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

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Allergan brand fillers and injectables: Botox, Juvederm, Latisse, Vivite

Allergan brand fillers and injectables: Botox, Juvederm, Latisse, Vivite


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  • 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.
  • 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 ® .
  • 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.
  • 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.
  • 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.
  • References BOTOX ® Cosmetic Prescribing Information, August 2009.
  • 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.
  • 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.
  • References 1. Facial Injectables Consumer User Survey; July 2009. 2. Aesthetic Surgery Education and Research Foundation (ASERF), BOTOX ® Cosmetic Use Survey, April 2005.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Transcript

    • 1. Leadership Through Innovationin Facial Aesthetics
    • 2. Allergan Programs Policy:Off-Label Questions If a physician-speaker is asked an unsolicited question, he/she maybriefly answer that question even if the question involves informationinconsistent with Allergan’s approved product labeling Physician-speaker must adhere to the Programs Policy whenanswering a question involving an off-label use of Allergan products The physician must:– Indicate that the information under discussion is not consistent with theFDA-approved labeling– Note that the information being exchanged is based on his/her ownprofessional clinical experience as a physician, and– If the physician believes, in the exercise of his/her medical and scientificjudgment, that the question should be answered, he/she may brieflyanswer the question, but the speaker should then immediately return thediscussion to approved uses of Allergan products
    • 3. The Allergan Medical Family of ProductsThe first andonly FDA-approved productindicated to treathypotrichosis ofthe eyelashes byincreasing theirgrowth, includinglength, thickness,and darknessThe first andonly FDA-approved productindicated to treathypotrichosis ofthe eyelashes byincreasing theirgrowth, includinglength, thickness,and darknessThe first treatmentapproved by theFDA for moderateto severe glabellarlines in patients18 to 65 years of ageThe first treatmentapproved by theFDA for moderateto severe glabellarlines in patients18 to 65 years of ageThe #1 selling dermalfiller in the US1with:Smooth FlowSmooth ConsistencyProvides a smooth,natural look and feelSmooth OutcomesThe #1 selling dermalfiller in the US1with:Smooth FlowSmooth ConsistencyProvides a smooth,natural look and feelSmooth OutcomesAdvances skincare with GLXTechnology™to help dailyrejuvenationAdvances skincare with GLXTechnology™to help dailyrejuvenationFacial Aesthetics PortfolioPlease see BOTOX® Cosmetic Important Safety Information including Boxed Warning on slides 7-15, JUVEDERM ® Important SafetyInformation on slide 16, and LATISSE®Important Safety Information on slides 39-43.1. Data on file, Allergan, Inc., November 2009; US Facial Injectables MarketShare Report; GuidePoint Global Filler Share Tracker.
    • 4. Allergan Provides a Complete Array of Products forFacial AestheticsModerate tosevere glabellarlinesChin Wrinkles*Nasolabial Folds*Perioral Lines*Marionette Lines*Hypotrichosis ofthe EyelashesSkin Care*When diagnosed as a moderate to severe wrinkle or fold.Please see BOTOX®Cosmetic ImportantSafety Informationincluding BoxedWarning on slides 7-15,JUVEDERM ®ImportantSafety Information onslide 16, and LATISSE®Important SafetyInformation on slides39-43.
