pmr-jun-2017-0017 rems educationprogram 8.21 · december 2012 adasuve® (loxapine) inhalation...

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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PulmonarySafetyStudiesinPatientsWithAsthmaandCOPD– UseofRescueAlbuterol

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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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StepsforSafeUseofADASUVE®

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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3. Explainprocedurestothepatient.Explaintheadministrationprocedurestothepatientpriortouse,andadvisethepatientthatitisimportanttofollowtheinstructions.

Informthepatientthattheinhalermayproduceaflashoflightandaclickingsound,anditmaybecomewarmduringuse.Thesearenormal.

4. Instructthepatienttoexhale.Instructthepatienttoholdtheinhalerawayfromthemouthandbreatheoutfullytoemptythelungs.

-continued-

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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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pmr-jun-2017-0017 rems educationprogram 8.21 · december 2012 adasuve® (loxapine) inhalation...

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