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    <Version>3.0</Version>
    <Date>20120717</Date>
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  <Details>
    <RegimId>NRB-12575</RegimId>
    <Name>Rukaparib</Name>
    <ShortName/>
    <MajorVersion>1</MajorVersion>
    <MinorVersion>1</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: Behandlingsstart 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 och därefter en gång i månaden: Kontroll av blodstatus inklusive neutrofila, lever- och elektrolytstatus och kreatinin. \nFör behandlingsstart: neutrofila &gt; 1.5, TPK &gt; 100, Hb &gt;= 80.\nVanlig debut av hematologisk toxicitet efter 8-10 veckors behandling. \nKontroll av illamåendebesvär.\n\nInteraktionsbenägen substans via CYP3A systemet bland annat, var god se FASS. \n\nDosreduktion rekommendation: Uppehåll och dosjustering kan bli nödvändig pga toxicitet. \nDosminskning i tre steg  - 500 mg X2 (83 %)  - 400 mg X2 (67%) - 300 mg X2 (50%)\n\nFörhöjt ASAT/ALAT inträffar tidigt i behandlingen och är i allmänhet övergående. Vid biverkningar av grad 4 är behandlingsmodifiering nödvändig (sehttps://www.fass.se/LIF/product?userType=0&amp;nplId=20161105000013#dosage ).\n\n\nEmetogenicitet:Medel.\n\nBehandlingsöversikt: Kontinuerlig behandling.\nPåbörjas senast 8 veckor efter sista dosen av platinuminnehållande behandling. .\n\nDiagnoskod: C56.\n\nKurintervall: 28 dagar.\n\nBiverkningar för substanser i regimen\nrukaparib\nHematologisk toxicitet(Anemi, trombocytopeni och neutropeni mycket vanligt. Eventuellt behov av dosminskning/uppehåll i behandling.\nMyelodysplastiskt syndrom/Akut myeloid leukemi (MDS/AML) har rapporterats.\nGastrointestinal påverkan(Illamående, kräkningar, diarré och buksmärta vanligt, oftast grad 1-2, antiemetika kan behövas. Nedsatt aptit och förändrad smakupplevelse också vanligt.\nHudtoxicitet(Utslag vanligt. Fotosensitivitetsreaktioner förekommer varför rekommendation om att skydda hud mot exponering för solljus.\nÖvrigt(Fatigue/trötthet mycket vanligt. Feber förekommer.\nLevertoxicitet(Förhöjda levervärden mycket vanligt, oftast grad 1-2, men kan kräva dosjustering eller behandlingsuppehåll.\nNjurtoxicitet(Förhöjt kreatinin mycket vanligt, oftast grad 1-2.\nAndningsvägar(Dyspné vanligt, oftast grad 1-2.\nGraviditetsvarning(Rukaparib kan enligt djurstudier orsaka fosterskador. Effektiva preventivmedel bör användas av fertila kvinnor och graviditetstest före behandlingsstart rekommenderas.\nInteraktionsbenägen substans(Försiktighet bör iakttas vid samtidig administrering med CYP2C9 substrat med smala terapeutiska intervall (till exempel warfarin och phenytoin). (Studier har visat att Rukaparib ökar Warfarinkoncentration.) \nFörsiktighet bör iakttas vid samtidig administrering med CYP3A substrat med smala terapeutiska intervall (till exempel alfentanil, ciklosporin, dihydroergotamin, ergotamin, fentanyl, kinidin, sirolimus, takrolimus).\nRukaparib är en potent hämmare av MATE1 och MATE2, måttlig hämmare av OCT1 och svag hämmare av OCT2, varför Rukaparib skulle kunna öka metformins renala elimination och minska leverns upptag av metformin, varför försiktighet bör iakttas vid samtidig administrering.\nRukaparib är en hämmare av BCRP vilket skulle kunna öka exponering för BCRP substrat (till exempel rosuvastatin).\nRukaparib är en hämmare av UGT1A1, men klinisk betydelse är oklar, men försiktighet bör iakttas vid samtidig administrering UGT1A1 substrat (till exempel irinotekan) hos patienter med UGT1A1*28 (dålig metabolism) då detta skulle kunna ge ökad exponering för metaboliter och således ökad risk för toxicitet.\n</PhysicianComment>
