ALACARE

Main information

  • Trade name:
  • ALACARE Medicated Plaster 8 Milligram
  • Dosage:
  • 8 Milligram
  • Pharmaceutical form:
  • Medicated Plaster
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ALACARE Medicated Plaster 8 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1782/001/001
  • Authorization date:
  • 24-02-2012
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Alacare8mgmedicatedplaster

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmedicatedplasterof4cm²contains8mg5-aminolevulinicacid,2mgpercm 2

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Medicatedplaster.

Eachplasterhasasizeof4cm²,issquarewithroundedcornersandconsistsofaskintonebackingfoilandaself-

adhesivematrix,coveredbyareleaselinerwhichisremovedpriortouse.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Singleusetreatmentofmildactinickeratoseslesionswithamaximumdiameterof1.8cmonthefaceandscalp

(hairlessareas).

4.2Posologyandmethodofadministration

Adults(includingtheelderly)

ForthetreatmentofAKwithonesessionphotodynamictherapy(PDT),applyuptoamaximumofsixAlacarepatches

usedonsixdifferentlesionstothepatientonasingletreatmentsession.IftheAlacareplasterdoesnotsticktothe

lesionsproperly,itcanbefixedwithanadhesivestrip.

Afterfourhours,removetheAlacareplaster(s)andexposethelesion(s)toredlightwithanarrowbandredlightsource

withaspectrumof630 ±

3nmandatotallightdoseof37J/cm²atthelesionsurface.OnlyCEmarkedlampsshouldbe

used,equippedwithnecessaryfiltersand/orreflectingmirrorstominimizeexposuretoheat,bluelightandUV

radiation.Itisimportanttoensurethatthecorrectlightdoseisadministered.Thelightdoseisdeterminedbyfactors

suchasthesizeofthelightfield,thedistancebetweenlampandskinsurfaceandilluminationtime.Thesefactorsvary

withlamptype,andthelampshouldbeusedaccordingtotheusermanual.Patientandoperatorshouldadheretosafety

instructionsprovidedwiththelightsource.Duringilluminationpatientandoperatorshouldwearprotectivegoggles

whichcorrespondtothelamplightspectrum.

Untreatedskinsurroundingthelesiondoesnotneedtobeprotectedduringillumination.

Lesionresponsesshouldbeassessedafterthreemonths.IftheareatreatedwithAlacareisnotlesionfreeat3months

followingsingleusepleaseusealternativetherapiesforremovalofactinickeratosislesions.

Childrenandadolescents:

Thereisnoexperienceoftreatingpatientsbelowtheageof18years.

4.3Contraindications

Hypersensitivitytotheactivesubstanceortotheplastermaterial.

NoresponsetopreviousPDTwith5aminolevulinicacid-containingpreparations.

Porphyria

4.4Specialwarningsandprecautionsforuse

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Verythick,red,scalyinduratedAKlesionsshouldnotbetreatedwithAlacare.

ThereisnoexperienceoftreatingAKlesionsinpatientswithdarkbrownorblackskin(skinsunsensitivitytypeVor

VIaccordingtoFitzpatrick).

NodataregardingefficacyandsafetyareavailableforrepeatedtreatmentofAKlesionswithAlacare.

AnyUV-therapyshouldbediscontinuedbeforetreatment.Asageneralprecaution,sunexposureofthetreatedlesion

sitesandsurroundingskinshouldbeavoidedforapproximately48hoursfollowingtreatment.

DirecteyecontactwithAlacareshouldbeavoided.

Alacareshouldonlybeadministeredbyanurseorotherhealthcareprofessionaltrainedwiththeuseofphotodynamic

therapiesunderthesupervisionofaphysician

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

AshypericincanincreasephototoxicreactionsinducedbyPDT,treatmentwithhypericin-containingproducts(St

John'sWort,Hypericumperforatum)shouldbediscontinuedtwoweeksbeforePDTwithAlacare.

