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SHENGCHANCHANGJIA: ZHENGDATIANQINGYAOYEJITUANGUFENYOUXIANGONGSI

PIZHUNWENHAO:GUOYAOZHUNZIH20193278

YAOPINGUIGE:100mg

YAOPINJIAGE:¥996YUAN

注射用阿扎胞苷
藥師來電

注射用阿扎胞苷的說明書

【SHANGPINMING】

【TONGYONGMINGCHENG】ZHUSHEYONGAZHABAOGAN

【YINGWENMINGCHENG】Azacitidine for Injection

【HANYUPINYIN】Zhu She Yong A Zha Bao Gan

【CHENGFEN】

AZHABAOGAN。

HUAXUEMINGCHENG:4-ANJI-1-β-D-FUHEYAXIAONIAO-s-SANQIN-2(1H)-TONG

HUAXUEJIEGOUSHI:

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分子式:C8H12N4O5

FENZILIANG:244

斗牛棋牌BENPINZHONGSUOYONGFULIAOWEIGANLUCHUN。

【XINGZHUANG】

斗牛棋牌BENPINWEIBAISESHUSONGKUAIZHUANGWUHUOFENMO。

【SHIYINGZHENG】

BENPINSHIYONGYUYIXIACHENGNIANHUANZHE:

·GUOJIYUHOUPINGFENXITONG(IPSS)ZHONGDEZHONGWEI-2JIGAOWEIGUSUIZENGSHENGYICHANGZONGHEZHENG(MDS),

斗牛棋牌·MANXINGLI-DANHEXIBAOBAIXUEBING(CMML),

·ANZHAOSHIJIEWEISHENGZUZHI(WHO)FENLEIDEJIXINGSUIXIBAIXUEBING(AML)、GUSUIYUANSHIXIBAOWEI20-30%BANDUOXIFAYUZAOCHANG。

【YONGFAYONGLIANG】

1.SHOUGEZHILIAOZHOUQI

對于所有患者,不考慮基線血液學實驗室檢查值如何,首個治療周期的推薦起始劑量為75mg/m2斗牛棋牌,每天經皮下給藥,共7天。給予患者預防用藥,以預防惡心和嘔吐。

斗牛棋牌SHOUCIGEIYAOQIANYINGDANGSHOUJIHUANZHEQUANXUEXIBAOJISHU、GANZANGSHENGHUAZHIBIAOHEXUEQINGJIGANZHI。

2.HOUXUZHILIAOZHOUQI

斗牛棋牌MEI4ZHOUWEIYIZHILIAOZHOUQI。JIANYIHUANZHEZHISHAOJIESHOU6GEZHOUQIDEZHILIAO。DANDUIYUWANQUANHUOBUFENHUANJIEDEHUANZHEKENENGXUYAOZENGJIAZHILIAOZHOUQI。ZHIYAOHUANZHECHIXUSHOUYI,JIKECHIXUZHILIAO。

斗牛棋牌YINGDANGJIANCEHUANZHEDEXUEYEXUEHUANJIEQINGKUANGHESHENZANGDUXING(JIAN【ZHUYISHIXIANG】),KENENGYOUBIYAOANZHAOXIAWENSUOSHUYANCHIGEIYAOHUOJIANXIAOJILIANG。

3.JIYUXUEYEXUESHIYANSHIJIANCHAZHIJINXINGJILIANGDIAOZHENG

·對于基線(治療開始)WBC≥3.0*109/L、ANC≥1.5*109/L,且血小板≥75.0X109斗牛棋牌/L的患者,基于任何治療周期的最低值計數,劑量調整如下:

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· 對于基線計數為WBC<3.0*109/L、ANC<1.5*109/L或血小板<75.0*109斗牛棋牌/L的患者,劑量調整應當基于最低值計數和最低值時骨髓活組織檢查細胞構成。如下文所述,除非下一個周期時細胞分化有明顯改善(成熟粒細胞的百分比值高,ANC高于療程起始時),則應當繼續使用當前治療的劑量。

