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<CourseDefinition>
  <Schema>
    <Version>3.0</Version>
    <Date>20120717</Date>
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  <Details>
    <RegimId>NRB-2554</RegimId>
    <Name>APL: Induktion enligt AIDA, högrisk</Name>
    <ShortName/>
    <MajorVersion>1</MajorVersion>
    <MinorVersion>0</MinorVersion>
    <DefinitionStatus>COMPLETED</DefinitionStatus>
    <PatientMaxSurface/>
    <CourseICDZCode>NONE</CourseICDZCode>
    <CourseAUC>0.00</CourseAUC>
    <MaxAge/>
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    <ValidForAllDiagnoses/>
    <IsStudyDefinition>NO</IsStudyDefinition>
    <PhysicianComment>Villkor för start av regimen: Kontroll av blod-, lever- och elektrolytstatus med kreatinin. \nEKG.\nTretionin Avrunda dosen uppåt till jämnt 10 mg.\nGes till uppnådd CR (komplett remission), max till dag 60.\n\nAnvisningar för ordination: Kontroll av blod-, lever- och elektrolytstatus.\n\nAPL differentieringssyndrom (DS) - symtom är dyspné, lunginfiltrat, feber, snabb viktuppgång, pleura- eller perikardvätska, hypotension eller njursvikt. Incidens 2-27 %.\nProfylax med Prednison 0,5 mg/kg peroralt dag 1-21 skall ges.\nVid tecken på svår DS rekommenderas tillfällig utsättning av Tretionin och högdos glukokortikoider iv (Betapred 10 mgx2 eller Dexametason 10 mgx2) + diuretika intravenöst vid behov, se Vårdprogrammet.\nRisk för DS kvarstår tills patienten uppnått remission - ingen risk därefter.\n\nDosreduktion rekommendation: Uppmärksamhet på pseudotumor cerebri, huvudvärk, illamående, kräkningar och dimsyn. Tretionin avbryts temporärt, behandling ges med opiater och osmotiska diuretika (Diamox) ges. Reducera dosen Tretionin till 12,5 mg/m2 per administrationstillfälle. Den reducerade dosen används fortsatt vid konsolideringar och underhållsbehandling.\n\nHepatotoxicitet - ASAT, ALAT eller ALP stiger &gt; 5 ggr ska Tretionin tillfälligt seponeras.\n\nEmetogenicitet:Låg.\n\nBehandlingsöversikt: Högrisk, LPK &gt;10, se Vårdprogram Akut myeloisk leukemi (AML).\nGes till uppnådd CR (komplett remission), max till dag 60. Benmärgsundersökning (morfologi) görs vid regeneration av blodvärdena eller senast dag 28. Om CR inte uppnåtts, rekommenderas veckovisa undersökningar. Om patienten inte nått CR dag 60 kontakta regionansvarig för APL/AML..\n\nDiagnoskod: C92.4.\n\nBiverkningar för substanser i regimen\ntretinoin\nHematologisk toxicitet(APL differentieringssyndrom (eller vitamin A-syra-APL) vanligt. (Feber, dyspné, ökad vikt, lunginfiltrat och pleurala eller perikardiella utgjutningar, hypotension, ödem, leversvikt, njursvikt eller multiorgansvikt, med eller utan leukocytos.) Syndromet kan vara dödligt. Vid första tecken på syndrom, ge högdossteroider.\nSnabbt utvecklad hyperleukocytos vanligt.\nHjärttoxicitet(Arytmi angiven som vanlig, men knapphändiga uppgifter om sort och svårighetsgrad.\nCNS påverkan(Huvudvärk vanligt. Yrsel, parestesi (domning), konfusion, oro/ångest, depression och insomningssvårigheter förekommer.\nGastrointestinal påverkan(Torra slemhinnor mycket vanligt. Illamående, kräkning, buksmärtor och nedsatt aptit vanliga. Diarré och förstoppning förekommer.\nHudtoxicitet(Utslag, klåda, alopeci (håravfall) och svettning vanligt.\nÖgonpåverkan(Synpåverkan vanlig.\nHörselpåverkan(Hörselpåverkan vanlig.\nAndningsvägar(Övre luftvägssymtom vanliga, respiratorisk svikt och astma förekommer.\nÖvrigt(Hyperkolesterolemi och hypertriglyceridemia vanligt, reversibelt efter avslutad behandling.\nBensmärta vanligt.\nInteraktionsbenägen substans(Tretinoin skall ej administreras samtidigt med Tetracykliner, då det finns en liten ökad risk för ökat intrakraniellt tryck för både Tretinoin och Tetracyklin enskilda och samtidig administration kan innebära ökad risk för detta.\nTretinoin skall ej administreras samtidigt med Vitamin A, då hypervitaminos A symtom skulle kunna förvärras.\nTromboembolism(Ökad risk för tromboembolism under behandlingens första månad, varför försiktighet skall iakttagas vid samtidig behandling med anti-fibrinolytiska läkemedel.\n\nidarubicin\nHematologisk toxicitet(Hematologisk toxicitet kan vara behandlingsmålet.