PleaseseeadditionalImportantSafetyInformationonpages12-15 andaccompanyingfulprescribinginformationandpatientinformation.

Transkript

1 REI GNI TE MYFI GHT AZYKADI At r eat mentgui def or pat i ent sandt hei rcar egi ver s Pl eas es eeaddi t i onal I mpor t antsaf et yi nf or mat i ononpages andac c ompany i ngf ul l Pr es c r i bi ngi nf or mat i onandpat i enti nf or mat i on.

2 PleaseseeadditionalImportantSafetyInformationonpages12-15 andaccompanyingfulprescribinginformationandpatientinformation.

3 TABLEOFCONTENTS NON-SMALLCELLLUNGCANCERANDALK WHATISZYKADIA (ceritinib)? HOW ZYKADIAMAYHELP UNDERSTANDINGSIDEEFFECTS HOW TOGETZYKADIA IMPORTANTSAFETYINFORMATION

4 NON-SMALLCELLLUNG CANCERAND ALK TheALKgene Advancesingeneticresearchhaverevealedthatnon-smal cellungcancer(nsclc)isnotasingledisease,butrather manytypesofcancerwithspecificgeneticdiferences. Becauseofthesesmalbutimportantdiferences,lung cancermedicinesthattargetspecificgenes,suchas anaplasticlymphomakinase(alk),canbedeveloped. About2%-7%ofpeoplewithNSCLCareconsideredtobe ALKpositive(ALK+).Butgeneticdiferencesaren ttheonly diferencesbetweenpeoplewhohavealk+nsclcand peoplewhohavegeneralnsclc.otherimportant diferencesincludeageatdiagnosisandsmokinghistory. Understandingdiseaseprogressionanddrugresistance AlthoughALK+NSCLCtumorscaninitialyrespondtoALK+ treatment,overtimetheymaybecomeresistant(orstop responding).thiscouldhappenwithinayearoftreatment andmayresultinarelapseforthepatient.signsmayinclude anincreaseinsizeoftumorordevelopmentofnewtumors. Ifyouexperienceanyhealth-relatedchanges,it simportant totalktoyourdoctor. PleaseseeadditionalImportantSafetyInformationonpages12-15 andaccompanyingfulprescribinginformationandpatientinformation.

5 ARTIST HUSBAND FIGHTER I M STILLWRITINGMYSTORY Resistancetotreatmentmaydevelopwhen: Mutations(orchanges)totheALKgeneinterferewith howaspecificalkinhibitorworks OthergeneswithsimilaractionstoALKbecomeactivein thetumor Othermutationsnotafectedbytreatmentappearwithin thetumor TumorsthatbecomeresistanttooneALKinhibitormaystil beresponsivetoadiferentalkinhibitor. 5

6 WHATIS ZYKADIA (ceritinib)? ZYKADIAcapsulesisaprescriptionmedicinethatisusedto treatpeoplewithnon-smalcellungcancer(nsclc)that: Iscausedbyadefectinagenecaledanaplastic lymphomakinase(alk),and Hasspreadtootherpartsofthebody(metastatic),and Whohavetakenthemedicinecrizotinib,buttheirNSCLC worsenedortheycannottoleratetakingcrizotinib TheefectivenessofZYKADIAinthesepatientsisbasedon astudythatmeasuredtwotypesofresponsetotreatment (responserateanddurationofresponse).thereisnoclinical informationavailabletoshowifpatientstreatedwith ZYKADIAlivelongeroriftheirsymptomsimprove.There areongoingstudiestofindouthowzykadiaworksover alongerperiodoftime.itisnotknownifzykadiaissafe andefectiveinchildren. HowZYKADIAworks TheALKgeneisthoughttoplayacriticalroleinthegrowth ofsomensclcs.zykadiaisanalkinhibitor,whichmeans itmayblocktheactionofthealkgene.it sbelievedthat thishelpstoshrinkorslowcancergrowth. Youandyourdoctorneedtodiscussthepossible benefitsandrisksoftreatmentwithzykadia, takingintoaccountyourmedicalhistoryand curentmedications. PleaseseeImportantSafetyInformationonpages12-13 PleaseseeadditionalImportantSafetyInformationonpages12-15 andfulprescribinginformationenclosed. andaccompanyingfulprescribinginformationandpatientinformation.

