pmr-jun-2017-0017 rems educationprogram 8.21 · december 2012 adasuve® (loxapine) inhalation...
TRANSCRIPT
December 2012
ADASUVE®(LOXAPINE)INHALATIONPOWDER
EDUCATIONPROGRAMforHEALTHCAREPROFESSIONALS
August2017
PMR-JUN-2017-0017
ADASUVE® RiskEvaluationandMitigationStrategy(REMS)EducationProgramContentAttheendofthiseducationprogram,youshouldunderstand:• ADASUVEREMSProgramRequirements• ADASUVEProductInformation
– Indication– Dose
• ImportantSafetyInformation– RiskofbronchospasmwithADASUVE– UseofalbuterolrescuetreatmenttotreatbronchospasminasthmaandCOPDpatients
– Decreasedforcedexpiratoryvolumein1second(FEV1)inasthmaandCOPDpatients– SafetyofADASUVEinagitationtrials– AdministeronlyasingledoseofADASUVEperpatientwithinany24-hourperiod
2Forcompletesafetyprofile,seethePrescribingInformationincludingBoxedWarning.
ADASUVE® RiskEvaluationandMitigationStrategy(REMS)EducationProgramContent-continued-
• HowtouseADASUVEsafely– Appropriatepatientselection– Dosageandadministration– Observationandmanagementofpatient
• HowtoenrollintheADASUVEREMSProgram
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ADASUVE® REMSProgram
• ThepurposeoftheADASUVEREMS Programistomitigatetheriskofbronchospasmthathasthepotentialtoleadtorespiratorydistressandrespiratoryarrest
• Tomitigatetherisk,theADASUVEREMSProgramrequiresthatADASUVEisadministeredonlyinenrolledhealthcarefacilities:
– Withimmediateaccessonsitetosuppliesandpersonneltrainedtomanageacutebronchospasmandreadyaccesstoemergencyresponseservices
• TheREMSProgramwillinformhealthcareprofessionalsabout:– TheriskofbronchospasmafterADASUVEadministration
– Appropriatepatientselection
– MonitoringpatientsafterADASUVEadministration
– ManagementofADASUVE-inducedbronchospasm
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RiskofBronchospasm
• ADASUVE®cancausebronchospasmthathasthepotentialtoleadtorespiratorydistressandrespiratoryarrest
• AdministerADASUVEonlyinanenrolledhealthcarefacilitythathas:
– Immediateaccessonsitetosuppliesandpersonneltrainedtomanageacutebronchospasmandreadyaccesstoemergencyresponseservices.Thishealthcarefacilitymusthaveashort-actingbronchodilator(e.g.,albuterol),includinganebulizerandinhalationsolution,fortheimmediatetreatmentofbronchospasm
– Medical/psychiatric(physicians,nurses,etc.)staffonsiteatalltimes(24hoursaday/7daysaweek)trainedtomanageacutebronchospasm
• PriortoadministeringADASUVE,askpatientsregarding:
– Ahistoryorsymptomsofasthma,COPD,andotherlungdiseases
– Examine(includingchestauscultation)patientsforrespiratoryabnormalities(e.g.,wheezing)
• FollowingtreatmentwithADASUVE,monitorforsignsandsymptomsofbronchospasm
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Contraindications
• ADASUVE®iscontraindicatedinpatientswiththefollowing:
– Currentdiagnosisorhistoryofasthma,COPD,orotherlungdiseaseassociatedwithbronchospasm
– Acuterespiratorysignsorsymptoms(e.g.,wheezing)
– Currentuseofmedicationstotreatairwaysdisease,suchasasthmaorCOPD
– HistoryofbronchospasmfollowingADASUVEtreatment
– Hypersensitivitytoloxapineoramoxapine(e.g.,seriousskinreaction)
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ADASUVE®:ProductInformation
• TheefficacyofADASUVEwasestablishedinonestudyofacuteagitationinpatientswithschizophreniaandonestudyofacuteagitationinpatientswithbipolarIdisorder
DosingandAdministration• ADASUVEisasingle-usedisposableproductthatdeliversanaerosolofloxapineinasingleinhalation
– ADASUVEisadministeredonlybyoralinhalation– ADASUVEmustbeadministeredonlybyahealthcareprofessional,inanenrolledhealthcarefacility
– RecommendeddoseofADASUVEis10mg– Onlyasingledoseperpatientshouldbeadministeredinany24-hourperiod
ADASUVE isatypicalantipsychoticindicatedfortheacutetreatmentofagitationassociatedwithschizophreniaorbipolarIdisorderinadults.