    • 5. BOTOX®Cosmetic(onabotulinumtoxinA)5Please see BOTOX®Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
    • 6. History of Development, FDA Approvals, andClinical TrialsFDA approval forcervical dystoniaFDA approvalfor moderate tosevere glabellar linesFDA approvalfor hyperhidrosisinadequately managedwith topical agentsBOTOX®(onabotulinumtoxinA)20th anniversaryBotulinum ToxinType A first isolated1920s 1978 1989 2000 2002 2004 20091991FDA = US Food and Drug Administration.First therapeutictesting in humanswith OculinumDr. Allen ScottFDA approval ofOculinum forblepharospasm,strabismusAllergan changesproduct nameto BOTOX®6
    • 7. IndicationsBOTOX®is indicated for the treatment of cervical dystonia in adults to decrease theseverity of abnormal head position and neck pain associated with cervical dystonia.BOTOX®is indicated for the treatment of strabismus and blepharospasm associated withdystonia, including benign essential blepharospasm or VII nerve disorders in patients12 years of age and above.The efficacy of BOTOX®treatment in deviations over 50 prism diopters, in restrictivestrabismus, in Duane’s syndrome with lateral rectus weakness, and in secondarystrabismus caused by prior surgical over-recession of the antagonist has not beenestablished. BOTOX®is ineffective in chronic paralytic strabismus except when usedin conjunction with surgical repair to reduce antagonist contracture.BOTOX®is indicated for the treatment of severe primary axillary hyperhidrosis that isinadequately managed with topical agents.BOTOX®Cosmetic is indicated for the temporary improvement in the appearance ofmoderate to severe glabellar lines associated with corrugator and/or procerus muscleactivity in patients 18 to 65 years of age.BOTOX®(onabotulinumtoxinA) & BOTOX®Cosmetic(onabotulinumtoxinA) Important Safety Information7
    • 8. IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNINGDistant Spread of Toxin EffectPostmarketing reports indicate that the effects of BOTOX®or BOTOX®Cosmetic and allbotulinum toxin products may spread from the area of injection to produce symptomsconsistent with botulinum toxin effects. These may include asthenia, generalizedmuscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria,urinary incontinence, and breathing difficulties. These symptoms have been reportedhours to weeks after injection. Swallowing and breathing difficulties can be lifethreatening, and there have been reports of death. The risk of symptoms is probablygreatest in children treated for spasticity, but symptoms can also occur in adultstreated for spasticity and other conditions, particularly in those patients who haveunderlying conditions that would predispose them to these symptoms. In unapproveduses, including spasticity in children and adults, and in approved indications, cases ofspread of effect have occurred at doses comparable to those used to treat cervicaldystonia and at lower doses.BOTOX®(onabotulinumtoxinA) & BOTOX®Cosmetic(onabotulinumtoxinA) Important Safety Information(continued)8
    • 9. CONTRAINDICATIONSBOTOX®and BOTOX®Cosmetic are contraindicated in the presence of infection at theproposed injection site(s) and in individuals with known hypersensitivity to anybotulinum toxin preparation or to any of the components in the formulation.WARNINGSThe recommended dosage and frequency of administration for BOTOX®orBOTOX®Cosmetic should not be exceeded. Risks resulting from administrationat higher dosages are not known.Lack of Interchangeability Between Botulinum Toxin ProductsThe potency Units of BOTOX®and BOTOX®Cosmetic are specific to the preparation andassay method utilized. They are not interchangeable with other preparations ofbotulinum toxin products and, therefore, Units of biological activity of BOTOX®andBOTOX®Cosmetic cannot be compared to or converted into Units of any otherbotulinum toxin products assessed with any other specific assay method.9BOTOX®(onabotulinumtoxinA) & BOTOX®Cosmetic(onabotulinumtoxinA) Important Safety Information(continued)
    • 10. WARNINGS (continued)Spread of Toxin EffectPlease refer to Boxed Warning for Distant Spread of Toxin Effect.No definitive, serious adverse event reports of distant spread of toxin effect associatedwith dermatologic use of BOTOX®/BOTOX®Cosmetic at the labeled dose of 20 Units(for glabellar lines) or 100 Units (for severe primary axillary hyperhidrosis) havebeen reported.No definitive, serious adverse event reports of distant spread of toxin effect associatedwith BOTOX®for blepharospasm at the recommended dose (30 Units and below) orfor strabismus at the labeled doses have been reported.Hypersensitivity ReactionsSerious and/or immediate hypersensitivity reactions have been reported. These reactionsinclude anaphylaxis, urticaria, soft-tissue edema, and dyspnea. If such reactionsoccur, further injection of BOTOX®or BOTOX®Cosmetic should be discontinued andappropriate medical therapy immediately instituted. One fatal case of anaphylaxis hasbeen reported in which lidocaine was used as the diluent and, consequently, thecausal agent cannot be reliably determined.10BOTOX®(onabotulinumtoxinA) & BOTOX®Cosmetic(onabotulinumtoxinA) Important Safety Information(continued)
