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<CourseDefinition>
  <Schema>
    <Version>3.0</Version>
    <Date>20120717</Date>
  </Schema>
  <Details>
    <RegimId>NRB-2512</RegimId>
    <Name>Alektinib</Name>
    <ShortName/>
    <MajorVersion>1</MajorVersion>
    <MinorVersion>8</MinorVersion>
    <DefinitionStatus>COMPLETED</DefinitionStatus>
    <PatientMaxSurface/>
    <CourseICDZCode>NONE</CourseICDZCode>
    <CourseAUC>0.00</CourseAUC>
    <MaxAge/>
    <CycleLength/>
    <ValidForAllDiagnoses/>
    <IsStudyDefinition>NO</IsStudyDefinition>
    <PhysicianComment>Villkor för start av regimen: ALK-positiv NSCLC status ska fastställas.\nKontroll av blod-, lever och elektrolytstatus inkl. kreatinin.\n\nAnvisningar för ordination: Kontroll av blod-, lever och elektrolytstatus inkl. kreatinin.\n\nKapslar finns i styrkan 150 mg.\n\nDosreduktion rekommendation: Vid biverkningar görs dosreduktion, tillfälligt uppehåll eller utsättning av preparatet. I första steg doseras Alektinib till 450 mg x 2 dagligen. I nästa steg doseras Alektinib 300 mg x 2 dagligen. Se FASS för dosjusteringar.\n\nEmetogenicitet:Låg.\n\nBehandlingsöversikt: Kontinuerlig behandling.\nVid adjuvant behandling av resekterad icke-småcellig lungcancer (NSCLC) pågår behandlingen i högst 2 år. .\n\nDiagnoskod: C34.\n\nBiverkningar för substanser i regimen\nalektinib\nHematologisk toxicitet(Anemi vanligt, oftast grad 1-2.\nAndningsvägar(Fallrapporter om interstitiell lungsjukdom finns.\nLevertoxicitet(Förhöjda transaminaser vanligt, kan bli grad 3-4.  Kontroll av leverfunktion med ALAT, ASAT och totalt bilirubin bör ske före behandlingsstart och därefter kontinuerligt, se FASS. Tillfälligt uppehåll, dosjustering eller permanent utsättning vid förhöjda värden, se FASS.\nÖvrigt(Muskelsmärta (myalgi) vanligt, kan bli uttalad. Kreatinfosfokinas (CK) förhöjningar vanligt. Eventuell dosjusteringsbehov, se FASS.\nHjärttoxicitet(Symtomatisk bradykardi förekommer.\nGastrointestinal påverkan(Förstoppning mycket vanligt. Illamående, kräkning och diarre vanligt. Stomatit förekommer.\nHudtoxicitet(Hudutslag vanligt. Fotosensitivitet har rapporterats. Undvik långvarig soljusexponering under behandlingen till och med 7 dagar efter behandlingens avslut.\nÖvrigt(Ödem vanligt.\nNjurtoxicitet(Förhöjningar av kreatinin förekommer. Njursvikt har rapporterats.\nGraviditetsvarning(Kan orsaka fosterskador. Effektiva preventivmedel måste användas av fertila kvinnliga patienter under behandlingen och minst tre månader efter sista dosen av Alektinib.\nInteraktionsbenägen substans(Vid samtidig administrering av starka CYP3A4-inducerare med Alektinib rekommenderas lämplig övervakning, viss påverkan på koncentration skulle kunna förekomma, men det är olika effekt på substans och aktiv metabolit, se FASS.(Exempel på starka CYP3A4-inducerare är: karbamazepin, fenobarbital, fenytoin, rifabutin, rifampicin och Johannesört (hypericum perforatum).)\nVid samtidig administrering av starka CYP3A4-hämmare med Alektinib rekommenderas lämplig övervakning, viss påverkan på koncentration skulle kunna förekomma, men det är olika effekt på substans och aktiv metabolit, se FASS.(Exempel på starka CYP3A4-hämmare är: ritonavir, sakvinavir, telitromycin, ketokonazol, itrakonazol, vorikonazol, posakonazol nefazodon, grapefrukt och pomerans.)\nVid samtidig administrering av P-gp-substrat med Alektinib rekommenderas lämplig övervakning, då ökning av plasmakoncentration av P-gp-substrat skulle kunna öka. (Exempel på P-gp-substrat är: digoxin, dabigatranetexilat, topotekan, sirolimus, everolimus, nilotinib och lapatinib.)\nVid samtidig administrering av BCRP-substrat med Alektinib rekommenderas lämplig övervakning, då ökning av plasmakoncentration av BCRP-substrat skulle kunna öka. (Exempel på BCRP-substrat är: metotrexat, mitoxantron, topotekan och lapatinib.)\n</PhysicianComment>