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PulmonarySafetyStudiesinPatientsWithAsthmaandCOPDAlbuterolRescueTreatmentAfterAdministrationofADASUVE®
• Dedicatedpulmonarysafetystudieswereperformedinsubjectswithmild-to-moderatepersistentasthmaormild-to-severeCOPD
• AfterreceivingADASUVE(Dose1andDose2):
– 54%ofpatientswithasthmarequiredtreatmentwithalbuteroltotreatpulmonaryadverseevents
– 23%ofpatientswithCOPDrequiredtreatmentwithalbuterol
Donotuseinpatientswithacuterespiratorysignsandsymptoms;withacurrentdiagnosisorhistoryofasthma,COPDandotherlungdiseaseassociatedwithbronchospasm;orwithcurrentuseofmedicationstotreatairwaysdisease,suchasasthmaorCOPD.
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PulmonarySafetyStudiesinPatientsWithAsthmaandCOPDDecreasedForcedExpiratoryVolumeinOneSecond(FEV1)AfterADASUVE® Administration• Dedicatedpulmonarysafetystudieswereperformedinsubjectswithmild-to-moderatepersistentasthmaormild-to-severeCOPD
• ThereweresignificantlymoreasthmaandCOPDpatientswhoexperiencedadecreaseinFEV1 of>10%,>15%,and>20%intheADASUVE-treatedpatientscomparedwiththeplacebo-treatedpatients
Donotuseinpatientswithacuterespiratorysignsandsymptoms;withacurrentdiagnosisorhistoryofasthma,COPDandotherlungdiseaseassociatedwithbronchospasm;orwithcurrentuseofmedicationstotreatairwaysdisease,suchasasthmaorCOPD.
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MaximumDecreaseinFEV1 fromBaselineinHealthyVolunteer,Asthma,andCOPDTrials
FEV1 categories are cumulative, ie, a subject with a maximum decrease of 21% is included in all 3 categories.Patients with a >20% decrease in FEV1 did not receive a second dose of study drug. Dose 1 = time 0, Dose 2 = 10 hours after time 0
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PulmonarySafetyStudiesinPatientsWithAsthmaandCOPDIncreasedPulmonaryAdverseEventsafterDose2ofADASUVE®
• AhigherpercentageofpatientsrequiredalbuteroltreatmentafterDose2comparedwithDose1(Slide9)
• AhigherpercentageofpatientstreatedwithADASUVEhadadecreaseinFEV1 afterDose2comparedwithDose1(Slide11)
• FEV1sdidnotreturntobaselineupto24hoursafteradministrationoftheseconddoseofADASUVE(Slide13)
ADASUVEmayonlybeadministeredtoapatientoncein24hours.
HealthcarefacilitiesmusthavepoliciesinplacetolimitadministrationofADASUVEtoasingledoseperpatientina24-hourperiod.
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MeanChangeFromBaselineinFEV1 inPatientsWithAsthma
Subjects in the ADASUVE group who had a >20% decrease in FEV1 or developed respiratory symptoms after the first dose did not receive a second dose of ADASUVE in the pulmonary safety studies. Therefore, 9 of 26 (35%) subjects in the asthma study did not receive a second dose.
