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    <Version>3.0</Version>
    <Date>20120717</Date>
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  <Details>
    <RegimId>NRB-7224</RegimId>
    <Name>Abemaciklib</Name>
    <ShortName/>
    <MajorVersion>1</MajorVersion>
    <MinorVersion>9</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: Östrogenreceptor positiv, HER2-negativ bröstcancer.\nVid uppstart: Kontroll av blod-, lever- och elektrolytstatus inkl. kreatinin. Neutrofila &gt;= 1,5 och TPK &gt;= 100 och Hb &gt;=80\n\nAnvisningar för ordination: Kontroll av blod- och leverstatus varannan vecka under de första två månaderna, en gång i månaden de följande två månaderna samt när kliniskt indicerat.\nKreatinin och elektrolytstatus när kliniskt indicerat ex. vid biverkan diarré. Komplettera med eGFR och/eller cystatin C vid kreatininförhöjning.\nKur 1 och 2 - Ordinera dag 1-14 och därefter dag 15-28 efter blodprover dag 14.\nFrån kur 3 - Ordinera dag 1-28\nPatienten skall informeras om att fördröjd diarré är en vanlig biverkan och erhålla anvisningar och recept på Loperamid.\n\nDosreduktion rekommendation: Dosreduktion kan bli nödvändig för att hantera biverkningar och görs i två steg till 100 mg X 2 och 50 mg X 2. \nFör hematologiska biverkningar och biverkan med diarré, förhöjda aminotransferaser och interstitiell lungsjukdom - se separata scheman ihttps://www.fass.se/LIF/product?userType=0&amp;nplId=20170728000034#dosage  . \n\nFör övriga biverkningar grad 1-2  - ingen dosreduktion\nVid ihållande biverkning grad 2 och 3-4: Gör uppehåll i behandling till grad 1 eller mindre och återuppta med lägre dos. \nDosreduktion kan också bli aktuell för att parera interaktioner med starka CYP3A4-hämmare, som inte är lämpliga att sätta ut. I dessa all kan man gå ner ytterligare i dos och ge Abemaciklib en gång om dagen.\n\nEmetogenicitet:Låg.\n\nBehandlingsöversikt: Kontinuerlig behandling.\nAbemaciklib ges tillsammans med aromatashämmare, Tamoxifen eller Fulvestrant som tas kontinuerligt. \nTill pre- eller perimenopausala kvinnor ska man alltid kombinera med en LHRH-agonist, alternativt överväga ooforektomi..\n\nDiagnoskod: C50.\n\nKurintervall: 28 dagar.\n\nBiverkningar för substanser i regimen\nabemaciklib\nHematologisk toxicitet(Följ dosreduktionsinstruktioner och/eller skjut upp nästa dos.\nInfektionsrisk(Infektioner vanliga, oftast grad 1-2.\nTromboembolism(Ökad tromboembolirisk förekommer vid samtidig behandling med fulvestrant eller aromatashämmare. Utred vid tecken eller symtom på tromboembolism.\nGastrointestinal påverkan(Diarré mycket vanligt. Patienter bör vara instruerade att starta behandling mot diarré (t ex loperamid) vid första tecknet på lös avföring, öka sitt vätskeintag och meddela sin vårdande enhet. Eventuellt dosjusteringsbehov, se FASS.\nNedsatt aptit, kräkningar och illamående vanligt. Förändrad smakupplevelse förekommer.\nLevertoxicitet(Förhöjning av ALAT, ASAT är vanligt, oftast grad 1-2, men kan nå grad 3-4. Eventuellt dosjusteringsbehov, se FASS.\nHudtoxicitet(Alopeci (håravfall) förekommer. Klåda, utslag och torr hud förekommer, oftast milda.\nÖvrigt(Utmattning (fatigue) vanligt. Yrsel och muskelsvaghet förekommer. Ökat tårflöde förekommer.\nNjurtoxicitet(Kreatinin ökning vanligt, enligt FASS räknas ej som toxicitet, då det visat sig bero på hämning av de transportproteiner som medverkar i den tubulära sekretionen i njurarna utan att inverka på den glomerulära funktionen (uppmätt som iohexol-clearance).\nInteraktionsbenägen substans(Samtidig användning av starka CYP3A4-hämmare med abemaciklib ska undvikas, då samtidig användning kan öka effekten av abemaciklib. \n(Exempel på starka CYP3A4-hämmare: klaritromycin, itrakonazol, ketokonazol, lopinavir/titonavir, posakonazole eller vorikonazol. Undvik även grapefrukt och grapefruktjuice.)\nSamtidig användning av starka CYP3A4-inducerare ska undvikas, då samtidig användning kan minska effekten av abemaciklib. \n(Exempel på starka CYP3A4-inducerare: karbamazepin, fenytoin, rifampicin och johannesört.)\n</PhysicianComment>
