阿法依泊汀注射液说明书

阿法依泊汀注射液|PROCRIT(Epoetinalfa）【中文品名】阿法依泊汀【药效类别】抗贫血药【通用药名】EPOETINALFA【别名】EPO,Epoade,Epogen,Eprex,Erypo,Erythropoietin,Espo,Globuren,KRN-5702E,Procrit【化学名称】1-165-Erythropoietin(humancloneIambdaHEPOFL13proteinmoiety),glycoformα【CA登记号】[113427-24-0]【结构式】【分子式】CHNOPS·【分子量】【收录药典】【开发单位】Amgen【首次上市】1989年，美国【性状】【用途】一种重组促红细胞生成素，用于依赖透析的慢性肾衰相关的贫血。还用于癌症病人由于化疗引起的贫血。(促红细胞生成素-αepoetinepo，利血宝，怡泼津)本品是一种刺激红细胞生成的糖蛋白。它是应用dna重组技术及细胞培养技术而制成的人类红细胞生成素-α，与内源性红细胞生成素有相同的生物活性。【药理作用】红细胞生成素在红细胞系发育的其后各阶段的作用，包括对原始红细胞刺激增加合成血红蛋白，当激素处于高浓度时，加速网织红细胞由骨髓向循环释放。内源性红细胞生成素主要由肾脏产生，慢性肾衰病人红细胞生成素的产生受到抑制因而不足，是这类病人贫血的原发因素。红细胞生成素对包括需要透析和不需要经常透析的慢性肾衰贫血病人可刺激红细胞生成。【药代动力学】慢性肾衰病人静脉给药循环半衰期大约为4～13h。肝脏是主要的清除途径，肾脏是清除的次要途径。【适应症】慢性肾衰伴有贫血的病人(包括透析和不透析的病人)，也用于多发性骨髓瘤相关的贫血和骨髓增生异常及癌症引起的贫血。【用法与用量】开始剂量：3000u，静注，每周3次，然后根据病情逐渐减少至维持量1500u，静注，每周2～3次：最高维持剂量不得超过3000u/次，每周3次。【不良反应】不良反应：偶可发生血压升高，心悸、高血压性脑病、头痛、头晕、发热、关节痛、肌肉痛、恶心、呕吐、腹泻、got及gpt升高、瘙痒、皮疹、过敏性休克。【注意事项】①用药期间应定期检查血红蛋白浓度与红细胞比容值(血红蛋白浓度不超过12g/dl或红细胞比容值36%以上)。密切观察血压变化情况，防止高血压性脑病发生，②使用本品应注意补充铁质。③本品应慎用于心肌梗塞、肺梗塞、脑梗塞、高血压、孕妇、儿童或有过敏倾向的病人。【制剂、规格及参考单价】注射液：1500u/瓶，3000u/瓶，EPOGEN®(Epoetinalfa)isusedtotreatalowerthannormalnumberofredbloodcells(anemia)causedbychronickidneyfailureinpatientsondialysis.EPOGEN®stimulatesthebonemarrowtomakemoreredbloodcellsandlessenstheneedforredbloodcelltransfusions.Havingmoreredbloodcellsraisesthehemoglobinlevel.EPOGEN®shouldnotbeusedfortreatmentofanemiainplaceofemergencytreatment(redbloodcelltransfusions).ImportantSafetyInformationUsingEPOGEN®canleadtodeathorotherserioussideeffects.Allpatients,includingpatientswithcancerorchronickidneyfailure:Youmaygetseriousheartproblemssuchasheartattack,stroke,heartfailure,andmaydiesoonerifyouaretreatedwithEPOGEN®toahemoglobinlevelabove12g/dL.SerioushealthproblemsmayhappenevenifyoutakeEPOGEN®anddonothaveanincreaseinyourhemoglobinlevel.Yourdoctorshouldmonitoryourhemoglobinregularly.YoumaygetbloodclotsatanytimewhiletakingEPOGEN®.Ifyouaregoingtohavesurgery,talktoyourhealthcareprovideraboutwhetheryouwillneedabloodthinnertolessenthechanceofbloodclotsduringorfollowingsurgery.Callyourhealthcareproviderorgetmedicalhelprightawayifyouhavesymptomsofbloodclotssuchaschestpain;troublebreathingorshortnessofbreath;painorswellinginyourlegs;armorlegfeelscoolorappearspale;suddenconfusionortroublewithspeech;suddennumbnessorweaknessinyourface,arm,orleg;suddentroubleseeing;suddendizzinessortroublewithwalkingorbalance;lossofconsciousness(fainting);yourhemodialysisvascularaccessstopsworking.Patientswithcancer:YourhealthcareproviderhasreceivedspecialtrainingthroughtheESAAPPRISEOncologyPrograminordertoprescribeEPOGEN®.BeforeyoucanbegintoreceiveEPOGEN®,youmustsigntheESAAPPRISEOncologyPatientandHealthcareProfessional(HCP)AcknowledgementFormtodocumentthatyourhealthcareproviderdiscussedtherisksofEPOGEN®withyou.Whenyousignthisform,youarestatingthatyouareawareoftherisksassociatedwithuseofEPOGEN®.Ifyouhavebreast,non-smallcelllung,headandneck,lymphoid,orcervicalcancer,yourtumormaygrowfasterandyoumaydiesoonerwhenEPOGEN®isusedexperimentallytotrytoraiseyourhemoglobinbeyondtheamountneededtoavoidredbloodcelltransfusion,orifyouaretakingEPOGEN®andnotgettingstrongdosesofchemotherapy.ItisnotknownwhethertheserisksexistwhenEPOGEN®isgivenaccordingtotheFDA-approveddirectionsforuse.YourhealthcareprovidershouldprescribethesmallestdoseofEPOGEN®tolowerthechanceofgettingredbloodcelltransfusionsAfteryouhavefinishedyourchemotherapycourse,EPOGEN®treatmentshouldbestoppedYoushouldnottakeEPOGEN®ifyou:HavecancerandhavenotbeencounseledbyyourhealthcareproviderregardingtherisksofEPOGEN®andsignedtheESAAPPRISEOncologyProgramPatientandHealthcareProfessional(HCP)AcknowledgementFormbeforeyoubegintoreceiveEPOGEN®.Havehighbloodpressurethatisnotcontrolled(uncontrolledhypertension).HavebeentoldbyyourhealthcareproviderthatyouhaveorhaveeverhadatypeofanemiacalledPureRedCellAplasia(PRCA)thatstartsaftertreatmentwithEPOGEN®orothererythropoietinmedicines.HaveallergiestoanyoftheingredientsinEPOGEN®.DonotgiveEPOGEN®frommultidosevialstoprematurebabies.Othersideeffects,whichmayalsobeserious,include:Highbloodpressureinpatientswithchronickidneyfailure.YourbloodpressuremaygouporbedifficulttocontrolwithbloodpressuremedicinewhiletakingEPOGEN®.Thiscanhappenevenifyouhaveneverhadhighbloodpressurebefore.Yourhealthcareprovidershouldcheckyourbloodpressureoften.Seizures.SeizureshaveoccurredinpatientstakingEPOGEN®.Ifyouhaveaseizure,getmedicalhelprightaway.AntibodiestoEPOGEN®.YourbodymaymakeantibodiestoEPOGEN®thatcanblockorlessenyourbody’sabilitytomakeredbloodcellsandcauseyoutohavesevereanemia.Callyourhealthcareproviderifyouhavesignsofanemiasuchasunusualtiredness,lackofenergy,dizziness,orfainting.Seriousallergicreactions.Seriousallergicreactionscancausearashoveryourwholebody,shortnessofbreath,dizziness,andfaintingbecauseofadropinbloodpressure,swellingaroundyourmouthoreyes,fastpulse,orsweating.Ifyouhavesuchareaction,stopusingEPOGEN®andgetmedicalhelprightaway.DangersofgivingEPOGEN®toprematurebabies.EPOGEN®frommulti-dosevialscontainsbenzylalcoholandshouldnotbegiventop