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ProfileofBronchospasmOccurringAfteraFirstDoseofADASUVE® inSubjectsWithAsthmaorCOPD
InsubjectswhodevelopedbronchospasmafterafirstdoseofADASUVE:• Timing:
– Symptomsoccurredwithamediantimeof4minutesinasthmasubjectsand10minutesinCOPDsubjects
– In11/12subjectswithasthmaorCOPD,symptomsbeganwithin25minutes
• Outcome:– Whentreatmentwasrequired,bronchospasmresolvedwithuseofaninhaledbronchodilator(viametered-doseinhalerornebulizer),withoutsequelae
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ProfileofBronchospasmOccurringAfteraFirstDosea
ofADASUVE® inSubjectsWithAsthmaorCOPD-continued-InsubjectswhodevelopedbronchospasmafterafirstdoseofADASUVE:• Albuterolwasusedby:
– 7/26(26.9%)asthmasubjectsafterADASUVE10mg,comparedwith1/26(3.8%)afterplacebo
– 2/26(7.7%)COPDsubjectsafterADASUVE10mg,comparedwith1/27(3.7%)afterplacebo
• Afteralbuteroltreatment,FEV1b wasdocumentedtoreturntowithin10%ofbaselinein≤1hour
– Asthmasubjects:in7/8(87.5%)instances– COPDsubjects:in2/3(66.7%)instances– Atlater,scheduledspirometrytimepointsintheremaining2instances
a And before Dose 2 in those who received it at the 10-hour time pointb Forced expiratory volume in 1 second, as measured by spirometry
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BronchospasminAgitationTrials
• Bronchospasm(includingreportsofwheezing,shortnessofbreath,orcough)wasreportedinpremarketingphase2and3trialsinpatientswithagitationassociatedwithschizophreniaorbipolarIdisorder
• Onepatientwithschizophrenia,withoutahistoryofpulmonarydisease,hadsignificantbronchospasmrequiringrescuetreatmentwithabronchodilatorandoxygen
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ADASUVE® AdverseReactionsa inPremarketingAgitationTrials
AdverseReactionsinShort-Term,Placebo-ControlledPhase2and3Trials
a Adverse reactions (incidence >2% and greater than placebo) for ADASUVE 10 mg
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StepstoReduceRiskofBronchospasm
ThisposterisavailabletoenrolledhealthcarefacilitiestoreinforcehowtouseADASUVE®safely.
HealthcarefacilitiesareencouragedtopostthiswhereADASUVEwillbeadministered.
Additionalcopiescanbeorderedatwww.adasuverems.com orbycalling855-755-0492.
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ReportingAdverseEventsAssociatedWithADASUVE®
Healthcareprofessionalsshouldunderstandtheimportanceofreportingeventsofbronchospasmthatrequireemergencyresponseservices,inadditiontoanyfatalitiesthatoccurfollowingADASUVEtreatment.
Suspectedadverseeventsmaybereportedbythefollowingmethods:
• ADASUVEMedicalInformationat800-284-0062oremailcustomer.services@galen-pharma.com
• FDAat1-800-FDA-1088
• FDAatwww.fda.gov/medwatch/report.htm
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PatientCounseling
DiscusstherisksassociatedwithADASUVE®treatmentwithpatientsandtheircaregivers,includingthesafeuseofADASUVE.
• ExplainthatpatientsmayhavebronchospasmafterusingADASUVE
• Askpatientstotellyouiftheyarecurrentlytakingmedicationstotreatasthma,COPD,otherbreathingproblems
• InformpatientsofothercommonsideeffectsthatmayoccurwithADASUVE(tasteandsleepiness)
• Informpatientsofotherserioussideeffectsthatcanoccurwithantipsychotics,ingeneral
• Askpatientstotellyouimmediatelyiftheyexperience:- Difficultybreathing- Chesttightness- Wheezing
• Tellpatientsyouhaveamedicineavailabletotreatbreathingproblemsthatmightoccur
HelpingPatientsandCaregiversUnderstandRisks
HelpingPatientsReportSigns/SymptomsofBronchospasm
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AdministrationofADASUVE®
• ADASUVEisonlyadministeredbyoralinhalation• Administeronlyasingledosewithinany24-hourperiod• ADASUVEmustbeadministeredonlybyahealthcareprofessional,inanenrolledhealthcarefacility
RequiredExaminationPriortoDosing:• PriortoadministeringADASUVE,screenallpatientsfor:
– CurrentuseofmedicationstotreatasthmaorCOPD– Historyofasthma,COPDorotherpulmonarydisease– Examinepatients(includingchestauscultation)forrespiratoryabnormalities(e.g.,wheezing)
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BecomingFamiliarWithADASUVE®
ThepicturesbelowshowtheimportantfeaturesoftheADASUVEproduct
• ADASUVEisprovidedinasealedpouch
• TheindicatorlightisoffwhenADASUVEisremovedfromthepouch
• Theindicatorlightturnson(green)whenthetabispulledout.Theproductisthenreadyforuse
• Theindicatorlightturnsoffafterthepatientinhales.Thisindicatesthatthedosehasbeendelivered
• IftheindicatorlightdoesNOTturnoff,thedosehasNOTbeendelivered
(bothsidesshown)
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ADASUVE®:ImportantAdministrationInstructions
1. Openthepouch.Whenreadytouse, tearopenthefoilpouchandremovetheinhalerfromthepackage.
WhentheADASUVEinhalerisremovedfromthepouch,theindicatorlightisoff.
