOTOX®
Cosmetic
(onabotulinumtoxinA) Important Safety Information
(continued)
ADVERSE REACTIONS (continued)
Overdosage
Excessive doses of BOTOX®
or BOTOX®
Cosmetic may be expected to produce
neuromuscular weakness with a variety of symptoms. Respiratory support may be
required where excessive doses cause paralysis of respiratory muscles. In the event
of overdose, the patient should be medically monitored for symptoms of excessive
muscle weakness or muscle paralysis.
In the event of suspected or actual overdosage, please contact your local or state health
department to process a request for antitoxin through the Centers for Disease Control
and Prevention (CDC). If you do not receive a response within 30 minutes, please
contact the CDC directly at 1-770-488-7100.
Note to representative: Please provide full BOTOX®
and BOTOX®
Cosmetic
Prescribing Information, including Medication Guide, when presenting
this material.
15
BOTOX®
(onabotulinumtoxinA) & BOTOX®
Cosmetic
(onabotulinumtoxinA) Important Safety Information
(continued)
JUVÉDERM®
Important Safety Information
JUVÉDERM®
injectable gel (including JUVÉDERM®
Ultra,
JUVÉDERM®
Ultra Plus, JUVÉDERM®
Ultra XC, and JUVÉDERM®
Ultra Plus XC) is indicated for injection into the mid-to-deep dermis for
correction of moderate to severe facial wrinkles and folds (such as
nasolabial folds). Side effects were usually mild to moderate, lasting 7
days or less, and included temporary injection-site reactions such as
redness, pain, firmness, swelling, and bumps. JUVÉDERM®
is not for
people with severe allergies. For more information, please click on the
About Safety link at www.juvederm.com or call the Allergan Product
Support line at 1-877-345-5372. JUVÉDERM®
injectable gel is available
by prescription only.
BOTOX®
(onabotulinumtoxinA) and BOTOX®
Cosmetic
(onabotulinumtoxinA): Experience Worldwide
1. Data on file, Allergan, Inc.; 2. The American Society of Plastic Surgeons (ASPS). 2009 Report of the 2008 Statistics: National Clearinghouse of Plastic
Surgery Statistics. The American Society of Plastic Surgeons (ASPS) Web site. http://www.plasticsurgery.org/Media/stats/2008-US-cosmetic-reconstructive-
plastic-surgery-minimally-invasive-statistics.pdf. Accessed 2010.
17
BOTOX®
Cosmetic (onabotulinumtoxinA):
Unique Molecular Structure
Please see BOTOX®
Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
Proven Treatment for Moderate to Severe
Glabellar Lines
 First physician-administered, nonsurgical aesthetic treatment
approved by the FDA to temporarily treat moderate to severe
glabellar lines in patients 18-65 years of age
 High levels of patient satisfaction1,2
– Precise delivery with physician control
– Predictable clinical outcomes3
Frown lines are caused by overactive facial muscles.
1. Aesthetic Surgery Education and Research Foundation (ASERF), BOTOX®
Cosmetic Use Survey, April 2005.; 2. Facial Injectables Consumer User Survey;
July 2009. 3. BOTOX®
Cosmetic Prescribing Information, August 2009.
Precise Control for Predictable Outcomes
In clinical trials at day 7, 74% of
patients demonstrated none or
mild glabellar line severity at
maximum frown as compared to
6% in placebo; at day 30, 80% of
patients demonstrated the same
as compared to 3% in placebo.1
Side effects associated with the
injection include localized pain,
infection, inflammation,
tenderness, swelling, redness,
and/or bleeding/bruising.
1. BOTOX®
Cosmetic Prescribing Information, August 2009.
Unretouched photos
taken at maximum frown
before treatment with
BOTOX®
Cosmetic and
taken at maximum frown
after treatment with
BOTOX®
Cosmetic at days 2
and 14. The photos
featured here are of actual
BOTOX®
Cosmetic patients.
Individual results may vary.
Before Day 14Day 2
20
Please see BOTOX®
Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
BOTOX®
Cosmetic (onabotulinumtoxinA)
Begins Working Within 24 to 48 Hours1
1. BOTOX®
Cosmetic Prescribing Information, August 2009.
21
74
80
70
48
25
82
89
82
63
39
6 3 2 2 2
9 7 4 3 1
7 30a 60 90 120 7 30a 60 90 120
BOTOX Cosmetic (onabotulinumtoxinA) (N = 405) Placebo (N = 132)
BOTOX®
Cosmetic (onabotulinumtoxinA):
74% “Full Response” by Day 71
aDay 30: Co-primary efficacy time point, P < .001.
1. BOTOX®
Cosmetic Prescribing Information, August 2009.
Day of Investigator’s Assessment Day of Subject’s Assessment
®
Responders(%)
22
Patient Satisfaction Is Paramount in Aesthetic Practices
1. Fagien S, et al. Plast Reconstr Surg. 2008.
Please see BOTOX®
Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
BOTOX®
Cosmetic (onabotulinumtoxinA):
97% Patient Satisfaction in Surveyed Patients1,2
1. Facial Injectables Consumer User Survey; July 2009; 2. Aesthetic Surgery Education and Research Foundation (ASERF), BOTOX®
Cosmetic Use Survey,
April 2005.
24
Very Satisfied
69.2%
Somewhat Satisfied
27.4%Not Satisfied
3.4%
Self-reported responses
N = 117
Why High Satisfaction With BOTOX®
Cosmetic
(onabotulinumtoxinA)
1. The American Society of Plastic Surgeons (ASPS) Web site. Accessed 2010; 2. BOTOX®
Cosmetic Prescribing Information, 2009.
Please see BOTOX®
Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
BOTOX®
Cosmetic (onabotulinumtoxinA): A Specific
Formulation Not Shared by Any Other Product
≈ 5 nanograms of onabotulinumtoxinA,
≈ 900-kDa neurotoxin complex
0.9 mg sodium chloride
0.5 mg serum albumin
BOTOX®
Cosmetic (onabotulinumtoxinA):
A Legacy of Experience
1. The American Society of Plastic Surgeons (ASPS) Web site. Accessed 2010; 2. Aesthetic Surgery Education and Research Foundation (ASERF),
BOTOX®
Cosmetic Use Survey, April 2005; 3. Facial Injectables Consumer User Survey; July 2009; 4. BOTOX®
Cosmetic Prescribing Information, 2009.
27
Summary of FDA Labeling Changes to
BOTOX®
Cosmetic (onabotulinumtoxinA)
 Unique nonproprietary name
 Addition of Boxed Warning regarding distant spread of toxin effect
– No definitive reports of distant spread of toxin effect with
BOTOX®
Cosmeticat the labeled dose of 20 U
 Revised lack of interchangeability
 Statement of nondetectability of BOTOX®
Cosmetic in peripheral blood
 Revised content regarding:
– Pre-existing neuromuscular disorders
– Dysphagia and breathing difficulties in the treatment of cervical dystonia
– Information for patients/provision of approved patient Medication Guide
by physician
– Adverse reactions regarding local weakness of muscles adjacent
to injection
– Overdosage including the addition of new text and instructions
28
Summary of BOTOX®
Cosmetic (onabotulinumtoxinA)
Risk Evaluation and Mitigation Strategies (REMS)
29
• Medication Guide
– Included in each carton
– Notice to distribute Medication Guide to patient
– Additional copies of Medication Guide available from Allergan
• Communication Plan
– Support healthcare providers in the implementation of REMS
– “Dear Healthcare Provider” Letter (DHPL)
– DHPL, updated prescribing information, and Medication Guide provided to all
BOTOX®
/BOTOX®
Cosmetic (onabotulinumtoxinA) purchasers
Please see BOTOX®
Cosmetic Important Safety Information
including Boxed Warning on slides 7-15.
Allergan’s Proactive Steps to Protect Patient Safety
Importation of
pharmaceuticals
and biologic
products into the
United States has
drawn media
attention
Direct-to-physician
sales help ensure
product integrity
Exacta®
vial to
ensure product
authenticity
• Flip-top cap and purple-
colored crimp
• ALLERGAN appears on
the holographic label
Importation of Foreign Pharmaceuticals or Biologics Into
the United States Without FDA Approval Remains Illegal
Please see BOTOX®
Cosmetic Important Safety
Information including Boxed Warning on slides 7-15.
Botulinum Toxin Units Are Not Interchangeable
According to the Label
1. BOTOX® Cosmetic Prescribing Information, 2009; 2. Dysport™ Prescribing Information, 2009.
32
“…Units of biological
activity of
BOTOX®
Cosmetic cannot
be compared to or
converted into Units of any
other botulinum toxin…”1
“…Units of biological
activity of
BOTOX®
Cosmetic cannot
be compared to or
converted into Units of any
other botulinum toxin…”1
“The potency Units of
Dysport™ are specific to
the preparation and assay
method utilized. They are
not interchangeable with
other preparations
of botulinum
toxin products…”2
“The potency Units of
Dysport™ are specific to
the preparation and assay
method utilized. They are
not interchangeable with
other preparations
of botulinum
toxin products…”2
Evaluating Botulinum Toxin Properties
1. BOTOX®
Cosmetic Prescribing Information, 2009; 2. Dysport™ Prescribing Information, 2009; 3. Lietzow et al. Protein J. 2008; 4. Hambleton. J Neurol.
1992.; 5. Wenzel et al. J Clin Pharm Ther. 2007; 6. Panjwani et al. Botulinum J. 2008.
BOTOX®
Cosmetic
(onabotulinumtoxinA)
(2002)
Dysport™
(abobotulinumtoxinA)
(1991)
BoNT A
SNAP-251
BoNT A
SNAP-252
≈ 9003
≥ 3004
Vacuum-dried
NaCl
Albumin1
Freeze-dried2
Lactose2
Albumin2
Neutral5
Neutral5
100 U1
300 U/500 U2
≈ 5 ng5 4.35 ng per 500 LD50 U6
2.5 mL per 100 U1
1.5 mL per 300 U
or
2.5 mL per 300 U2
20 U
4 U per .01 mL x 51
50 U2
10 U per .05 mL x 52
or 10
U per .08 mL x 52
33
Serotype/SubstrateSerotype/Substrate
Complex weight (kDa)Complex weight (kDa)
FormulationFormulation
pHpH
Units/VialUnits/Vial
Total ProteinTotal Protein
(ng/vial)(ng/vial)
ReconstitutionReconstitution
Approved doseApproved dose
Botulinum Toxin Injection Patterns Vary
1. BOTOX®
Cosmetic Prescribing Information, 2009; 2. Moy et al. Arch Facial Plastic Surg. 2009.
34
Please see BOTOX®
Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
Botulinum Toxins Perform Differently: Results From a
Double-Blind, Randomized, Parallel-Group Study1
1. Lowe et al. J Am Acad Dermatol. 2006.
35
Glabellar Line Severity Improved With
BOTOX®
Cosmetic (onabotulinumtoxinA)1
Duration from a double-blind, randomized, parallel-group study.
Incidence of at least a 1-grade improvement from baseline in
glabellar line severity at maximum contraction.
1. Lowe et al. J Am Acad Dermatol. 2006.
94%
(29/31)
77%
(24/31)
53%
(16/30)
97%
(29/30)
59%
(17/29)
28%
(8/29)
0
20
40
60
80
100
8 12 16
P = .04
Patients(%)
Weeks
BOTOX®
Cosmetic (onabotulinumtoxinA) (20 U)
Dysport™
(abobotulinumtoxinA) (50 U)
36
Considerations in Switching to Another
Botulinum Toxin
Physicians considering switching to another botulinum
toxin need to evaluate:
 Differences in the approved dose, dilution, volume, and
injection sites
 Potential side effects
Patients considering treatment with another botulinum
toxin need to evaluate:
 Experience of injector with specific toxin
 Side effects with specific toxin
 Effectiveness of specific toxin
37
Please see BOTOX®
Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
The Science of LATISSE®
(bimatoprost ophthalmic solution) 0.03%
©2010 Allergan, Inc., Irvine, CA 92612
®
and ™ marks owned by Allergan, Inc.
JUVÉDERM®
mark owned by Allergan Industrie, SAS.
Dysport is a trademark of Ipsen Biopharm Limited.
Perlane and Restylane are registered trademarks of HA North American Sales AB.
PowerPoint is a registered trademark of Microsoft Corporation in the United States and/or other countries.
www.botoxcosmetic.com 1-800-BOTOXMD www.juvederm.com/professional
Re-order: APC58HR10
39