4.6Fertility,pregnancyandlactation

Therearenoadequatedatafromtheuseof5-aminolevulinicacidinpregnantwomen.Animalstudiesareinsufficient

withrespecttoeffectsonpregnancy,embryonalandfetaldevelopment,parturitionandpostnataldevelopment(see

section5.3).Thepotentialriskforhumansisunknown.Alacareshouldnotbeusedduringpregnancyunlessclearly

necessary.

Itisunknownwhether5-aminolevulinicacidisexcretedinhumanbreastmilk.Theexcretionof5-aminolevulinicacid

hasnotbeenstudiedinanimals.Breast-feedingshouldbediscontinuedfor48hafterapplicationofAlacare.

4.7Effectsonabilitytodriveandusemachines

None

4.8Undesirableeffects

a)Almostallpatients(99%)experienceadversereactionslocalisedatthetreatmentsite(localreactions)thatare

attributabletotoxiceffectsofthephotodynamictherapy(phototoxicity).DuringapplicationofAlacareandpriorto

illuminationofthetreatmentsite,33%ofpatientsshowlocalreactions,mostfrequentlypruritus,burninganderythema.

Duringillumination,erythema,burningandpainarethelocalreactionsreportedmostoften.Thesymptomsareusually

ofmildormoderateseverityandrequireearlyterminationofilluminationin1%ofthepatients.Coolingofthetreated

areamayalleviatethesesymptoms.Aftertherapy,pruritus,erythema,scabbingandexfoliationarethemostfrequent

localreactionswhicharelikewisemainlymildtomoderateandpersistfor1to2weeksoroccasionallylonger.

Acommon(<10%)adversereactionnotinvolvingthetreatmentsiteisheadache.

b)TheincidenceofadversereactionsinpatientsreceivingAlacareplusillumination,isshowninthetablebelow.

Adversereactionsinvolvingthetreatmentsite(localreactions)

Generaldisordersandapplicationsite

conditions Verycommon

1/10 Erythema,exfoliation,irritation,

pain,pruritus,scab

Common

1/100,<1/10 Bleeding,desquamation,discharge,

discomfort,erosion,

hyper/hypopigmentation,oedema,

reaction,swelling,vesicles

Uncommon

1/1000,<1/100 Burn,discolouration,excoriation,

inflammation,ulcer

Infectionsandinfestations Common

1/100,<1/10 Pustules

Uncommon

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4.9Overdose

Nocaseofoverdosehasbeenreported.Nevertheless,reactionsatthetreatmentsitemaybemorepronouncedifthe

Alacareplastersareappliedformuchmorethan4hoursorifamuchhigherlightdosethantherecommended37J/cm²

ischosen.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:

SensitisersusedinPhotodynamic/Radiationtherapy,ATCCode:L01XD04

Mechanismofaction:

Aftertopicalapplicationof5-aminolevulinicacid,protoporphyrinIX(PPIX)accumulatesintracellularlyinthetreated

AKlesions.TheintracellularPPIXisaphotoactive,fluorescingcompoundand,uponlightactivationinthepresenceof

oxygen,singletoxygenisformedwhichcausesdamagetocellularcompartmentsofthelight-exposedtargetcells,in

particularthemitochondria.

Clinicalefficacyandsafety

Withregardtoclinicalsafetyandefficacy,Alacarewascomparedwithplacebotreatment,inarandomisedobserver

blindedclinicaltrialwhichenrolled107patientswithafollow-updurationof6,9and12months.Allpatientshada

minimumof3mildtomoderateAKlesionsontheheadand/orface.AlacarewasappliedtoAKlesionsfor4hours

withoutpreparationofthelesion,afterwhichtheywereilluminatedwithredlightat 630 ±

3nm(37J/cm²).

