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<CourseDefinition>
  <Schema>
    <Version>3.0</Version>
    <Date>20120717</Date>
  </Schema>
  <Details>
    <RegimId>NRB-7819</RegimId>
    <Name>Darolutamid</Name>
    <ShortName/>
    <MajorVersion>1</MajorVersion>
    <MinorVersion>7</MinorVersion>
    <DefinitionStatus>COMPLETED</DefinitionStatus>
    <PatientMaxSurface/>
    <CourseICDZCode>NONE</CourseICDZCode>
    <CourseAUC>0.00</CourseAUC>
    <MaxAge/>
    <CycleLength>28</CycleLength>
    <ValidForAllDiagnoses/>
    <IsStudyDefinition>NO</IsStudyDefinition>
    <PhysicianComment>Villkor för start av regimen: Kontroll av Hb, LPK, TPK, Na, K, Ca, kreatinin, ASAT, ALAT.\n\nAnvisningar för ordination: Om baslinjeprover normala: Hb, LPK, TPK, ASAT, ALAT 1 gång/månad de första 3 månaderna, därefter var 3:e månad.\nDen basala kastrationsbehandlingen ska behållas under behandlingen.\n\n\nDosreduktion rekommendation: Vid biverkningar &gt;= grad 3 eller en icke tolererbar biverkning, gör uppehåll eller minska dosen till 300 mg x 2 tills symtomen förbättrats till &lt;= grad 1. Behandlingen kan sedan återupptas med 600 mg x 2.\nDet rekommenderas inte att minska dosen till under 300 mg två gånger dagligen eftersom effekt inte har fastställts, se FASS.\n\nEmetogenicitet:Minimal.\n\nBehandlingsöversikt: Kontinuerlig behandling..\n\nDiagnoskod: C61.\n\nKurintervall: 28 dagar.\n\nBiverkningar för substanser i regimen\ndarolutamid\nHematologisk toxicitet(Minskat antal neutrofila vanligt, oftast grad 1-2, enstaka fall grad 3-4. Mediantid till nadir 256 dagar.\nHjärttoxicitet(Ischemisk hjärtsjukdom och hjärtsvikt förekommer. \nHudtoxicitet(Utslag förekommer.\nÖvrigt(Trötthet/fatigue vanligt. Frakturer förekommer. Muskuloskeletal smärta och extremitets smärta förekommer.\nLevertoxicitet(Förhöjning av ASAT och bilirubin vanligt, oftast grad 1-2.  Förhöjningarna är reversibla och uppstår lång tid efter behandlingsstart, se FASS.\nInteraktionsbenägen substans(Samtidig administrering av starka och måttliga CYP3A4-inducerare och P-gp-inducerare med Darolutamid rekommenderas inte, då risk för minskning av Darolutamid koncentrationen föreligger. (Exempel på starka och måttliga CYP3A4-inducerare och P-gp-inducerare är: karbamazepin, fenobarbital, johannesört, fenytoin och rifampicin.)\nSamtidig administrering av CYP3A4-, P-gp- och BCRP-hämmare med Darolutamid kan göras, men bör föranleda övervakning av eventuella biverkningar, då risk föreligger för ökad koncentration av Darolutamid. Eventuell dosjustering av Darolutamid kan övervägas, se FASS. (Exempel på stark hämmare av CYP3A4-, P-gp- och BCRP är itrakonazol.)\nSamtidig administrering av rosuvastatin (substrat för BCRP, OATP1B1 och OATP1B3) med Darolutamid ska om möjligt undvikas, då rosuvastatin kan öka betydligt i koncentration vid samtidig administrering.  \nSamtidig administrering av andra substrat för BCRP, OATP1B1 och OATP1B3 och Darolutamid kan kräva övervakning av eventuella biverkningar av substraten, då dessa koncentrationer kan komma att öka vid samtidig administrering. (Exempel på substrat för BCRP, OATP1B1 och OATP1B3 är metotrexat, sulfasalazin, fluvastatin, atorvastatin, pitavastatin.)\nSamtidig administrering av substanser med potential att förlänga QT-intervall med Durolutamid ska göras med försiktighet. (Exempel på substanser med potential att förlänga QT-intervall är: kinidin, disopyramid, amiodaron, sotalol, dofetilid, ibutilid, metadon, moxifloxacin, antipsykotika (t.ex. haloperidol).)\n</PhysicianComment>
    <NurseComment>Villkor och kontroller för administration: Johannesört får ej intas under pågående behandling.\nGlömd dos - ta inte dubbel dos (två doser på en gång) för att kompensera för en glömd dos.\n\nInformation från basfakta för substanser i regimen\ndarolutamid\nDosering i förhållande till måltid: Tas i samband med måltid\n\n</NurseComment>
    <PharmacistComment/>
    <PatientComment/>
    <ExternalDocumentation/>
    <ExternalPhysicianDoc>https://kunskapsbanken.cancercentrum.se/redirect/regim/7819</ExternalPhysicianDoc>
