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<CourseDefinition>
  <Schema>
    <Version>3.0</Version>
    <Date>20120717</Date>
  </Schema>
  <Details>
    <RegimId>NRB-1154</RegimId>
    <Name>Cyklofosfamid-Kapecitabin</Name>
    <ShortName/>
    <MajorVersion>1</MajorVersion>
    <MinorVersion>5</MinorVersion>
    <DefinitionStatus>COMPLETED</DefinitionStatus>
    <PatientMaxSurface/>
    <CourseICDZCode>NONE</CourseICDZCode>
    <CourseAUC>0.00</CourseAUC>
    <MaxAge/>
    <CycleLength>21</CycleLength>
    <ValidForAllDiagnoses/>
    <IsStudyDefinition>NO</IsStudyDefinition>
    <PhysicianComment>Villkor för start av regimen: Kontroll av blod-, lever- och elektrolytstatus med kreatinin.\nEKG vid anamnes på hjärtsjukdom. \nTest av DPD-aktivitet rekommenderas för att undvika allvarliga biverkningar av Kapecitabin.\n\nAnvisningar för ordination: Blodstatus inkl. neutrofila. \nKontroll av hand-fotsyndrom och GI-biverkningar.\n\nDosreduktion rekommendation: Vid intolerabla biverkningar gör uppehåll tills biverkningarna upphört och starta därefter försiktigt\n\nEmetogenicitet:Låg.\n\nDiagnoskod: C50.\n\nKurintervall: 21 dagar.\n\nBiverkningar för substanser i regimen\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\ncyklofosfamidmonohydrat\nHematologisk toxicitet(Följ dosreduktionsinstruktioner och/eller skjut upp nästa dos.\nCystit(Hemorragisk cystit förekommer, kan bli allvarlig. Dosberoende. Strålbehandling mot blåsa ökar risk. Hydrering viktigt. Eventuellt Mesna som profylax, följ vårdprogram eller behandlingsprotokoll. Enligt ASCO ges Mesna endast vid högdos cyklofosfamid, i Up to Date angivet som 50mg/kg eller 2g/m2. Barn har angett doser över 1 g/m2 som behov av Mesna profylax.\nHög emetogenicitet(Illamående, kräkning vanligt vid högre doser iv (mer än 1500 mg). Antiemetika enligt riktlinjer.\nTumörlyssyndrom(Tumörlyssyndrom kan uppstå till följd av snabb lys av tumörceller vid vissa sjukdomar under vissa förutsättningar (exempelvis vanligast i uppstartsbehandling). Viktigt att patient är väl hydrerad och har god diures. Som skydd ges eventuellt Allopurinol under behandlingstiden. Vid behov kan antidoten rasburikas (Fasturtec) ges.\nHudtoxicitet(Alopeci (håravfall) förekommer.\nInteraktionsbenägen substans(Cyklofosfamid aktiveras och metaboliseras via CYP450 systemet.\nSamtidig administrering av cyklofosfamid med CYP450-inducerare kan öka koncentrationen av cytotoxiska metaboliter av cyklofosfamid. (Exempel på CYP450-inducerare är: rifampicin, fenobarbital, karbamazepin, fenytoin, johannesört och kortikosteroider.)\nSamtidig administrering av cyklofosfamid med CYP450-hämmare kan minska aktiveringen av cyklofosfamid och därmed minska effekten. (Exempel på CYP450-hämmare är: amiodaron, aprepitant, bupropion, busulfan, ciprofloxacin, flukonazol, itrakonazol, ketokonazol, klaritromycin, posakonazol, prasugrel, sulfonamider, telitromycin, tiotepa, vorikonazol.)\nSamtidig administrering av cyklofosfamid med allopurinol, cimetidin eller hydroklortiazider kan via hämmad nedbrytning eller minskad njurutsöndring ge ökad koncentration av toxiska metaboliter.\nYtterligare ett antal möjliga interaktioner eller farmakodynamiska interaktioner finns angivna, se FASS. Bland annat omnämns risk för ökade toxiska effekter vid kombination med: Antracykliner, cytarabin, trastuzumab (kardiologisk toxicitet), ACE-hämmare, natalizumab, paklitaxel, zidovudin (hematologisk toxicitet), azatioprin (levertoxicitet), amfotericin B (njurtoxicitet), amiodarone, G-CSF, GM-CSF (lungtoxicitet), tamoxifen (tromboemboliska effekter).\n</PhysicianComment>
    <NurseComment>Villkor och kontroller för administration: Kapecitabin - Kontroll av hand-fotsyndrom och GI-biverkningar efter 1 vecka, därefter enligt individuell bedömning.\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\nÖvrig information: Patienten ska få tydlig information om biverkningar och vikten av att höra av sig för eventuell dosreduktion.\n\n</NurseComment>
