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<CourseDefinition>
  <Schema>
    <Version>3.0</Version>
    <Date>20120717</Date>
  </Schema>
  <Details>
    <RegimId>NRB-6012</RegimId>
    <Name>Nintedanib</Name>
    <ShortName/>
    <MajorVersion>1</MajorVersion>
    <MinorVersion>4</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 blodstatus inkl. neutrofila-, elektrolyt- och leverstatus samt kreatinin.\n\nAnvisningar för ordination: Kontroll av blodstatus inkl. neutrofila-, elektrolyt- och leverstatus samt kreatinin.\n\n\n\nDosreduktion rekommendation: Icke-hematologiska biverkningar \nVid diarré, kräkningar och/eller illamående grad 2 eller mer - avbryt behandlingen med Nintedanib till biverkningarna avtagit (grad 1 eller utgångsläget). Behandlingen återupptas med reducerad dos 150 mg x 2. Om en andra dosreduktion bedöms nödvändig ges 100 mg x 2, se FASS.\n\nLeverpåverkan - ASAT och/eller ALAT &gt; 2,5 x ULN i kombination med totalt bilirubin &gt;= 1,5 x ULN ELLER ASAT och/eller ALAT &gt; 5 x ULN - avbryt behandlingen med Nintedanib till ASAT/ALAT &lt;= 2,5 x ULN och bilirubin normalt. \nBehandlingen återupptas med reducerad dos 150 mg x 2. Om en andra dosreduktion bedöms nödvändig ges 100 mg x 2, se FASS.\nASAT och/eller ALAT &gt; 3 x ULN i kombination med totalt bilirubin &gt;= 2 x ULN och ALP &lt; 2 x ULN - om ingen annan orsak kan fastställas , sätts Nintedanib ut permanent.\n\nEmetogenicitet:Låg.\n\nBehandlingsöversikt: Kontinuerlig behandling..\n\nDiagnoskod: C50.\n\nKurintervall: 28 dagar.\n\nBiverkningar för substanser i regimen\nnintedanib\nHematologisk toxicitet(Viss ökad risk för neutropeni och febril sepsis, framför allt vid kombinationsbehandling med Docetaxel. Kontroll av blodstatus och eventuellt dosjusteringsbehov, se FASS.\nTrombocytopeni förekommer. \nBlödningshändelser finns rapporterade, kan bli allvarliga. Andningsvägar inklusive näsblödning, magtarmkanal och CNS. Eventuellt rekommenderas ej behandling vid lokal invasion av större blodkärl eller radiologiska tecken på kaviterande eller nekrotiska tumörer, liksom vid aktiva hjärnmetastaser, se FASS.\nTromboembolism(Ökad risk för venös tromboembolism.\nIngen bevisad ökning av arteriell tromboembolism, men försiktighet vid känd förhöjd kardiovaskulär risk. Behandlingsuppehåll bör övervägas vid akut myokardischemi.\nGastrointestinal påverkan(Diarré mycket vanligt. Illamående, kräkning och buksmärta vanligt. Aptitnedgång.\nEventuell behandlingsuppehåll och dosjustering, se FASS.\nGastrointestinal perforation omnämnd som fallrapporter, försiktighet bör iakttagas vid tidigare bukkirurgi eller tidigare perforation, se FASS. \nLevertoxicitet(Förhöjda leverenzymer vanligt. Eventuellt behandlingsuppehåll eller dosjustering, se FASS. Ökad risk för kvinnor, asiater och vid låg kroppsvikt.\nÖvrigt(Kapslarna innehåller soja, varför kontraindicerat vid soja eller jordnötsallergi.\nInteraktionsbenägen substans(Vid samtidig administrering av Nintedanib och starka P-gp-hämmare kan exponeringen för Nintedanib öka och således risk för ökade biverkningar. Noggrann monitorering bör utföras för att hantera biverkningar. (Exempel på starka P-gp-hämmare är ketokonazol och erytromycin.)\nVid samtidig administrering av Nintedanib och starka P-gp-inducerare kan exponeringen för Nintedanib minska och således risk för minskad effekt. Samtidigt administreringsbehov måste övervägas noggrant. (Exempel på starka P-gp-inducerare är rifampicin, karbamazepin, fenytoin och johannesört.)\n</PhysicianComment>
    <NurseComment>Villkor och kontroller för administration: Nintedanib - kapslarna tas med cirka 12 timmars mellanrum. Johannesört får ej intas under pågående behandling. Om en dos missats tas nästa dos på den vanliga tiden.\n\nInformation från basfakta för substanser i regimen\nnintedanib\nDosering i förhållande till måltid: Tas i samband med måltid\n\n</NurseComment>
    <PharmacistComment/>
    <PatientComment/>
    <ExternalDocumentation/>
    <ExternalPhysicianDoc>https://kunskapsbanken.cancercentrum.se/redirect/regim/6012</ExternalPhysicianDoc>