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RUGUOFASHENGLEERBIAOZHONGDINGYIDEZUIDIZHI,RUGUOSUIHOUWBCHEXUEXIAOBANJISHUJUNBIZUIDIZHIZENGGAO>25%QIEZHENGZAISHENGGAO,ZEXIAYIGELIAOCHENGYINGDANGZAIQIANYILIAOCHENGKAISHIHOU28TIANJINXING。RUGUOQIANYIGEZHOUQIZHONG,ZHIZHIDI28TIANSHIJUNMEIYOUGUANCHADAOJIAOZUIDIZHIZENGJIA>25%,YINGDANGMEI7TIANKEPINGGUJISHU。RUGUOZHIZHIDI42TIANSHIMEIYOUGUANCHADAO25%ZENGJIA,ZEHUANZHESUIHOUYINGDANGJIESHOUJIHUAJILIANGDE50%JINXINGZHILIAO。

斗牛棋牌4.JIYUXUEQINGDIANJIEZHIHESHENZANGDUXINGJINJILIANGDIAOZHENG

如果發生無法解釋的血清碳酸氫鹽水平水平降低至<20mEq/L,下一個療程中劑量應當減少50%,類似地,如果發生無法解釋的血尿素氮(BUN) 或血肌百升高,下一個周期應當延遲給藥直至以上實驗室值恢復至正常或基線,并且下個療程的劑量應減少50%(見【注意事項】)。

5.LAONIANHUANZHEYONGYAO

YIZHIAZHABAOGANJIQIDAIXIEWUJIBENSHANGTONGGUOSHENZANGPAIXIE,SHENGONGNENGSHOUSUNDEHUANZHEDUIBENPINKENENGCHANSHENGDEDUXINGFANYINGFENGXIANHUIGENGDAYIXIE。YOUYULAONIANHUANZHEGENGRONGYICHUXIANSHENGONGNENGXIAJIANG,YINCIJILIANGXUANZESHIYINGJINZHEN,DUISHENGONGNENGJINXINGJIANCEKENENGYOUYONG(JIAN【ZHUYISHIXIANG】 HE【LAONIANYONGYAO】)。

6.YAOWUPEIZHI

BENPINSHIYIZHONGXIBAOZHIDUYAOWU,ZHENGRUQITAYOUQIANZAIDUXINGDEHUAHEWUYIYANG,CHULIHEZHIBEISHIYINGDANGJINSHEN。

斗牛棋牌BENPINFURONGHOUYAOYERUGUOJIECHUPIFU。LIJIYONGFEIZAOHESHUICHONGFENQINGXI。RUGUOJIECHULENIANMO。YINGYONGQINGSHUICHONGFENQINGXI。

斗牛棋牌BENPINBAOZHUANGZAIDANCISHIYONGXIAOPINGZHONG,BUHANRENHEFANGFUJI。MEIGEXIAOPINGZHONGWEISHIYONGDEBUFENYINGDANGQIZHI。BUYAOBAOCUNHEWEIYONGBUFENGONGYIHOUSHIYONG。

7.PIXIAZHUSHEGEIYAOZHINAN

斗牛棋牌BENPINMEIPINGYINGDANGSHIYONG4mLWUJUNZHUSHEYONGSHUIFURONG。XISHIYEYINGDANGHUANMANZHUDEZHIXIAOPINGZHONG,JULIEZHENYAOHUOZHUANDONGXIAOPING,ZHIZHIHUODEJUNZHIXUANZHUOYE。HUNXUANYEYINGHUNZHUO,ZHIBEIDEHUNXUANYEHANAZHABAOGAN25mg/mL。ZHONGRONGHOUHUNXUANYEBUDEGUOLV,ZHEYANGCAOZUOKENENGLVCHUHUOXINGCHENGFEN。

YONGYUJIKEPIXIAGEIYAODEZHIJI:DAYU4mlDEJILIANGYINGDANGJUNFENZHILIANGZHIZHUSHEQIZHONG。CHANPINKEZAISHIWENXIAZUICHANGBAOCUN1XIAOSHI,DANSHIBIXUZAIFURONGHOU1XIAOSHINEIGEIYAO。

斗牛棋牌YONGYUYANCHIPIXIAGEIYAODEZHIJI:FURONGYAOYEBIXUBAOCUNZAIXIAOPINGZHONGHUOCHOUQUZHIYIZHIZHUSHEQIZHONG,

DAYU4mLDEJILIANGYINGDANGJUNDENGFENZHILIANGZHIZHUSHEQIZHONG。FURONGHOUBIXULIJILENGZANG,DANGSHIYONGWEIJINGLENGZANGDEZHUSHEYONGSHUIFURONGBENPINSHI,FURONGYAOYEZAILENGZANGTIAOJIAN(2℃ -8℃)XIAKEBAOCUNZUICHANGDA8XIAOSHI,DANGSHIYONGLENGZANG(2℃ -8℃)ZHUSHEYONGSHUIFURONGBENPINSHI,FURONGYAOYEZAILENGZANGTIAOJIAN(2℃- 8℃) XIAKEBAOCUNZUICHANGDA22XIAOSHI。

