PMA P110033I'3013I’A003
`
`Final labeling Amendment
`
`. ‘
`
`Jjuvéderm
`
`VOLBELLA'"XC
`
`Allergen Confidential
`Juvéderm® Valhalla XC
`
`About JUVEDERM VOLBELLAKE’ XC
`
`mmimmmflmmmimmhhnmion.
`1. GLOSSARY
`{Notetiiattemisinthewssaryare boldthroughoutlhisdocunent.)
`W—adbstamethatreduwssensilivitympaii
`WWW—apmmfiaddemmemdlyhtemdyflkems
`skin moisturizedandsoflHAfillers incllxhgtleJlNEDEHlv‘l’Iarmofproducts
`areamodifiedtomiottiel-lAthatisraturallyinyourbody.
`Wasyntiedccompoundusedasahmlanesflefictodecreasepain
`W—lieareafihtflroundthemoutharfllbs
`WWW—amnimridiflmdatmmminaclarmhddnmlor
`WWaflifioralheahnerdwiflidemalfllerdatisghenaflertie
`etlectsoflhe inilialtreatmenthavewomott inorderlo maintainthedesiredresult
`WuoifleMapflbdhamrlainmeaddesldimdafiedthy
`theareatowhidi itisapplied
`W—anadifimal iriactionotasmall armuntotcbmialtlerusuallygiven
`about2weeksto1 monti1attertheinilialinjection.Atotch—uptreatmentnaybe
`remasaryloactl'evelhedesred restit
`WW” Midday—a unique nanufaituring processthatprmrides a high
`mrmnhafimofumsflinimtrbngdasflrgreslsfloeatesadimmmmy
`gettiattbmeadlyintolheddnandprovidesasrrmth raturallookandfeel
`2. PHtIJlIB'I' IESBIIPTIDH
`Malisit?
`.ll'v'EIIRMVOLBEliA'XC injectziilegel isasnmth. clear, cohrlessm
`acidfllqueldatcomainsasnallqumfityofhalansflnficflml. ltflis
`anatllallyomurringsugartound inthehumanbirlyfl'terobotl-Ilintheddnisto
`chlhermhbnlsardhehdeddnrefiiitsmhlalnnishmandeEfiM
`MBHLMXCinjeclablegplenamlmhIedushgmthMghe
`a specialzed srmotiigal tillerlhatproduces long—lasting resills atthetreatment site.
`I'IJIIEIJSilIIMI?
`MEIRMWA'XCisaoyslalckargddatisirhfiedfiedlyhbarflarmm
`the his using an ultrafine needle to temporarily plum) the lips tor lip enhancement
`andtosmooththeappearameotlinesaroundlhemillthin adullsovertheage
`ot21.TheiMna'nthegel improvesthecomtortoflheinjectionbyreclning
`sensitivityto pain.
`3. mm
`
`mummmmlduflmtmcfinmflmm
`xc iniactahla gel?
`Youmchirwilladalnityournedial
`XCisr'IjitforyouXousmuldmtuse
`
`' mmmotcemoeaw
`MVOLBE|1A°XCih
`
`O You havesevere allergies marked lryahistoryotseverereactions (armhyhxis)
`or history or presence of multiple severe allergies Use may result'In an
`alergic react'm.
`O You are allergic to lithca'na or to the proteins used to make the HAIn
`.llvEIIHMtIUBEiNXCfiam-podfivetnderhlprotehs). Usenayrcaltinan
`alergic react'm.
`4. PREMII'IHS
`Munitiomstmldnymadvisemahwl?
`The tollowing are important heatment considerations for you to Iiscuss with your
`MadurmmdinuddmhehmflurmfiSMIymllsaflmnflmfius
`O Milnizeshenmtsemrciseandmuremeidenshesunorleatvdfliintie
`fid24tnusmfiigheahimEiqmuemanycitimemaytametenmary
`redness, swelling, andlor itching atthe inject'nn site.
`O Telyourchcmriiyouaremhgarymedkafiondatianpmbngtteedingsm
`as aspirin, iuirofen, orother bloodti‘I'nneIs. Aswith arIy injection, tiI's may
`increase bruising or bleeciig atthe injection site.
`
`O Tel your doctor if you are phoning laser heatmerit, chemial peeling, or any
`otherprocedtreaftertreahnentwithll‘bflflillll VOLBE|1A°XC. There'Isa
`possfibridmfan'nflammatoryreacthn attietrealhientsite
`
`OTellyuIdoctorvdmhareasotyuItamyoumfliiemhaveheated. This
`product'Is intended for use in the lips and parietal area. The safety and
`etledheressforheahnedhoderareastavendbeenestaldistedincorirdlei
`clinicalstodies.