\nInfektionsrisk(Ökad infektionsrisk föreligger.\nHjärttoxicitet(Tidiga (akuta) effekter som sinustakykardi och icke specifik ST - T vågs-förändring förekommer. Även andra takyarytmier har rapporterats. Förekomst av akuta hjärttoxiska effekter förutsäger inte en utveckling av sena (fördröjda) hjärttoxiska effekter.\nSena (fördröjda) effekter som kardiomyopati med hjärtsvikt förekommer. Kan utvecklas sent i behandlingen eller långt efter behandlingens avslut. Utgångsvärde på hjärtfunktion med LVEF och fortsatta kontroller under behandlingen. Riskfaktorer är hjärt-kärl-sjukdom, tidigare eller pågående radioterapi mot mediastinum, tidigare behandling med andra antracykliner eller antracenedioner, samt samtidig tillförsel av hjärttoxiska läkemedel, se FASS.\nGastrointestinal påverkan(Illamående, kräkningar mycket vanligt. Diarré vanligt.\nStomatit vanligt, esofagit mindre vanligt. Uppträder oftast tidigt i behandlingen, kan utvecklas till erosioner, ulcerationer. Reversibelt. Perforation gastrointestinalkanal har rapporterats.\nTumörlyssyndrom(Tumörlyssyndrom kan uppstå till följd av snabb lys av tumörceller vid vissa sjukdomar under vissa förutsättningar (exempelvis vanligast i uppstartsbehandling). Viktigt att patient är väl hydrerad och har god diures. Som skydd ges eventuellt Allopurinol under behandlingstiden. Vid behov kan antidoten rasburikas (Fasturtec) ges.\nÖvrigt(Kan orsaka rödfärgning av urin under 1-2 dagar efter administrering.\nStarkt vävnadsretande(Antracykliner skall ges via central infart.\nExtravasering(Vävnadstoxisk - risk för nekros (hög risk för vävnadsskada).\nVid behov följ instruktion för kylbehandling, se stöddokument Extravasering.\nVid konstaterad extravasering av antracykliner överväg behandling med Dexrazoxan (Savene), se regim Dexrazoxan. Eventuell kylbehandling som startats i väntan på Dexrazoxan skall avslutas minst 15 minuter före Dexrazoxan påbörjas. Om Dexrazoxan helt saknas, eller inte kan startas inom 6 timmar, överväg DMSO behandling, se stöddokument Extravasering.\n</PhysicianComment>
    <NurseComment>Övrig information: Tretionin = ATRA, All-trans retinoic acid. Licenspreparat Vesanoid finns.\n\n</NurseComment>
    <PharmacistComment/>
    <PatientComment/>
    <ExternalDocumentation/>
    <ExternalPhysicianDoc>https://kunskapsbanken.cancercentrum.se/redirect/regim/2554</ExternalPhysicianDoc>
    <ExternalNurseDoc>https://kunskapsbanken.cancercentrum.se/redirect/regim/2554</ExternalNurseDoc>
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  </Details>
  <Miscellaneous>
    <OriginOfExport>Regimbiblioteket</OriginOfExport>
    <IsAuthorized/>
    <CommittedBy/>
    <CreatedBy/>
    <CreatedDate>20260421</CreatedDate>
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    <Substance Name="tretinoin">
      <Observandum Name="Hematologisk toxicitet" Tillagg="APL differentieringssyndrom (eller vitamin A-syra-APL) vanligt. (Feber, dyspné, ökad vikt, lunginfiltrat och pleurala eller perikardiella utgjutningar, hypotension, ödem, leversvikt, njursvikt eller multiorgansvikt, med eller utan leukocytos.) Syndromet kan vara dödligt. Vid första tecken på syndrom, ge högdossteroider.\nSnabbt utvecklad hyperleukocytos vanligt."/>
      <Observandum Name="Hjärttoxicitet" Tillagg="Arytmi angiven som vanlig, men knapphändiga uppgifter om sort och svårighetsgrad."/>
      <Observandum Name="CNS påverkan" Tillagg="Huvudvärk vanligt. Yrsel, parestesi (domning), konfusion, oro/ångest, depression och insomningssvårigheter förekommer."/>
      <Observandum Name="Gastrointestinal påverkan" Tillagg="Torra slemhinnor mycket vanligt. Illamående, kräkning, buksmärtor och nedsatt aptit vanliga. Diarré och förstoppning förekommer."/>
      <Observandum Name="Hudtoxicitet" Tillagg="Utslag, klåda, alopeci (håravfall) och svettning vanligt."/>
      <Observandum Name="Ögonpåverkan" Tillagg="Synpåverkan vanlig."/>
      <Observandum Name="Hörselpåverkan" Tillagg="Hörselpåverkan vanlig."/>
      <Observandum Name="Andningsvägar" Tillagg="Övre luftvägssymtom vanliga, respiratorisk svikt och astma förekommer."/>