    <PharmacistComment/>
    <PatientComment/>
    <ExternalDocumentation/>
    <ExternalPhysicianDoc>https://kunskapsbanken.cancercentrum.se/redirect/regim/1154</ExternalPhysicianDoc>
    <ExternalNurseDoc>https://kunskapsbanken.cancercentrum.se/redirect/regim/1154</ExternalNurseDoc>
    <ExternalPharmacistDoc/>
    <ExternalPatientDoc/>
    <Rounding/>
    <HasSteps/>
  </Details>
  <Miscellaneous>
    <OriginOfExport>Regimbiblioteket</OriginOfExport>
    <IsAuthorized/>
    <CommittedBy/>
    <CreatedBy/>
    <CreatedDate>20260421</CreatedDate>
  </Miscellaneous>
  <Sideeffects>
    <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>
    <Substance Name="cyklofosfamidmonohydrat">
      <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="Cystit" Tillagg="Hemorragisk cystit förekommer, kan bli allvarlig. Dosberoende. Strålbehandling mot blåsa ökar risk. Hydrering viktigt. Eventuellt Mesna som profylax, följ vårdprogram eller behandlingsprotokoll. Enligt ASCO ges Mesna endast vid högdos cyklofosfamid, i Up to Date angivet som 50mg/kg eller 2g/m2. Barn har angett doser över 1 g/m2 som behov av Mesna profylax.">
        <Control Name="Monitorering">
          <SupportingTreatment Name="Hydrering"/>
          <SupportingTreatment Name="Mesna"/>
        </Control>
      </Observandum>
      <Observandum Name="Hög emetogenicitet" Tillagg="Illamående, kräkning vanligt vid högre doser iv (mer än 1500 mg). Antiemetika enligt riktlinjer.">
        <Control Name="Monitorering">
          <SupportingTreatment Name="Antiemetika"/>
        </Control>
      </Observandum>
      <Observandum Name="Tumörlyssyndrom" Tillagg="Tumörlyssyndrom kan uppstå till följd av snabb lys av tumörceller vid vissa sjukdomar under vissa förutsättningar (exempelvis vanligast i uppstartsbehandling). Viktigt att patient är väl hydrerad och har god diures. Som skydd ges eventuellt Allopurinol under behandlingstiden. Vid behov kan antidoten rasburikas (Fasturtec) ges.">
        <Control Name="Urat">
          <SupportingTreatment Name="Hydrering"/>
          <SupportingTreatment Name="Allopurinol"/>
        </Control>
      </Observandum>
      <Observandum Name="Hudtoxicitet" Tillagg="Alopeci (håravfall) förekommer."/>
      <Observandum Name="Interaktionsbenägen substans" Tillagg="Cyklofosfamid aktiveras och metaboliseras via CYP450 systemet.\nSamtidig administrering av cyklofosfamid med CYP450-inducerare kan öka koncentrationen av cytotoxiska metaboliter av cyklofosfamid. (Exempel på CYP450-inducerare är: rifampicin, fenobarbital, karbamazepin, fenytoin, johannesört och kortikosteroider.)\nSamtidig administrering av cyklofosfamid med CYP450-hämmare kan minska aktiveringen av cyklofosfamid och därmed minska effekten. (Exempel på CYP450-hämmare är: amiodaron, aprepitant, bupropion, busulfan, ciprofloxacin, flukonazol, itrakonazol, ketokonazol, klaritromycin, posakonazol, prasugrel, sulfonamider, telitromycin, tiotepa, vorikonazol.)\nSamtidig administrering av cyklofosfamid med allopurinol, cimetidin eller hydroklortiazider kan via hämmad nedbrytning eller minskad njurutsöndring ge ökad koncentration av toxiska metaboliter.\nYtterligare ett antal möjliga interaktioner eller farmakodynamiska interaktioner finns angivna, se FASS. Bland annat omnämns risk för ökade toxiska effekter vid kombination med: Antracykliner, cytarabin, trastuzumab (kardiologisk toxicitet), ACE-hämmare, natalizumab, paklitaxel, zidovudin (hematologisk toxicitet), azatioprin (levertoxicitet), amfotericin B (njurtoxicitet), amiodarone, G-CSF, GM-CSF (lungtoxicitet), tamoxifen (tromboemboliska effekter)."/>
    </Substance>
  </Sideeffects>
  <Diagnoses>
    <Diagnose Text="Bröstcancer"/>
  </Diagnoses>
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</CourseDefinition>