Más contenido relacionado

La actualidad más candente

La actualidad más candente (20)

Biostimulant dermal fillers
Biostimulant dermal fillersBiostimulant dermal fillers
Biostimulant dermal fillers
 
Botox injection
Botox injectionBotox injection
Botox injection
 
Face Design with Aesthefill(Poly Lactic Acid)
Face Design with Aesthefill(Poly Lactic Acid)Face Design with Aesthefill(Poly Lactic Acid)
Face Design with Aesthefill(Poly Lactic Acid)
 
PRP Art & science
PRP Art & sciencePRP Art & science
PRP Art & science
 
Facial Esthetics | Ashok Vihar | Delhi
Facial Esthetics | Ashok Vihar | DelhiFacial Esthetics | Ashok Vihar | Delhi
Facial Esthetics | Ashok Vihar | Delhi
 
Dermal filler from basic to practice
Dermal filler from basic to practiceDermal filler from basic to practice
Dermal filler from basic to practice
 
EuroThreads Before & After PDO Thread Lift Presentation
EuroThreads Before & After PDO Thread Lift PresentationEuroThreads Before & After PDO Thread Lift Presentation
EuroThreads Before & After PDO Thread Lift Presentation
 
Cog | Face Lift Surgery
Cog | Face Lift SurgeryCog | Face Lift Surgery
Cog | Face Lift Surgery
 
Botox® cosmetic show
Botox® cosmetic showBotox® cosmetic show
Botox® cosmetic show
 
BOTOX - Botulinum toxin in aesthesis
BOTOX - Botulinum toxin in aesthesisBOTOX - Botulinum toxin in aesthesis
BOTOX - Botulinum toxin in aesthesis
 
Threadlift pp anti aging
Threadlift pp anti agingThreadlift pp anti aging
Threadlift pp anti aging
 
Why choose Dermal Fillers Treatment ?
Why choose Dermal Fillers Treatment ?Why choose Dermal Fillers Treatment ?
Why choose Dermal Fillers Treatment ?
 
