Beruflich Dokumente
Kultur Dokumente
RegimenMonograph
RegimenName|DrugRegimen|CycleFrequency|PremedicationandSupportiveMeasures|DoseModifications|Adverse
Effects|Interactions|DrugAdministrationandSpecialPrecautions|RecommendedClinicalMonitoring|Administrative
Information|References|OtherNotes|Disclaimer
A-RegimenName
FOLFIRINOXRegimen
FolinicAcid(Leucovorin)-Fluorouracil-Irinotecan-Oxaliplatin
DiseaseSite Gastrointestinal-Pancreas
Intent Palliative
Regimen Evidence-Informed:
Category
Regimenisconsideredappropriateaspartofthestandardcareofpatients
meaningfullyimprovesoutcomes(survival,qualityoflife),tolerabilityorcosts
comparedtoalternatives(recommendedbytheDiseaseSiteTeamand
nationalconsensusbodye.g.pan-CanadianOncologyDrugReview,
pCODR).RecommendationisbasedonanappropriatelyconductedphaseIII
clinicaltrialrelevanttotheCanadiancontextOR(wherephaseIIItrialsarenot
feasible)anappropriatelysizedphaseIItrial.Regimenswhereoneormore
drugsarenotapprovedbyHealthCanadaforanyindicationwillbeidentified
underRationaleandUse.
Rationaleand First-linetreatmentoflocallyadvancedunresectableormetastaticpancreatic
Uses adenocarcinomainpatientswithECOGstatusof0to1andbilirubin<1.5x
ULN.Clinicaltrialsexcludedpatients>75yearsorwithsignificantcardiac
diseaseorpoororganfunction.
Note:FOLFIRINOXwillnotbefundedifapatienthaspreviouslyprogressedon
GEMCNPAC.
Supplementary oxaliplatin
PublicFunding NewDrugFundingProgram(OxaliplatinandIrinotecan-AdvancedPancreatic
Cancer(FOLFIRINOX))
irinotecan
NewDrugFundingProgram(Irinotecan(withOxaliplatin)-Metastatic
PancreaticAdenocarcinoma)
Anyuseoftheinformationissubject,atalltimes,toCCOsTermsandConditions.
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B-DrugRegimen
*maybeomittediftoxicityofconcern
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C-CycleFrequency
REPEATEVERY14DAYS
Continueuntildiseaseprogressionorunacceptabletoxicityintheclinicaltrial12cycleswere
recommendedforrespondingpatients,whilethemediannumberofcycleswas10(range1-47).
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D-PremedicationandSupportiveMeasures
AntiemeticRegimen: Moderate
OtherSupportiveCare:
Irinotecan-Cholinergicadverseeffects(earlydiarrhea)
Unlesscontraindicated,atropine0.25-1mgIV/SCmaybegivenforcholinergicadverseeffects
Anyuseoftheinformationissubject,atalltimes,toCCOsTermsandConditions.
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(earlydiarrhea)
Prophylacticatropinemaybeconsideredinpatientsexperiencingcholinergicsymptoms
Diarrhea(abdominalcramp=diarrhea)maybesevereanddelayedwithirinotecanuse
loperamide4mgattheonsetofdiarrhea,then2mgq2huntilpatientisdiarrhea-freefor12
hours
Filgrastimusemaybeconsideredassecondaryprophylaxisforneutropenia.
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E-DoseModifications
Dosesshouldbemodifiedaccordingtotheprotocolbywhichthepatientisbeingtreated.The
followingrecommendationshavebeenadaptedfromclinicaltrialsorproductmonographsandcould
beconsidered.
Dosagewithtoxicity
Donotstartnewcycleuntilplatelets75x109/LandANC1.5x109/L,recoveryfromdiarrhea(to
baselinewithoutloperamideforatleast24hours),andothernon-hematologictoxicitieshave
recoveredtograde2.
Dosesshouldbeadjustedbasedontheworstprecedingtoxicity.Donotre-escalatedoseifreduced
fortoxicity.Discontinuetheregimeniftoxicityrecursafter2dosereductions.
Leucovorindoseisnotreducedfortoxicityhoweveritshouldbeomittediffluorouracilisomitted.
DoseLevels:
(Refertodosemodificationtableonthenextpage)
Anyuseoftheinformationissubject,atalltimes,toCCOsTermsandConditions.
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DoseModifications:
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Toxicity(Continued) Occurrence Irinotecana,b Oxaliplatina,b Flurouracila,b
OR
RPLS
OR
Hemolyticuremic
syndromeoranysigns
ofmicroangiopathic
hemolyticanemia
Pharyngolaryngeal - - infusionto6 -
dysesthesia hours
a
DonottreatuntilANC1.5x109/L,platelets75x109/L,diarrhearesolvedtobaselineandother
toxicitygrade2.Donotre-escalatedoseifreducedfortoxicity.
bDiscontinuetheregimeniftoxicityrecursafter2dosereductionsorifcycledelayedfor>2weeks.
HepaticImpairment
^Ifbilirubin,considerinvestigatingforreversiblecausessuchasbiliaryobstructionandreevaluate
afterstent.
Anyuseoftheinformationissubject,atalltimes,toCCOsTermsandConditions.
