promacta(eltrombopag)-艾曲波帕使用说明书

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1、HIGHLIGHTSOFPRESCRIBINGINFORMATIONChronicHepatitisC-associatedThrombocytopenia:InitiateThesehighlightsdonotincludealltheinformationneededtousePROMACTAat25mgoncedailyforallpatients.AdjusttoachievetargetPROMACTAsafelyandeffectively.Seefullprescribinginformationfo

2、rplateletcountrequiredtoinitiateantiviraltherapy.DonotexceedadailyPROMACTA.doseof100mg.(2.2)SevereAplasticAnemia:InitiatePROMACTAat50mgoncedailyforPROMACTA(eltrombopag)tablets,fororalusemostpatients.ReduceinitialdoseinpatientswithhepaticimpairmentorPROMACTA(elt

3、rombopag)fororalsuspensionpatientsofEastAsianancestry.AdjusttomaintainplateletcountgreaterInitialU.S.Approval:20089than50x10/L.Donotexceed150mgperday.(2.3,8.6,8.8)---------------------DOSAGEFORMSANDSTRENGTHS---------------------WARNING:RISKFORHEPATICDECOMPENSATI

4、ONINPATIENTSTablets:12.5mg,25mg,50mg,75mg,and100mg(3)WITHCHRONICHEPATITISCFororalsuspension:25mg(3)Seefullprescribinginformationforcompleteboxedwarning.-------------------------------CONTRAINDICATIONS-------------------------------Inpatientswithchronichepatiti

5、sC,PROMACTAincombinationwithNone.(4)interferonandribavirinmayincreasetheriskofhepaticdecompensation.-----------------------WARNINGSANDPRECAUTIONS-----------------------(5.1)Hepatotoxicity:Monitorliverfunctionbeforeandduringtherapy.(5.2)-------------------------

6、--RECENTMAJORCHANGES---------------------------Thrombotic/ThromboembolicComplications:PortalveinthrombosishasIndicationsandUsage,TreatmentofThrombocytopeniain08/2015beenreportedinpatientswithchronicliverdiseasereceivingPROMACTA.PatientswithChronicITP(1.1)Monito

7、rplateletcountsregularly.(5.3)IndicationsandUsage,TreatmentofSevereAplasticAnemia08/2014------------------------------ADVERSEREACTIONS------------------------------(1.3)InadultpatientswithITP,themostcommonadversereactions(greaterDosageandAdministration,ChronicI

8、mmune(Idiopathic)08/2015thanorequalto5%andgreaterthanplacebo)were:nausea,diarrhea,Thrombocytopenia(2.1)upperrespiratorytractinfection,vomiting,increasedALT,myalgia,an