Anatomy toxin injections
Anatomy toxin injectionsAnatomy toxin injections
Anatomy toxin injections
 
Face lift without surgery
Face lift without surgeryFace lift without surgery
Face lift without surgery
 
Dermal filler sminar
Dermal filler sminarDermal filler sminar
Dermal filler sminar
 
Dermal fillers
Dermal fillersDermal fillers
Dermal fillers
 
Microneedling, A brief review by Dr. Mohammad Baghaei
Microneedling,  A brief review by Dr. Mohammad Baghaei Microneedling,  A brief review by Dr. Mohammad Baghaei
Microneedling, A brief review by Dr. Mohammad Baghaei
 
Dermal Fillers
Dermal FillersDermal Fillers
Dermal Fillers
 
The Tear Trough Deformity
The Tear Trough DeformityThe Tear Trough Deformity
The Tear Trough Deformity
 
Botox
BotoxBotox
Botox
 

Destacado

2009 botox gregg
2009 botox gregg2009 botox gregg
2009 botox gregg
gregghogan
 
Professional and Home Care for Acne
Professional and Home Care for AcneProfessional and Home Care for Acne
Professional and Home Care for Acne
Jordana Lewis
 

Destacado (13)

Botox case study
Botox case studyBotox case study
Botox case study
 
Botulinum toxin in dermatology ppt
Botulinum toxin in dermatology pptBotulinum toxin in dermatology ppt
Botulinum toxin in dermatology ppt
 
'The History of Botox®' by Dr Patrick Treacy
'The History of  Botox®' by Dr Patrick Treacy 'The History of  Botox®' by Dr Patrick Treacy
'The History of Botox®' by Dr Patrick Treacy
 
History Of Botox
History Of BotoxHistory Of Botox
History Of Botox
 
Juvederm brochure 8 points lift
Juvederm brochure 8 points liftJuvederm brochure 8 points lift
Juvederm brochure 8 points lift
 
5 Statistics About Botox
5 Statistics About Botox5 Statistics About Botox
5 Statistics About Botox
 
2009 botox gregg
2009 botox gregg2009 botox gregg
2009 botox gregg
 
11. palatal resections alterations at surgery to enhance the prosthetic progn...
11. palatal resections alterations at surgery to enhance the prosthetic progn...11. palatal resections alterations at surgery to enhance the prosthetic progn...
11. palatal resections alterations at surgery to enhance the prosthetic progn...
 
15. (new)implants maxillary defects
15. (new)implants maxillary defects15. (new)implants maxillary defects
15. (new)implants maxillary defects
 
Body Peel Puerto Rico Workshop 2013 spanish version
Body Peel Puerto Rico Workshop 2013 spanish versionBody Peel Puerto Rico Workshop 2013 spanish version
Body Peel Puerto Rico Workshop 2013 spanish version
 
Eye Treatments
Eye TreatmentsEye Treatments
Eye Treatments
 
Professional and Home Care for Acne
Professional and Home Care for AcneProfessional and Home Care for Acne
Professional and Home Care for Acne
 
Survey on vietnamese usage of beauty services en
Survey on vietnamese usage of beauty services   enSurvey on vietnamese usage of beauty services   en
Survey on vietnamese usage of beauty services en
 

Similar a Leadership Through Innovation in Facial Aesthetics: Botox, Juvederm, Latisse, Vivite

Treatment of periorbital_rhytids_with_botox[1]
Treatment of periorbital_rhytids_with_botox[1]Treatment of periorbital_rhytids_with_botox[1]
Treatment of periorbital_rhytids_with_botox[1]
Jeffrey Spiegel
 
BOTOX-Migraine_DetailAid_withDisclaimer
BOTOX-Migraine_DetailAid_withDisclaimerBOTOX-Migraine_DetailAid_withDisclaimer
BOTOX-Migraine_DetailAid_withDisclaimer
Rosalyn Johnson, PhD
 
Information on Botox, Laser Aesthetica
Information on Botox, Laser AestheticaInformation on Botox, Laser Aesthetica
Information on Botox, Laser Aesthetica
smartindesign
 
Pharmacovigilance in Focus by Dr.Prashant, Cipla
Pharmacovigilance in Focus by Dr.Prashant, CiplaPharmacovigilance in Focus by Dr.Prashant, Cipla
Pharmacovigilance in Focus by Dr.Prashant, Cipla
Until ROI
 
/Home/nauman/desktop/uspi arthrotec
/Home/nauman/desktop/uspi arthrotec/Home/nauman/desktop/uspi arthrotec
/Home/nauman/desktop/uspi arthrotec
chasamendoza
 

Similar a Leadership Through Innovation in Facial Aesthetics: Botox, Juvederm, Latisse, Vivite (20)

Dysport Injection Training Course Documentation
Dysport Injection Training Course DocumentationDysport Injection Training Course Documentation
Dysport Injection Training Course Documentation
 
Treatment of periorbital_rhytids_with_botox[1]
Treatment of periorbital_rhytids_with_botox[1]Treatment of periorbital_rhytids_with_botox[1]
Treatment of periorbital_rhytids_with_botox[1]
 
Dr. Darm Latisse by Allergan
Dr. Darm Latisse by AllerganDr. Darm Latisse by Allergan
Dr. Darm Latisse by Allergan
 
The Science of Latisse
The Science of Latisse The Science of Latisse
The Science of Latisse
 
Botulinum toxin and its application in omfs
Botulinum toxin and its application in omfsBotulinum toxin and its application in omfs
Botulinum toxin and its application in omfs
 
2-Butoxy Ethanol - Hazardous Substance Fact Sheet
2-Butoxy Ethanol - Hazardous Substance Fact Sheet 2-Butoxy Ethanol - Hazardous Substance Fact Sheet
2-Butoxy Ethanol - Hazardous Substance Fact Sheet
 
Hazardous Substance Fact Sheet - Butoxy Ethanol
Hazardous Substance Fact Sheet - Butoxy Ethanol Hazardous Substance Fact Sheet - Butoxy Ethanol
Hazardous Substance Fact Sheet - Butoxy Ethanol
 
BOTOX-Migraine_DetailAid_withDisclaimer
BOTOX-Migraine_DetailAid_withDisclaimerBOTOX-Migraine_DetailAid_withDisclaimer
BOTOX-Migraine_DetailAid_withDisclaimer
 
Unit 5: Principles of Botulinum Toxin Use in Aesthetic Medicine
Unit 5: Principles of Botulinum Toxin Use in Aesthetic MedicineUnit 5: Principles of Botulinum Toxin Use in Aesthetic Medicine
Unit 5: Principles of Botulinum Toxin Use in Aesthetic Medicine
 
Information on Botox, Laser Aesthetica
Information on Botox, Laser AestheticaInformation on Botox, Laser Aesthetica
Information on Botox, Laser Aesthetica
 
Pharmacovigilance Bioproducts & Biosimilars.pptx
Pharmacovigilance Bioproducts & Biosimilars.pptxPharmacovigilance Bioproducts & Biosimilars.pptx
Pharmacovigilance Bioproducts & Biosimilars.pptx
 
botox en enfermedad de hiperhidrosis axilar.ppt
botox en enfermedad de hiperhidrosis axilar.pptbotox en enfermedad de hiperhidrosis axilar.ppt
botox en enfermedad de hiperhidrosis axilar.ppt
 