7 MOTHER TEACHER FIGHTER I M READYTO REIGNITEMYFIGHT HOW ZYKADIAMAYHELP Overalresponseanddurationofresponse Inaclinicaltrial,ZYKADIAwasshowntoshrinkorslow thegrowthoftumors.inthistrial,163patientswithalk+ metastaticnsclcwhohavetakenthemedicinecrizotinib, buttheirnsclcworsenedortheycouldnottoleratetaking crizotinib,weretreatedwithzykadia % Overalresponse ratetotreatment withzykadia 7.4 MONTHS Medianlengthof responsetotreatment Ofthosewhoresponded,1.2%ofpatientshadacomplete responsetotreatment(whichisnotthesameasbeingcured) and53.4%ofpatientshadapartialresponse.thismeansthat inthesepatientstheamountorspreadofcancerdecreased ortumorsshrank.responsetotreatmentlastedamedian of7.4months. ImportantSafetyInformation ZYKADIAcancauseserioussideefectsinsomepeople. SerioussideefectsassociatedwithZYKADIAinclude stomachandintestinalproblems,liverinjury,severeor life-threateningswelingofthelungs,andeitherveryslow, veryfast,orabnormalheartbeats.peoplewhohavediabetes orglucoseintolerance,orwhotakeacorticosteroidmedicine, haveanincreasedriskofhighbloodsugarwithzykadia. ZYKADIAcancausepancreatitisthathasledtodeath. 7

8 HowshouldItakeZYKADIA IA (ceritinib)? TakeZYKADIAexactlyasyourdoctortelsyou.Donot yourdoctortelsyou.donot changeyourdoseorstoptakingitunlessyourdoctor takingitunlessyourdoctor telsyouto. TakeZYKADIAonceaday ay TakeZYKADIAonanemptystomach(ie,donottake ZYKADIAwithin2hoursofameal) FIVECAPSULESONCEDAILYON AILYON AN EMPTYSTOMACH NoFood 2 Hours Before 5CAPSULES 2 NoFood Hours After ContinuetakingZYKADIAforaslongasyourdoctor telsyou. IfyouvomitaftertakingZYKADIA,donottakeanadditional dose,butcontinuewiththenextscheduleddose. enextscheduleddose. Ifyoumissadose,makeupthatdoseunlessthenextdose isduewithin12hours. ImportantSafetyInformation tion Themostcommonsideefectsexperiencedbypatients inaclinicaltrialwithzykadiaincludeddiarhea,nausea, vomiting,stomach-areapain,tiredness,decreased in,tiredness,decreased appetite,andconstipation.. PleaseseeadditionalImportantSafetyInformationonpages12-15 andaccompanyingfulprescribinginformationandpatientinformation. 9

9 UNDERSTANDING SIDEEFFECTS TreatmentforALK+metastaticNSCLCmeansstayingon therapyaslongasitcontinuestowork.manypeopleare concernedaboutpossiblesideefectsthatmayresult. Talktoyourdoctoraboutyoursideefects Besuretotelyourdoctorhowyouarefeelingorifyou haveanyconcernsaboutyourtreatment,especialy ifyouthinkyouareexperiencinganytreatmentside efects.someofthegastrointestinalsideefectscanbe managedbysupportivecarewithstandardantiemetics (fornausea/vomiting),antidiarhealmedications,and/orfluid replacement.consultyourdoctortodevelopanappropriate sideefectsmanagementplan.yourdoctormaytemporarily interupt,reduce,ordiscontinueyourdoseofzykadia. VisittheNationalCancerInstituteatcancer.govfor additionalinformationaboutsideefects. 9

10 HOW TOGET ZYKADIA (ceritinib) NovartisOncologyiscommitedtohelpingyougetthe medicinesyouneed.getingaccesstomedicationscan sometimesbedificultorconfusing.patientassistance NowOncology(PANO)oferstoolsandsupportdesigned specificalytohelpmakethatprocesseasier. Herearesomewayswecanhelp: Ofersupportwithyourinsuranceverificationtohelpyou understandyourfinancialresponsibilitiesandassistwith anychangesinyourinsuranceplan Helpyoufindapharmacycoveredbyyourplan ProvideInsuranceandMedicareeducation Provideinformationaboutfinancialorco-pay assistancethatmaybeavailableviaindependent charitablefoundations Assistancewithappeals PatientSupportCounselorswhospeakover 160languages Onesinglepointofcontacttohelpguideyouthrough alaspectsoftreatmentandsupport PleaseseeadditionalImportantSafetyInformationonpages12-15 andaccompanyingfulprescribinginformationandpatientinformation.