    <ExternalNurseDoc>https://kunskapsbanken.cancercentrum.se/redirect/regim/7819</ExternalNurseDoc>
    <ExternalPharmacistDoc/>
    <ExternalPatientDoc/>
    <Rounding/>
    <HasSteps/>
  </Details>
  <Miscellaneous>
    <OriginOfExport>Regimbiblioteket</OriginOfExport>
    <IsAuthorized/>
    <CommittedBy/>
    <CreatedBy/>
    <CreatedDate>20260421</CreatedDate>
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    <Substance Name="darolutamid">
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      <Observandum Name="Hjärttoxicitet" Tillagg="Ischemisk hjärtsjukdom och hjärtsvikt förekommer. "/>
      <Observandum Name="Hudtoxicitet" Tillagg="Utslag förekommer."/>
      <Observandum Name="Övrigt" Tillagg="Trötthet/fatigue vanligt. Frakturer förekommer. Muskuloskeletal smärta och extremitets smärta förekommer."/>
      <Observandum Name="Levertoxicitet" Tillagg="Förhöjning av ASAT och bilirubin vanligt, oftast grad 1-2.  Förhöjningarna är reversibla och uppstår lång tid efter behandlingsstart, se FASS."/>
      <Observandum Name="Interaktionsbenägen substans" Tillagg="Samtidig administrering av starka och måttliga CYP3A4-inducerare och P-gp-inducerare med Darolutamid rekommenderas inte, då risk för minskning av Darolutamid koncentrationen föreligger. (Exempel på starka och måttliga CYP3A4-inducerare och P-gp-inducerare är: karbamazepin, fenobarbital, johannesört, fenytoin och rifampicin.)\nSamtidig administrering av CYP3A4-, P-gp- och BCRP-hämmare med Darolutamid kan göras, men bör föranleda övervakning av eventuella biverkningar, då risk föreligger för ökad koncentration av Darolutamid. Eventuell dosjustering av Darolutamid kan övervägas, se FASS. (Exempel på stark hämmare av CYP3A4-, P-gp- och BCRP är itrakonazol.)\nSamtidig administrering av rosuvastatin (substrat för BCRP, OATP1B1 och OATP1B3) med Darolutamid ska om möjligt undvikas, då rosuvastatin kan öka betydligt i koncentration vid samtidig administrering.  \nSamtidig administrering av andra substrat för BCRP, OATP1B1 och OATP1B3 och Darolutamid kan kräva övervakning av eventuella biverkningar av substraten, då dessa koncentrationer kan komma att öka vid samtidig administrering. (Exempel på substrat för BCRP, OATP1B1 och OATP1B3 är metotrexat, sulfasalazin, fluvastatin, atorvastatin, pitavastatin.)\nSamtidig administrering av substanser med potential att förlänga QT-intervall med Durolutamid ska göras med försiktighet. (Exempel på substanser med potential att förlänga QT-intervall är: kinidin, disopyramid, amiodaron, sotalol, dofetilid, ibutilid, metadon, moxifloxacin, antipsykotika (t.ex. haloperidol).)"/>
    </Substance>
  </Sideeffects>
  <Diagnoses>
    <Diagnose Text="Prostatacancer"/>
  </Diagnoses>
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            <Calculation/>
          </Fluid>
          <Comments>
            <Comment Text="Kvällsdos"/>
          </Comments>
        </Line>
      </Lines>
    </Day>
    <Day Number="26">
      <Details>
        <Name/>
        <ConfirmationMandatory>NO</ConfirmationMandatory>
        <Comment/>
      </Details>
      <CriticalParameters/>
      <Lines>
        <Line Number="1">
          <Details>
            <Type>SUBSTANCE</Type>
            <Route>PO</Route>
            <InfusionHours>0</InfusionHours>
            <InfusionMinutes>0</InfusionMinutes>
            <ProductionBy>WARD</ProductionBy>
            <RelationType>NONE</RelationType>
          </Details>
          <Substance Name="darolutamid">
            <Dose Max="">600</Dose>
            <Steps>0</Steps>
            <Unit>MG</Unit>
            <Calculation>STANDARD</Calculation>
          </Substance>
          <Fluid Name="Ej aktuellt">
            <Volume/>
            <Unit/>
            <Calculation/>
          </Fluid>
          <Comments>
            <Comment Text="Morgondos"/>
          </Comments>
        </Line>
        <Line Number="2">
          <Details>
            <Type>SUBSTANCE</Type>
            <Route>PO</Route>
            <InfusionHours>0</InfusionHours>