Slides Test
Slides TestSlides Test
Slides Test
 
Restricteddrugpate
RestricteddrugpateRestricteddrugpate
Restricteddrugpate
 
Training module for nurses for AMSP1.pptx
Training module for nurses for AMSP1.pptxTraining module for nurses for AMSP1.pptx
Training module for nurses for AMSP1.pptx
 
Pharmacovigilance Risk Management for Biosimilars
Pharmacovigilance Risk Management for BiosimilarsPharmacovigilance Risk Management for Biosimilars
Pharmacovigilance Risk Management for Biosimilars
 
Restricteddrugpate
RestricteddrugpateRestricteddrugpate
Restricteddrugpate
 
application of microbiology in pharma qc industry
application of microbiology in pharma qc industryapplication of microbiology in pharma qc industry
application of microbiology in pharma qc industry
 
Pharmacovigilance in Focus by Dr.Prashant, Cipla
Pharmacovigilance in Focus by Dr.Prashant, CiplaPharmacovigilance in Focus by Dr.Prashant, Cipla
Pharmacovigilance in Focus by Dr.Prashant, Cipla
 
/Home/nauman/desktop/uspi arthrotec
/Home/nauman/desktop/uspi arthrotec/Home/nauman/desktop/uspi arthrotec
/Home/nauman/desktop/uspi arthrotec
 

Último

🌹Attapur⬅️ Vip Call Girls Hyderabad 📱9352852248 Book Well Trand Call Girls In...
🌹Attapur⬅️ Vip Call Girls Hyderabad 📱9352852248 Book Well Trand Call Girls In...🌹Attapur⬅️ Vip Call Girls Hyderabad 📱9352852248 Book Well Trand Call Girls In...
🌹Attapur⬅️ Vip Call Girls Hyderabad 📱9352852248 Book Well Trand Call Girls In...
Call Girls In Delhi Whatsup 9873940964 Enjoy Unlimited Pleasure
 

Último (20)

Independent Call Girls In Jaipur { 8445551418 } ✔ ANIKA MEHTA ✔ Get High Prof...
Independent Call Girls In Jaipur { 8445551418 } ✔ ANIKA MEHTA ✔ Get High Prof...Independent Call Girls In Jaipur { 8445551418 } ✔ ANIKA MEHTA ✔ Get High Prof...
Independent Call Girls In Jaipur { 8445551418 } ✔ ANIKA MEHTA ✔ Get High Prof...
 
The Most Attractive Hyderabad Call Girls Kothapet 𖠋 9332606886 𖠋 Will You Mis...
The Most Attractive Hyderabad Call Girls Kothapet 𖠋 9332606886 𖠋 Will You Mis...The Most Attractive Hyderabad Call Girls Kothapet 𖠋 9332606886 𖠋 Will You Mis...
The Most Attractive Hyderabad Call Girls Kothapet 𖠋 9332606886 𖠋 Will You Mis...
 
Call Girls Service Jaipur {9521753030} ❤️VVIP RIDDHI Call Girl in Jaipur Raja...
Call Girls Service Jaipur {9521753030} ❤️VVIP RIDDHI Call Girl in Jaipur Raja...Call Girls Service Jaipur {9521753030} ❤️VVIP RIDDHI Call Girl in Jaipur Raja...
Call Girls Service Jaipur {9521753030} ❤️VVIP RIDDHI Call Girl in Jaipur Raja...
 
Mumbai ] (Call Girls) in Mumbai 10k @ I'm VIP Independent Escorts Girls 98333...
Mumbai ] (Call Girls) in Mumbai 10k @ I'm VIP Independent Escorts Girls 98333...Mumbai ] (Call Girls) in Mumbai 10k @ I'm VIP Independent Escorts Girls 98333...
Mumbai ] (Call Girls) in Mumbai 10k @ I'm VIP Independent Escorts Girls 98333...
 
Night 7k to 12k Navi Mumbai Call Girl Photo 👉 BOOK NOW 9833363713 👈 ♀️ night ...
Night 7k to 12k Navi Mumbai Call Girl Photo 👉 BOOK NOW 9833363713 👈 ♀️ night ...Night 7k to 12k Navi Mumbai Call Girl Photo 👉 BOOK NOW 9833363713 👈 ♀️ night ...
Night 7k to 12k Navi Mumbai Call Girl Photo 👉 BOOK NOW 9833363713 👈 ♀️ night ...
 
Top Quality Call Girl Service Kalyanpur 6378878445 Available Call Girls Any Time
Top Quality Call Girl Service Kalyanpur 6378878445 Available Call Girls Any TimeTop Quality Call Girl Service Kalyanpur 6378878445 Available Call Girls Any Time
Top Quality Call Girl Service Kalyanpur 6378878445 Available Call Girls Any Time
 
Top Rated Bangalore Call Girls Richmond Circle ⟟ 9332606886 ⟟ Call Me For Ge...
Top Rated Bangalore Call Girls Richmond Circle ⟟  9332606886 ⟟ Call Me For Ge...Top Rated Bangalore Call Girls Richmond Circle ⟟  9332606886 ⟟ Call Me For Ge...
Top Rated Bangalore Call Girls Richmond Circle ⟟ 9332606886 ⟟ Call Me For Ge...
 
O898O367676 Call Girls In Ahmedabad Escort Service Available 24×7 In Ahmedabad
O898O367676 Call Girls In Ahmedabad Escort Service Available 24×7 In AhmedabadO898O367676 Call Girls In Ahmedabad Escort Service Available 24×7 In Ahmedabad
O898O367676 Call Girls In Ahmedabad Escort Service Available 24×7 In Ahmedabad
 
Top Rated Hyderabad Call Girls Chintal ⟟ 9332606886 ⟟ Call Me For Genuine Se...
Top Rated  Hyderabad Call Girls Chintal ⟟ 9332606886 ⟟ Call Me For Genuine Se...Top Rated  Hyderabad Call Girls Chintal ⟟ 9332606886 ⟟ Call Me For Genuine Se...
Top Rated Hyderabad Call Girls Chintal ⟟ 9332606886 ⟟ Call Me For Genuine Se...
 
🌹Attapur⬅️ Vip Call Girls Hyderabad 📱9352852248 Book Well Trand Call Girls In...
🌹Attapur⬅️ Vip Call Girls Hyderabad 📱9352852248 Book Well Trand Call Girls In...🌹Attapur⬅️ Vip Call Girls Hyderabad 📱9352852248 Book Well Trand Call Girls In...
🌹Attapur⬅️ Vip Call Girls Hyderabad 📱9352852248 Book Well Trand Call Girls In...
 
(Low Rate RASHMI ) Rate Of Call Girls Jaipur ❣ 8445551418 ❣ Elite Models & Ce...
(Low Rate RASHMI ) Rate Of Call Girls Jaipur ❣ 8445551418 ❣ Elite Models & Ce...(Low Rate RASHMI ) Rate Of Call Girls Jaipur ❣ 8445551418 ❣ Elite Models & Ce...
(Low Rate RASHMI ) Rate Of Call Girls Jaipur ❣ 8445551418 ❣ Elite Models & Ce...
 