`
`OTellyourdoctIifwuaIeontherapyusedmdecreasefliebody’simmune
`responsellsemayresult‘nan'mreasediiskofiritedion.
`OTerommctIflwuaIepmgardorbreasfleedrig.nesatetyforlIsedudrig
`pregnancy orinwomenvdnarebreastteecingmasnotbeenshmd.
`OTeroII doctorii youtaveahistoryotmssivesianingttiflghardsmrs).
`ResaletyotJNEDEHMVDIBHiA'XCinjmtabbgelhpafimtsvflfliahistxy
`otmhresmninghasnotbeenshfledandmayresultinadditiiralsiars.
`OTellyourmctorilyouhamahistIyoffiymntaflmm. 'l'hesalety
`of JUVEDERM VOLBELLA° XC'In patients with a history of pigmentation
`Whasmtbeensllfled. Llse'nthesepatientsmayresultinchangpa
`inpignentation.
`5. BUIIGALSTIJDY
`waasfliepmtliclslutiod?
`TodetailishdesatetyarflefledherIessoiJmlflflMVOLflfliA°X8mrimprodng
`bhimsarlidnodi'mgtheappeararmofmaroundlhenmth 168stbjects
`received treatment with JUVEDERM VOLBELLA‘” X8 and 56 subjects received
`trealIIIeIitwitliarIotiIerdernialfillecTomliavesijeds' desiedresullsatnuch-w
`heateeMwasallmed1nnrMIafleriniflalheahnentAfler1yeansmjectsweIe
`otteIedanmliIiactinn.
`The amount oflhlEDERM VOLBELLA° XC usedIn the cliniial stlxlyto achieve
`optimaloutmrresrangedtrom0.5mLt06.l]meiliiamedianvolumeot2..6nl_
`hgeneral tieanmuntotMv‘EJWVOLBEliA’XCusedtorlietmflHmand
`matinjuflionwaslemtiantietirdtreahnent. Foreachstbjectthevolme
`usedwasbasedonlheirdes'red results.
`
`To evaluate the safety dim VOLBEIUP XC injectable gel, smjects noted
`cunnnnsideettectshdailydiadesSkieefiectswerealsorepmtedbydocmrs
`basedmmtbeddtsvdmearhdlihctltmeofficevisilsindmddiscesigary
`sympmnlsormmplziitsvdflifledbjedsarflaflngtiemmameotdeiiis
`ardlflillfilareaToeIalIatedeefiecfiiemssofdeprodnttmliieriamemenL
`a5poiMstalewasusedA41JoiddalewasIBedmeIalIatetheefiecfiveness
`otlheproductforsmootiiing|imsaroundlienmthA5pointstalewasusedto
`evaltateoveralacatheticimprovement
`6. BENEFITS
`
`flatwiilaccnnlisll?
`fieresultsoftieJNEthVOLBfliMXCclinkalsmdydmwedtiatflepmmct
`temporarily improves lip fullness and smooths the appearance of lines amund
`themouth.
`
`litmddttncilml suidystiovv?
`Wmexmdsfummmmmmmumamm
`tieaxiearamcilinmarmnddennuflfltedinkalshflydnsedtiatlflflflM
`lIItCt_BEI_LI1\")<{3laststh’ough1 yearinthema'prityofsubjects.
`Thestudydoctors reported:
`O 30%ostijects had atbasta 1—point inprovement in liptullness 3 months
`attertrealmerlt
`
`O 62% ofsubjects had at leasta 1—point improvement in Ii) fullness 1 year
`attertrealmerlt
`
`O Overfifl‘ltaotsulijectshaiatleadaHJoidinprommemindeappearameof
`lines aroundlhe mouththrough 1 yearaltertreatmerit
`O0verallaesdeficimprovenBMwasseenh93titIofsuljectsat3nmdBafler
`heatmentandfiQ‘ltIofsubjectsaH yearaltertreatment
`Subjectsreported:
`O Improvemeritthrough1 yearinsalistaitionwiththeiriisarliliplinesbasedon
`satisfactimquesthnnaires
`O Overgmtadnughtdieirlipslodtedamteltrahlaltor1yearaflerheahnerd
`7.IISKS
`Infilsidufloclsmsomiilhaiinimlsmdy?
`Subjectsreportedsicbet’lectsin 301iaydailydiaries.lithesesideefiectshsted
`brigerdan3fldaystieywerere|ntedasamrseevenmAdverseeventsmuld
`alsobereporledbychctorsatanylimetiroughoutthestudy
`
`[Corrti'luedon reverse side.)
