贝伐珠单抗注射液说明书FDA-GENENTECH

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1、LimitationofUse:AvastinisnotindicatedforadjuvanttreatmentofcolonHIGHLIGHTSOFPRESCRIBINGINFORMATIONcancer.(1.1)ThesehighlightsdonotincludealltheinformationneededtouseAVASTINsafelyandeffectively.Seefullprescribinginformationfor------------------------DOSAGEANDADMINISTRATION------------

2、---------AVASTIN.•DonotadministerasanIVpushorbolus.(2.1)•DonotinitiateAvastinfor28daysfollowingmajorsurgeryanduntilAVASTIN(bevacizumab)surgicalwoundisfullyhealed.(2.1)SolutionforintravenousinfusionMetastaticcolorectalcancer(2.2)InitialU.S.Approval:2004•5mg/kgIVevery2weekswithbolus-I

3、FL•10mg/kgIVevery2weekswithFOLFOX4•5mg/kgIVevery2weeksor7.5mg/kgIVevery3weekswithWARNING:GASTROINTESTINALPERFORATIONS,SURGERYfluoropyrimidine-irinotecanorfluoropyrimidine-oxaliplatinbasedANDWOUNDHEALINGCOMPLICATIONS,andHEMORRHAGEchemotherapyafterprogressiononafirst-lineAvastincontain

4、ingregimenSeefullprescribinginformationforcompleteboxedwarning.Nonsquamousnonsmallcelllungcancer(2.2)GastrointestinalPerforation:Occursinupto3.2%of•15mg/kgIVevery3weekswithcarboplatin/paclitaxelAvastin-treatedpatients.DiscontinueAvastinforgastrointestinalGlioblastoma(2.2)perforati

5、on.(5.1)•10mg/kgIVevery2weeksSurgeryandWoundHealingComplications:DiscontinueinMetastaticrenalcellcarcinoma(mRCC)(2.2)patientswithwounddehiscence.Discontinueatleast28daysprior•10mg/kgIVevery2weekswithinterferonalfatoelectivesurgery.DonotinitiateAvastinforatleast28daysafterPersistent,

6、recurrent,ormetastaticcarcinomaofthecervix(2.2)surgeryanduntilthesurgicalwoundisfullyhealed.(5.3)•15mg/kgIVevery3weekswithpaclitaxel/cisplatinorHemorrhage:Severeorfatalhemorrhage,hemoptysis,paclitaxel/topotecangastrointestinalbleeding,CNShemorrhage,andvaginalbleedingPlatinum-resista

7、ntrecurrentepithelialovarian,fallopiantubeorprimaryareincreasedinAvastin-treatedpatients.Donotadministerperitonealcancer(2.2)Avastintopatientswithserioushemorrhageorrecenthemoptysis.•10mg/kgIVevery2weekswithpaclitaxel,pegylatedliposomal(5.4)doxorubicinorweeklytopotecan•15mg/kgIVevery

8、3weekswithto