Download IMPORTANT DRUG INFORMATION February 6, 2017 Subject

DIV/ERW/US/703/01
IMPORTANTDRUGINFORMATION
February6,2017
Subject:
ERWINAZE®Batch180K-NoticeofSpecialHandlingInstructions
ForIntramuscularAdministrationOnly
Usea5-micronfilterneedleforpreparationofvialsofERWINAZE®
(asparaginaseErwiniachrysanthemi)fromBATCH180K
DearHealthCareProvider:
ThepurposeofthisletteristoalertyouthatERWINAZE(asparaginaseErwiniachrysanthemi)
fromBatch180Kshouldbeadministeredintramuscularlyonlyandthatyouwillneedtousea5micronfilterneedletowithdrawthereconstitutedERWINAZEproductfromthevials.Thisis
becauseparticulatematterwasobservedinsomevialsfromthisbatch.Becauseofthecritical
necessityofthisdrug,JazzPharmaceuticalsisaskinghealthcareproviderstotakethese
necessarystepsforpatientsafety.
DuringroutinevisualinspectionsofERWINAZEBatch180K,particulatematterwasobservedin
somevials.Theseaffectedvialsweresetasideandnotreleased.However,thereremainsa
possibilitythatsomeofthereleasedvialsmaycontainparticulatematter,which,ifpresentin
reconstitutedERWINAZE,mayposeasafetyrisktopatients.
Inordertominimizethepotentialriskofadverseevents,healthcareprovidersshould
administervialsfromBatch180Kbyintramuscularadministrationonly,notbyintravenous
administration.Additionally,healthcareprovidersshouldcontinuetouseastandard5-micron
filterneedletowithdrawthereconstitutedERWINAZEproductfromthevial,andthendiscard
thefilterneedleandreplaceitwithanappropriateneedlepriortoadministration.
PleasefollowtheinstructionsbelowpriortowithdrawingthereconstitutedERWINAZEproduct
fromthevialsandadministeringittopatients.
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DIV/ERW/US/703/01
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Priortoreconstitution,carefullyinspecteachvial.Ifyouobserveparticulatematter
anywhereinthevial,quarantinethevial.Ifyoudonotobserveparticulatematterin
thevials,reconstitutetheproductassetforthbelow.
FollowallrecommendedstepsforreconstitutionofERWINAZEinaccordancewiththe
PrescribingInformation.
Carefullyinspect reconstitutedproduct. Intheeventthatyoudiscover visible
particulatematterinthereconstitutedproduct,donotadministertothepatientand
quarantinethevial.
Ifnovisibleparticulatematterisseeninthereconstitutedproduct,useastandard5micronfilterneedletowithdrawthereconstitutedproductfromthevial.Seefilter
needlemanufacturer’sinstructionsorusageguidelinesforproperuseoffilterneedle.
Discardthefilterneedleandreplacewithanappropriateneedlepriortopatient
administration.DonottransfertoanIVinfusionbag.Administerintramuscularlyonly.
Ifyouseeparticulatematteranywhereinthevial,donotadministertothepatientand
quarantinethevial.ContactJazzPharmaceuticalsMedicalInformationat
1-800-520-5568toreporttheissueandtodiscussappropriateresolution.
Thefollowinglabel,attachedtothecarton,canidentifyvialsfromERWINAZEBatch180K:
FORINTRAMUSCULARADMINISTRATIONONLY
REQUIRES5-MICRONFILTERNEEDLEFORPREPARATION
SEEINCLUDEDIMPORTANTDRUGINFORMATIONLETTER
VialsfromERWINAZEBatch180Kcanalsobeidentifiedbynumberingontheindividualvial
labels.Vialsfromtheaffectedbatchwillhaveoneofthefollowinglotnumbers:180K117,
180K217,180K317,or180K417.
Pleaseensureyourstaffandanyproviderinyourinstitutionwhomaybeinvolvedinthe
reconstitutionandadministrationofERWINAZEreceivesacopyofthisletterandspecifically
reviewstheUpdatedInstructionsforPreparationappendedtothisletter.Pleasepayspecial
attentiontotheupdatesinsteps#1-#7thatincludeobservationofparticulatematterandthe
useofa5-micronfilterneedletowithdrawthereconstitutedERWINAZE,andintramuscular
administrationonly.
