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<CourseDefinition>
  <Schema>
    <Version>3.0</Version>
    <Date>20120717</Date>
  </Schema>
  <Details>
    <RegimId>NRB-6387</RegimId>
    <Name>Kapecitabin-Mitomycin under strålbehandling</Name>
    <ShortName/>
    <MajorVersion>1</MajorVersion>
    <MinorVersion>5</MinorVersion>
    <DefinitionStatus>COMPLETED</DefinitionStatus>
    <PatientMaxSurface/>
    <CourseICDZCode>NONE</CourseICDZCode>
    <CourseAUC>0.00</CourseAUC>
    <MaxAge/>
    <CycleLength/>
    <ValidForAllDiagnoses/>
    <IsStudyDefinition>NO</IsStudyDefinition>
    <PhysicianComment>Villkor för start av regimen: Kontroll av blodstatus inkl neutrofila-, lever- och elektrolytstatus inkl kreatinin.\nEKG vid anamnes på hjärtsjukdom.\nTest av DPD-aktivitet rekommenderas för att undvika allvarliga biverkningar av Kapecitabin.\n\nAnvisningar för ordination: Vid lokalt avancerad tumör ges Mitomycin 10 mg/m2 också dag 29.\nMitomycin - maxdos /administrationstillfälle 20 mg.\nBlodstatus inkl. neutrofila. Neutrofila &gt;=1,5 och TPK &gt;=75 för behandlingsstart.\nKontroll av hand-fotsyndrom och GI-biverkningar.\n\nDosreduktion rekommendation: Se "Dosjustering under behandling" i FASS.\n\nEmetogenicitet:Låg.\n\nBehandlingsöversikt: Behandlingen ges konkomitant (samtidigt) med strålbehandling, som regel ges uppdelat på 27 fraktioner, fem dagar per vecka. Kapecitabin ges samtliga stråldagar.\nVid lokalt avancerad tumör ges Mitomycin 10 mg/m2 också dag 29..\n\nDiagnoskod: C21.\n\nBehandlingsavsikt: Adjuvant, Palliativ.\n\nBiverkningar för substanser i regimen\nmitomycin\nHematologisk toxicitet(Benmärgspåverkan mycket vanlig med leukopenia och trombocytopeni. \nAndningsvägar(Interstitiell pneumoni förekommer, men även enbart andnöd, hosta. Risk för lungtoxicitet ökar vid kombination med vinkaalkaloider eller bleomycin. Avbryt behandling, utred och behandla eventuellt med kortikosteroider.\nGastrointestinal påverkan(Illamående, kräkning vanligt. Mukosit, stomatit och anorexi förekommer.\nHudtoxicitet(Hudutslag, erytem förekommer. Alopeci/håravfall förekommer.\nNjurtoxicitet(Förhöjd kreatininnivå förekommer. Hemolytiskt uremiskt syndrom finns rapporterat.\nStarkt vävnadsretande(Vävnadsnekros finns rapporterat, även fördröjd efter flera veckor.\nExtravasering(Klassas som vävnadstoxisk, risk för nekros (hög risk för vävnadsskada).\nVesicant (blåsbildande, brännskadeliknande) DNA bindande. \nVävnadsnekros och cellulit finns angivna. Fördröjd erythema och/eller ulceration finns beskrivet.\nCentral infart rekommenderas.\nFölj instruktion för kylbehandling, se stöddokument Extravasering.\nDMSO kan övervägas, se stöddokument Extravasering.\n\nkapecitabin\nHematologisk toxicitet(Följ dosreduktionsinstruktioner och/eller skjut upp nästa dos.\nGastrointestinal påverkan(Diarré. Biverkningskontroll enligt lokala riktlinjer. Vid kraftiga symptom avbryts behandlingen, överväg övervakning och vid behov ges vätske- och elektrolytersättning.\nVid lindriga till måttliga symptom kan behandling med tablett Loperamid övervägas.\nSlemhinnetoxicitet(Stomatit.\nHjärttoxicitet(Hjärtinfarkt, angina, arytmier, kardiogen chock och EKG-förändringar kan uppträda. Försiktighet hos patienter med tidigare hjärtsjukdom. Nytillkomna hjärtbesvär bör utredas.\nHudtoxicitet(Hand- och fotsyndrom. Biverkningskontroll enligt lokala riktlinjer. Se FASS angående åtgärder vid respektive toxicitetsgrad.\nÖvrigt(DPD (dihydropyrimidin dehydrogenas) brist leder till ökad toxicitet, med risk för mycket allvarliga eller fatala förlopp. Enligt rekommendationer från Läkemedelsverket bör patienter testas för DPD brist före behandlingsstart. Vid partiell brist reducerad dos, vid total brist avstå behandling.\nDå test inte hittar alla med nedsatt DPD aktivitet ska DPD brist misstänkas oavsett testresultat vid allvarlig toxicitet (slemhinnetoxicitet, hematologisk toxicitet och/eller neurotoxicitet) eller vid anamnes på svår toxicitet på tidigare fluoropyrimidin behandling. Överväg avbrytande av behandling eller kraftigt reducerad dos. \n</PhysicianComment>