CONGLENGZANGTIAOJIANXIAQUCHUHOU,ZAIGEIYAOQIAN30FENZHONGNEIYUNXUHUNXUANYELIUPINGHENGZHISHIWEN。

PIXIAGEIYAO

WEILETIGONGJUNZHIHUNXUANYE,GEIYAOZHUSHEQINEIYAOYEBIXUZAIGEIYAOQIANCHONGFENHUNXUAN。ZAIHUNXUANSHI,ZAISHOUZHANGZHIJIANYONGLIGUNDONGZHUSHEQI。ZHIDAOXINGCHENGJUNZHI,HUNZHUODEHUNXUANYE。

斗牛棋牌BENPINHUNXUANYEPIXIAGEIYAO。DAYU4mLDEYAOYEYINGDANGJUNDENGFENZHILIANGZHIZHUSHEQIZHONG,ZHUSHEZHILIANGGEBUTONGBUWEI。MEICIZHUSHESHILUNHUANRANGSHEBUWEI(DATUI,FUBUHUOSHANGBEI)。XINDEZHUSHEBUWEIYINGDANGJULIJIUZHUSHEBUWEIZHISHAO2.5cm,BUDEZHUSHEZHICHUBU,CUOSHANG、FAHONGHUOJIANYINGBUWEI。

斗牛棋牌HUNXUANYEWENDINGXING:GONGPIXIAGEIYAODEFEILENGZANGZHUSHEYONGSHUIFURONGDEYAOYEKEBAOCUNZAI25ºCXIAZUICHANGDA1XIAOSHIHUOBAOCUNZAI2ºC-8ºCZHIJIANZUICHANGDA8XIAOSHI;DANGCAIYONGLENGZANG(2ºC-8ºC)ZHUSHEYONGSHUIFURONGSHI,KEBAOCUNZAI2ºC-8ºCZHIJIAN22XIAOSHI。

【YAOLIDULI】

ZUOYONGJIZHI

阿扎胞苷是胞嘧啶核苷類似物,通過引起DNA去甲基化和對骨髓中異常造血細胞的直接細胞毒作用而產生抗腫瘤作用。阿扎胞苷在體外對DNA甲基化有最大抑制作用時的濃度對DNA的合成未見明顯的抑制作用。DNA的去甲基化可修復基因的正常功能,該功能對于細胞的分化和增殖起關鍵作用。阿扎胞苷的細胞毒作用可引起處于快速分裂狀態的細胞死亡,包括對正常生長調控機制不產生應答的癌細胞。非增殖期的細胞對阿扎胞苷相對不敏感。

DULIYANJIU

斗牛棋牌YICHUANDUXING:AZHABAOGANDUIXIJUN(SHUSHANGHANSHAMENJUNTA100、trpE8JUNZHU、DACHANGGANJUNZHUWP14Pro、WP3103P、WP3104P、CC103DEAmesSHIYAN)HEBURUDONGWUXIBAO(XIAOSHULINBALIUXIBAOHERENLINBAMUXIBAOTIWAIDINGXIANGJIYINTUBIANSHIYAN)YOUZHITUBIANZUOYONG。TIWAIWEIHESHIYANZHONG,AZHABAOGANKEYOUDAOXIAOSHULINBALIUXIBAOL5178YHEXULIYACANGSHUPEITAIXIBAOZHONGDEWEIHE,XIANSHIQIYOUZHIRANSETIDUANLIEDEZUOYONG。

生殖毒性:雄性小鼠連續3天給藥阿扎胞苷9.9mg/m2(以mg/m2計,約為人每日推薦劑量的9%)后,與未給藥的雌性小鼠交配,導致生育力降低,并引起胎仔在出生前后的發育過程中死亡。雄性大鼠連續11或16周給藥阿扎胞苷15-30mg/m2(以mg/m2計,約為人每日推薦劑量的20-40%),每周給藥3次,導致睪丸和附睪重量減輕和精子數降低,并引起交配的雌性大鼠的妊娠率降低和胚胎丟失增加。另一項相關研究中,雄性大鼠連續16周給藥阿扎胞苷24mg/m2,引起與其交配后妊娠的雌性大鼠的異常胚胎增加(在妊娠第2天檢查)。