    • 11. WARNINGS (continued)Pre-existing Neuromuscular DisordersIndividuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, orneuromuscular junctional disorders (eg, myasthenia gravis or Lambert-Eatonsyndrome) should be monitored particularly closely when given botulinum toxin.Patients with neuromuscular disorders may be at increased risk of clinically significanteffects including severe dysphagia and respiratory compromise from typical doses ofBOTOX®or BOTOX®Cosmetic.11BOTOX®(onabotulinumtoxinA) & BOTOX®Cosmetic(onabotulinumtoxinA) Important Safety Information(continued)
    • 12. PRECAUTIONSCaution should be used when BOTOX®or BOTOX®Cosmetic treatment is used in patientswho have an inflammatory skin problem at the injection site, marked facial asymmetry,ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or theinability to substantially lessen glabellar lines by physically spreading them apart.Information for PatientsPatients should be counseled that if loss of strength, muscle weakness, or impairedvision occur, they should avoid driving a car or engaging in other potentiallyhazardous activities.PregnancyAdministration of BOTOX®or BOTOX®Cosmetic is not recommended duringpregnancy. There are no adequate and well-controlled studies of BOTOX®orBOTOX®Cosmetic in pregnant women.Nursing MothersIt 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 whenBOTOX®or BOTOX®Cosmetic are administered to a nursing woman.12BOTOX®(onabotulinumtoxinA) & BOTOX®Cosmetic(onabotulinumtoxinA) Important Safety Information(continued)
    • 13. ADVERSE REACTIONSGeneralThe most serious adverse events reported after treatment with botulinum toxin includespontaneous 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 ofthese patients had risk factors including pre-existing cardiovascular disease.Cervical DystoniaThe most frequently reported adverse reactions following injection of BOTOX®for cervicaldystonia include dysphagia (19%), upper respiratory infection (12%), neck pain(11%), and headache (11%).13BOTOX®(onabotulinumtoxinA) & BOTOX®Cosmetic(onabotulinumtoxinA) Important Safety Information(continued)
    • 14. ADVERSE REACTIONS (continued)BlepharospasmThe most frequently reported treatment-related adverse reactions following injection ofBOTOX®for blepharospasm include ptosis (20.8%), superficial punctate keratitis(6.3%), and eye dryness (6.3%).StrabismusThe most frequently reported adverse events following injection of BOTOX®forstrabismus include ptosis (15.7%) and vertical deviation (16.9%).Primary Axillary HyperhidrosisThe most frequently reported adverse events (3% to 10% of patients) following injectionof BOTOX®for severe primary axillary hyperhidrosis include injection-site pain andhemorrhage, non-axillary sweating, infection, pharyngitis, flu syndrome, headache,fever, neck or back pain, pruritus, and anxiety.Glabellar LinesThe most frequently reported adverse events following injection of BOTOX®Cosmeticinclude blepharoptosis and nausea.14BOTOX®(onabotulinumtoxinA) & BOTOX®Cosmetic(onabotulinumtoxinA) Important Safety Information(continued)
    • 15. ADVERSE REACTIONS (continued)OverdosageExcessive doses of BOTOX®or BOTOX®Cosmetic may be expected to produceneuromuscular weakness with a variety of symptoms. Respiratory support may berequired where excessive doses cause paralysis of respiratory muscles. In the eventof overdose, the patient should be medically monitored for symptoms of excessivemuscle weakness or muscle paralysis.In the event of suspected or actual overdosage, please contact your local or state healthdepartment to process a request for antitoxin through the Centers for Disease Controland Prevention (CDC). If you do not receive a response within 30 minutes, pleasecontact the CDC directly at 1-770-488-7100.Note to representative: Please provide full BOTOX®and BOTOX®CosmeticPrescribing Information, including Medication Guide, when presentingthis material.15BOTOX®(onabotulinumtoxinA) & BOTOX®Cosmetic(onabotulinumtoxinA) Important Safety Information(continued)
    • 16. JUVÉDERM®Important Safety InformationJUVÉDERM®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 forcorrection of moderate to severe facial wrinkles and folds (such asnasolabial folds). Side effects were usually mild to moderate, lasting 7days or less, and included temporary injection-site reactions such asredness, pain, firmness, swelling, and bumps. JUVÉDERM®is not forpeople with severe allergies. For more information, please click on theAbout Safety link at www.juvederm.com or call the Allergan ProductSupport line at 1-877-345-5372. JUVÉDERM®injectable gel is availableby prescription only.
