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    <Version>3.0</Version>
    <Date>20120717</Date>
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  <Details>
    <RegimId>NRB-6409</RegimId>
    <Name>Olaparib tablett</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: Underhållsbehandling av avancerad, platinumkänslig, BRCA muterad, höggradig epitelial ovarialcancer, i minst partiell remission efter första linjens cytostatikabehandling.\nBehandlingsstart senast 8 veckor efter sista dos platinumbaserad cytostatikabehandling.\nKontroll av blodstatus inklusive neutrofila, lever och elektrolytstatus och kreatinin.\n\nAnvisningar för ordination: Inför kur 1: Kontroll av blodstatus inklusive neutrofila, lever- och elektrolytstatus och kreatinin. För behandlingsstart  neutrofila &gt; 1.5, TPK &gt; 100, Hb &gt;= 80.\nInför varje kur: Blodstatus inklusive neutrofila, leverstatus, kreatinin. \nKontroll av illamåendebesvär.\n\nInteraktionsbenägen substans via CYP3A systemet bland annat, var god se FASS. Försiktighet med statiner rekommenderas.\n\nDosreduktion rekommendation: Hematologisk toxicitet\nHb &lt;80: Gör behandlingsuppehåll, dosreduktion kan övervägas.\nGastrointestinal toxicitet\nVid uttalat illamående: Behandlingsuppehåll till symtomfrihet, därefter återinsättande av preparatet i oförändrad dosering. Antiemetika vid behov.\n\nEmetogenicitet:Medel.\n\nBehandlingsöversikt: Kontinuerlig behandling.\nObs! Lynparza (Olaparib) tabletter (100 och 150 mg) får INTE bytas ut mot Lynparza kapslar (50 mg) pga skillnader i dosering och biotillgänglighet för respektive formulering..\n\nDiagnoskod: C56.\n\nBehandlingsavsikt: Underhållsbehandling.\n\nBiverkningar för substanser i regimen\nolaparib\nGraviditetsvarning(Fertila kvinnor: effektivt preventivmedel under behandling och 1 månad efter sista dos. Beakta interaktionsrisk som medför dålig effekt av hormonella preventivmedel.\nGastrointestinal påverkan(Illamående, kräkning, diarré, nedsatt aptit och buksmärta mycket vanligt. Dyspepsi vanligt till mycket vanligt. Stomatit vanligt. Förstoppning anges som vanligt i annan databas än FASS, tas ej upp i FASS.\nHematologisk toxicitet(Följ dosreduktionsinstruktioner och/eller skjut upp nästa dos.\nAndningsvägar(Övre luftvägsinfektion, hosta, andfåddhet vanligt. Enstaka fall med pneumonit, utred vid misstanke.\nCNS påverkan(Trötthet. Yrsel. Huvudvärk.\nInteraktionsbenägen substans(Olaparibs nedbrytning sker via CYP3A4/5.\nSamtidig administrering av starka inducerare av CYP3A4/5 rekommenderas ej, då Olaparibs effekt kan minska betydligt. (Exempel: fenytoin, rifampicin, rifapentin, karbamazepin, nevirapin, fenobarbital och johannesört.)\nSamtidig administrering av måttliga inducerare av CYP3A4/5 rekommenderas ej, då Olaparibs effekt kan minska, men kunskap saknas om hur mycket. (Exempel: efavirenz, rifabutin)\nSamtidig administrering av starka eller måttliga hämmare av CYP3A rekommenderas ej, då effekten av Olaparib kan öka betydligt. (Exempel starka hämmare: itrakonazol, telitromycin, klaritromycin, proteashämmare förstärkta med ritonavir eller kobicistat, boceprevir, telaprevir och exempel på måttliga hämmare: erytromycin, diltiazem, flukonazol, verapamil). Om samtidig administrering nödvändig ska dosen av Olaparib minskas, se FASS.\nGrapefruktjuice konsumtion bör också undvikas samtidigt med behandling med Olaparib.\nOlaparib anses vara en mild hämmare av CYP3A varför försiktighet bör iakttas vid samtidig administrering med för CYP3A känsliga substanser eller substanser med smalt terapeutisk index (t.ex. simvastatin, cisaprid, ciklosporin, ergotalkaloider, fentanyl, pimozid, sirolimus, takrolimus och quetiapin)\nSamtidig administrering av statiner skall ske med försiktighet då även andra nebrytningsvägar kan påverkas.\nYtterligare möjliga interaktioner finns, se FASS.\nNjurtoxicitet(Förhöjt kreatinin vanligt, oftast lätt till måttligt förhöjt, kan bli uttalat.\n</PhysicianComment>
