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CENTERFORDRUGEVALUATIONANDRESEARCHAPPLICATIONNUMBER:125469Orig1s000LABELING1HIGHLIGHTSOFPRESCRIBINGINFORMATIONThesehighlightsdonotincludealltheinformationneededtouseTRULICITYsafelyandeffectively.SeefullprescribinginformationforTRULICITY.TRULICITY(dulaglutide)injection,forsubcutaneoususeInitialU.S.Approval:2014WARNING:RISKOFTHYROIDC-CELLTUMORSSeefullprescribinginformationforcompleteboxedwarning.•DulaglutidecausesthyroidC-celltumorsinrats.ItisunknownwhetherTRULICITYcausesthyroidC-celltumors,includingmedullarythyroidcarcinoma(MTC),inhumansashumanrelevancecouldnotbedeterminedfromclinicalornonclinicalstudies(5.1,13.1).•TRULICITYiscontraindicatedinpatientswithapersonalorfamilyhistoryofMTCandinpatientswithMultipleEndocrineNeoplasiasyndrometype2(MEN2)(4.1).----------------------------INDICATIONSANDUSAGE---------------------------TRULICITY™isaglucagon-likepeptide(GLP-1)receptoragonistindicatedasanadjuncttodietandexercisetoimproveglycemiccontrolinadultswithtype2diabetesmellitus.LimitationsofUse:•Notrecommendedasfirst-linetherapyforpatientsinadequatelycontrolledondietandexercise(1,5.1).•Hasnotbeenstudiedinpatientswithahistoryofpancreatitis.Consideranotherantidiabetictherapy(1,5.2).•Notfortreatmentoftype1diabetesmellitusordiabeticketoacidosis.•Notforpatientswithpre-existingseveregastrointestinaldisease.•Hasnotbeenstudiedincombinationwithbasalinsulin.------------------------DOSAGEANDADMINISTRATION-----------------------•Administeronceweeklyatanytimeofday(2.1).•Injectsubcutaneouslyintheabdomen,thigh,orupperarm(2.1).•Initiateat0.75mgsubcutaneouslyonceweekly.Dosecanbeincreasedto1.5mgonceweeklyforadditionalglycemiccontrol(2.1).•Ifadoseismissedadministerwithin3daysofmisseddose(2.1).----------------------DOSAGEFORMSANDSTRENGTHS---------------------•Injection:0.75mg/0.5mLsolutioninasingle-dosepen(3)•Injection:1.5mg/0.5mLsolutioninasingle-dosepen(3)•Injection:0.75mg/0.5mLsolutioninasingle-doseprefilledsyringe(3)•Injection:1.5mg/0.5mLsolutioninasingle-doseprefilledsyringe(3)-------------------------------CONTRAINDICATIONS------------------------------•DonotuseinpatientswithapersonalorfamilyhistoryofmedullarythyroidcarcinomaorinpatientswithMultipleEndocrineNeoplasiasyndrometype2(4.1,5.1,13.1).•DonotuseifhistoryofserioushypersensitivitytoTRULICITYoranyproductcomponents(4.2,5.4).------------------------WARNINGSANDPRECAUTIONS-----------------------•ThyroidC-celltumorsinanimals:Counselpatientsregardingtheriskofmedullarythyroidcarcinomaandthesymptomsofthyroidtumors(5.1).•Pancreatitis:Hasbeenreportedinclinicaltrials.Discontinuepromptlyifpancreatitisissuspected.Donotrestartifpancreatitisisconfirmed.Considerotherantidiabetictherapiesinpatientswithhistoryofpancreatitis(5.2).•Hypoglycemia:WhenTRULICITYisusedwithaninsulinsecretagogue(e.g.,asulfonylurea)orinsulin,considerloweringthedoseofthesulfonylureaorinsulintoreducetheriskofhypoglycemia(5.3).•HypersensitivityReactions:DiscontinueTRULICITYifsuspected.Monitorandtreatpromptlyperstandardofcareuntilsignsandsymptomsresolve(5.4).•RenalImpairment:Monitorrenalfunctioninpatientswithrenalimpairmentreportingsevereadversegastrointestinalreactions(5.5).•Macrovascularoutcomes:TherehavebeennostudiesestablishingconclusiveevidenceofmacrovascularriskreductionwithTRULICITYoranyotherantidiabeticdrug(5.7).-------------------------------ADVERSEREACTIONS------------------------------Themostcommonadversereactions,reportedin≥5%ofpatientstreatedwithTRULICITYare:nausea,diarrhea,vomiting,abdominalpain,anddecreasedappetite(6.1).ToreportSUSPECTEDADVERSEREACTIONS,contactEliLillyandCompanyat1-800-LillyRx(1-800-545-5979)orFDAat1-800-FDA-1088or(7.1,12.3).-----------------------USEINSPECIFICPOPULATIONS----------------------•Pregnancy:TRULICITYmaycausefetalharm;onlyuseifpotentialbenefitjustifiespotentialrisktofetus(8.1).•NursingMothers:DiscontinuenursingordiscontinueTRULICITY(8.3).•RenalImpairment:Nodosageadjustmentrecommended.Monitorrenalfunctioninpatientswithrenalimpairmentreportingsevereadversegastrointestinalreactions(5.5,8.7).See17forPATIENTCOUNSELINGINFORMATIONandFDA-approvedMedicationGuideRevised:09/2014FULLPRESCRIBINGINFORMATION:CONTENTS*WARNING:RISKOFTHYROIDC-CELLTUMORS1INDICATIONSANDUSAGE1.1LimitationsofUse2DOSAGEANDADMINISTRATION2.1Dosage2.2ConcomitantUsewithanInsulinSecretagogue(e.g.,Sulfonylurea)orwithInsulin2.3DosageinPatientswithRenalImpairment2.4ImportantAdministrationInstructions3DOSAGEFORMSANDSTRENGTHS4CONTRAINDICATIONS4.1MedullaryThyroidCarcinoma4.2Hypersensitivity5WARNINGSANDPRECAUTIONS5.1RiskofThyroidC-cellTumors5.2Pancreatitis5.3HypoglycemiawithConcomitantUseofInsulinSecretagoguesorInsulin5.4HypersensitivityReactions5.5RenalImpairment5.6SevereGastrointestinalDisease5.7MacrovascularOutcomes6ADVERSEREACTIONS6.1ClinicalStudiesExperience7DRUGINTERACTIONS7.1OralMedications8USEINSPECIFICPOPULATIONS8.1Pregnancy8.3Nursin