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

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


  • 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 Allergans 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 GLXTechnologyto help dailyrejuvenationAdvances skincare with GLXTechnologyto help dailyrejuvenationFacial Aesthetics PortfolioPlease see BOTOX Cosmetic Important Safety Information including Boxed Warning on slides 7-15, JUVEDERM Important SafetyInformation on slide 16, and LATISSEImportant 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 BOTOXCosmetic ImportantSafety Informationincluding BoxedWarning on slides 7-15,JUVEDERM ImportantSafety Information onslide 16, and LATISSEImportant SafetyInformation on slides39-43. 5. BOTOXCosmetic(onabotulinumtoxinA)5Please see BOTOXCosmetic 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 BOTOX6 7. IndicationsBOTOXis indicated for the treatment of cervical dystonia in adults to decrease theseverity of abnormal head position and neck pain associated with cervical dystonia.BOTOXis 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 BOTOXtreatment in deviations over 50 prism diopters, in restrictivestrabismus, in Duanes syndrome with lateral rectus weakness, and in secondarystrabismus caused by prior surgical over-recession of the antagonist has not beenestablished. BOTOXis ineffective in chronic paralytic strabismus except when usedin conjunction with surgical repair to reduce antagonist contracture.BOTOXis indicated for the treatment of severe primary axillary hyperhidrosis that isinadequately managed with topical agents.BOTOXCosmetic 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) & BOTOXCosmetic(onabotulinumtoxinA) Important Safety Information7 8. IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNINGDistant Spread of Toxin EffectPostmarketing reports indicate that the effects of BOTOXor BOTOXCosmetic 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) & BOTOXCosmetic(onabotulinumtoxinA) Important Safety Information(continued)8 9. CONTRAINDICATIONSBOTOXand BOTOXCosmetic 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 BOTOXorBOTOXCosmetic should not be exceeded. Risks resulting from administrationat higher dosages are not known.Lack of Interchangeability Between Botulinum Toxin ProductsThe potency Units of BOTOXand BOTOXCosmetic 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 BOTOXandBOTOXCosmetic cannot be compared to or converted into Units of any otherbotulinum toxin products assessed with any other specific assay method.9BOTOX(onabotulinumtoxinA) & BOTOXCosmetic(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/BOTOXCosmetic 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 BOTOXfor 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 BOTOXor BOTOXCosmetic 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) & BOTOXCosmetic(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 ofBOTOXor BOTOXCosmetic.11BOTOX(onabotulinumtoxinA) & BOTOXCosmetic(onabotulinumtoxinA) Important Safety Information(continued) 12. PRECAUTIONSCaution should be used when BOTOXor BOTOXCosmetic 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 BOTOXor BOTOXCosmetic is not recommended duringpregnancy. There are no adequate and well-controlled studies of BOTOXorBOTOXCosmetic in pregnant women.Nursing MothersIt is not known whether BOTOXor BOTOXCosmetic are excreted in human milk.Because many drugs are excreted in human milk, caution should be exercised whenBOTOXor BOTOXCosmetic are administered to a nursing woman.12BOTOX(onabotulinumtoxinA) & BOTOXCosmetic(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 fac