    • 17. BOTOX®(onabotulinumtoxinA) and BOTOX®Cosmetic(onabotulinumtoxinA): Experience Worldwide1. Data on file, Allergan, Inc.; 2. The American Society of Plastic Surgeons (ASPS). 2009 Report of the 2008 Statistics: National Clearinghouse of PlasticSurgery 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 StructurePlease see BOTOX®Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
    • 19. Proven Treatment for Moderate to SevereGlabellar Lines First physician-administered, nonsurgical aesthetic treatmentapproved by the FDA to temporarily treat moderate to severeglabellar lines in patients 18-65 years of age High levels of patient satisfaction1,2– Precise delivery with physician control– Predictable clinical outcomes3Frown 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 OutcomesIn clinical trials at day 7, 74% ofpatients demonstrated none ormild glabellar line severity atmaximum frown as compared to6% in placebo; at day 30, 80% ofpatients demonstrated the sameas compared to 3% in placebo.1Side effects associated with theinjection include localized pain,infection, inflammation,tenderness, swelling, redness,and/or bleeding/bruising.1. BOTOX®Cosmetic Prescribing Information, August 2009.Unretouched photostaken at maximum frownbefore treatment withBOTOX®Cosmetic andtaken at maximum frownafter treatment withBOTOX®Cosmetic at days 2and 14. The photosfeatured here are of actualBOTOX®Cosmetic patients.Individual results may vary.Before Day 14Day 220Please see BOTOX®Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
    • 21. BOTOX®Cosmetic (onabotulinumtoxinA)Begins Working Within 24 to 48 Hours11. BOTOX®Cosmetic Prescribing Information, August 2009.21
    • 22. 748070482582898263396 3 2 2 29 7 4 3 17 30a 60 90 120 7 30a 60 90 120BOTOX Cosmetic (onabotulinumtoxinA) (N = 405) Placebo (N = 132)BOTOX®Cosmetic (onabotulinumtoxinA):74% “Full Response” by Day 71aDay 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 Practices1. 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 Patients1,21. Facial Injectables Consumer User Survey; July 2009; 2. Aesthetic Surgery Education and Research Foundation (ASERF), BOTOX®Cosmetic Use Survey,April 2005.24Very Satisfied69.2%Somewhat Satisfied27.4%Not Satisfied3.4%Self-reported responsesN = 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 SpecificFormulation Not Shared by Any Other Product≈ 5 nanograms of onabotulinumtoxinA,≈ 900-kDa neurotoxin complex0.9 mg sodium chloride0.5 mg serum albumin
    • 27. BOTOX®Cosmetic (onabotulinumtoxinA):A Legacy of Experience1. 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 toBOTOX®Cosmetic (onabotulinumtoxinA) Unique nonproprietary name Addition of Boxed Warning regarding distant spread of toxin effect– No definitive reports of distant spread of toxin effect withBOTOX®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 Guideby physician– Adverse reactions regarding local weakness of muscles adjacentto injection– Overdosage including the addition of new text and instructions28
    • 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 allBOTOX®/BOTOX®Cosmetic (onabotulinumtoxinA) purchasersPlease see BOTOX®Cosmetic Important Safety Informationincluding Boxed Warning on slides 7-15.