Best Rate (Guwahati ) Call Girls Guwahati ⟟ 8617370543 ⟟ High Class Call Girl...
Best Rate (Guwahati ) Call Girls Guwahati ⟟ 8617370543 ⟟ High Class Call Girl...Best Rate (Guwahati ) Call Girls Guwahati ⟟ 8617370543 ⟟ High Class Call Girl...
Best Rate (Guwahati ) Call Girls Guwahati ⟟ 8617370543 ⟟ High Class Call Girl...
 
Top Rated Bangalore Call Girls Ramamurthy Nagar ⟟ 9332606886 ⟟ Call Me For G...
Top Rated Bangalore Call Girls Ramamurthy Nagar ⟟  9332606886 ⟟ Call Me For G...Top Rated Bangalore Call Girls Ramamurthy Nagar ⟟  9332606886 ⟟ Call Me For G...
Top Rated Bangalore Call Girls Ramamurthy Nagar ⟟ 9332606886 ⟟ Call Me For G...
 
Model Call Girls In Chennai WhatsApp Booking 7427069034 call girl service 24 ...
Model Call Girls In Chennai WhatsApp Booking 7427069034 call girl service 24 ...Model Call Girls In Chennai WhatsApp Booking 7427069034 call girl service 24 ...
Model Call Girls In Chennai WhatsApp Booking 7427069034 call girl service 24 ...
 
Call Girls Service Jaipur {8445551418} ❤️VVIP BHAWNA Call Girl in Jaipur Raja...
Call Girls Service Jaipur {8445551418} ❤️VVIP BHAWNA Call Girl in Jaipur Raja...Call Girls Service Jaipur {8445551418} ❤️VVIP BHAWNA Call Girl in Jaipur Raja...
Call Girls Service Jaipur {8445551418} ❤️VVIP BHAWNA Call Girl in Jaipur Raja...
 
Top Rated Bangalore Call Girls Majestic ⟟ 9332606886 ⟟ Call Me For Genuine S...
Top Rated Bangalore Call Girls Majestic ⟟  9332606886 ⟟ Call Me For Genuine S...Top Rated Bangalore Call Girls Majestic ⟟  9332606886 ⟟ Call Me For Genuine S...
Top Rated Bangalore Call Girls Majestic ⟟ 9332606886 ⟟ Call Me For Genuine S...
 
Pondicherry Call Girls Book Now 9630942363 Top Class Pondicherry Escort Servi...
Pondicherry Call Girls Book Now 9630942363 Top Class Pondicherry Escort Servi...Pondicherry Call Girls Book Now 9630942363 Top Class Pondicherry Escort Servi...
Pondicherry Call Girls Book Now 9630942363 Top Class Pondicherry Escort Servi...
 
Manyata Tech Park ( Call Girls ) Bangalore ✔ 6297143586 ✔ Hot Model With Sexy...
Manyata Tech Park ( Call Girls ) Bangalore ✔ 6297143586 ✔ Hot Model With Sexy...Manyata Tech Park ( Call Girls ) Bangalore ✔ 6297143586 ✔ Hot Model With Sexy...
Manyata Tech Park ( Call Girls ) Bangalore ✔ 6297143586 ✔ Hot Model With Sexy...
 
Call Girls Kakinada Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Kakinada Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Kakinada Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Kakinada Just Call 9907093804 Top Class Call Girl Service Available
 
Call Girls Tirupati Just Call 8250077686 Top Class Call Girl Service Available
Call Girls Tirupati Just Call 8250077686 Top Class Call Girl Service AvailableCall Girls Tirupati Just Call 8250077686 Top Class Call Girl Service Available
Call Girls Tirupati Just Call 8250077686 Top Class Call Girl Service Available
 

Leadership Through Innovation in Facial Aesthetics: Botox, Juvederm, Latisse, Vivite