`
`ALL 2008
`PROLLENIUM V. ALLERGAN
`|PR2020-00084
`
`1
`
`ALL 2008
`PROLLENIUM V. ALLERGAN
`IPR2020-00084
`
`

`

`Allergen Confidential
`Juvédcml® Volbclla XC
`
`Weideetfeetewereseeninttleciliealstudyflcmthed)
`Based on the clinics! study, the licelitcod of experieming side effects atiertreatmerrt
`MthJNEDEI-‘tMVOLBEIiAWCisshmm bemianJle1.AmajoiiwofsrtJjectsin
`the chiral study experienced aside effect. such as swelling, tendemess, bruising,
`finnnem, lumpshumps, newness, or pain at ttre injection site, as reported in their
`www.mwefieamere usuelymild {easiymleiatedjcr moderate
`{uncomfortable} in severity, although some subjects emerierxiedsesere sideettects
`finmmmflnQMostotmesesideetfectsyiematyaymmeirMMin 30days
`Omasmelymmstbjectsemeiemedsdeefiectsdathstedmgermanmdays.
`
`Table 1. Side Effects After Treatments»h
`
`_
`mm
`AnySichttect
`
`sweling
`
`Tenderness
`
`BnJis'ng
`
`Ftnnness
`
`LumpsiBmips
`
`Redness
`
`Pain
`
`moderation
`
`Itching
`
`LiteitmtlofEtmeIiem'IlgSitleEtfect
`Jwanmmvmcalmxc
`97MBf100people{97%}
`
`93mt0f100people{93%}
`
`godndrwopedprereos}
`
`89MBf100people{89%}
`
`89MBf100people{89%}
`
`88MBf100people{88%}
`
`83MBf100people{83%}
`
`81MOT1IIIpeopIB{81%}
`
`42mt0f100people{42%}
`
`31mt0f1IIIpeoplef31‘tb}
`
`
`
`Dlyness
`mmighessmsmjecte
`mmmtnmmmWWW-mmmimmm
`sideetfedsmthei'fltialtremm
`
`5dndr1oopedpre{5%}
`
`
`
`ttltfltadueleeeventsllereseeninthetill'edstudy?
`MersementsmrysideefiectsdatlastedhngerdanmeSDdaydailydaryfi
`attemeetentsreportedbymctosatanyfimemmugmmmestudijerermorted
`omdemrmedefly.Aflemmwith.lM§DEFlM VOLBEIiA°XC, the
`nnstocmnnnadterseaentsforsmjectsweremesameasmosereportedinme
`daily diary, such as hmsihumps, bmising, pa'n, timness, and swelling. Most of
`theseleyeiseerentswere mildandwentawaymtheirmmwithinSOdays.
`In the cinical study, 7 subjects tad hnpsr'burms or swelling that occurred weeks
`mmonthsatmrtreabnentfillottheseadyerseemntswere mildormoderate.An
`over—theocunter pain reliener or an antibiotic was given for the swelling, and no
`medication wasgiyentorthe lumpsibumpsfilottheseeyentswentawaywithcut
`anylong—tennetfects.
`Subjects experiemd simiaradterseaentsatterrepeat'liection.
`tr'rltfltareottlerpoesihleattvemeettents?
`As with all skin—injection promdures, there is a riskof iifection.
`One of the risks with using this product is the unintentional injection into a blood
`vesseLThe chances ct this haipening are tery snail, but if it does happen, the
`complications can be serious, and may be permanentTheee complications, which
`hate been reportedtortacial injections,can includeyision abnon’nalitiea, nineteen,
`stroke,termoraryscabs, orpennanentscaniig ofthesk'n.
`NMIghmostsideefiectswimmheMinSOdaysscnesideefiemsmaypersist
`higer.Yourptwsiciainaymocsembeatmmmmeditafions,stchasanflicfics
`steroids,cr hyaluronidase{an enzymethatbrezksdown Hit}.
`8. BEFORE PROCEDURE lltlFtJtthtAfllJtt
`What havens in the ottice hefnl'ethe iiection?
`mmmmcmrmymyeaunnuemmrasmingaflheafingmfiens
`The following is an example of what you would likely experience with a typical
`promdure. Before the iijection procedure, your doctor will askyou questions about
`ywrnedtalhtsmaswdlasymrbeamangoasYourdocmrleldsmssm
`youareanappropriatecandithtetorJNEDW VOLBELLA‘DXCandreyiewwhaI
`to ermct dining and after treatment, including possble side effects. Your motorwill
`alsoexamineyouriisande'orskin inandaroundthetreatmentarea,and maytake
`phomsDflfeiemmmsforpainmanagemnynlbedsmssedfimnprebeabnen
`numbiigisdesired,ab:|iedeidiasidneinecream,orodermeeflflieagem
`maybeudehetreatmentareawill becleanedandthen preparedvdth alcohol
`
`PMA P110033l'3013fA003
`
`Final labeling Amendment
`
`orother antiseptic.Yourdoctormayuseapen mmarkyourtaoe, identifyingthe
`planned areas of injection.