    • 30. Allergan’s Proactive Steps to Protect Patient SafetyImportation ofpharmaceuticalsand biologicproducts into theUnited States hasdrawn mediaattentionDirect-to-physiciansales help ensureproduct integrityExacta®vial toensure productauthenticity• Flip-top cap and purple-colored crimp• ALLERGAN appears onthe holographic label
    • 31. Importation of Foreign Pharmaceuticals or Biologics Intothe United States Without FDA Approval Remains IllegalPlease see BOTOX®Cosmetic Important SafetyInformation including Boxed Warning on slides 7-15.
    • 32. Botulinum Toxin Units Are Not InterchangeableAccording to the Label1. BOTOX® Cosmetic Prescribing Information, 2009; 2. Dysport™ Prescribing Information, 2009.32“…Units of biologicalactivity ofBOTOX®Cosmetic cannotbe compared to orconverted into Units of anyother botulinum toxin…”1“…Units of biologicalactivity ofBOTOX®Cosmetic cannotbe compared to orconverted into Units of anyother botulinum toxin…”1“The potency Units ofDysport™ are specific tothe preparation and assaymethod utilized. They arenot interchangeable withother preparationsof botulinumtoxin products…”2“The potency Units ofDysport™ are specific tothe preparation and assaymethod utilized. They arenot interchangeable withother preparationsof botulinumtoxin products…”2
    • 33. Evaluating Botulinum Toxin Properties1. 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 ASNAP-251BoNT ASNAP-252≈ 9003≥ 3004Vacuum-driedNaClAlbumin1Freeze-dried2Lactose2Albumin2Neutral5Neutral5100 U1300 U/500 U2≈ 5 ng5 4.35 ng per 500 LD50 U62.5 mL per 100 U11.5 mL per 300 Uor2.5 mL per 300 U220 U4 U per .01 mL x 5150 U210 U per .05 mL x 52or 10U per .08 mL x 5233Serotype/SubstrateSerotype/SubstrateComplex weight (kDa)Complex weight (kDa)FormulationFormulationpHpHUnits/VialUnits/VialTotal ProteinTotal Protein(ng/vial)(ng/vial)ReconstitutionReconstitutionApproved doseApproved dose
    • 34. Botulinum Toxin Injection Patterns Vary1. BOTOX®Cosmetic Prescribing Information, 2009; 2. Moy et al. Arch Facial Plastic Surg. 2009.34Please see BOTOX®Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
    • 35. Botulinum Toxins Perform Differently: Results From aDouble-Blind, Randomized, Parallel-Group Study11. Lowe et al. J Am Acad Dermatol. 2006.35
    • 36. Glabellar Line Severity Improved WithBOTOX®Cosmetic (onabotulinumtoxinA)1Duration from a double-blind, randomized, parallel-group study.Incidence of at least a 1-grade improvement from baseline inglabellar 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)0204060801008 12 16P = .04Patients(%)WeeksBOTOX®Cosmetic (onabotulinumtoxinA) (20 U)Dysport™(abobotulinumtoxinA) (50 U)36
    • 37. Considerations in Switching to AnotherBotulinum ToxinPhysicians considering switching to another botulinumtoxin need to evaluate: Differences in the approved dose, dilution, volume, andinjection sites Potential side effectsPatients considering treatment with another botulinumtoxin need to evaluate: Experience of injector with specific toxin Side effects with specific toxin Effectiveness of specific toxin37Please 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/professionalRe-order: APC58HR1039