  • 2. Allergan Programs Policy: Off-Label Questions  If a physician-speaker is asked an unsolicited question, he/she may briefly answer that question even if the question involves information inconsistent with Allergan’s approved product labeling  Physician-speaker must adhere to the Programs Policy when answering a question involving an off-label use of Allergan products  The physician must: – Indicate that the information under discussion is not consistent with the FDA-approved labeling – Note that the information being exchanged is based on his/her own professional clinical experience as a physician, and – If the physician believes, in the exercise of his/her medical and scientific judgment, that the question should be answered, he/she may briefly answer the question, but the speaker should then immediately return the discussion to approved uses of Allergan products
  • 3. The Allergan Medical Family of Products The first and only FDA- approved product indicated to treat hypotrichosis of the eyelashes by increasing their growth, including length, thickness, and darkness The first and only FDA- approved product indicated to treat hypotrichosis of the eyelashes by increasing their growth, including length, thickness, and darkness The first treatment approved by the FDA for moderate to severe glabellar lines in patients 18 to 65 years of age The first treatment approved by the FDA for moderate to severe glabellar lines in patients 18 to 65 years of age The #1 selling dermal filler in the US1 with: Smooth Flow Smooth Consistency Provides a smooth, natural look and feel Smooth Outcomes The #1 selling dermal filler in the US1 with: Smooth Flow Smooth Consistency Provides a smooth, natural look and feel Smooth Outcomes Advances skin care with GLX Technology™ to help daily rejuvenation Advances skin care with GLX Technology™ to help daily rejuvenation Facial Aesthetics Portfolio Please see BOTOX® Cosmetic Important Safety Information including Boxed Warning on slides 7-15, JUVEDERM ® Important Safety Information on slide 16, and LATISSE® Important Safety Information on slides 39-43. 1. Data on file, Allergan, Inc., November 2009; US Facial Injectables Market Share Report; GuidePoint Global Filler Share Tracker.
  • 4. Allergan Provides a Complete Array of Products for Facial Aesthetics Moderate to severe glabellar lines Chin Wrinkles* Nasolabial Folds*Perioral Lines* Marionette Lines* Hypotrichosis of the Eyelashes Skin Care *When diagnosed as a moderate to severe wrinkle or fold. Please see BOTOX® Cosmetic Important Safety Information including Boxed Warning on slides 7-15, JUVEDERM ® Important Safety Information on slide 16, and LATISSE® Important Safety Information on slides 39-43.
  • 5. BOTOX® Cosmetic (onabotulinumtoxinA) 5 Please see BOTOX® Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
  • 6. History of Development, FDA Approvals, and Clinical Trials FDA approval for cervical dystonia FDA approval for moderate to severe glabellar lines FDA approval for hyperhidrosis inadequately managed with topical agents BOTOX® (onabotulinumtoxinA) 20th anniversary Botulinum Toxin Type A first isolated 1920s 1978 1989 2000 2002 2004 20091991 FDA = US Food and Drug Administration. First therapeutic testing in humans with Oculinum Dr. Allen Scott FDA approval of Oculinum for blepharospasm, strabismus Allergan changes product name to BOTOX® 6
  • 7. Indications BOTOX® is indicated for the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia. BOTOX® is indicated for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above. The efficacy of BOTOX® treatment in deviations over 50 prism diopters, in restrictive strabismus, in Duane’s syndrome with lateral rectus weakness, and in secondary strabismus caused by prior surgical over-recession of the antagonist has not been established. BOTOX® is ineffective in chronic paralytic strabismus except when used in conjunction with surgical repair to reduce antagonist contracture. BOTOX® is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents. BOTOX® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in patients 18 to 65 years of age. BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic (onabotulinumtoxinA) Important Safety Information 7
  • 8. IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING Distant Spread of Toxin Effect Postmarketing reports indicate that the effects of BOTOX® or 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, blurred vision, 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 underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses. BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic (onabotulinumtoxinA) Important Safety Information (continued) 8
  • 9. CONTRAINDICATIONS BOTOX® and BOTOX® Cosmetic are 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 The recommended dosage and frequency of administration for BOTOX® or BOTOX® Cosmetic should not be exceeded. Risks resulting from administration at higher dosages are not known. Lack of Interchangeability Between Botulinum Toxin Products The potency Units of BOTOX® and 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® and BOTOX® Cosmetic cannot be compared to or converted into Units of any other botulinum toxin products assessed with any other specific assay method. 9 BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic (onabotulinumtoxinA) Important Safety Information (continued)
  • 10. WARNINGS (continued) 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® /BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines) or 100 Units (for severe primary axillary hyperhidrosis) have been reported. No definitive, serious adverse event reports of distant spread of toxin effect associated with BOTOX® for blepharospasm at the recommended dose (30 Units and below) or for strabismus at the labeled doses have been reported. Hypersensitivity Reactions Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, urticaria, soft-tissue edema, and dyspnea. If such reactions occur, further injection of BOTOX® or 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. 10 BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic (onabotulinumtoxinA) Important Safety Information (continued)
  • 11. WARNINGS (continued) Pre-existing Neuromuscular Disorders Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of BOTOX® or BOTOX® Cosmetic. 11 BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic (onabotulinumtoxinA) Important Safety Information (continued)
  • 12. PRECAUTIONS Caution should be used when BOTOX® or BOTOX® Cosmetic treatment is used in patients who have an inflammatory skin problem at the injection site, marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or the inability to substantially lessen glabellar lines by physically spreading them apart. Information for Patients Patients should be counseled that if loss of strength, muscle weakness, or impaired vision occur, they should avoid driving a car or engaging in other potentially hazardous activities. Pregnancy Administration of BOTOX® or BOTOX® Cosmetic is not recommended during pregnancy. There are no adequate and well-controlled studies of BOTOX® or BOTOX® Cosmetic in pregnant women. Nursing Mothers It is not known whether BOTOX® or BOTOX® Cosmetic are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BOTOX® or BOTOX® Cosmetic are administered to a nursing woman. 12 BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic (onabotulinumtoxinA) Important Safety Information (continued)
  • 13. ADVERSE REACTIONS General The most serious adverse events reported after treatment with botulinum toxin include spontaneous reports of death, sometimes associated with anaphylaxis, dysphagia, pneumonia, and/or other significant debility. There have also been reports 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. Cervical Dystonia The most frequently reported adverse reactions following injection of BOTOX® for cervical dystonia include dysphagia (19%), upper respiratory infection (12%), neck pain (11%), and headache (11%). 13 BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic (onabotulinumtoxinA) Important Safety Information (continued)
  • 14. ADVERSE REACTIONS (continued) Blepharospasm The most frequently reported treatment-related adverse reactions following injection of BOTOX® for blepharospasm include ptosis (20.8%), superficial punctate keratitis (6.3%), and eye dryness (6.3%). Strabismus The most frequently reported adverse events following injection of BOTOX® for strabismus include ptosis (15.7%) and vertical deviation (16.9%). Primary Axillary Hyperhidrosis The most frequently reported adverse events (3% to 10% of patients) following injection of BOTOX® for severe primary axillary hyperhidrosis include injection-site pain and hemorrhage, non-axillary sweating, infection, pharyngitis, flu syndrome, headache, fever, neck or back pain, pruritus, and anxiety. Glabellar Lines The most frequently reported adverse events following injection of BOTOX® Cosmetic include blepharoptosis and nausea. 14 BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic (onabotulinumtoxinA) Important Safety Information (continued)
  • 15. ADVERSE REACTIONS (continued) Overdosage Excessive doses of BOTOX® or BOTOX® Cosmetic may be expected to produce neuromuscular weakness with a variety of symptoms. Respiratory support may be required where excessive doses cause paralysis of respiratory muscles. In the event of overdose, the patient should be medically monitored for symptoms of excessive muscle weakness or muscle paralysis. In the event of suspected or actual overdosage, please contact your local or state health department to process a request for antitoxin through the Centers for Disease Control and Prevention (CDC). If you do not receive a response within 30 minutes, please contact the CDC directly at 1-770-488-7100. Note to representative: Please provide full BOTOX® and BOTOX® Cosmetic Prescribing Information, including Medication Guide, when presenting this material. 15 BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic (onabotulinumtoxinA) Important Safety Information (continued)