    <NurseComment>Villkor och kontroller för administration: Tabletterna tas med cirka 12 timmars mellanrum. Vid kräkning eller missad dos tas nästa dos vid nästa ordinarie doseringstillfälle.\n\nInformation från basfakta för substanser i regimen\nrukaparib\nDosering i förhållande till måltid: Tas med eller utan mat vid ungefär samma tidpunkt varje dag\n\nÖvrig information: Fotosensitivitet. Undvik direkt solljus och använd skyddande klädsel och solskyddsmedel. \n\n</NurseComment>
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    <ExternalDocumentation/>
    <ExternalPhysicianDoc>https://kunskapsbanken.cancercentrum.se/redirect/regim/12575</ExternalPhysicianDoc>
    <ExternalNurseDoc>https://kunskapsbanken.cancercentrum.se/redirect/regim/12575</ExternalNurseDoc>
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    <OriginOfExport>Regimbiblioteket</OriginOfExport>
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    <CommittedBy/>
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    <CreatedDate>20251216</CreatedDate>
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      <Observandum Name="Gastrointestinal påverkan" Tillagg="Illamående, kräkningar, diarré och buksmärta vanligt, oftast grad 1-2, antiemetika kan behövas. Nedsatt aptit och förändrad smakupplevelse också vanligt."/>
      <Observandum Name="Hudtoxicitet" Tillagg="Utslag vanligt. Fotosensitivitetsreaktioner förekommer varför rekommendation om att skydda hud mot exponering för solljus."/>
      <Observandum Name="Övrigt" Tillagg="Fatigue/trötthet mycket vanligt. Feber förekommer."/>
      <Observandum Name="Levertoxicitet" Tillagg="Förhöjda levervärden mycket vanligt, oftast grad 1-2, men kan kräva dosjustering eller behandlingsuppehåll."/>
      <Observandum Name="Njurtoxicitet" Tillagg="Förhöjt kreatinin mycket vanligt, oftast grad 1-2."/>
      <Observandum Name="Andningsvägar" Tillagg="Dyspné vanligt, oftast grad 1-2."/>
      <Observandum Name="Graviditetsvarning" Tillagg="Rukaparib kan enligt djurstudier orsaka fosterskador. Effektiva preventivmedel bör användas av fertila kvinnor och graviditetstest före behandlingsstart rekommenderas."/>
      <Observandum Name="Interaktionsbenägen substans" Tillagg="Försiktighet bör iakttas vid samtidig administrering med CYP2C9 substrat med smala terapeutiska intervall (till exempel warfarin och phenytoin). (Studier har visat att Rukaparib ökar Warfarinkoncentration.) \nFörsiktighet bör iakttas vid samtidig administrering med CYP3A substrat med smala terapeutiska intervall (till exempel alfentanil, ciklosporin, dihydroergotamin, ergotamin, fentanyl, kinidin, sirolimus, takrolimus).\nRukaparib är en potent hämmare av MATE1 och MATE2, måttlig hämmare av OCT1 och svag hämmare av OCT2, varför Rukaparib skulle kunna öka metformins renala elimination och minska leverns upptag av metformin, varför försiktighet bör iakttas vid samtidig administrering.\nRukaparib är en hämmare av BCRP vilket skulle kunna öka exponering för BCRP substrat (till exempel rosuvastatin).\nRukaparib är en hämmare av UGT1A1, men klinisk betydelse är oklar, men försiktighet bör iakttas vid samtidig administrering UGT1A1 substrat (till exempel irinotekan) hos patienter med UGT1A1*28 (dålig metabolism) då detta skulle kunna ge ökad exponering för metaboliter och således ökad risk för toxicitet."/>
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    <Diagnose Text="Äggstockscancer"/>
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        <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="rukaparib">
            <Dose Max="">600</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="rukaparib">
            <Dose Max="">600</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="rukaparib">
            <Dose Max="">600</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="rukaparib">
            <Dose Max="">600</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>