早期胚胎毒性研究中,小鼠于妊娠第10天單次腹腔注射阿扎胞苷6mg/m2(以mg/m2計,約為人每日推薦劑量的8%),子宮內胚胎死亡率(含增加的吸收胎)為44%。小鼠于妊娠第15天或之前給藥阿扎胞苷3-12mg/m2(以mg/m2斗牛棋牌計,約為人每日推薦劑量的4%-16%),引起大腦發育異常。

大鼠于妊娠第4-8天(植入后)腹腔注射阿扎胞苷6mg/m2(以mg/m2計,約為人每日推薦劑量的8%),阿扎胞苷顯示有明顯的胚胎毒性,在植入前期(妊娠第1-3天)給藥阿扎胞苷,對胚胎未見不良影響。大鼠分別于妊娠第9、10、11或12天單次腹腔注射阿扎胞苷3-12mg/m2(以mg/m2斗牛棋牌計,約為人每日推薦劑量的8%),顯示有致畸作用,導致多種胚胎異常,如中樞神經系統(CNS)異常(露腦/腦疝),肢體異常(短肢、畸形足、并趾癥、少趾畸形),以及其它異常(小頜,腹裂,水腫和肋骨異常),于妊娠第9和10天給藥時,阿扎胞苷引起胚胎死亡,妊娠第9天給藥最高劑量時,阿扎胞苷組的每窩平均存活動物減少至對照組的9%。

致癌性:小鼠52周的致癌試驗中,雌性小鼠腹腔注射阿扎胞苷2.2mg/kg(6.6mg/m2),約為人每日推薦劑量的8%(以mg/m2計),每周給藥3次,可誘發造血系統腫瘤。小鼠50周的致癌試驗中,小鼠腹腔注射阿扎胞苷2mg/kg(6mg/m2),約為人每日推薦劑量的8%(以mg/m2計),每周給藥1次,可見淋巴網狀系統、肺、乳腺和皮膚的腫瘤發生率增加。致瘤性試驗中,大鼠給藥阿扎胞苷15或60mg/m2(以mg/m2斗牛棋牌計,約為人每日推薦劑量的20-80%),每周給藥2次,與對照組相比,睪丸腫瘤發生率增加。

【YAODAIDONGLIXUE】

YAODAIDONGLIXUE

在6名MDS患者中研究了75mg/m2單次皮下給藥和75mg/m2單次靜脈給藥后阿扎胞苷的藥代動力學特征。皮下給藥后阿扎胞苷快速吸收;峰血漿濃度750±403ng/ml出現在給藥后0.5小時。基于曲線下面積,阿扎胞苷皮下給藥相對于阿扎胞苷靜脈給藥的生物利用度約為89%。靜脈給藥后,平均分布容積是76±26L,平均表觀皮下給藥清除率是167±49L/小時,皮下給藥后平均半衰期是41±8分鐘。25-100mg/m2斗牛棋牌劑量范圍內,21名癌癥患者中阿扎胞苷皮下給藥的AUC和Cmax大致與劑量成比例。以推薦劑量方案多次給藥并未導致藥物蓄積。

已發表的研究表明尿液排泄是阿扎胞苷及其代謝產物的主要消除途徑。經靜脈途徑給予5名癌癥患者放射性阿扎胞苷后,放射性劑量的累積尿液排泄率為85%。3天內,糞便排泄占給予放射性的<1%。14C-阿扎胞苷皮下給藥后尿液中放射性的平均排泄率是50%。靜脈給藥和皮下給藥后總放射性(阿扎胞苷及其代謝產物)的平均消除半衰期相似,約為4小時。

TESHURENQUN

癌癥患者中,比較了每天以75mg/m2/d的劑量皮下給藥(第1-5天)后,6名正常腎功能患者(CLcr>80mL/min)與6名重度腎損害患者(CLcr<30mL/min)間阿扎胞苷的藥代動力學特征。重度腎損害使單次皮下給藥后阿扎胞苷暴露量增加約70%,多次皮下給藥后的暴露量增加41%。該暴露量增加未伴有不良事件增加。暴露量與接受100mg/m2斗牛棋牌的正常腎功能患者中的暴露量相似。因而,不建議進行第1周期的劑量調整。