12weeksaftertreatment,completeclinicalclearanceonlesionandonpatientbasisofaonce-onlyphotodynamic

therapywithAlacarewasstatisticallysignificantlymoreeffectivethanphotodynamictherapywithplacebo.Thiswas

sustainedduringfollow-up,inwhichpatientswereseenevery3months(after6,9and12months).Inanopen

randomisedtrial,whichenrolled349patients,AlacarePDTinthesameregimeasdescribedabove,wascomparedwith

cryosurgeryandplacebo-PDT.Inthistrial,Alacare-PDTprovednon-inferiortocryosurgery.After12weeksintheFull

AnalysisSet87%oflesionstreatedwithAlacare-PDTwerecleared,comparedto77%aftercryosurgery(OddsRatio

1.86;95%CI[1.18,2.93])and32%afterplacebo-PDT.Differencesweresustainedduringthecompletefollow-up

period(after6,9and12months).Recurrenceratesofclearedlesions12monthsaftertherapywere12%forAlacare-

PDTand18%forcryosurgery(OddsRatio0.627;95%CI[0.461,0.854]).

5.2Pharmacokineticproperties

Pharmacokineticdatafromaclinicaltrialinpatientswithmildtomoderateactinickeratosesontheheadand/orface,

whohad8Alacareplastersappliedfor4h,showedabaselinecorrectedCmaxof16.4µg/LandanAUC

0-24 of101.4

µg*h/Lofsystemicexogenous5-aminolevulinicacid.Tmaxwasat4hoursTheexcretionof5 -ALAinurineduringthe

Adversereactionsnotinvolvingthetreatmentsite

Nervoussystemdisorders Common

1/100,<1/10 Headache

InfectionsandInfestations Uncommon

1/1000,<1/100 Pyoderma

Psychiatricdisorders Uncommon

1/1000,<1/100 Emotionaldistress

Respiratory,thoracicandmediastinal

disorders Uncommon

1/1000,<1/100 Epistaxis

Skinandsubcutaneoustissue

disorders Uncommon

1/1000,<1/100 Skindiscolouration

Investigations Uncommon

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PPIXwasnotdetectedinanyoftheplasmasamples.

Inanotherclinicaltrialin12AKpatientswithmildtomoderateAKlesionsontheheadand/orface,itcouldbeshown

thatAlacare-inducedPPIXspecificfluorescenceishigherinAKlesionsthaninnormalskinandincreaseswith

durationoftheAlacareexposure.However,extendingapplicationintervalbeyond4hdidnotresultinhigherPPIX

fluorescence.

5.3Preclinicalsafetydata

Preclinicalstudiesongeneraltoxicityandgenotoxicitystudiesinthepresenceorabsenceofphotoactivation,donot

indicatepotentialrisksforman.Conventionalcarcinogenicitystudieshavenotbeenperformedwith5-aminolevulinic

acid.Studiesreportedintheliteraturedonotindicateacarcinogenicpotential.Studiesonthereproductivefunction

havenotbeenperformed.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Plasters: Acrylicpressuresensitiveadhesive

(Poly[(2-ethylhexyl)acrylate-co-methylacrylate-co-acrylicacid-co-glycidylmethacrylate])

Backingfilm: PigmentedpolyethyleneAluminiumvaporcoatedpolyester

Releaseliner(polyethyleneterephthalatefilm)whichisremovedpriortoapplication.

6.2Incompatibilities

Notapplicable.

6.3Shelflife

3years.

Usewithin3monthsafterfirstopening.

6.4Specialprecautionsforstorage

Afteropeningstoreplasterinthesachetinordertoprotectfromlight.

6.5Natureandcontentsofcontainer

4medicatedplasterssealedinprotectivesachetsconsistingof4layers:paper(outerlayer),polyethyleneLDPE,

aluminium,ethylenecopolymer(innerlayer).

Packsizesof4or8medicatedplasters(1or2protectivesachet(s)).

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposal

Afterremoval,theusedpatchshouldbefoldedinhalf,adhesivesideinwardssothattheadhesiveisnotexposed,and

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7MARKETINGAUTHORISATIONHOLDER

SpirigPharmaEuropeGmbH

Teichstrae66

79539Lörrach

Germany

8MARKETINGAUTHORISATIONNUMBER

PA1782/001/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:28thAugust2009

10DATEOFREVISIONOFTHETEXT

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