            <InfusionMinutes>0</InfusionMinutes>
            <ProductionBy>WARD</ProductionBy>
            <RelationType>NONE</RelationType>
          </Details>
          <Substance Name="darolutamid">
            <Dose Max="">600</Dose>
            <Steps>0</Steps>
            <Unit>MG</Unit>
            <Calculation>STANDARD</Calculation>
          </Substance>
          <Fluid Name="Ej aktuellt">
            <Volume/>
            <Unit/>
            <Calculation/>
          </Fluid>
          <Comments>
            <Comment Text="Kvällsdos"/>
          </Comments>
        </Line>
      </Lines>
    </Day>
    <Day Number="27">
      <Details>
        <Name/>
        <ConfirmationMandatory>NO</ConfirmationMandatory>
        <Comment/>
      </Details>
      <CriticalParameters/>
      <Lines>
        <Line Number="1">
          <Details>
            <Type>SUBSTANCE</Type>
            <Route>PO</Route>
            <InfusionHours>0</InfusionHours>
            <InfusionMinutes>0</InfusionMinutes>
            <ProductionBy>WARD</ProductionBy>
            <RelationType>NONE</RelationType>
          </Details>
          <Substance Name="darolutamid">
            <Dose Max="">600</Dose>
            <Steps>0</Steps>
            <Unit>MG</Unit>
            <Calculation>STANDARD</Calculation>
          </Substance>
          <Fluid Name="Ej aktuellt">
            <Volume/>
            <Unit/>
            <Calculation/>
          </Fluid>
          <Comments>
            <Comment Text="Morgondos"/>
          </Comments>
        </Line>
        <Line Number="2">
          <Details>
            <Type>SUBSTANCE</Type>
            <Route>PO</Route>
            <InfusionHours>0</InfusionHours>
            <InfusionMinutes>0</InfusionMinutes>
            <ProductionBy>WARD</ProductionBy>
            <RelationType>NONE</RelationType>
          </Details>
          <Substance Name="darolutamid">
            <Dose Max="">600</Dose>
            <Steps>0</Steps>
            <Unit>MG</Unit>
            <Calculation>STANDARD</Calculation>
          </Substance>
          <Fluid Name="Ej aktuellt">
            <Volume/>
            <Unit/>
            <Calculation/>
          </Fluid>
          <Comments>
            <Comment Text="Kvällsdos"/>
          </Comments>
        </Line>
      </Lines>
    </Day>
    <Day Number="28">
      <Details>
        <Name/>
        <ConfirmationMandatory>NO</ConfirmationMandatory>
        <Comment/>
      </Details>
      <CriticalParameters/>
      <Lines>
        <Line Number="1">
          <Details>
            <Type>SUBSTANCE</Type>
            <Route>PO</Route>
            <InfusionHours>0</InfusionHours>
            <InfusionMinutes>0</InfusionMinutes>
            <ProductionBy>WARD</ProductionBy>
            <RelationType>NONE</RelationType>
          </Details>
          <Substance Name="darolutamid">
            <Dose Max="">600</Dose>
            <Steps>0</Steps>
            <Unit>MG</Unit>
            <Calculation>STANDARD</Calculation>
          </Substance>
          <Fluid Name="Ej aktuellt">
            <Volume/>
            <Unit/>
            <Calculation/>
          </Fluid>
          <Comments>
            <Comment Text="Morgondos"/>
          </Comments>
        </Line>
        <Line Number="2">
          <Details>
            <Type>SUBSTANCE</Type>
            <Route>PO</Route>
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            <InfusionMinutes>0</InfusionMinutes>
            <ProductionBy>WARD</ProductionBy>
            <RelationType>NONE</RelationType>
          </Details>
          <Substance Name="darolutamid">
            <Dose Max="">600</Dose>
            <Steps>0</Steps>
            <Unit>MG</Unit>
            <Calculation>STANDARD</Calculation>
          </Substance>
          <Fluid Name="Ej aktuellt">
            <Volume/>
            <Unit/>
            <Calculation/>
          </Fluid>
          <Comments>
            <Comment Text="Kvällsdos"/>
          </Comments>
        </Line>
      </Lines>
    </Day>
  </Days>
</CourseDefinition>