    <NurseComment>Villkor och kontroller för administration: Grapefruktjuice och Johannesört ska undvikas. \nGlömd dos: Nästa dos tas vid vanlig tidpunkt.\n\nInformation från basfakta för substanser i regimen\nolaparib\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/6409</ExternalPhysicianDoc>
    <ExternalNurseDoc>https://kunskapsbanken.cancercentrum.se/redirect/regim/6409</ExternalNurseDoc>
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  </Details>
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    <OriginOfExport>Regimbiblioteket</OriginOfExport>
    <IsAuthorized/>
    <CommittedBy/>
    <CreatedBy/>
    <CreatedDate>20251216</CreatedDate>
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    <Substance Name="olaparib">
      <Observandum Name="Graviditetsvarning" Tillagg="Fertila kvinnor: effektivt preventivmedel under behandling och 1 månad efter sista dos. Beakta interaktionsrisk som medför dålig effekt av hormonella preventivmedel."/>
      <Observandum Name="Gastrointestinal påverkan" Tillagg="Illamående, kräkning, diarré, nedsatt aptit och buksmärta mycket vanligt. Dyspepsi vanligt till mycket vanligt. Stomatit vanligt. Förstoppning anges som vanligt i annan databas än FASS, tas ej upp i FASS."/>
      <Observandum Name="Hematologisk toxicitet" Tillagg="Följ dosreduktionsinstruktioner och/eller skjut upp nästa dos.">
        <Control Name="Blodvärden">
          <SupportingTreatment Name="Enligt lokala riktlinjer"/>
        </Control>
      </Observandum>
      <Observandum Name="Andningsvägar" Tillagg="Övre luftvägsinfektion, hosta, andfåddhet vanligt. Enstaka fall med pneumonit, utred vid misstanke."/>
      <Observandum Name="CNS påverkan" Tillagg="Trötthet. Yrsel. Huvudvärk."/>
      <Observandum Name="Interaktionsbenägen substans" Tillagg="Olaparibs nedbrytning sker via CYP3A4/5.\nSamtidig administrering av starka inducerare av CYP3A4/5 rekommenderas ej, då Olaparibs effekt kan minska betydligt. (Exempel: fenytoin, rifampicin, rifapentin, karbamazepin, nevirapin, fenobarbital och johannesört.)\nSamtidig administrering av måttliga inducerare av CYP3A4/5 rekommenderas ej, då Olaparibs effekt kan minska, men kunskap saknas om hur mycket. (Exempel: efavirenz, rifabutin)\nSamtidig administrering av starka eller måttliga hämmare av CYP3A rekommenderas ej, då effekten av Olaparib kan öka betydligt. (Exempel starka hämmare: itrakonazol, telitromycin, klaritromycin, proteashämmare förstärkta med ritonavir eller kobicistat, boceprevir, telaprevir och exempel på måttliga hämmare: erytromycin, diltiazem, flukonazol, verapamil). Om samtidig administrering nödvändig ska dosen av Olaparib minskas, se FASS.\nGrapefruktjuice konsumtion bör också undvikas samtidigt med behandling med Olaparib.\nOlaparib anses vara en mild hämmare av CYP3A varför försiktighet bör iakttas vid samtidig administrering med för CYP3A känsliga substanser eller substanser med smalt terapeutisk index (t.ex. simvastatin, cisaprid, ciklosporin, ergotalkaloider, fentanyl, pimozid, sirolimus, takrolimus och quetiapin)\nSamtidig administrering av statiner skall ske med försiktighet då även andra nebrytningsvägar kan påverkas.\nYtterligare möjliga interaktioner finns, se FASS."/>
      <Observandum Name="Njurtoxicitet" Tillagg="Förhöjt kreatinin vanligt, oftast lätt till måttligt förhöjt, kan bli uttalat."/>
    </Substance>
  </Sideeffects>
  <Diagnoses>
    <Diagnose Text="Äggstockscancer"/>
  </Diagnoses>
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            <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="olaparib">
            <Dose Max="">300</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="olaparib">
            <Dose Max="">300</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="olaparib">
            <Dose Max="">300</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="olaparib">
            <Dose Max="">300</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>