      <Observandum Name="Övrigt" Tillagg="Hyperkolesterolemi och hypertriglyceridemia vanligt, reversibelt efter avslutad behandling.\nBensmärta vanligt."/>
      <Observandum Name="Interaktionsbenägen substans" Tillagg="Tretinoin skall ej administreras samtidigt med Tetracykliner, då det finns en liten ökad risk för ökat intrakraniellt tryck för både Tretinoin och Tetracyklin enskilda och samtidig administration kan innebära ökad risk för detta.\nTretinoin skall ej administreras samtidigt med Vitamin A, då hypervitaminos A symtom skulle kunna förvärras."/>
      <Observandum Name="Tromboembolism" Tillagg="Ökad risk för tromboembolism under behandlingens första månad, varför försiktighet skall iakttagas vid samtidig behandling med anti-fibrinolytiska läkemedel."/>
    </Substance>
    <Substance Name="idarubicin">
      <Observandum Name="Hematologisk toxicitet" Tillagg="Hematologisk toxicitet kan vara behandlingsmålet.">
        <Control Name="Blodvärden">
          <SupportingTreatment Name="Enligt lokala riktlinjer"/>
        </Control>
      </Observandum>
      <Observandum Name="Infektionsrisk" Tillagg="Ökad infektionsrisk föreligger.">
        <Control Name="Monitorering">
          <SupportingTreatment Name="Infektionsbehandling/profylax"/>
        </Control>
      </Observandum>
      <Observandum Name="Hjärttoxicitet" Tillagg="Tidiga (akuta) effekter som sinustakykardi och icke specifik ST - T vågs-förändring förekommer. Även andra takyarytmier har rapporterats. Förekomst av akuta hjärttoxiska effekter förutsäger inte en utveckling av sena (fördröjda) hjärttoxiska effekter.\nSena (fördröjda) effekter som kardiomyopati med hjärtsvikt förekommer. Kan utvecklas sent i behandlingen eller långt efter behandlingens avslut. Utgångsvärde på hjärtfunktion med LVEF och fortsatta kontroller under behandlingen. Riskfaktorer är hjärt-kärl-sjukdom, tidigare eller pågående radioterapi mot mediastinum, tidigare behandling med andra antracykliner eller antracenedioner, samt samtidig tillförsel av hjärttoxiska läkemedel, se FASS.">
        <Control Name="Hjärtfunktion"/>
      </Observandum>
      <Observandum Name="Gastrointestinal påverkan" Tillagg="Illamående, kräkningar mycket vanligt. Diarré vanligt.\nStomatit vanligt, esofagit mindre vanligt. Uppträder oftast tidigt i behandlingen, kan utvecklas till erosioner, ulcerationer. Reversibelt. Perforation gastrointestinalkanal har rapporterats.">
        <Control Name="Biverkningskontroll"/>
      </Observandum>
      <Observandum Name="Tumörlyssyndrom" Tillagg="Tumörlyssyndrom kan uppstå till följd av snabb lys av tumörceller vid vissa sjukdomar under vissa förutsättningar (exempelvis vanligast i uppstartsbehandling). Viktigt att patient är väl hydrerad och har god diures. Som skydd ges eventuellt Allopurinol under behandlingstiden. Vid behov kan antidoten rasburikas (Fasturtec) ges.">
        <Control Name="Urat">
          <SupportingTreatment Name="Hydrering"/>
          <SupportingTreatment Name="Allopurinol"/>
        </Control>
      </Observandum>
      <Observandum Name="Övrigt" Tillagg="Kan orsaka rödfärgning av urin under 1-2 dagar efter administrering."/>
      <Observandum Name="Starkt vävnadsretande" Tillagg="Antracykliner skall ges via central infart."/>
      <Observandum Name="Extravasering" Tillagg="Vävnadstoxisk - risk för nekros (hög risk för vävnadsskada).\nVid behov följ instruktion för kylbehandling, se stöddokument Extravasering.\nVid konstaterad extravasering av antracykliner överväg behandling med Dexrazoxan (Savene), se regim Dexrazoxan. Eventuell kylbehandling som startats i väntan på Dexrazoxan skall avslutas minst 15 minuter före Dexrazoxan påbörjas. Om Dexrazoxan helt saknas, eller inte kan startas inom 6 timmar, överväg DMSO behandling, se stöddokument Extravasering.">
        <SupportingTreatment Name="Kyla"/>
        <SupportingTreatment Name="Dexrazoxan"/>
        <SupportingTreatment Name="DMSO"/>
      </Observandum>
    </Substance>
  </Sideeffects>
  <Diagnoses>
    <Diagnose Text="Akut myeloisk leukemi (AML)"/>
  </Diagnoses>
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