培美曲塞说明书-英文-FDA

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1、HIGHLIGHTSOFPRESCRIBINGINFORMATION-------------------------------CONTRAINDICATIONS------------------------------ThesehighlightsdonotincludealltheinformationneededtouseHistoryofseverehypersensitivityreactiontopemetrexed.(4)ALIMTAsafelyandeffectively.Seefullprescribing

2、informationfor------------------------WARNINGSANDPRECAUTIONS-----------------------ALIMTA.•Premedicationregimen:InstructpatientstotakefolicacidandALIMTA(pemetrexeddisodium)Injection,Powder,Lyophilized,ForvitaminB12.PretreatmentwithdexamethasoneorequivalentreducesSolu

3、tionforIntravenoususecutaneousreaction.(5.1)InitialU.S.Approval:2004•Bonemarrowsuppression:Reducedosesforsubsequentcyclesbasedonhematologicandnonhematologictoxicities.(5.2)---------------------------RECENTMAJORCHANGES--------------------------•Renalfunction:Donotadmi

4、nisterwhenCrCl<45mL/min.(2.4,5.3)IndicationsandUsage,Non-SmallCellLungCancer—Combinationwith•NSAIDswithrenalinsufficiency:UsecautioninpatientswithmildtoCisplatin(1.1)09/2008moderaterenalinsufficiency(CrCl45-79mL/min).(5.4)3•Labmonitoring:DonotbeginnextcycleunlessANCu

5、1500cells/mm,IndicationsandUsage,Non-SmallCellLungCancer—Single-Agent(1.2)3plateletsu100,000cells/mm,andCrClu45mL/min.(5.5)09/2008•Pregnancy:FetalharmcanoccurwhenadministeredtoapregnantDosageandAdministrationCombinationUsewithCisplatin(2.1)09/2008woman.Womenshouldbea

6、dvisedtouseeffectivecontraceptionmeasurestopreventpregnancyduringtreatmentwithALIMTA.(5.6)----------------------------INDICATIONSANDUSAGE---------------------------ALIMTA®isafolateanalogmetabolicinhibitorindicatedfor:-------------------------------ADVERSEREACTIONS---

7、---------------------------•NonsquamousNon-SmallCellLungCancer:initialtreatmentinThemostcommonadversereactions(incidenceu20%)withsingle-agentusecombinationwithcisplatin.(1.1)arefatigue,nausea,andanorexia.Additionalcommonadversereactionswhen•NonsquamousNon-SmallCellLu

8、ngCancerasasingle-agentafterpriorusedincombinationwithcisplatinincludevomiting,neutropenia,leukopenia,chemotherapy(1.2)anemia,stoma