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<CourseDefinition>
  <Schema>
    <Version>3.0</Version>
    <Date>20120717</Date>
  </Schema>
  <Details>
    <RegimId>NRB-2070</RegimId>
    <Name>Krizotinib</Name>
    <ShortName/>
    <MajorVersion>1</MajorVersion>
    <MinorVersion>4</MinorVersion>
    <DefinitionStatus>COMPLETED</DefinitionStatus>
    <PatientMaxSurface/>
    <CourseICDZCode>NONE</CourseICDZCode>
    <CourseAUC>0.00</CourseAUC>
    <MaxAge/>
    <CycleLength/>
    <ValidForAllDiagnoses/>
    <IsStudyDefinition>NO</IsStudyDefinition>
    <PhysicianComment>Villkor för start av regimen: ALK-positiv eller ROS-1 positiv NSCLC status ska fastställas.\nKontroll av blod-, lever och elektrolytstatus inkl. kreatinin. EKG.\nVärdering av risk/nytta för patienter med hjärtproblematik, se FASS.\n\nAnvisningar för ordination: Kontroll av blod-, lever och elektrolytstatus inkl. kreatinin.\n\nKapslar finns i styrkorna 200 och 250 mg.\n\nDosreduktion rekommendation: Vid biverkningar görs dosreduktion, tillfälligt uppehåll eller utsättning av preparatet. I första steg doseras Krizotinib till 200 mg x 2 dagligen. I nästa steg doseras Krizotinib 250 mg x 1 dagligen. Se FASS för dosjusteringar.\n\nEmetogenicitet:Låg.\n\nBehandlingsöversikt: Kontinuerlig behandling..\n\nDiagnoskod: C34.\n\nBiverkningar för substanser i regimen\nkrizotinib\nHjärttoxicitet(Förlängd QT-tid förekommer. EKG, elektrolyter och njurfunktion kontrolleras hos patienter med relevant känd hjärtsjukdom och/eller elektrolytrubbning.\nSymtomatisk bradykardi (t.ex. synkope, yrsel, hypotoni) kan förekomma och kan uppstå flera veckor efter behandlingsstart.\nEnstaka fall med hjärtsvikt har rapporterats, inklusive grad 3 och 4.\nLevertoxicitet(Transaminas förhöjningar vanliga. Följ leverfunktionsvärden, eventuell dosjustering se FASS. Leversvikt finns rapporterat.\nAndningsvägar(Interstitiell lungsjukdom (ILD)/pneumonit förekommer. Lungsymtom följs upp, uppehåll med Krizotinib vid misstanke om pneumonit, utsättning om verifierad diagnos.\nÖgonpåverkan(Synrubbning mycket vanligt. (Exempelvis förekommer diplopi/dubbelseende, halofenomen, fotofobi/ljusskugghet, dimsyn, nedsatt synskärpa, förhöjd uppfattning av ljusstyrka och grumlingar i glaskropp.) Eventuellt uppehåll i behandling och utredning av symtomen.\nInteraktionsbenägen substans(Samtidig användning av starka CYP3A-hämmare kan öka koncentrationen av Krizotinib och bör undvikas (exempelvis proteashämmare som atazanavir, indinavir, nelfinavir, ritonavir och sakvinavir, vissa azolantimykotika som itrakonazol, ketokonazol och vorikonazol, samt vissa makrolider som klaritromycin, telitromycin och troleandomycin).\nGrapefrukt och grapefruktjuice kan också öka plasmakoncentrationerna av Crizotinib och bör undvikas.\nSamtidig användning av starka CYP3A-inducerare kan minska koncentrationen av Krizotinib och bör undvikas (exempelvis karbamazepin, fenobarbital, fenytoin, rifampicin och Johannesört).\nSamtidig användning av CYP3A-substrat med eget snävt terapeutiskt index ska undvikas alternativt övervakas noggrant (exempelvis alfentanil, cisaprid, cyklosporin, ergotderivat, fentanyl, pimozid, kinidin, sirolimus och takrolimus)\nI övrigt var god se FASS.\nHematologisk toxicitet(Följ dosreduktionsinstruktioner och/eller skjut upp nästa dos enligt vårdprogram eller lokala instruktioner.\n</PhysicianComment>
    <NurseComment>Villkor och kontroller för administration: Tas med eller utan föda. Grapefrukt och grapefruktjuice bör undvikas.\nOm en dos missats ska den endast tas om det är mer än 6 timmar kvar till nästa planerade dos.\n\n</NurseComment>
    <PharmacistComment/>
    <PatientComment/>
