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<CourseDefinition>
  <Schema>
    <Version>3.0</Version>
    <Date>20120717</Date>
  </Schema>
  <Details>
    <RegimId>NRB-6740</RegimId>
    <Name>Axitinib</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: Blodstatus: Hb, LPK, TPK, Diff.(diff för att kartlägga  njurcancerpopulation)\nElektrolytstatus: Na, K, Ca, kreatinin\nLeverstatus: Albumin, ASAT, ALAT, bilirubin, LD\nHjärtstatus: EKG, Blodtryck\nThyroidea: TSH, T4 fritt\nUrinsticka (proteinuri)\n\nVid behov antihypertensiv behandling. Försiktighet till patienter med risk för emboliska händelser.\n\nAnvisningar för ordination: Blodstatus: Hb, LPK, TPK\nElektrolytstatus: Na, K, Ca, kreatinin\nLeverstatus: Albumin, ASAT, ALAT, bilirubin, LD\nThyroidea: TSH, T4 fritt\n\nObservans på hud- och GI-biverkningar. \nStartdos med 5 mg x 2. Vid frånvaro av biverkningar av grad 3 och 4 under de första två veckornas behandling samt ett blodtryck (behandlat eller obehandlat) under 150/90 mm Hg, kan dosen ökas till 7 mg x 2. Om denna dos tolereras väl enligt samma premisser kan dosen ökas till 10 mg x 2. \n\n\nDosreduktion rekommendation: Dosreduktion eller uppehåll kan bli aktuellt baserat på biverkningar. Vid dosreduktion rekommenderas först till 3 mg x 2 och sedan vid behov till 2 mg x 2. \n\nEmetogenicitet:Låg.\n\nBehandlingsöversikt: Kontinuerlig behandling. \nHur väl patienten tolererar Axitinib styr dosen, startdosen 5 mg x 2 höjs vid god tolerans..\n\nDiagnoskod: C64-C65.\n\nKurintervall: 28 dagar.\n\nBiverkningar för substanser i regimen\naxitinib\nHematologisk toxicitet(Anemi förekommer, oftast grad 1-2. Trombocytopeni och neutropeni  ovanligt och endast enstaka fall mer än grad 2. \nPolycytemi (förhöjt Hb) förekommer.\nHypertoni(Hypertoni mycket vanligt. Kontroll av blodtryck före och under behandling, blodtrycksbehandling vid behov, eventuell dosjustering eller tillfälligt uppehåll med Axitinib, se FASS.\nTromboembolism(Tromboemboliska händelser förekommer, både arteriella och venösa.\nÖvrigt(Blödningshändelser inklusive allvarliga har rapporterats. Tillfälligt uppehåll av behandling med Axitinib om blödning kräver medicinsk intervention.\nHjärttoxicitet(Hjärtsvikt finns rapporterat.\nGastrointestinal påverkan(Diarré, illamående, kräkningar, buksmärtor och förstoppning mycket vanligt. . Nedsatt aptit och viktminskning mycket vanligt. Stomatit och dyspepsi förekommer. Gastrointestinal perforation och fistelbildning finns rapporterat.\nHudtoxicitet(Hand-fot-syndrom (PPE) vanligt, oftast grad 1-2. Utslag, torr hud, klåda och håravfall (alopeci) förekommer.\nEndokrinologi(Hypothyreos vanligt, oftast grad 1-2. Hyperthyreos finns rapporterat. Kontroll av thyreoideavärden före och under behandling.\nCNS påverkan(Huvudvärk och trötthet mycket vanligt. Yrsel förekommer. Enstaka fallrapporter finns om Posteriort reversibelt encefalopatisyndrom (PRES) Symtom på PRES är huvudvärk, kramper, letargi, synrubbningar och neurologiska rubbningar, Vid misstanke om PRES görs tillfälligt uppehåll med Axitinib och utredning startas.\nÖvrigt(Ledsmärta, muskelsmärta vanligt. Proteinuri vanligt. Förhöjda leverprover förekommer. Hosta vanligt.\nSämre sårläkning(Inga studier finns, men generell kunskap om möjlig försämrad sårläkning på gruppnivå, varför uppehåll med Axitinib behandling bör startas minst 24 timmar före planerat kirurgiskt ingrepp.\nInteraktionsbenägen substans(Samtidig administrering av axitinib och starka CYP3A4/5-hämmare (t ex ketokonazol, itrakonazol, klaritromycin, erytromycin, atazanavir, indinavir, nefazodon, nelfinavir, ritonavir, sakvinavir, telitromycin och grapefruktjuice) kan öka plasmakoncentrationen av Axitinib. Om samtidig administration ej kan undvikas rekommenderas dosjustering av Axitinib, se FASS.\nSamtidig administrering av axitinib och starka CYP 3A4/5-inducerare (t ex rifampicin, dexametason, fenytoin, karbamazepin, rifabutin, rifapentin, fenobarbital och Hypericum perforatum (Johannesört)) kan sänka plasmakoncentrationen av Axitinib. Om samtidig administration ej kan undvikas rekommenderas dosjustering av Axitinib, se FASS.\n</PhysicianComment>