  • 16. JUVÉDERM® Important Safety Information JUVÉDERM® injectable gel (including JUVÉDERM® Ultra, JUVÉDERM® Ultra Plus, JUVÉDERM® Ultra XC, and JUVÉDERM® Ultra Plus XC) is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). Side effects were usually mild to moderate, lasting 7 days or less, and included temporary injection-site reactions such as redness, pain, firmness, swelling, and bumps. JUVÉDERM® is not for people with severe allergies. For more information, please click on the About Safety link at www.juvederm.com or call the Allergan Product Support line at 1-877-345-5372. JUVÉDERM® injectable gel is available by prescription only.
  • 17. BOTOX® (onabotulinumtoxinA) and BOTOX® Cosmetic (onabotulinumtoxinA): Experience Worldwide 1. Data on file, Allergan, Inc.; 2. The American Society of Plastic Surgeons (ASPS). 2009 Report of the 2008 Statistics: National Clearinghouse of Plastic Surgery Statistics. The American Society of Plastic Surgeons (ASPS) Web site. http://www.plasticsurgery.org/Media/stats/2008-US-cosmetic-reconstructive- plastic-surgery-minimally-invasive-statistics.pdf. Accessed 2010. 17
  • 18. BOTOX® Cosmetic (onabotulinumtoxinA): Unique Molecular Structure Please see BOTOX® Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
  • 19. Proven Treatment for Moderate to Severe Glabellar Lines  First physician-administered, nonsurgical aesthetic treatment approved by the FDA to temporarily treat moderate to severe glabellar lines in patients 18-65 years of age  High levels of patient satisfaction1,2 – Precise delivery with physician control – Predictable clinical outcomes3 Frown lines are caused by overactive facial muscles. 1. Aesthetic Surgery Education and Research Foundation (ASERF), BOTOX® Cosmetic Use Survey, April 2005.; 2. Facial Injectables Consumer User Survey; July 2009. 3. BOTOX® Cosmetic Prescribing Information, August 2009.
  • 20. Precise Control for Predictable Outcomes In clinical trials at day 7, 74% of patients demonstrated none or mild glabellar line severity at maximum frown as compared to 6% in placebo; at day 30, 80% of patients demonstrated the same as compared to 3% in placebo.1 Side effects associated with the injection include localized pain, infection, inflammation, tenderness, swelling, redness, and/or bleeding/bruising. 1. BOTOX® Cosmetic Prescribing Information, August 2009. Unretouched photos taken at maximum frown before treatment with BOTOX® Cosmetic and taken at maximum frown after treatment with BOTOX® Cosmetic at days 2 and 14. The photos featured here are of actual BOTOX® Cosmetic patients. Individual results may vary. Before Day 14Day 2 20 Please see BOTOX® Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
  • 21. BOTOX® Cosmetic (onabotulinumtoxinA) Begins Working Within 24 to 48 Hours1 1. BOTOX® Cosmetic Prescribing Information, August 2009. 21
  • 22. 74 80 70 48 25 82 89 82 63 39 6 3 2 2 2 9 7 4 3 1 7 30a 60 90 120 7 30a 60 90 120 BOTOX Cosmetic (onabotulinumtoxinA) (N = 405) Placebo (N = 132) BOTOX® Cosmetic (onabotulinumtoxinA): 74% “Full Response” by Day 71 aDay 30: Co-primary efficacy time point, P < .001. 1. BOTOX® Cosmetic Prescribing Information, August 2009. Day of Investigator’s Assessment Day of Subject’s Assessment ® Responders(%) 22
  • 23. Patient Satisfaction Is Paramount in Aesthetic Practices 1. Fagien S, et al. Plast Reconstr Surg. 2008. Please see BOTOX® Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
  • 24. BOTOX® Cosmetic (onabotulinumtoxinA): 97% Patient Satisfaction in Surveyed Patients1,2 1. Facial Injectables Consumer User Survey; July 2009; 2. Aesthetic Surgery Education and Research Foundation (ASERF), BOTOX® Cosmetic Use Survey, April 2005. 24 Very Satisfied 69.2% Somewhat Satisfied 27.4%Not Satisfied 3.4% Self-reported responses N = 117
  • 25. Why High Satisfaction With BOTOX® Cosmetic (onabotulinumtoxinA) 1. The American Society of Plastic Surgeons (ASPS) Web site. Accessed 2010; 2. BOTOX® Cosmetic Prescribing Information, 2009. Please see BOTOX® Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
  • 26. BOTOX® Cosmetic (onabotulinumtoxinA): A Specific Formulation Not Shared by Any Other Product ≈ 5 nanograms of onabotulinumtoxinA, ≈ 900-kDa neurotoxin complex 0.9 mg sodium chloride 0.5 mg serum albumin
  • 27. BOTOX® Cosmetic (onabotulinumtoxinA): A Legacy of Experience 1. The American Society of Plastic Surgeons (ASPS) Web site. Accessed 2010; 2. Aesthetic Surgery Education and Research Foundation (ASERF), BOTOX® Cosmetic Use Survey, April 2005; 3. Facial Injectables Consumer User Survey; July 2009; 4. BOTOX® Cosmetic Prescribing Information, 2009. 27
  • 28. Summary of FDA Labeling Changes to BOTOX® Cosmetic (onabotulinumtoxinA)  Unique nonproprietary name  Addition of Boxed Warning regarding distant spread of toxin effect – No definitive reports of distant spread of toxin effect with BOTOX® Cosmeticat the labeled dose of 20 U  Revised lack of interchangeability  Statement of nondetectability of BOTOX® Cosmetic in peripheral blood  Revised content regarding: – Pre-existing neuromuscular disorders – Dysphagia and breathing difficulties in the treatment of cervical dystonia – Information for patients/provision of approved patient Medication Guide by physician – Adverse reactions regarding local weakness of muscles adjacent to injection – Overdosage including the addition of new text and instructions 28
  • 29. Summary of BOTOX® Cosmetic (onabotulinumtoxinA) Risk Evaluation and Mitigation Strategies (REMS) 29 • Medication Guide – Included in each carton – Notice to distribute Medication Guide to patient – Additional copies of Medication Guide available from Allergan • Communication Plan – Support healthcare providers in the implementation of REMS – “Dear Healthcare Provider” Letter (DHPL) – DHPL, updated prescribing information, and Medication Guide provided to all BOTOX® /BOTOX® Cosmetic (onabotulinumtoxinA) purchasers Please see BOTOX® Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
  • 30. Allergan’s Proactive Steps to Protect Patient Safety Importation of pharmaceuticals and biologic products into the United States has drawn media attention Direct-to-physician sales help ensure product integrity Exacta® vial to ensure product authenticity • Flip-top cap and purple- colored crimp • ALLERGAN appears on the holographic label
  • 31. Importation of Foreign Pharmaceuticals or Biologics Into the United States Without FDA Approval Remains Illegal Please see BOTOX® Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
  • 32. Botulinum Toxin Units Are Not Interchangeable According to the Label 1. BOTOX® Cosmetic Prescribing Information, 2009; 2. Dysport™ Prescribing Information, 2009. 32 “…Units of biological activity of BOTOX® Cosmetic cannot be compared to or converted into Units of any other botulinum toxin…”1 “…Units of biological activity of BOTOX® Cosmetic cannot be compared to or converted into Units of any other botulinum toxin…”1 “The potency Units of Dysport™ are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products…”2 “The potency Units of Dysport™ are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products…”2
  • 33. Evaluating Botulinum Toxin Properties 1. BOTOX® Cosmetic Prescribing Information, 2009; 2. Dysport™ Prescribing Information, 2009; 3. Lietzow et al. Protein J. 2008; 4. Hambleton. J Neurol. 1992.; 5. Wenzel et al. J Clin Pharm Ther. 2007; 6. Panjwani et al. Botulinum J. 2008. BOTOX® Cosmetic (onabotulinumtoxinA) (2002) Dysport™ (abobotulinumtoxinA) (1991) BoNT A SNAP-251 BoNT A SNAP-252 ≈ 9003 ≥ 3004 Vacuum-dried NaCl Albumin1 Freeze-dried2 Lactose2 Albumin2 Neutral5 Neutral5 100 U1 300 U/500 U2 ≈ 5 ng5 4.35 ng per 500 LD50 U6 2.5 mL per 100 U1 1.5 mL per 300 U or 2.5 mL per 300 U2 20 U 4 U per .01 mL x 51 50 U2 10 U per .05 mL x 52 or 10 U per .08 mL x 52 33 Serotype/SubstrateSerotype/Substrate Complex weight (kDa)Complex weight (kDa) FormulationFormulation pHpH Units/VialUnits/Vial Total ProteinTotal Protein (ng/vial)(ng/vial) ReconstitutionReconstitution Approved doseApproved dose
  • 34. Botulinum Toxin Injection Patterns Vary 1. BOTOX® Cosmetic Prescribing Information, 2009; 2. Moy et al. Arch Facial Plastic Surg. 2009. 34 Please see BOTOX® Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
  • 35. Botulinum Toxins Perform Differently: Results From a Double-Blind, Randomized, Parallel-Group Study1 1. Lowe et al. J Am Acad Dermatol. 2006. 35
  • 36. Glabellar Line Severity Improved With BOTOX® Cosmetic (onabotulinumtoxinA)1 Duration from a double-blind, randomized, parallel-group study. Incidence of at least a 1-grade improvement from baseline in glabellar line severity at maximum contraction. 1. Lowe et al. J Am Acad Dermatol. 2006. 94% (29/31) 77% (24/31) 53% (16/30) 97% (29/30) 59% (17/29) 28% (8/29) 0 20 40 60 80 100 8 12 16 P = .04 Patients(%) Weeks BOTOX® Cosmetic (onabotulinumtoxinA) (20 U) Dysport™ (abobotulinumtoxinA) (50 U) 36
  • 37. Considerations in Switching to Another Botulinum Toxin Physicians considering switching to another botulinum toxin need to evaluate:  Differences in the approved dose, dilution, volume, and injection sites  Potential side effects Patients considering treatment with another botulinum toxin need to evaluate:  Experience of injector with specific toxin  Side effects with specific toxin  Effectiveness of specific toxin 37 Please see BOTOX® Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
  • 38. The Science of LATISSE® (bimatoprost ophthalmic solution) 0.03%
  • 39. ©2010 Allergan, Inc., Irvine, CA 92612 ® and ™ marks owned by Allergan, Inc. JUVÉDERM® mark owned by Allergan Industrie, SAS. Dysport is a trademark of Ipsen Biopharm Limited. Perlane and Restylane are registered trademarks of HA North American Sales AB. PowerPoint is a registered trademark of Microsoft Corporation in the United States and/or other countries. www.botoxcosmetic.com 1-800-BOTOXMD www.juvederm.com/professional Re-order: APC58HR10 39