    <ExternalNurseDoc>https://kunskapsbanken.cancercentrum.se/redirect/regim/6012</ExternalNurseDoc>
    <ExternalPharmacistDoc/>
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    <Rounding/>
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  </Details>
  <Miscellaneous>
    <OriginOfExport>Regimbiblioteket</OriginOfExport>
    <IsAuthorized/>
    <CommittedBy/>
    <CreatedBy/>
    <CreatedDate>20260520</CreatedDate>
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    <Substance Name="nintedanib">
      <Observandum Name="Hematologisk toxicitet" Tillagg="Viss ökad risk för neutropeni och febril sepsis, framför allt vid kombinationsbehandling med Docetaxel. Kontroll av blodstatus och eventuellt dosjusteringsbehov, se FASS.\nTrombocytopeni förekommer. \nBlödningshändelser finns rapporterade, kan bli allvarliga. Andningsvägar inklusive näsblödning, magtarmkanal och CNS. Eventuellt rekommenderas ej behandling vid lokal invasion av större blodkärl eller radiologiska tecken på kaviterande eller nekrotiska tumörer, liksom vid aktiva hjärnmetastaser, se FASS."/>
      <Observandum Name="Tromboembolism" Tillagg="Ökad risk för venös tromboembolism.\nIngen bevisad ökning av arteriell tromboembolism, men försiktighet vid känd förhöjd kardiovaskulär risk. Behandlingsuppehåll bör övervägas vid akut myokardischemi."/>
      <Observandum Name="Gastrointestinal påverkan" Tillagg="Diarré mycket vanligt. Illamående, kräkning och buksmärta vanligt. Aptitnedgång.\nEventuell behandlingsuppehåll och dosjustering, se FASS.\nGastrointestinal perforation omnämnd som fallrapporter, försiktighet bör iakttagas vid tidigare bukkirurgi eller tidigare perforation, se FASS. "/>
      <Observandum Name="Levertoxicitet" Tillagg="Förhöjda leverenzymer vanligt. Eventuellt behandlingsuppehåll eller dosjustering, se FASS. Ökad risk för kvinnor, asiater och vid låg kroppsvikt."/>
      <Observandum Name="Övrigt" Tillagg="Kapslarna innehåller soja, varför kontraindicerat vid soja eller jordnötsallergi."/>
      <Observandum Name="Interaktionsbenägen substans" Tillagg="Vid samtidig administrering av Nintedanib och starka P-gp-hämmare kan exponeringen för Nintedanib öka och således risk för ökade biverkningar. Noggrann monitorering bör utföras för att hantera biverkningar. (Exempel på starka P-gp-hämmare är ketokonazol och erytromycin.)\nVid samtidig administrering av Nintedanib och starka P-gp-inducerare kan exponeringen för Nintedanib minska och således risk för minskad effekt. Samtidigt administreringsbehov måste övervägas noggrant. (Exempel på starka P-gp-inducerare är rifampicin, karbamazepin, fenytoin och johannesört.)"/>
    </Substance>
  </Sideeffects>
  <Diagnoses>
    <Diagnose Text="Lungcancer"/>
  </Diagnoses>
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        <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="nintedanib">
            <Dose Max="">200</Dose>
            <Steps>0</Steps>
            <Unit>MG</Unit>
            <Calculation>STANDARD</Calculation>
          </Substance>
          <Fluid Name="Ej aktuellt">
            <Volume/>
            <Unit/>
            <Calculation/>
          </Fluid>
          <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="nintedanib">
            <Dose Max="">200</Dose>
            <Steps>0</Steps>
            <Unit>MG</Unit>
            <Calculation>STANDARD</Calculation>
          </Substance>
          <Fluid Name="Ej aktuellt">
            <Volume/>
            <Unit/>
            <Calculation/>
          </Fluid>
          <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="nintedanib">
            <Dose Max="">200</Dose>
            <Steps>0</Steps>
            <Unit>MG</Unit>
            <Calculation>STANDARD</Calculation>
          </Substance>
          <Fluid Name="Ej aktuellt">
            <Volume/>
            <Unit/>
            <Calculation/>
          </Fluid>
          <Comments/>
        </Line>
      </Lines>
    </Day>
  </Days>
</CourseDefinition>