`9. PROGEDIBE um
`“that humans titling the proeetltre'.’
`Atterthelirstinjection,ymrdocttxwillwaitatewseocnthtoalbwtheidncaile
`to take effect before moving forward with the rest ot the treatment. JLNEDEHM
`VOLBEtiA' XC will be injected in small amounts into the treatment area until the
`desiredaestteficamisammxourdomrmaymassagemeueahnemama
`genttytoassurethattheproductimegateshthesldnaflisesenlydistrhrtedtor
`asmcoth amearanoeJoemaybeamliedtorabnetperiodfolloMrgueabnemto
`mininiae swelling and reduce pain.
`Do the 'Ii'pctinns lltrt?
`lrjedimsmaymsesumthnnhfidflrgmdaflerdeperehmeJNEDflw
`VOLBEUA' XC clinical study, immedately after the injection, subjects rated pain,
`on averageasaBonan 11—pcintscalewhere0isncpainand 10'swcistpain
`imagirmle. .JlN‘EDEI-‘tM WLBELLA' XC contains idoetl'ne to reduce irjecticn site
`pain.Ycurdocmrmayatscdncsemnumb{armmwae)meueahnemareaynm a
`topied or injecmd nurrliing agent to further minimize dscomfcri.
`1|]. AFI'ER PROCEDURE ItFDlthIimutt
`Wallet!” lexpectfolluw'ligttlewoeetllle?
`ln the.lNEDEFlM VOLBEtiA' XC cinical triatthe most common side effectswere
`temporary remorses at the beatment site such as swelling, tendemeei, bruising,
`finnness,and lumpshumpsIhesesideetfectsusualylasted2meksorlmsSee
`Section 7 for adultional information on side effects m in the clinical study.
`Your doctor will also tell you what to expect tollcwing treatment with JLlliEDEl-‘tM
`VOLBEtiA' XC. Within the first 24 hours, you should minimize strenuous exercise
`andermosuretoextensiyesun or heat. Eiqiomretoanycftheaboyemayincrease
`temporary redness, swelling, andr'or itching at the injection site. If there is swelling,
`youmayneedtcphoean icemkoyerthemollen aranou shouldaskycurdoctor
`when lineupmaybeappliedafteryourtreabnent.
`Witneedmolettmonetleatmenttnaetieuemydesi'edrewlb?
`You should discuss your treatment goals and plan with your doctor. In the clinical
`stixly,62%otsubjectsbeatedwithJU\iEDEHMVOLBEuA°XC miredatoueh—
`up beatment 1 month after initial beatment in crderto achienethe desired results.
`Dotttereults Btforevet?
`mt'ohilehdiyidual reams nayyary, inthecl'nical study,the results lastedfort year
`in martinis cfsubjectstreatedwith .JlN‘EDEI-‘tM WLBELLA“ XC.Atterth's, repeat
`iliwtioneateusualyneededmmaintainyourdesired result.
`11. WHEHTOGALLYOUB DOCTOR
`WMIHmW
`Callyourdoctorimmediatelyifyou hate:
`1}Cha1gesinyourvisicn
`2} Signscfastroke ancludng suddentifliculty spetk'ng, nunbnesscrwettmesc
`in your face, anns, or legs, tifiiculty walking, taoe doopi1g,seyere headache,
`dunemmrconfusion}
`3}“hiteamearancecftheskin
`4} Unusual pa'n (tiring or shortlyatmr beatmerrt
`Besuretocall yourdoctorifyou have:
`1}Signifitant pain awayfrnn the injection site
`2}Any rednessaidfortislilestsellirgthatlaststor rncrethanatewdays
`3}Anysideettectthatoocursweet<sormonthsattertreatment
`4}Anyotherspnptomsthatcauseyou concern
`12. ADltmtttlAL INFORMATION
`
`ltyou belietettatyou hateeiqoerienced amiimsproblem relatedtoJNEDEFlM
`VOLBEliA' XC i'ljBCtElJle gel, you should call your doctor.Ycu may also contact the
`Allergan Product Survelanoe linetlr'ng nomal business hous at 1 377—345—53?2
`to report any side effects.
`Walnutflldoiflllaueadtitimalqueetions?
`For hither questions and infcrrration, please call Allergan at 1—800—76t‘r01 71.
`
`.
`0'.
`0
`.a'
`Q 2016 Allel'gm. NI rights reserved.
`‘3.
`"'3' Allergan' All trademarks are the property of their respective Mm
`Painted. See: mimmnflpmductafpmmmfieee.
`mjuuetbrmeom 053116 161782
`
`2
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