2. Pulltab.Firmlypulltheplastictabfromtherearoftheinhaler.Checkthatthegreenlightturnson.Thisindicatesthattheinhalerisreadyforuse.
Usetheinhalerwithin15minutesafterremovingtabtopreventautomaticdeactivationoftheinhaler.
Thegreenlightwillturnoff,indicatingthattheinhalerisnotusable.Discardtheinhalerafteroneuse.
BeforeadministeringADASUVE:
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ADASUVE®:ImportantAdministrationInstructions
3. Explainprocedurestothepatient.Explaintheadministrationprocedurestothepatientpriortouse,andadvisethepatientthatitisimportanttofollowtheinstructions.
Informthepatientthattheinhalermayproduceaflashoflightandaclickingsound,anditmaybecomewarmduringuse.Thesearenormal.
4. Instructthepatienttoexhale.Instructthepatienttoholdtheinhalerawayfromthemouthandbreatheoutfullytoemptythelungs.
-continued-
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ADASUVE®:ImportantAdministrationInstructions
5. Instructthepatienttoinhale.Instructthepatienttoputthemouthpieceoftheinhalerbetweenthelips,closethelips,andinhalethroughthemouthpiecewithasteadydeepbreath.
Checkthatthegreenlightturnsoff,indicatingthatthedosehasbeendelivered.
-continued-
6. Instructthepatienttoholdbreath.Instructthepatienttoremovethemouthpiecefromthemouthandholdthebreathforaslongaspossible,upto10seconds.
Important:Ifthegreenlightremainsonafterthepatientinhales,thedoseofADASUVEhasNOTbeendelivered.InstructthepatienttorepeatStep4,Step5,andStep6upto2additionaltimes.Ifthegreenlightstilldoesnotturnoff,discardtheinhaleranduseanewone.
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ADASUVE®:MonitoringtoAssessSafety
• MonitorthepatientforsignsorsymptomsofbronchospasmafterADASUVEadministration
• Performaphysicalexamination,includingchestauscultation,atleastevery15minutesforatleastonehourafterADASUVEadministration
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HowtoEnrollintheADASUVE® REMSProgram• ADASUVEwillbedispensedtopatientsonlyincertainhealthcarefacilitiesthatareenrolledintheADASUVEREMSProgram
• Wholesalers/DistributorswillshipADASUVEonlytoenrolledhealthcarefacilities
• Eachhealthcarefacilitymustbeabletoprovide:– Immediateaccessonsitetosuppliesandpersonneltrainedtomanageacutebronchospasmandreadyaccesstoemergencyresponseservices.Thishealthcarefacilitymusthaveashort-actingbronchodilator(e.g.,albuterol),includinganebulizerandinhalationsolution,fortheimmediatetreatmentofbronchospasm
– Medical/psychiatric(physicians,nurses,etc.)staffonsiteatalltimes(24hoursaday/7daysaweek)trainedtomanageacutebronchospasm
– Healthcareproviderswithinthefacility(prescribers,nurses,monitoringstaff,orpharmacists)whoaretrainedonsafeuseofADASUVEusingtheADASUVEEducationProgram
– Procedures,protocoland/orordersetsguidingsafeuseofADASUVE
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Procedures,Protocols,OrderSetsforSafeUseofADASUVE®
Procedures,protocols,and/orordersetstoensurethefollowing:• Patientsarescreened,priortotreatmentwithADASUVE:
– Forahistoryofpulmonarydisease– Foracuterespiratorysignsandsymptomsbyphysicalexam,includingtakingvitalsignsandchestauscultation
– InquiringifpatientistakingmedicationtotreatasthmaorCOPD• Patientsaremonitoredatleastevery15minutesforaminimumofonehourfollowingtreatmentwithADASUVEforsignsandsymptomsofbronchospasm
– Takingvitalsigns– Chestauscultation
• AdministrationofADASUVEislimitedtoonedoseperpatientwithin24hours
Order Set/Protocol templates are available to review, order, or print at www.adasuverems.com or by calling 1-855-755-0492 29
DesignateanAuthorizedHealthcareFacilityRepresentativeForeachfacility,anauthorizedhealthcarefacilityrepresentativeisrequiredto:• ReviewtheADASUVE®EducationProgram• Completeandsignthe HealthcareFacilityEnrollmentInformationandForm
– Acknowledgingthattheenrolledhealthcarefacilitymeetsspecificrequirements
• HealthcareFacilityRepresentative:– MaybeaPharmacistoranotherhealthcareprofessionalwithappropriatelevelofresponsibilitywithinthefacility
– Authorizedtoactonbehalfofthefacility
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AuthorizedHealthcareFacilityRepresentativeActions
• ReviewtheHealthcareFacilityEnrollmentInformation and Form tobecomefamiliarwiththeenrollmentrequirements
• ReviewtheADASUVEREMSEducationProgram tobecomefamiliarwithsafeuseconditionsforADASUVE
• CompleteandsigntheHealthcareFacilityEnrollmentForm• Submitthecompletedformon-line,viafax,viaemail
TheHealthcareFacilityEnrollmentInformationand Formareavailableatwww.adasuverems.com orbycalling855-755-0492
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ADASUVE® REMSMaterialsforEnrolledHealthcareFacilitiesThefollowingmaterialsarepartoftheADASUVEREMSProgramandwillassistenrolledhealthcarefacilitiesincomplyingwithADASUVEREMSrequirements.Theyareavailabletoreview,orderorprintatwww.adasuverems.com orbycalling855-755-0492.
