Simponi(golimumab)戈利木单抗

1HIGHLIGHTSOFPRESCRIBINGINFORMATIONThesehighlightsdonotincludealltheinformationneededtouseSIMPONIsafelyandeffectively.SeefullprescribinginformationforSIMPONI.SIMPONI(golimumab)injection,forsubcutaneoususeInitialU.S.Approval:2009WARNING:SERIOUSINFECTIONSANDMALIGNANCYSeefullprescribinginformationforcompleteboxedwarning.•Seriousinfectionsleadingtohospitalizationordeathincludingtuberculosis(TB),bacterialsepsis,invasivefungal(suchashistoplasmosis),andotheropportunisticinfectionshaveoccurredinpatientsreceivingSIMPONI(5.1)•DiscontinueSIMPONIifapatientdevelopsaseriousinfectionorsepsis(5.1)•PerformtestforlatentTB;ifpositive,starttreatmentforTBpriortostartingSIMPONI(5.1)•MonitorallpatientsforactiveTBduringtreatment,evenifinitiallatentTBtestisnegative(5.1)•Lymphomaandothermalignancies,somefatal,havebeenreportedinchildrenandadolescentpatientstreatedwithTNFblockers,ofwhichSIMPONIisamember(5.2)--------------------------------RECENTMAJORCHANGES---------------------------------WarningsandPrecautions(5.2)12/2014--------------------------------INDICATIONSANDUSAGE---------------------------------SIMPONIisatumornecrosisfactor(TNF)blockerindicatedforthetreatmentofadultpatientswith:•Moderatelytoseverelyactiverheumatoidarthritis(RA)incombinationwithmethotrexate(1.1)•Activepsoriaticarthritis(PsA)alone,orincombinationwithmethotrexate(1.2)•Activeankylosingspondylitis(AS)(1.3)•ModeratetosevereUlcerativecolitis(UC)withaninadequateresponseorintoleranttopriortreatmentorrequiringcontinuoussteroidtherapy(1.4)•inducingandmaintainingclinicalresponse•improvingendoscopicappearanceofthemucosaduringinduction•inducingclinicalremission•achievingandsustainingclinicalremissionininductionresponders----------------------------DOSAGEANDADMINISTRATION------------------------------•RA,PsA,andAS:50mgadministeredbysubcutaneousinjectiononceamonth(2.1)•UC:200mginitiallyadministeredbysubcutaneousinjectionatWeek0,followedby100mgatWeek2andthen100mgevery4weeks(2.2)---------------------------DOSAGEFORMSANDSTRENGTHS----------------------------Injection(3):•50mg/0.5mLinasingledoseprefilledSmartJect®autoinjector•50mg/0.5mLinasingledoseprefilledsyringe•100mg/1mLinasingledoseprefilledSmartJect®autoinjector•100mg/1mLinasingledoseprefilledsyringe---------------------------------CONTRAINDICATIONS-------------------------------------•None(4)----------------------------WARNINGSANDPRECAUTIONS------------------------------•SeriousInfections:DonotstartSIMPONIduringanactiveinfection.Ifaninfectiondevelops,monitorcarefully,andstopSIMPONIifinfectionbecomesserious(5.1)•InvasiveFungalInfections:ForpatientswhodevelopasystemicillnessonSIMPONI,considerempiricantifungaltherapyforthosewhoresideinortraveltoregionswheremycosesareendemic(5.1)•HepatitisBReactivation:MonitorHBVcarriersduringandseveralmonthsaftertherapy.Ifreactivationoccurs,stopSIMPONIandbeginanti-viraltherapy(5.1)•Malignancies:IncidenceoflymphomawasgreaterthaninthegeneralU.S.population.CasesofothermalignancieshavebeenobservedamongpatientsreceivingTNF-blockers(5.2)•HeartFailure:Worsening,ornewonset,mayoccur.StopSIMPONIifneworworseningsymptomsoccur(5.3)•DemyelinatingDisease:Exacerbationornewonset,mayoccur(5.4)•HypersensitivityReactions:Serioussystemichypersensitivityreactionsincludinganaphylaxismayoccur(5.10)----------------------------------ADVERSEREACTIONS-------------------------------------Mostcommonadversereactions(incidence5%)areupperrespiratorytractinfection,nasopharyngitis,injectionsitereactions(6.1)ToreportSUSPECTEDADVERSEREACTIONS,contactJanssenBiotech,Inc.at1-800-JANSSEN(1-800-526-7736)orFDAat1-800-FDA-1088or•Abatacept:Increasedriskofseriousinfection(5.1,5.5,7.2)•Anakinra:Increasedriskofseriousinfection(5.1,5.6,7.2).•Livevaccines/therapeuticinfectiousagents:AvoidusewithSIMPONI(5.9,7.3).See17forPATIENTCOUNSELINGINFORMATIONandMedicationGuide.Revised:June2015SIMPONI®(golimumab)FULLPRESCRIBINGINFORMATION:CONTENTS*WARNING:SERIOUSINFECTIONSANDMALIGNANCY1INDICATIONSANDUSAGE1.1RheumatoidArthritis1.2PsoriaticArthritis1.3AnkylosingSpondylitis1.4UlcerativeColitis2DOSAGEANDADMINISTRATION2.1DosageinRheumatoidArthritis,PsoriaticArthritis,AnkylosingSpondylitis2.2DosageinModeratelytoSeverelyActiveUlcerativeColitis2.3MonitoringtoAssessSafety2.4ImportantAdministrationInstructions3DOSAGEFORMSANDSTRENGTHS4CONTRAINDICATIONS5WARNINGSANDPRECAUTIONS5.1SeriousInfections5.2Malignancies5.3CongestiveHeartFailure5.4DemyelinatingDisorders5.5UsewithAbatacept5.6UsewithAnakinra5.7SwitchingBetweenBiologicalDiseaseModifyingAntirheumaticDrugs5.8HematologicCytopenias5.9Vaccinations/TherapeuticInfectiousAgents5.10HypersensitivityReactions6ADVERSEREACTIONS6.1ClinicalTrialsExperience6.2Post-marketingExperience7DRUGINTERACTIONS7.1Methotrexate7.2BiologicalProductsforRA,PsA,and/orAS7.3LiveVaccines/TherapeuticInfectiousAgents7.4CytochromeP450Substrates8USEINSPECIFICPOPULATIONS8.1Pregnancy8.3NursingMothers8.4PediatricUse8.5GeriatricUse10OVERDOSAGE11DES