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VIVITROL
VIVITROL(naltrexoneforextendedrelease
injectablesuspension)isaoncemonthlymedication
forthetreatmentofalcoholdependenceaswellasfor
thepreventionofrelapsetoopioiddependence,
followingopioiddetoxification.
VIVITROListhefirstandonlynonnarcotic,non
addictive,oncemonthlymedicationapprovedforthe
treatmentofopioiddependence.Treatmentwith
VIVITROLshouldbepartofacomprehensivemanagementprogramthatincludespsychosocialsupport.
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Formoreinformation,visitwww.vivitrol.com(http://www.vivitrol.com).
ImportantSafetyInformationforVIVITROL(naltrexoneforextendedreleaseinjectablesuspension)
IMPORTANTSAFETYINFORMATION
WHATISVIVITROL?
VIVITROL(naltrexoneforextendedreleaseinjectablesuspension)isaprescriptioninjectablemedicineusedto:
Treatalcoholdependence.YoushouldstopdrinkingbeforestartingVIVITROL.
Preventrelapsetoopioiddependenceafteropioiddetox.Youmuststoptakingopioidsorotheropioid
containingmedicationsbeforestartingVIVITROL.
VIVITROLmustbeusedwithotheralcoholordrugrecoveryprogramssuchascounseling.
VIVITROLmaynotworkforeveryoneandhasnotbeenstudiedinchildren.
DONOTTAKEVIVITROLIFYOU:
Arestillusingorstillhaveanysymptomsofphysicalwithdrawalduetodependenceonopioidstreetdrugsor
opioidcontainingmedicines.
Haveopioidwithdrawalsymptoms.
AreallergictonaltrexoneoranyoftheingredientsinVIVITROLortheliquidusedtomixVIVITROL.
SeetheMedicationGuideformoreinformationaboutopioidwithdrawalandtheingredientsinVIVITROLandthe
liquidusedtomixit.
WHATISTHEMOSTIMPORTANTINFORMATIONISHOULDKNOWABOUTVIVITROL?
VIVITROLcancauseserioussideeffects,including:
RISKOFOPIOIDOVERDOSE
Usingopioids,eveninamountsthatyouusedbeforeVIVITROLtreatment,canleadtoaccidentaloverdose,serious
injury,coma,ordeath.Toavoidaccidentaloverdose:
DonottakelargeamountsofopioidsortrytoovercometheopioidblockingeffectsofVIVITROL.
DonotuseopioidsinamountsthatyouusedbeforeVIVITROLtreatment.Youmayevenbemoresensitiveto
loweramountsofopioids:
Afterdetox
WhenyournextVIVITROLdoseisdue.
IfyoumissadoseofVIVITROL.
AfteryoustopVIVITROLtreatment.
Getemergencymedicalhelprightawayifyouhavetroublebreathingbecomeverydrowsywithslowedbreathing
haveslow,shallowbreathingfeelfaint,dizzy,confusedorhaveotherunusualsymptoms.
SEVEREREACTIONSATTHEINJECTIONSITE
VIVITROLmaycausesevereinjectionsitereactions,includingtissuedeath.Someinjectionsitereactionshave
requiredsurgery.Callyourdoctorrightawayifyounoticeanyofthefollowingatyourinjectionsite:
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Intensepain
Theareafeelshard
Swelling
Lumps
Blisters
Anopenwound
Adarkscab
Tellyourdoctoraboutanyinjectionsitereactionthatconcernsyou,getsworseovertimeordoesnotgetbetterby
twoweeksaftertheinjection.
SUDDENOPIOIDWITHDRAWAL
Toavoidsuddenopioidwithdrawal,youmuststoptakinganyopioidsoropioidcontainingmedications,including
buprenorphineormethadone,foratleast7to14daysbeforestartingVIVITROL.Ifyourdoctordecidesthatyou
dontneedtocompletedetoxfirst,heorshemaygiveyouVIVITROLinamedicalfacilitythatcantreatsudden
opioidwithdrawal.
Suddenopioidwithdrawalcanbesevereandmayrequirehospitalization.
LIVERDAMAGEORHEPATITIS
Naltrexone,theactiveingredientinVIVITROL,cancauseliverdamageorhepatitis.Tellyourdoctorifyouhaveany
ofthefollowingsymptomsofliverproblemsduringVIVITROLtreatment:
Stomachareapainlastingmorethanafewdays
Yellowingofthewhitesofyoureyes
Darkurine
Tiredness
OTHERPOSSIBLESIDEEFFECTS
VIVITROLcancauseotherserioussideeffects,suchas:
DepressedmoodSometimesthisleadstosuicideorsuicidalthoughtsandbehavior.Tellthoseclosestto
youthatyouaretakingVIVITROL.Youorthoseclosesttoyoushouldcallyourdoctorrightawayifyou
becomedepressedorhaveanyneworworseningdepressionsymptoms.
AllergicpneumoniaTellyourhealthcareproviderifyouhaveshortnessofbreath,wheezing,oracough
thatdoesntgoaway.
SeriousallergicreactionsGetmedicalhelpimmediatelyifyouhaveaskinrashswellingofyourface,
eyes,mouth,ortonguetroublebreathingorwheezingchestpainorarefeelingdizzyorfaint.
CommonsideeffectsofVIVITROLincludenausea,tiredness,headache,dizziness,vomiting,decreasedappetite,
painfuljoints,andmusclecrampsinaddition,commonsideeffectsinpeopletakingVIVITROLforopioid
dependencealsoincludecoldsymptoms,troublesleeping,andtoothache.
ThesearenotallofthesideeffectsofVIVITROL.Formoreinformation,askyourhealthcareprovider.Tellyour
doctorrightawayifyouhaveanysideeffectthatdoesnotgoaway.SeetheattachedMedicationGuideformore
information.
Callyourdoctorformedicaladviceaboutanysideeffects.Youareencouragedtoreportnegativesideeffects
totheFDA.Visitwww.fda.gov/medwatch(http://www.fda.gov/medwatch)orcall1800FDA1088.
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