11 FRIEND COLLEAGUE FIGHTER I M FOCUSED ON MOVINGFORWARD Financialassistance Youmaybeeligibleforimmediateco-paysavingson yournextprescription: Commercialyinsuredpatientspayno $ 25 morethan$25permonthuntilannual CO-PAY maximum ismet Annualmaximum of$15,000per calendaryear Tofindoutifyouareeligibletosaveonyournext prescription:cal orvisituson Co-payOferTermsandConditions:Thisoferisvalidonlyforthosewith commercialinsurance.ofernotvalidundermedicare,medicaid,oranyother federalorstateprogram.notvalidforcash-payingpatients,whereproductisnot coveredbypatient scommercialinsurance,orwhereplanreimbursesyouforentire costofyourprescriptiondrug.oferisnotvalidwhereprohibitedbylaw.validonlyin theunitedstatesandpuertorico.thisprogram isnothealthinsurance.ofermay notbecombinedwithanyotherrebate,coupon,orofer.thecardisthepropertyof NovartisPharmaceuticalsCorporationandmustbereturneduponrequest.Novartis reservestherighttorescind,revoke,oramendtheprogram withoutnotice.patient certifiesresponsibilityforcomplyingwithapplicablelimitations,ifany,ofany commercialinsuranceandreportingreceiptofprogram rewards,ifnecessary, toanycommercialinsurer.thisoferexpiresondecember31,2017. Afree14-daytrialisavailableforeligiblepatients.Askyourdoctorformore information. 11

12 IMPORTANTSAFETY INFORMATION ABOUT ZYKADIA (ceritinib)capsules ZYKADIAmaycauseserioussideefects,suchas: Stomachandintestinalproblems ZYKADIAcausesstomachandintestinalproblemsin mostpeopl mostpeople,includingdiarhea,nausea,vomiting,and stomach-areapain.theseproblemscansometimesbe severe.folowyourhealthcareprovider sinstructionsabout takingmedicinestohelpthesesymptoms.calyourhealth careproviderforadviceifyoursymptomsaresevereordo notgoaway. Liverproblems ZYKADIAmaycauseliverinjur ZYKADIAmaycauseliverinjury.Yourhealthcareprovider shoulddobloodtestsatleasteverymonthtocheckyour liverwhileyouaretakingzykadia.telyourdoctorright awayifyouexperienceanyofthefolowingsymptoms: Tiredness(fatigue) Yelowingofskinorthe whitesofeyes Decreasedappetite Urineturnsdarkorbrown Itchyskin Lungproblems(pneumonitis) ZYKADIAmaycausesevereorlife-threateningsweling (inflammation)ofthelungsduringtreatmentthatcanlead todeath.symptomsmaybesimilartothosesymptomsfrom lungcancer.telyourdoctorrightawayifyouhaveanynew orworseningsymptoms,including: Troublebreathingor shortnessofbreath Cough,withorwithoutmucous Nauseaorvomiting Painontherightside ofyourstomach Bleedorbruisemore easilythannormal Fever Chestpain SAFETY N ABOUT ritinib)capsules oussideefects,suchas: roblems andintestinalproblemsin rhea,nausea,vomiting,and problemscansometimesbe careprovider sinstructionsabout hesesymptoms.calyourhealth yoursymptomsaresevereordo injur injury.yourhealthcareprovider asteverymonthtocheckyour ZYKADIA.Telyourdoctorright yofthefolowingsymptoms: wn nitis) reorlife-threateningsweling duringtreatmentthatcanlead besimilartothosesymptomsfrom torrightawayifyouhaveanynew ncluding: Nauseaorvomiting Painontherightside ofyourstomach Bleedorbruisemore easilythannormal

13 Heartproblems ZYKADIAmaycauseveryslow,veryfast,orabnormal heartbeats.yourhealthcareprovidermaycheckyourheart duringtreatmentwithzykadia.telyourhealthcare providerrightawayifyoufeelnewchestpainordiscomfort, dizzinessorlightheadedness,faint,orhaveabnormal heartbeats.telyourhealthcareproviderifyoustarttotake orhaveanychangesinheartorbloodpressuremedicines. Highbloodsugar(hyperglycemia) Peoplewhohavediabetesorglucoseintolerance,orwho takeacorticosteroidmedicinehaveanincreasedriskof highbloodsugarwithzykadia.yourhealthcareprovider wilcheckyourbloodsugarlevelbeforestartingzykadia andasneededduringtreatmentwithzykadia.calyour healthcareproviderrightawayifyouhaveanysymptomsof highbloodsugar,including: Increasedthirst Headaches Urinatingoften Tiredness Increasedhunger Troublethinkingorconcentrating Bluredvision Yourbreathsmelslikefruit Inflammationofthepancreas(pancreatitis) ZYKADIAcancausepancreatitisthathasledtodeath. Youmaydevelopincreasedpancreaticenzymeblood levels,whichmaybeasignofpancreatitis.signsand symptomsofpancreatitisincludeupperabdominalpain thatmayspreadtothebackandgetworsewitheating. Yourhealthcareprovidershoulddobloodteststocheck yourpancreaticenzymebloodlevelsbeforeyoustart ZYKADIAandasneededduringyourtreatment. 13