    <NurseComment>Villkor och kontroller för administration: Central infart rekommenderas.\nSjuksköterskekontakt varje vecka under behandling.\nVid missad dos tas nästa dos enligt ordination, dvs ingen extra dos ska tas.\n\nInformation från basfakta för substanser i regimen\nkapecitabin\nDosering i förhållande till måltid: Tas inom en halv timme efter måltid\n\n</NurseComment>
    <PharmacistComment/>
    <PatientComment/>
    <ExternalDocumentation/>
    <ExternalPhysicianDoc>https://kunskapsbanken.cancercentrum.se/redirect/regim/6387</ExternalPhysicianDoc>
    <ExternalNurseDoc>https://kunskapsbanken.cancercentrum.se/redirect/regim/6387</ExternalNurseDoc>
    <ExternalPharmacistDoc/>
    <ExternalPatientDoc/>
    <Rounding/>
    <HasSteps/>
  </Details>
  <Miscellaneous>
    <OriginOfExport>Regimbiblioteket</OriginOfExport>
    <IsAuthorized/>
    <CommittedBy/>
    <CreatedBy/>
    <CreatedDate>20260321</CreatedDate>
  </Miscellaneous>
  <Sideeffects>
    <Substance Name="mitomycin">
      <Observandum Name="Hematologisk toxicitet" Tillagg="Benmärgspåverkan mycket vanlig med leukopenia och trombocytopeni. ">
        <Control Name="Blodvärden">
          <SupportingTreatment Name="Enligt lokala riktlinjer"/>
        </Control>
      </Observandum>
      <Observandum Name="Andningsvägar" Tillagg="Interstitiell pneumoni förekommer, men även enbart andnöd, hosta. Risk för lungtoxicitet ökar vid kombination med vinkaalkaloider eller bleomycin. Avbryt behandling, utred och behandla eventuellt med kortikosteroider."/>
      <Observandum Name="Gastrointestinal påverkan" Tillagg="Illamående, kräkning vanligt. Mukosit, stomatit och anorexi förekommer."/>
      <Observandum Name="Hudtoxicitet" Tillagg="Hudutslag, erytem förekommer. Alopeci/håravfall förekommer."/>
      <Observandum Name="Njurtoxicitet" Tillagg="Förhöjd kreatininnivå förekommer. Hemolytiskt uremiskt syndrom finns rapporterat.">
        <Control Name="Njurfunktion"/>
      </Observandum>
      <Observandum Name="Starkt vävnadsretande" Tillagg="Vävnadsnekros finns rapporterat, även fördröjd efter flera veckor."/>
      <Observandum Name="Extravasering" Tillagg="Klassas som vävnadstoxisk, risk för nekros (hög risk för vävnadsskada).\nVesicant (blåsbildande, brännskadeliknande) DNA bindande. \nVävnadsnekros och cellulit finns angivna. Fördröjd erythema och/eller ulceration finns beskrivet.\nCentral infart rekommenderas.\nFölj instruktion för kylbehandling, se stöddokument Extravasering.\nDMSO kan övervägas, se stöddokument Extravasering.">
        <SupportingTreatment Name="Kyla"/>
        <SupportingTreatment Name="DMSO"/>
      </Observandum>
    </Substance>
    <Substance Name="kapecitabin">
      <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="Gastrointestinal påverkan" Tillagg="Diarré. Biverkningskontroll enligt lokala riktlinjer. Vid kraftiga symptom avbryts behandlingen, överväg övervakning och vid behov ges vätske- och elektrolytersättning.\nVid lindriga till måttliga symptom kan behandling med tablett Loperamid övervägas.">
        <Control Name="Biverkningskontroll">
          <SupportingTreatment Name="Hydrering"/>
          <SupportingTreatment Name="Loperamid"/>
        </Control>
      </Observandum>
      <Observandum Name="Slemhinnetoxicitet" Tillagg="Stomatit."/>
      <Observandum Name="Hjärttoxicitet" Tillagg="Hjärtinfarkt, angina, arytmier, kardiogen chock och EKG-förändringar kan uppträda. Försiktighet hos patienter med tidigare hjärtsjukdom. Nytillkomna hjärtbesvär bör utredas."/>
      <Observandum Name="Hudtoxicitet" Tillagg="Hand- och fotsyndrom. Biverkningskontroll enligt lokala riktlinjer. Se FASS angående åtgärder vid respektive toxicitetsgrad.">
        <Control Name="Biverkningskontroll">
          <SupportingTreatment Name="Mjukgörande hudkräm"/>
        </Control>
      </Observandum>