    <NurseComment>Villkor och kontroller för administration: Undvik samtidigt intag av grapefrukt, grapefruktjuice och johannesört under pågående behandling.\nOm en dos missats ska den endast tas om det är mer än 6 timmar kvar till nästa planerade dos.\nVid kräkning ska nästa dos tas vid den schemalagda tiden.\n\nInformation från basfakta för substanser i regimen\nalektinib\nDosering i förhållande till måltid: Tas i samband med måltid\n\n</NurseComment>
    <PharmacistComment/>
    <PatientComment/>
    <ExternalDocumentation/>
    <ExternalPhysicianDoc>https://kunskapsbanken.cancercentrum.se/redirect/regim/2512</ExternalPhysicianDoc>
    <ExternalNurseDoc>https://kunskapsbanken.cancercentrum.se/redirect/regim/2512</ExternalNurseDoc>
    <ExternalPharmacistDoc/>
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  </Details>
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    <OriginOfExport>Regimbiblioteket</OriginOfExport>
    <IsAuthorized/>
    <CommittedBy/>
    <CreatedBy/>
    <CreatedDate>20260421</CreatedDate>
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    <Substance Name="alektinib">
      <Observandum Name="Hematologisk toxicitet" Tillagg="Anemi vanligt, oftast grad 1-2."/>
      <Observandum Name="Andningsvägar" Tillagg="Fallrapporter om interstitiell lungsjukdom finns."/>
      <Observandum Name="Levertoxicitet" Tillagg="Förhöjda transaminaser vanligt, kan bli grad 3-4.  Kontroll av leverfunktion med ALAT, ASAT och totalt bilirubin bör ske före behandlingsstart och därefter kontinuerligt, se FASS. Tillfälligt uppehåll, dosjustering eller permanent utsättning vid förhöjda värden, se FASS."/>
      <Observandum Name="Övrigt" Tillagg="Muskelsmärta (myalgi) vanligt, kan bli uttalad. Kreatinfosfokinas (CK) förhöjningar vanligt. Eventuell dosjusteringsbehov, se FASS."/>
      <Observandum Name="Hjärttoxicitet" Tillagg="Symtomatisk bradykardi förekommer."/>
      <Observandum Name="Gastrointestinal påverkan" Tillagg="Förstoppning mycket vanligt. Illamående, kräkning och diarre vanligt. Stomatit förekommer."/>
      <Observandum Name="Hudtoxicitet" Tillagg="Hudutslag vanligt. Fotosensitivitet har rapporterats. Undvik långvarig soljusexponering under behandlingen till och med 7 dagar efter behandlingens avslut."/>
      <Observandum Name="Övrigt" Tillagg="Ödem vanligt."/>
      <Observandum Name="Njurtoxicitet" Tillagg="Förhöjningar av kreatinin förekommer. Njursvikt har rapporterats."/>
      <Observandum Name="Graviditetsvarning" Tillagg="Kan orsaka fosterskador. Effektiva preventivmedel måste användas av fertila kvinnliga patienter under behandlingen och minst tre månader efter sista dosen av Alektinib."/>
      <Observandum Name="Interaktionsbenägen substans" Tillagg="Vid samtidig administrering av starka CYP3A4-inducerare med Alektinib rekommenderas lämplig övervakning, viss påverkan på koncentration skulle kunna förekomma, men det är olika effekt på substans och aktiv metabolit, se FASS.(Exempel på starka CYP3A4-inducerare är: karbamazepin, fenobarbital, fenytoin, rifabutin, rifampicin och Johannesört (hypericum perforatum).)\nVid samtidig administrering av starka CYP3A4-hämmare med Alektinib rekommenderas lämplig övervakning, viss påverkan på koncentration skulle kunna förekomma, men det är olika effekt på substans och aktiv metabolit, se FASS.(Exempel på starka CYP3A4-hämmare är: ritonavir, sakvinavir, telitromycin, ketokonazol, itrakonazol, vorikonazol, posakonazol nefazodon, grapefrukt och pomerans.)\nVid samtidig administrering av P-gp-substrat med Alektinib rekommenderas lämplig övervakning, då ökning av plasmakoncentration av P-gp-substrat skulle kunna öka. (Exempel på P-gp-substrat är: digoxin, dabigatranetexilat, topotekan, sirolimus, everolimus, nilotinib och lapatinib.)\nVid samtidig administrering av BCRP-substrat med Alektinib rekommenderas lämplig övervakning, då ökning av plasmakoncentration av BCRP-substrat skulle kunna öka. (Exempel på BCRP-substrat är: metotrexat, mitoxantron, topotekan och lapatinib.)"/>
    </Substance>
  </Sideeffects>
  <Diagnoses>
    <Diagnose Text="Lungcancer"/>
  </Diagnoses>
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</CourseDefinition>