    <ExternalDocumentation/>
    <ExternalPhysicianDoc>https://kunskapsbanken.cancercentrum.se/redirect/regim/2070</ExternalPhysicianDoc>
    <ExternalNurseDoc>https://kunskapsbanken.cancercentrum.se/redirect/regim/2070</ExternalNurseDoc>
    <ExternalPharmacistDoc/>
    <ExternalPatientDoc/>
    <Rounding/>
    <HasSteps/>
  </Details>
  <Miscellaneous>
    <OriginOfExport>Regimbiblioteket</OriginOfExport>
    <IsAuthorized/>
    <CommittedBy/>
    <CreatedBy/>
    <CreatedDate>20260430</CreatedDate>
  </Miscellaneous>
  <Sideeffects>
    <Substance Name="krizotinib">
      <Observandum Name="Hjärttoxicitet" Tillagg="Förlängd QT-tid förekommer. EKG, elektrolyter och njurfunktion kontrolleras hos patienter med relevant känd hjärtsjukdom och/eller elektrolytrubbning.\nSymtomatisk bradykardi (t.ex. synkope, yrsel, hypotoni) kan förekomma och kan uppstå flera veckor efter behandlingsstart.\nEnstaka fall med hjärtsvikt har rapporterats, inklusive grad 3 och 4.">
        <Control Name="Elektrolyter"/>
        <Control Name="Hjärtfunktion"/>
      </Observandum>
      <Observandum Name="Levertoxicitet" Tillagg="Transaminas förhöjningar vanliga. Följ leverfunktionsvärden, eventuell dosjustering se FASS. Leversvikt finns rapporterat.">
        <Control Name="Leverfunktion"/>
      </Observandum>
      <Observandum Name="Andningsvägar" Tillagg="Interstitiell lungsjukdom (ILD)/pneumonit förekommer. Lungsymtom följs upp, uppehåll med Krizotinib vid misstanke om pneumonit, utsättning om verifierad diagnos.">
        <Control Name="Monitorering"/>
      </Observandum>
      <Observandum Name="Ögonpåverkan" Tillagg="Synrubbning mycket vanligt. (Exempelvis förekommer diplopi/dubbelseende, halofenomen, fotofobi/ljusskugghet, dimsyn, nedsatt synskärpa, förhöjd uppfattning av ljusstyrka och grumlingar i glaskropp.) Eventuellt uppehåll i behandling och utredning av symtomen."/>
      <Observandum Name="Interaktionsbenägen substans" Tillagg="Samtidig användning av starka CYP3A-hämmare kan öka koncentrationen av Krizotinib och bör undvikas (exempelvis proteashämmare som atazanavir, indinavir, nelfinavir, ritonavir och sakvinavir, vissa azolantimykotika som itrakonazol, ketokonazol och vorikonazol, samt vissa makrolider som klaritromycin, telitromycin och troleandomycin).\nGrapefrukt och grapefruktjuice kan också öka plasmakoncentrationerna av Crizotinib och bör undvikas.\nSamtidig användning av starka CYP3A-inducerare kan minska koncentrationen av Krizotinib och bör undvikas (exempelvis karbamazepin, fenobarbital, fenytoin, rifampicin och Johannesört).\nSamtidig användning av CYP3A-substrat med eget snävt terapeutiskt index ska undvikas alternativt övervakas noggrant (exempelvis alfentanil, cisaprid, cyklosporin, ergotderivat, fentanyl, pimozid, kinidin, sirolimus och takrolimus)\nI övrigt var god se FASS."/>
      <Observandum Name="Hematologisk toxicitet" Tillagg="Följ dosreduktionsinstruktioner och/eller skjut upp nästa dos enligt vårdprogram eller lokala instruktioner.">
        <Control Name="Blodvärden">
          <SupportingTreatment Name="Enligt lokala riktlinjer"/>
        </Control>
      </Observandum>
    </Substance>
  </Sideeffects>
  <Diagnoses>
    <Diagnose Text="Lungcancer"/>
  </Diagnoses>
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            <RelationType>NONE</RelationType>
          </Details>
          <Substance Name="krizotinib">
            <Dose Max="">250</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="krizotinib">
            <Dose Max="">250</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="krizotinib">
            <Dose Max="">250</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>