      <Observandum Name="Övrigt" Tillagg="DPD (dihydropyrimidin dehydrogenas) brist leder till ökad toxicitet, med risk för mycket allvarliga eller fatala förlopp. Enligt rekommendationer från Läkemedelsverket bör patienter testas för DPD brist före behandlingsstart. Vid partiell brist reducerad dos, vid total brist avstå behandling.\nDå test inte hittar alla med nedsatt DPD aktivitet ska DPD brist misstänkas oavsett testresultat vid allvarlig toxicitet (slemhinnetoxicitet, hematologisk toxicitet och/eller neurotoxicitet) eller vid anamnes på svår toxicitet på tidigare fluoropyrimidin behandling. Överväg avbrytande av behandling eller kraftigt reducerad dos. "/>
    </Substance>
  </Sideeffects>
  <Diagnoses>
    <Diagnose Text="Analcancer"/>
  </Diagnoses>
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            <Comment Text="Spoldropp att fördelas mellan och efter sista läkemedlet"/>
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          <Fluid Name="Ej aktuellt">
            <Volume/>
            <Unit/>
            <Calculation/>
          </Fluid>
          <Comments/>
        </Line>
      </Lines>
    </Day>
    <Day Number="33">
      <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="kapecitabin">
            <Dose Max="">825</Dose>
            <Steps>0</Steps>
            <Unit>MG</Unit>
            <Calculation>SURFACE</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="kapecitabin">
            <Dose Max="">825</Dose>
            <Steps>0</Steps>
            <Unit>MG</Unit>
            <Calculation>SURFACE</Calculation>
          </Substance>
          <Fluid Name="Ej aktuellt">
            <Volume/>
            <Unit/>
            <Calculation/>
          </Fluid>
          <Comments/>
        </Line>
      </Lines>
    </Day>
    <Day Number="36">
      <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="kapecitabin">
            <Dose Max="">825</Dose>
            <Steps>0</Steps>
            <Unit>MG</Unit>
            <Calculation>SURFACE</Calculation>
          </Substance>
          <Fluid Name="Ej aktuellt">
            <Volume/>
            <Unit/>
            <Calculation/>
          </Fluid>
          <Comments/>
        </Line>
        <Line Number="2">
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            <Type>SUBSTANCE</Type>
            <Route>PO</Route>
            <InfusionHours>0</InfusionHours>
            <InfusionMinutes>0</InfusionMinutes>
            <ProductionBy>WARD</ProductionBy>
            <RelationType>NONE</RelationType>
          </Details>
          <Substance Name="kapecitabin">
            <Dose Max="">825</Dose>
            <Steps>0</Steps>
            <Unit>MG</Unit>
            <Calculation>SURFACE</Calculation>
          </Substance>
          <Fluid Name="Ej aktuellt">
            <Volume/>
            <Unit/>
            <Calculation/>
          </Fluid>
          <Comments/>
        </Line>
      </Lines>
    </Day>
    <Day Number="37">
      <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="kapecitabin">
            <Dose Max="">825</Dose>
            <Steps>0</Steps>
            <Unit>MG</Unit>
            <Calculation>SURFACE</Calculation>
          </Substance>
          <Fluid Name="Ej aktuellt">
            <Volume/>
            <Unit/>
            <Calculation/>
          </Fluid>
          <Comments/>
        </Line>
        <Line Number="2">
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            <Route>PO</Route>
            <InfusionHours>0</InfusionHours>
            <InfusionMinutes>0</InfusionMinutes>
            <ProductionBy>WARD</ProductionBy>
            <RelationType>NONE</RelationType>
          </Details>
          <Substance Name="kapecitabin">
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            <Steps>0</Steps>
            <Unit>MG</Unit>
            <Calculation>SURFACE</Calculation>
          </Substance>
          <Fluid Name="Ej aktuellt">
            <Volume/>
            <Unit/>
            <Calculation/>
          </Fluid>
          <Comments/>
        </Line>
      </Lines>
    </Day>
  </Days>
</CourseDefinition>