    <NurseComment>Villkor och kontroller för administration: Axitinib kan ge högt blodtryck och detta kan uppkomma fort. Var uppmärksam på hypotoni vid dosreduktion. \n\nGrapefrukt och johannesört får ej intas under behandlingen. \n\nInformation från basfakta för substanser i regimen\naxitinib\nDosering i förhållande till måltid: Tas med eller utan mat vid ungefär samma tidpunkt varje dag\n\n</NurseComment>
    <PharmacistComment/>
    <PatientComment/>
    <ExternalDocumentation/>
    <ExternalPhysicianDoc>https://kunskapsbanken.cancercentrum.se/redirect/regim/6740</ExternalPhysicianDoc>
    <ExternalNurseDoc>https://kunskapsbanken.cancercentrum.se/redirect/regim/6740</ExternalNurseDoc>
    <ExternalPharmacistDoc/>
    <ExternalPatientDoc/>
    <Rounding/>
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  </Details>
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    <OriginOfExport>Regimbiblioteket</OriginOfExport>
    <IsAuthorized/>
    <CommittedBy/>
    <CreatedBy/>
    <CreatedDate>20260421</CreatedDate>
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    <Substance Name="axitinib">
      <Observandum Name="Hematologisk toxicitet" Tillagg="Anemi förekommer, oftast grad 1-2. Trombocytopeni och neutropeni  ovanligt och endast enstaka fall mer än grad 2. \nPolycytemi (förhöjt Hb) förekommer."/>
      <Observandum Name="Hypertoni" Tillagg="Hypertoni mycket vanligt. Kontroll av blodtryck före och under behandling, blodtrycksbehandling vid behov, eventuell dosjustering eller tillfälligt uppehåll med Axitinib, se FASS."/>
      <Observandum Name="Tromboembolism" Tillagg="Tromboemboliska händelser förekommer, både arteriella och venösa."/>
      <Observandum Name="Övrigt" Tillagg="Blödningshändelser inklusive allvarliga har rapporterats. Tillfälligt uppehåll av behandling med Axitinib om blödning kräver medicinsk intervention."/>
      <Observandum Name="Hjärttoxicitet" Tillagg="Hjärtsvikt finns rapporterat."/>
      <Observandum Name="Gastrointestinal påverkan" Tillagg="Diarré, illamående, kräkningar, buksmärtor och förstoppning mycket vanligt. . Nedsatt aptit och viktminskning mycket vanligt. Stomatit och dyspepsi förekommer. Gastrointestinal perforation och fistelbildning finns rapporterat."/>
      <Observandum Name="Hudtoxicitet" Tillagg="Hand-fot-syndrom (PPE) vanligt, oftast grad 1-2. Utslag, torr hud, klåda och håravfall (alopeci) förekommer."/>
      <Observandum Name="Endokrinologi" Tillagg="Hypothyreos vanligt, oftast grad 1-2. Hyperthyreos finns rapporterat. Kontroll av thyreoideavärden före och under behandling."/>
      <Observandum Name="CNS påverkan" Tillagg="Huvudvärk och trötthet mycket vanligt. Yrsel förekommer. Enstaka fallrapporter finns om Posteriort reversibelt encefalopatisyndrom (PRES) Symtom på PRES är huvudvärk, kramper, letargi, synrubbningar och neurologiska rubbningar, Vid misstanke om PRES görs tillfälligt uppehåll med Axitinib och utredning startas."/>
      <Observandum Name="Övrigt" Tillagg="Ledsmärta, muskelsmärta vanligt. Proteinuri vanligt. Förhöjda leverprover förekommer. Hosta vanligt."/>
      <Observandum Name="Sämre sårläkning" Tillagg="Inga studier finns, men generell kunskap om möjlig försämrad sårläkning på gruppnivå, varför uppehåll med Axitinib behandling bör startas minst 24 timmar före planerat kirurgiskt ingrepp."/>
