BLINCYTO-双特异性抗体-处方

HIGHLIGHTSOFPRESCRIBINGINFORMATIONThesehighlightsdonotincludealltheinformationneededtouseBLINCYTOTMsafelyandeffectively.SeefullprescribinginformationforBLINCYTO.BLINCYTO(blinatumomab)forinjection,forintravenoususeInitialU.S.Approval:2014---------------------------INDICATIONSANDUSAGE----------------------------BLINCYTOisabispecificCD19-directedCD3T-cellengagerindicatedforthetreatmentofPhiladelphiachromosome-negativerelapsedorrefractoryB-cellprecursoracutelymphoblasticleukemia(ALL).Thisindicationisapprovedunderacceleratedapproval.Continuedapprovalforthisindicationmaybecontingentuponverificationofclinicalbenefitinsubsequenttrials.(1)-----------------------DOSAGEANDADMINISTRATION-----------------------Dosage-Hospitalizationisrecommendedforthefirst9daysofthefirstcycleandthefirst2daysofthesecondcycle.(2)-Asinglecycleoftreatmentconsistsof4weeksofcontinuousintravenousinfusionfollowedbya2-weektreatment-freeinterval.(2.1)-Forpatientsatleast45kginweight,inCycle1,administerBLINCYTOat9mcg/dayonDays1–7andat28mcg/dayonDays8–28.Forsubsequentcycles,administerBLINCYTOat28mcg/dayonDays1–28.(2.1)Administration-Premedicatewithdexamethasone20mgintravenously1hourpriortothefirstdoseofBLINCYTOofeachcycle,priortoastepdose(suchasCycle1day8),orwhenrestartinganinfusionafteraninterruptionof4ormorehours.(2.2)-Administerasacontinuousintravenousinfusionataconstantflowrateusinganinfusionpump.(2.2)-TheIVbagshouldbeinfusedover24hoursor48hours.(2.2)-BLINCYTOshouldbeinfusedthroughadedicatedlumen.(2.2)Preparation-IVSolutionStabilizerisprovidedandisusedtocoattheprefilledIVbagpriortoadditionofreconstitutedBLINCYTO.(2.4)-ReconstituteBLINCYTOwithSterileWaterforInjection,USP,only.(2.4)-AseptictechniquemustbestrictlyobservedwhenpreparingthesolutionforinfusionsinceBLINCYTOdoesnotcontainantimicrobialpreservatives.(2.4)-Usethespecificvolumesdescribedintheadmixinginstructions.(2.4)---------------------DOSAGEFORMSANDSTRENGTHS----------------------Forinjection:35mcgoflyophilizedpowderinasingle-usevialforreconstitution.(3)-------------------------------CONTRAINDICATIONS------------------------------Knownhypersensitivitytoblinatumomabortoanycomponentoftheproductformulation.(4)---------------------------WARNINGSANDPRECAUTIONS--------------------Infections:Monitorpatientsforsignsorsymptomsandtreatappropriately.(5.3)EffectsonAbilitytoDriveandUseMachines:AdvisepatientstorefrainfromdrivingandengaginginhazardousoccupationsoractivitiessuchasoperatingheavyorpotentiallydangerousmachinerywhileBLINCYTOisbeingadministered.(5.6)PreparationandAdministrationErrors:Strictlyfollowinstructionsforpreparation(includingadmixing)andadministration.(5.9)------------------------------ADVERSEREACTIONS-------------------------------Themostcommonadversereactions(≥20%)werepyrexia,headache,peripheraledema,febrileneutropenia,nausea,hypokalemia,tremor,rash,andconstipation.(6.1)ToreportSUSPECTEDADVERSEREACTIONS,contactAmgenInc.at1-800-77-AMGEN(1-800-772-6436)orFDAat1-800-FDA-1088or(8.4)See17forPATIENTCOUNSELINGINFORMATIONandMedicationGuide.Revised:12/2014FULLPRESCRIBINGINFORMATION:CONTENTS*WARNING:CYTOKINERELEASESYNDROMEandNEUROLOGICALTOXICITIES1. INDICATIONSANDUSAGE 2. DOSAGEANDADMINISTRATION 2.1 Dosage 2.2Administration2.3DosageAdjustments 2.4 ReconstitutionandPreparationofSolutionforInfusion 2.5StorageRequirements3. DOSAGEFORMSANDSTRENGTHS 4. CONTRAINDICATIONS 5. WARNINGSANDPRECAUTIONS 5.1 CytokineReleaseSyndrome 5.2 NeurologicalToxicities5.3Infections5.4 TumorLysisSyndrome 5.5 NeutropeniaandFebrileNeutropenia5.6 EffectsonAbilitytoDriveandUseMachines 5.7 ElevatedLiverEnzymes 5.8 Leukoencephalopathy5.9PreparationandAdministrationErrors6. ADVERSEREACTIONS 6.1 ClinicalTrialsExperience 6.2 Immunogenicity 7. DRUGINTERACTIONS 8. USEINSPECIFICPOPULATIONS 8.1 Pregnancy 8.3 Lactation 8.4 PediatricUse 8.5 GeriatricUse 8.6 HepaticImpairment 8.7 RenalImpairment 10. OVERDOSAGE 11. DESCRIPTION 12. CLINICALPHARMACOLOGY 12.1 MechanismofAction 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13. NONCLINICALTOXICOLOGY 13.1 Carcinogenesis,Mutagenesis,ImpairmentofFertility 14. CLINICALSTUDIES 14.1 AcuteLymphoblasticLeukemia 16. HOWSUPPLIED/STORAGEANDHANDLING 16.1 HowSupplied 16.2 StorageandHandling 17. PATIENTCOUNSELINGINFORMATION*Sectionsorsubsectionsomittedfromthefullprescribinginformationarenotlisted.WARNING:CYTOKINERELEASESYNDROMEandNEUROLOGICALTOXICITIESSeefullprescribinginformationforcompleteboxedwarning.CytokineReleaseSyndrome(CRS),whichmaybelife-threateningorfatal,occurredinpatientsreceivingBLINCYTO.InterruptordiscontinueBLINCYTOasrecommended.(2.3),(5.1)Neurologicaltoxicities,whichmaybesevere,life-threatening,orfatal,occurredinpatientsreceivingBLINCYTO.InterruptordiscontinueBLINCYTOasrecommended.(2.3),(5.2)2FULLPRESCRIBINGINFORMATION1.INDICATIONSANDUSAGEBLINCYTOisindicatedforthetreatmentofPhiladelphiachromosome-negativerelapsedorrefractoryB-cellprecursoracutely