1.ADASUVEREMSEducationProgram– Mustbereviewedbyallhealthcareproviderswithinanenrolledhealthcarefacilitywho
willbeprescribingoradministeringADASUVE,orobservingpatientsafterADASUVEisadministered
2.StepsforSafeUseofADASUVEPoster– ShouldbepostedwhereADASUVEisadministeredwithinenrolledhealthcarefacilities
3.OrderSet/ProtocolTemplate– Forusebyenrolledhealthcarefacilitiestoassistwithdesigningprocedures,protocols
and/orordersetsthatmeettherequirementsoftheADASUVEREMSProgram
4.ADASUVEHealthcareProviderBrochure– ContainsinformationforprovidersontherisksandsafeuseofADASUVE– InformationonhealthcarefacilityenrollmentrequirementsoftheADASUVE
REMSProgram
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OtherResourcesAvailableatwww.adasuverems.com
• HealthcareFacilityEnrollmentInformationandForm• PrescribingInformation• ADASUVE®InstructionsforUse• ADASUVE®MedicationGuide
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ADASUVE® EducationProgramSummaryAttheendofthiseducationprogram,youshouldunderstand:• ADASUVEREMSProgramInformation
– TheADASUVEREMSProgramisnecessarytomitigatetheriskofbronchospasmthathasthepotentialtocauserespiratorydistressandrespiratoryarrest
• Importantsafetyinformation– ADASUVEcancausebronchospasm– Patientswithactiveairwaysdisease(asthma,COPD)areatincreasedriskofbronchospasmafterdosingwithADASUVE
– Itisimportanttoreporteventsofbronchospasmthatrequireemergencyresponseservices,inadditiontoanyfatalities,thatoccurfollowingADASUVEtreatment
– AdministeronlyasingledoseofADASUVEperpatientwithinany24-hourperiod
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ADASUVE® EducationProgramSummary-continued-
• HowtouseADASUVEsafely– SCREENpatientstoidentifyandselectappropriateADASUVEpatients– OBSERVEandMONITORpatientsevery15minutesforatleastonehourafterADASUVEtreatment
– MANAGEbronchospasmwithaninhaledshort-actingbeta-agonistbronchodilatororifnecessary,byaccessingemergencyresponseservices
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ADASUVE® EducationProgramSummary-continued-
HowtoenrollintheADASUVEREMSProgram• Eachhealthcarefacilitymustbeabletoprovide:
– Immediateaccessonsitetosuppliesandpersonneltrainedtomanageacutebronchospasmandreadyaccesstoemergencyresponseservices.Thishealthcarefacilitymusthaveashort-actingbronchodilator(e.g.,albuterol),includinganebulizerandinhalationsolution,fortheimmediatetreatmentofbronchospasm.
– Medical/psychiatric(physicians,nurses,etc.)staffonsiteatalltimes(24hoursaday/7daysaweek)trainedtomanageacutebronchospasm.
• Foreachfacility,anauthorizedhealthcarefacilityrepresentativeisrequiredtocompleteandsigntheHealthcareFacilityEnrollmentInformationandFormacknowledgingthattheenrolledhealthcarefacilitymeetsspecificrequirements
• Findmoreinformationatwww.adasuverems.com
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