    <NurseComment>Villkor och kontroller för administration: Vid kräkning eller om en dos missas, tas nästa dos enligt schema. Ingen extra dos tas. \nJohannesört och grapefrukt eller grapefruktjuice ska ej intas under behandlingen. \n\nInformation från basfakta för substanser i regimen\nabemaciklib\nDosering i förhållande till måltid: Tas med eller utan mat vid ungefär samma tidpunkt varje dag\n\nÖvrig information: Tablett finns i styrkorna 50mg, 100 mg och 150 mg. \n\n</NurseComment>
    <PharmacistComment/>
    <PatientComment/>
    <ExternalDocumentation/>
    <ExternalPhysicianDoc>https://kunskapsbanken.cancercentrum.se/redirect/regim/7224</ExternalPhysicianDoc>
    <ExternalNurseDoc>https://kunskapsbanken.cancercentrum.se/redirect/regim/7224</ExternalNurseDoc>
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  </Details>
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    <OriginOfExport>Regimbiblioteket</OriginOfExport>
    <IsAuthorized/>
    <CommittedBy/>
    <CreatedBy/>
    <CreatedDate>20260421</CreatedDate>
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    <Substance Name="abemaciklib">
      <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="Infektionsrisk" Tillagg="Infektioner vanliga, oftast grad 1-2."/>
      <Observandum Name="Tromboembolism" Tillagg="Ökad tromboembolirisk förekommer vid samtidig behandling med fulvestrant eller aromatashämmare. Utred vid tecken eller symtom på tromboembolism."/>
      <Observandum Name="Gastrointestinal påverkan" Tillagg="Diarré mycket vanligt. Patienter bör vara instruerade att starta behandling mot diarré (t ex loperamid) vid första tecknet på lös avföring, öka sitt vätskeintag och meddela sin vårdande enhet. Eventuellt dosjusteringsbehov, se FASS.\nNedsatt aptit, kräkningar och illamående vanligt. Förändrad smakupplevelse förekommer."/>
      <Observandum Name="Levertoxicitet" Tillagg="Förhöjning av ALAT, ASAT är vanligt, oftast grad 1-2, men kan nå grad 3-4. Eventuellt dosjusteringsbehov, se FASS.">
        <Control Name="Leverfunktion"/>
      </Observandum>
      <Observandum Name="Hudtoxicitet" Tillagg="Alopeci (håravfall) förekommer. Klåda, utslag och torr hud förekommer, oftast milda."/>
      <Observandum Name="Övrigt" Tillagg="Utmattning (fatigue) vanligt. Yrsel och muskelsvaghet förekommer. Ökat tårflöde förekommer."/>
      <Observandum Name="Njurtoxicitet" Tillagg="Kreatinin ökning vanligt, enligt FASS räknas ej som toxicitet, då det visat sig bero på hämning av de transportproteiner som medverkar i den tubulära sekretionen i njurarna utan att inverka på den glomerulära funktionen (uppmätt som iohexol-clearance).">
        <Control Name="Njurfunktion"/>
      </Observandum>
      <Observandum Name="Interaktionsbenägen substans" Tillagg="Samtidig användning av starka CYP3A4-hämmare med abemaciklib ska undvikas, då samtidig användning kan öka effekten av abemaciklib. \n(Exempel på starka CYP3A4-hämmare: klaritromycin, itrakonazol, ketokonazol, lopinavir/titonavir, posakonazole eller vorikonazol. Undvik även grapefrukt och grapefruktjuice.)\nSamtidig användning av starka CYP3A4-inducerare ska undvikas, då samtidig användning kan minska effekten av abemaciklib. \n(Exempel på starka CYP3A4-inducerare: karbamazepin, fenytoin, rifampicin och johannesört.)"/>
    </Substance>
  </Sideeffects>
  <Diagnoses>
    <Diagnose Text="Bröstcancer"/>
  </Diagnoses>
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            <RelationType>NONE</RelationType>
          </Details>
          <Substance Name="abemaciklib">
            <Dose Max="">150</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="abemaciklib">
            <Dose Max="">150</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="abemaciklib">
            <Dose Max="">150</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="abemaciklib">
            <Dose Max="">150</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="abemaciklib">
            <Dose Max="">150</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>
