Circular · Safety Notice AIFD · Güvenlik Duyuruları

SB TITCK Kaspofungin İçeren İlaçlar Acil Güvenlilik Kısıtlaması Görüş-Katkı (002)

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T.R.

MINISTRYOFHEALTH

TurkishMedicinesandMedicalDevicesAgency Number:E-24931227-510.01.04-5825389 22.01.2026 Subject: AboutDrugsContainingCaspofungin/EmergencySafety Restriction/Opinion-Contribution Thisdocumenthasbeensignedwithasecureelectronicsignature. DocumentVerificationCode: ZW56ZmxXak1Uak1Uak1Uak1UQ3NRZ1AxZmxX DocumentTrackingAddress:https://www.turkiye.gov.tr/saglik-titck-ebys SöğütözüMahallesi,2176.SokakNo:506520Çankaya/ANKARA Phone:(0312)2183000FaxNo:(0312)2183460 E-mail:[email protected]:https://www.titck.gov.tr Registerede-Mail(Kep)Address:[email protected] 1|2

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Regardingcaspofungin-containingdrugs,theEuropeanMedicinesAgency's(EMA)warning that"theuseofpolyacrylonitrile-basedmembranesduringcontinuousrenalreplacementtherapymay reducetheeffectivenessofcaspofungin"hasbeenevaluatedbyourAgencyandtheattachedstatements mustbeaddedtotheSummaryofProductCharacteristics(SmPC)andPatientInformationLeaflet(PIL) ofthesedrugs. Youropinions,recommendationsandcontributions,ifany,regardingthedecisiontakenmustbe submittedtothePharmacovigilanceRiskManagementUnitofthePharmacovigilanceandControlled SubstancesDepartmentwithin15days,andnoapplicationbemadetothePharmacologicalEvaluation UnitoftheDepartmentofMedicinalProductsMarketingAuthorizationwithinthisperiod. Ikindlyrequestthatyouareinformedandperformtherequiredaction. Prof.Dr.AhmetAYAR HeadoftheAgency Annex:SmPC-PILtext(1page) DistributionRequirement: PharmaceuticalManufacturersAssociationofTurkey AssociationofResearch-BasedPharmaceuticalCompanies PharmaceuticalIndustryAssociationofTurkey AssociationofHealthcareProducts PharmaceuticalIndustryandTechnologiesCommission AssociationofInnovativePharmaceuticalCompanies

T.R.

MINISTRYOFHEALTH

TurkishMedicinesandMedicalDevicesAgency Thisdocumenthasbeensignedwithasecureelectronicsignature. DocumentVerificationCode: ZW56ZmxXak1Uak1Uak1Uak1UQ3NRZ1AxZmxX DocumentTrackingAddress:https://www.turkiye.gov.tr/saglik-titck-ebys SöğütözüMahallesi,2176.SokakNo:506520Çankaya/ANKARA Phone:(0312)2183000FaxNo:(0312)2183460 E-mail:[email protected]:https://www.titck.gov.tr Registerede-Mail(Kep)Address:[email protected] 2|2 ChangestobeaddedtotherelevantsectionoftheSummaryofProductCharacteristics 4.4.Specialwarningsandprecautionsforuse Useduringrenalreplacementtherapy Duringtheuseofcaspofungininpatientsreceivingcontinuousrenalreplacementtherapy,theuseof polyacrylonitrile-derivedmembranes(e.g.usedduringhemofiltrationorhemodiafiltration)mayleadto adsorptionofthedrug,potentiallyreducingtheefficacyofcaspofungin.Increasingthedosemaynot preventthiseffect.Therefore,theuseofanalternativeextracorporealmembraneorotherantifungal agentisrecommended.Theriskoftreatmentfailurecanleadtoworseningoftheinfectionanddeath. ChangestobeaddedtotherelevantsectionofthePatientInformationLeaflet 2.Whatyouneedtoknowbeforeyoutake<DRUGNAME> Take<DRUGNAME>withCAUTIONinthefollowingconditions: Useduringrenalreplacementtherapy Ifyouarereceivingcontinuousrenalreplacementtherapy,theuseofpolyacrylonitrile-derived membranes(e.g.usedduringhemofiltrationorhemodiafiltration)duringtheuseofcaspofunginmay leadtoadsorptionofthedrugandconsequentlyadecreaseindrugefficacy.Thismaycausetheriskof treatmentfailure,worseningoftheinfection,anddeath.Increasingthedosemaynotpreventthiseffect. Youdoctormayrecommendtheuseofanalternativeextracorporealmembraneorotherantifungalagent.