SHANGWEIYANJIUGANSUNHAI、XINGBIEHENIANLINGDUIAZHABAOGANYAODAIDONGLIXUETEZHENGDEYINGXIANG。

ZHONGZUCHAYI

在12名中國患者考察了給予阿扎胞苷推薦劑量75mg/m2后的藥代特征,并將其與北美患者觀察到的藥代參數進行比較。

GENJUZHONGGUOHUANZHEHEBEIMEIHUANZHEDESHUJU,ZHONGGUOMDSHUANZHEDEAZHABAOGANYAODAITEZHENGHEYAODAICANSHU(CHULECmax)CHUYUBEIMEIMDSHUANZHEHUOQITAXUEYEXUEEXINGZHONGLIUDEYAODAITEZHENGHEYAODAICANSHUFANWEIZHINEI。

YAOWUJIANXIANGHUZUOYONG

斗牛棋牌WEIJINXINGAZHABAOGANZHENGSHILINCHUANGYAOWUXIANGHUZUOYONGYANJIU。

YIXIANGRENGANZANGZUZHIYUAZHABAOGANFUYUDETIWAIYANJIUBIAOMINGAZHABAOGANKEYITONGGUOGANZANGDAIXIE。SHANGWEIYANJIUAZHABAOGANDAIXIESHIFOUSHOUDAOYIZHIWEILITIMEIYIZHIJIHUOYOUDAOJIDEYINGXIANG。

斗牛棋牌YIXIANGPEIYANGRENGANXIBAODETIWAIYANJIUBIAOMINGZUIGAODA100µMNONGDU(JINGMOGEIYAOCmax=10.6µM)DEAZHABAOGANWEIDAOZHICYP2B6HECYP2C8DERENHEYIZHI。AZHABAOGANYIZHIQITAXIBAOSESUP450(CYP)MEIDEKENENGSHANGBUQINGCHU。

RENPEIYANGGANXIBAODETIWAIYANJIUBIAOMINGNONGDUWEI1.0µMZHI100µMDEAZHABAOGANBUYOUDAOCYP1A2、2C19HUO3A4/5。

【BULIANGFANYING】

ZAISHUOMINGSHUDEQITAZHANGJIEZHONGMIAOSHULEYIXIABULIANGFANYING:

斗牛棋牌oPINXUE,ZHONGXINGLIXIBAOJIANSHAOHEXUEXIAOBANJIANSHAO(JIAN【ZHUYISHIXIANG】)

斗牛棋牌oGANXINGHUNMI(JIAN【ZHUYISHIXIANG】)

oXUEJIGANSHENGGAO,SHENSHUAIJIEHESHENXIAOGUANSUANZHONGDU(JIAN【ZHUYISHIXIANG】)

oZHONGLIURONGJIEZONGHEZHENG(JIAN【ZHUYISHIXIANG】)

ZUICHANGFASHENGDEBULIANGFANYING:EXIN,PINXUE,XUEXIAOBANJIANSHAO,OUTU,FARE,BAIXIBAOJIANSHAO,FUXIE,ZHUSHEBUWEIHONGBAN,BIANMI,ZHONGXINGLIXIBAOJIANSHAO,YUBAN。

ZUIPINFAN(>2%)DAOZHILINCHUANGGANYUDEBULIANGFANYING:

TINGYAO:BAIXIBAOJIANSHAO,XUEXIAOBANJIANSHAO,ZHONGXINGLIXIBAOJIANSHAO。

ZANTINGGEIYAO:BAIXIBAOJIANSHAO,ZHONGXINGLIXIBAOJIANSHAO,XUEXIAOBANJIANSHAO,FARE,FEIYAN,ZHONGXINGLIXIBAOJIANSHAOXINGFARE。

斗牛棋牌JILIANGJIANGDI:BAIXIBAOJIANSHAO,ZHONGXINGLIXIBAOJIANSHAO,XUEXIAOBANJIANSHAO。

斗牛棋牌1.LINCHUANGSHIYANZHONGDEBULIANGFANYING

YOUYUKAIZHANLINCHUANGSHIYANDETIAOJIANCHAYIHENDA,MOUYAOWUZAIYIGESHIYANZHONGSUOGUANCHADAODEBULIANGFANYINGFASHENGLVBUNENGYUQITAYAOWUDELINCHUANGSHIYANZHONGSUOJIANDEBULIANGFANYINGFASHENGLVZHIJIEBIJIAO,TONGSHIYEXUWUFAFANYINGSHIJIZHILIAOZHONGDEBULIANGFANYINGFASHENGLV。