14 IMPORTANTSAFETY INFORMATION ABOUT ZYKADIA (ceritinib) CAPSULES(cont) BeforeyoutakeZYKADIA,telyourdoctorabout alofyourmedicalconditions,includingifyou: Haveliverproblems Havediabetesorhighbloodsugar Haveheartproblems,includingaconditioncaled longqtsyndrome Haveorhavehadpancreatitis Arepregnant,thinkyoumaybepregnant,orplan tobecomepregnant.zykadiamayharm your unbornbaby Womenwhoareabletobecomepregnantmustuse anefectivemethodofbirthcontrolduringtreatment withzykadiaandforatleast2weeksafterstopping ZYKADIA.Talktoyourhealthcareproviderabout birthcontrolmethodsthatmayberightforyou Arebreastfeedingorplantobreastfeed ItisnotknownifZYKADIApassesintoyourbreast ItisnotknownifZYKADIApassesintoyourbreast milk.youshouldnotbreastfeedifyoutakezykadia. Telyourdoctoraboutthemedicinesyoutake,including: Prescriptionmedicines Vitamins ThemostcommonsideefectsofZYKADIAinclude: Diarhea Stomach-areapain Nausea Tiredness(fatigue) Telyourdoctorifyouhaveanysideefectthatbothers youordoesnotgoaway.thesearenotalofthepossible Over-the-countermedicines Herbalsupplements Constipation Vomiting Decreasedappetite SAFETY N ABOUT ritinib) ont),telyourdoctorabout ions,includingifyou: bloodsugar includingaconditioncaled creatitis umaybepregnant,orplan YKADIAmayharm your obecomepregnantmustuse birthcontrolduringtreatment atleast2weeksafterstopping healthcareproviderabout hatmayberightforyou lantobreastfeed KADIApassesintoyourbreast KADIApassesintoyourbreast breastfeedifyoutakezykadia. emedicinesyoutake,including: fectsofzykadiainclude: Over-the-countermedicines Herbalsupplements Constipation Vomiting Decreasedappetite

15 sideefectsofzykadia.formoreinformation,askyour doctororpharmacist.youareencouragedtoreport negativesideefectsofprescriptiondrugstothefda. Visitwww.fda.gov/medwatchorcal1-800-FDA HowtotakeZYKADIAandwhattoavoid TakeZYKADIAexactlyasyourhealthcareprovidertels you.donotchangeyourdoseorstoptakingunlessyour healthcareprovidertelsyouto TakeZYKADIA1timeeachday TakeZYKADIAonanemptystomach,donoteatfor 2hoursbeforeanddonoteatfor2hoursafter takingzykadia IfyouvomitaftertakingZYKADIA,donottakean additionaldose,butcontinuewiththenext scheduleddose scheduleddose IfyoumissadoseofZYKADIA,takeitassoonasyou remember.ifyournextdoseisduewithin12hours,then skipthemisseddose.justtakethenextdoseatyour regulartime Youshouldnotdrinkgrapefruitjuiceoreatgrapefruit duringtreatmentwithzykadia.itmaymaketheamount ofzykadiainyourbloodincreasetoaharmfullevel PleaseseetheaccompanyingfulPrescribing InformationandthePatientInformationfor ZYKADIA (ceritinib)capsules. NOTES: 15 sideefectsofzykadia.formoreinformation,askyour doctororpharmacist.youareencouragedtoreport negativesideefectsofprescriptiondrugstothefda. Visitwww.fda.gov/medwatchorcal1-800-FDA HowtotakeZYKADIAandwhattoavoid TakeZYKADIAexactlyasyourhealthcareprovidertels you.donotchangeyourdoseorstoptakingunlessyour healthcareprovidertelsyouto TakeZYKADIA1timeeachday TakeZYKADIAonanemptystomach,donoteatfor 2hoursbeforeanddonoteatfor2hoursafter takingzykadia IfyouvomitaftertakingZYKADIA,donottakean additionaldose,butcontinuewiththenext scheduleddose scheduleddose IfyoumissadoseofZYKADIA,takeitassoonasyou remember.ifyournextdoseisduewithin12hours,then skipthemisseddose.justtakethenextdoseatyour regulartime Youshouldnotdrinkgrapefruitjuiceoreatgrapefruit duringtreatmentwithzykadia.itmaymaketheamount ofzykadiainyourbloodincreasetoaharmfullevel PleaseseetheaccompanyingfulPrescribing InformationandthePatientInformationfor ZYKADIA (ceritinib)capsules. NOTES:

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