      <Observandum Name="Interaktionsbenägen substans" Tillagg="Samtidig administrering av axitinib och starka CYP3A4/5-hämmare (t ex ketokonazol, itrakonazol, klaritromycin, erytromycin, atazanavir, indinavir, nefazodon, nelfinavir, ritonavir, sakvinavir, telitromycin och grapefruktjuice) kan öka plasmakoncentrationen av Axitinib. Om samtidig administration ej kan undvikas rekommenderas dosjustering av Axitinib, se FASS.\nSamtidig administrering av axitinib och starka CYP 3A4/5-inducerare (t ex rifampicin, dexametason, fenytoin, karbamazepin, rifabutin, rifapentin, fenobarbital och Hypericum perforatum (Johannesört)) kan sänka plasmakoncentrationen av Axitinib. Om samtidig administration ej kan undvikas rekommenderas dosjustering av Axitinib, se FASS."/>
    </Substance>
  </Sideeffects>
  <Diagnoses>
    <Diagnose Text="Njurcancer"/>
  </Diagnoses>
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            <Type>SUBSTANCE</Type>
            <Route>PO</Route>
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            <InfusionMinutes>0</InfusionMinutes>
            <ProductionBy>WARD</ProductionBy>
            <RelationType>NONE</RelationType>
          </Details>
          <Substance Name="axitinib">
            <Dose Max="">5</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="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="axitinib">
            <Dose Max="">5</Dose>
            <Steps>0</Steps>
            <Unit>MG</Unit>
            <Calculation>STANDARD</Calculation>
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          <Fluid Name="Ej aktuellt">
            <Volume/>
            <Unit/>
            <Calculation/>
          </Fluid>
          <Comments/>
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            <Route>PO</Route>
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            <InfusionMinutes>0</InfusionMinutes>
            <ProductionBy>WARD</ProductionBy>
            <RelationType>NONE</RelationType>
          </Details>
          <Substance Name="axitinib">
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            <Steps>0</Steps>
            <Unit>MG</Unit>
            <Calculation>STANDARD</Calculation>
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          <Fluid Name="Ej aktuellt">
            <Volume/>
            <Unit/>
            <Calculation/>
          </Fluid>
          <Comments/>
        </Line>
      </Lines>
    </Day>
    <Day Number="28">
      <Details>
        <Name/>
        <ConfirmationMandatory>NO</ConfirmationMandatory>
        <Comment/>
      </Details>
      <CriticalParameters/>
      <Lines>
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          <Details>
            <Type>SUBSTANCE</Type>
            <Route>PO</Route>
            <InfusionHours>0</InfusionHours>
            <InfusionMinutes>0</InfusionMinutes>
            <ProductionBy>WARD</ProductionBy>
            <RelationType>NONE</RelationType>
          </Details>
          <Substance Name="axitinib">
            <Dose Max="">5</Dose>
            <Steps>0</Steps>
            <Unit>MG</Unit>
            <Calculation>STANDARD</Calculation>
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          <Fluid Name="Ej aktuellt">
            <Volume/>
            <Unit/>
            <Calculation/>
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            <RelationType>NONE</RelationType>
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            <Unit>MG</Unit>
            <Calculation>STANDARD</Calculation>
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            <Volume/>
            <Unit/>
            <Calculation/>
          </Fluid>
          <Comments/>
        </Line>
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    </Day>
  </Days>
</CourseDefinition>