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DIV/ERW/US/703/01
FurtherInformation
PleaseseeaccompanyingFullPrescribingInformationforERWINAZE.
Formoreinformation,visitwww.erwinaze.comorcall1-800-520-5568.
Callforreporting
Healthcareprovidersshouldreportproductqualityproblemsandallsuspectedadverseevents
associatedwiththeuseofERWINAZE.Ifyoubecomeawareofapatientexperiencingan
adverseeventwhiletakingERWINAZEorproductqualityproblemswithERWINAZE,please
contactJazzPharmaceuticals,Inc.at1-800-520-5568. Adverseeventsorqualityproblems
experiencedwiththeuseofthisproductmayalsobereportedtotheFDA’sMedWatchAdverse
EventReportingProgrameitheronline,orregularmail,orbyfax:
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CompleteandsubmitthereportOnline:www.fda.gov/medwatch/report.htm
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RegularmailorFax:Downloadformwww.fda.gov/MedWatch/getforms.htmorcall1800-332-1088torequestareportingform,thencompleteandreturntotheaddresson
thepre-addressedform,orsubmitbyfaxto1-800-FDA-0178.
Sincerely,
NoamFrey,MDMBA
VicePresident,MedicalAffairs
JazzPharmaceuticals,Inc.
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DIV/ERW/US/703/01
UpdatedInstructionsforPreparation:ERWINAZEBatch180KVial
PreparationandHandlingInstructions
1.
2.
Carefullyinspecteachvial.Ifyouobserveparticulatematter,quarantinethevial.Ifyou
donotobserveparticulatematter,reconstitutetheproductasfollows.
Reconstitutethecontentsofeachvialbyslowlyinjecting1or2mLofpreservative
freesterilesodiumchloride(0.9%)injection(USP)againsttheinnervialwall.
3.
Donotforcefullyinjectsolutionforreconstitutiondirectlyontoorintothepowder.
Whenreconstitutedwith1mLtheresultantconcentrationis10,000International
UnitspermL.Whenreconstitutedwith2mLtheresultantconcentrationis5,000
InternationalUnitspermL.
4.
Dissolvecontentsbygentlemixingorswirling.Donotshakeorinvertvial.
5.
6.
Whenreconstituted,ERWINAZEshouldbeaclear,colorlesssolution.Inspectthe
solutionafterreconstitutionforanyvisibleparticlesorproteinaggregates,ifyou
observeparticulatematterinthereconstitutedproduct,quarantinethevial.
Calculatethedoseneededandthevolumeneededtoobtainthecalculateddose.
7.
Withdrawthevolumecontainingthecalculateddosefromthevialusinga5-micron
filterneedle(accordingtothefilterneedlemanufacturer’sinstructions)intoa
polypropylenesyringewithin15minutesofreconstitution.Discardthefilterneedle
andreplacewithanappropriateneedlepriortoadministration.
8.
Ifapartialvialisused,donotsaveorreusetheunuseddrugforlateradministration.
Discardunusedportions.
9.
Donotfreezeorrefrigeratereconstitutedsolutionandadministerwithin4hoursor
discard[seePrescribingInformation-HowSupplied/StorageandHandling(16)].
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DIV/ERW/US/703/01
10.
Ifyouseeparticulatematteranywhereotheronthantheundersideofthestopper
(pre-orpost-reconstitution),donotadministertothepatientandquarantinethe
vial.ContactJazzPharmaceuticalsMedicalInformation at1-800-520-5568toreport
theissueandtodiscussappropriateresolution.
AdministrationInstructionsforERWINAZEBatch180K
ERWINAZEsolutionmaybeadministeredbyintramuscularinjectiononly.Donotadministerby
intravenousinfusion.
• Forintramuscularuse,limitthevolumeofreconstitutedERWINAZEatasingleinjection
site to 2 mL; if reconstituted dose to be administered is greater than 2 mL, use
multiple injectionsites.
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