Chemotherapy_ Drugs E-O Policy (chemo drug e-o).doc
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Chemotherapy_ Drugs E-O Policy (chemo drug e-o).doc

Chemotherapy_DrugsE-OPolicy(chemodruge-o).doc

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locatorkeychemodruge-oChemotherapy:DrugsE-OPolicy2–SectionTitleMayWraptotheNextLineIfTooLongUmbrellaCommunity–ManualTitle000WrapSectionTitleMonth20062–Chemotherapy:DrugsE-OPolicyFebruary20122–DrugUseReview(DUR)ProgramApril2001Thissectioncontainspolicyrelatedtobillingforinjectionservices,listedinalphabeticalorderbygenericdrugnameordrugtype.Forgeneralbillingpolicyinformationregardinginjectionsservices,refertotheChemotherapy:AnOverviewsectioninthismanual.AdditionalpolicyinformationforchemotherapydrugservicescanbefoundintheChemotherapy:DrugsE-OandChemotherapy:P-Zsectionsinthismanual.Eculizumab(Soliris®)EculizumabisarecombinanthumanizedmonoclonalIgG2/4κantibodyproducedbymurinemyelomacellcultureandpurifiedbystandardbioprocesstechnology.ItisamonoclonalantibodythatspecificallybindstothecomplementproteinC5withhighaffinity,therebyinhibitingitscleavagetoC5aandC5bandpreventingthegenerationoftheterminalcomplementcomplexC5b-9.Eculizumabinhibitsterminalcomplementmediatedintravascularhemolysisinparoxysmalnocturnalhemoglobinuria(PNH)patientsandcomplementmediatedthromboticmicroangiopathyinpatientswithatypicalhemolyticuremicsyndrome(aHUS).IndicationsEculizumabisindicatedfor:ThetreatmentofadultpatientswithPNHtoreducehemolysisThetreatmentofpediatricandadultpatientswithaHUStoinhibitcomplement-mediatedthromboticmicroangiopathyLimitationofUseEculizumabisnotindicatedforthetreatmentofpatientswithShigatoxinE.colirelatedhemolyticuremicsyndrome.DosageWhentreatingpatientforeitherPNHoraHUS,eculizumabshouldbeadministeredattherecommendeddosageregimentimepoints,orwithintwodaysofthesetimepoints.PNHTherecommendeddoseis:600mgweeklyforthefirstfourweeks,followedby900mgforthefifthdoseoneweeklater,then900mgeverytwoweeksthereafteraHUSTherecommendeddoseinpatients18yearsofageandolderis:900mgweeklyforthefirstfourweeks,followedby1200mgforthefifthdoseoneweeklater,then1200mgeverytwoweeksthereafterForpatientslessthan18yearsofage,pleasereviewtheappropriateliteraturef