Notas del editor

  1. At Allergan Medical, we have seen a market evolution in the way facial aesthetics is defined, led by opinion leaders such as yourselves. We have moved from treating dynamic lines by reducing muscle activity to filling in static lines and folds, to restoration of lost volume. Most recently, we are using both toxin and fillers for facial shaping and contouring. Our aim is to provide best-in-class products that offer practitioners the opportunity to select the right product for the right patient need.
  2. In slightly more than 100 years, knowledge of Botulinum Toxin Type A has expanded from the identification of the bacterium Clostridium botulinum to the commercialization of BOTOX ® (onabotulinumtoxinA). In 1989, BOTOX ® was approved by the FDA (at that time the product was called Oculinum). Allergan conducted the clinical trials leading to this approval, and in 1991 acquired Oculinum, Inc., and obtained approval to change the product name to BOTOX ® .
  3. References 1. Data on file, Allergan, Inc. 2. The American Society of Plastic Surgeons (ASPS). 2009 Report of the 2008 Statistics: National Clearinghouse of Plastic Surgery Statistics. The American Society of Plastic Surgeons (ASPS) Web site. http://www.plasticsurgery.org/Media/stats/2008-US-cosmetic-reconstructive-plastic-surgery-minimally-invasive-statistics.pdf. Accessed 2010.
  4. BOTOX ® Cosmetic (onabotulinumtoxinA) is the first botulinum toxin to receive approval by the US Food and Drug Administration (FDA) for the temporary treatment of moderate to severe glabellar lines. References 1. Aesthetic Surgery Education and Research Foundation (ASERF), BOTOX ® Cosmetic Use Survey, April 2005. 2. Facial Injectables Consumer User Survey; July 2009. 3. BOTOX ® Cosmetic Prescribing Information, August 2009.
  5. With proper dosing of 20 Units in the glabellar region, the effects of treatment can last up to 4 months. 1 Treatment with BOTOX ® Cosmetic (onabotulinumtoxinA) can be repeated as long as the patient continues to respond and there are no allergic reactions. References BOTOX ® Cosmetic Prescribing Information, August 2009.
  6. References BOTOX ® Cosmetic Prescribing Information, August 2009.
  7. Investigator’s assessment of glabellar line severity at maximum frown–responder rates (percentage of subjects with severity of none or mild). Subject’s assessment of change in appearance of glabellar lines–responder rates (percentage of subjects with at least moderate improvement). References BOTOX ® Cosmetic Prescribing Information, August 2009.
  8. References Fagen S, Carrthers, JDA. A comprehensive review of patient-reported satisfaction with botulinum toxin type A for aesthetic procedures. Plast Reconstr Surg. 2008;122(6):1915-1925.
  9. References 1. Facial Injectables Consumer User Survey; July 2009. 2. Aesthetic Surgery Education and Research Foundation (ASERF), BOTOX ® Cosmetic Use Survey, April 2005.
  10. References 1. The American Society of Plastic Surgeons (ASPS). 2009 Report of the 2008 Statistics: National Clearinghouse of Plastic Surgery Statistics. The American Society of Plastic Surgeons (ASPS) Web site. http://www.plasticsurgery.org/Media/stats/2008-US-cosmetic-reconstructive-plastic-surgery-minimally-invasive-statistics.pdf. Accessed December, 2009. 2. BOTOX ® Cosmetic Prescribing Information, August 2009.
  11. References 1. The American Society of Plastic Surgeons (ASPS). 2009 Report of the 2008 Statistics: National Clearinghouse of Plastic Surgery Statistics. The American Society of Plastic Surgeons (ASPS) Web site. http://www.plasticsurgery.org/Media/stats/2008-US-cosmetic-reconstructive-plastic-surgery-minimally-invasive-statistics.pdf. Accessed December, 2009. 2. Aesthetic Surgery Education and Research Foundation (ASERF), BOTOX ® Cosmetic Use Survey, April 2005. 3. Facial Injectables Consumer User Survey, July 2009. 4. BOTOX ® Cosmetic Prescribing Information, August 2009.
  12. Due to clear differences between commercial botulinum toxin products, imparted through the manufacturing and formulation process, the FDA has mandated specific language in product labeling stating that Units of biological activity are not interchangeable nor simply converted between products. References 1. BOTOX ® Cosmetic Prescribing Information, August 2009. 2. Dysport ™ Prescribing Information, 2009.
  13. References 1. BOTOX ® Cosmetic Prescribing Information, August 2009. 2. Dysport ™ Prescribing Information, 2009. Lietzow MA, Gielow ET, Le D, Zhang J, Verhagen MF. Subunit stoichiometry of the Clostridium botulinum type A neurotoxin complex determined using denaturing capillary electrophoresis. Protein J. 2008;27(7-8):420-425. 3. Hambleton P. Clostridium botulinum toxins: a general review of involvement in disease, structure, mode of action and preparation for clinical use. J Neurol. 1992;239(1):16-20. 4. Wenzel R, Jones D, Borrego JA. Comparing two botulinum toxin type A formulations using manufacturers’ product summaries. J Clin Pharm Ther. 2007;32(4):387-402. 5. Panjwani N, O’Keeffe R, Picket A. Biochemical, functional and potency characteristics of type A botulinum toxin in clinical use. Botulinum J. 2008;1(1):153-166.
  14. References 1. BOTOX ® Cosmetic Prescribing Information, August 2009. 2. Moy R, Maas C, Monheit G, Huber MB; for Reloxin ® Investigational Group. Long-term safety and efficacy of a new botulinum toxin type A in treating glabellar lines. Arch Facial Plast Surg. 2009;11(2):77-83.
  15. References 1. Lowe P, Patnaik R, Lowe N. Comparison of two formulations of botulinum toxin type A for the treatment of glabellar lines: a double-blind, randomized study. J Am Acad Dermatol. 2006;55(6):975-980.
  16. References 1. Lowe P, Patnaik R, Lowe N. Comparison of two formulations of botulinum toxin type A for the treatment of glabellar lines: a double-blind, randomized study. J Am Acad Dermatol. 2006;55(6):975-980.