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RenalImpairment
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F-AdverseEffects
Refertooxaliplatin,leucovorin,irinotecan,fluorouracildrugmonograph(s)foradditionaldetailsof
adverseeffects
MostCommonSideEffects LessCommonSideEffects,butmaybe
SevereorLife-Threatening
Neuropathy(maybesevere)
Nausea/vomiting
Fatigue Arterialthromboembolism
Abdominalpain/cramping Hypersensitivity
Alopecia Cerebellarsyndrome
LFTs(maybesevere) GIobstruction
Diarrhea(earlyandlate,maybe GIperforation
severe) Cardiotoxicity
Anorexia Hemolyticuremicsyndrome
Mucositis Hepatotoxicity
Constipation Renalfailure
Edema Pancreatitis
Eyedisorders Pneumonitis
Myelosuppressioninfection, Rhabdomyolysis
bleeding(maybesevere) Seizure
Photosensitivity Venousthromboembolism
Rash
Hand-footsyndrome
Anyuseoftheinformationissubject,atalltimes,toCCOsTermsandConditions.
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G-Interactions
Refertooxaliplatin,leucovorin,irinotecan,fluorouracildrugmonograph(s)foradditionaldetails
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H-DrugAdministrationandSpecialPrecautions
Refertooxaliplatin,leucovorin,irinotecan,fluorouracildrugmonograph(s)foradditionaldetails
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I-RecommendedClinicalMonitoring
RecommendedClinicalMonitoring
CBCbaselineandregular
Liverandrenalfunctiontestsbaselineandregular
Electrolytes,includingmagnesiumbaselineandregular
MonitorINRcloselyforpatientsonwarfarin
RoutinetoxicityratingofdiarrheaandotherGIeffects,cholingericsymptoms,
hypersensitivity,pneumonitis,bleeding,infection,dehydration,pancreatitis,
neurological,thromboembolism,hand-footsyndrome,cardiactoxicityandfatigue.
GradetoxicityusingthecurrentNCI-CTCAE(CommonTerminologyCriteriafor
AdverseEvents)version
SuggestedClinicalMonitoring
Bloodglucose,especiallyinpatientswithdiabetesBaselineandregular
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J-AdministrativeInformation
ApproximatePatientVisit 4.5hours
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PharmacyWorkload(averagetimepervisit) 44.043minutes
NursingWorkload(averagetimepervisit) 75.833minutes
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K-References
ConroyT,DesseigneF,YchouM,etal.FOLFIRINOXversusgemcitabineformetastaticpancreatic
cancer.NEnglJMed2011364:1817-25.
May2017re-linkNDFPform
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L-OtherNotes
Diarrheacanbesevere,witheitherimmediateordelayedonset.Patientsmustbeinstructed
intheuseofLoperamideastreatmentfordiarrhea,andmusthaveasupplyofthisdrugupon
startingIrinotecantreatments.
ThephaseIIIPRODIGE4/ACCORD11trial(Conroyetal.)hasdemonstratedsignificant
improvementinmedianoverallsurvival,medianPFSandobjectiveresponseascompared
togemcitabine.Despitethetoxicities,FOLFIRINOXhasshowngreaterclinicalbenefitthan
gemcitabinewhencoupledwithadequatepatientselectionandeffectivemanagementof
toxicsideeffects.
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M-Disclaimer
RefertotheNewDrugFundingProgramorOntarioPublicDrugProgramswebsitesforthemostup-to-datepublic
fundinginformation.
Theinformationsetoutinthedrugmonographs,regimenmonographs,appendicesandsymptommanagement
information(forhealthprofessionals)containedintheDrugFormulary(the"Formulary")isintendedforhealthcare
providersandistobeusedforinformationalpurposesonly.Theinformationisnotintendedtocoverallpossibleuses,
directions,precautions,druginteractionsoradverseeffectsofaparticulardrug,norshoulditbeconstruedtoindicate
thatuseofaparticulardrugissafe,appropriateoreffectiveforagivencondition.TheinformationintheFormularyis
notintendedtoconstituteorbeasubstituteformedicaladviceandshouldnotberelieduponinanysuchregard.All
Anyuseoftheinformationissubject,atalltimes,toCCOsTermsandConditions.
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usesoftheFormularyaresubjecttoclinicaljudgmentandactualprescribingpatternsmaynotfollowtheinformation
providedintheFormulary.
Theformatandcontentofthedrugmonographs,regimenmonographs,appendicesandsymptommanagement
informationcontainedintheFormularywillchangeastheyarereviewedandrevisedonaperiodicbasis.Thedateof
lastrevisionwillbevisibleoneachpageofthemonographandregimen.Sincestandardsofusageareconstantly
evolving,itisadvisedthattheFormularynotbeusedasthesolesourceofinformation.Itisstronglyrecommended
thatoriginalreferencesorproductmonographbeconsultedpriortousingachemotherapyregimenforthefirsttime.
SomeFormularydocuments,suchasthemedicationinformationsheets,regimeninformationsheetsandsymptom
managementinformation(forpatients),areintendedforpatients.Patientsshouldalwaysconsultwiththeirhealthcare
provideriftheyhavequestionsregardinganyinformationsetoutintheFormularydocuments.
WhilecarehasbeentakeninthepreparationoftheinformationcontainedintheFormulary,suchinformationis
providedonanas-isbasis,withoutanyrepresentation,warranty,orcondition,whetherexpress,orimplied,statutory
orotherwise,astotheinformationsquality,accuracy,currency,completeness,orreliability.
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