SUOYOUSHUJULAIZIYU3XIANGLINCHUANGSHIYANZHONGJIESHOUAZHABAOGANDE395MINGMDSHUANZHE。YANJIUCALGB9221SHIYIXIANGZHICHIZHILIAODUIZHAOSHIYAN,YANJIUCALGB8921SHIYIXIANGDANBEISHIYAN,YANJIUAZAPHGL2003CL001SHIYIXIANGSUIJIDUIZHAODEGUOJIDUOZHONGXINSHIYAN(JIAN【LINCHUANGSHIYAN】)。

斗牛棋牌YANJIUCALGB9221HECALGB8921ZHONG,GONG220MINGHUANZHEJIESHOUAZHABAOGANZHILIAO,BAOKUO116MINGHUANZHEJIESHOU6GEZHOUQI(YUE6GEYUE)HUOGENGDUOZHOUQIDEZHILIAOYIJI60MINGHUANZHEJIESHOUDAYU12GEZHOUQI(YUEYINIAN)DEZHILIAO。SHUJUZHUYAOLAIZIYUZHICHIZHILIAODUIZHAOSHIYANHEFEIDUIZHAOSHIYAN(FENBIEWEIn=150HEn=70)。SHIYANRENQUN(n=220)WEI23-92SUI(PINGJUN66.4SUI),QIZHONG68%WEINANXING,94%WEIBAIZHONGREN,BINGQIEHUANMDSHUOAML。

研究AZAPHGL2003CL001中,共175名有較高MDS風險(主要是RAEB和RAEB-T亞型)的患者接受阿扎胞苷治療。這些患者中,119名接受阿扎胞苷治療6個或更多周期,63名接受阿扎胞苷治療至少12個周期。該人群的平均年齡為68.1歲(范圍從42-83歲),其中74%為男性,99%為白種人。大多數患者接受75mg/m2日劑量。

BIAO1LIECHULEYANJIUCALGB9221HECALGB8921ZHONGJIESHOUAZHABAOGANPIXIAGEIYAOZHILIAODEZHISHAO5%HUANZHEFASHENGDEBULIANGFANYING,YINGDANGZHUYIDAOAZHABAOGANZHILIAOZUYUGUANCHAZUXIANGBIZHILIAOCHIXUSHIJIANJIAOCHANG,ZHEYIDIANHENZHONGYAO:HUANZHEJIESHOUAZHABAOGANPINGJUN11.4GEYUE,ERGUANCHAZUZHONGPINGJUNSHIJIANWEI6.1GEYUE。

BIAO1:ZUICHANGGUANCHADAODEBULIANGFANYING(SUOYOUPIXIAGEIYAOVIDAZAZHILIAODEHUANZHEZHONG≥5.0%;YANJIUCALGB9221HECALGB8921)

\

BIAO2LIECHULEYANJIUAZAPHGL2003CL001ZHONGJIESHOUAZHABAOGANZHILIAODEZHISHAO5%HUANZHEFASHENGDEBULIANGFANYING。YUYANJIUCALGB9221HECALGB8921XIANGSI,AZHABAOGANZHILIAOCHIXUSHIJIAN(PINGJUN12.2GEYUE)YUZHICHIZHILIAO(PINGJUN7.5GEYUE)XIANGBIJIAOCHANG。

BIAO2:ZUICHANGGUANCHADAODEBULIANGFANYING(JIESHOUAZHABAOGANZHILIAODEHUANZHEZHONG≥5.0%HENCICTC3/4JIBULIANGFANYINGBAIFENLV;YANJIUAZAPHGL2003CL001)

\

斗牛棋牌CAIYONGAZHABAOGANPIXIAGEIYAODEYANJIUCALGB9221、CALGB8921HEAZAPHGL2003CL001ZHONG,SUIZHUAZHABAOGANJILIANGZENGJIA,ZHONGXINGLIXIBAOJIANSHAO、XUEXIAOBANJIANSHAO、PINXUE、EXIN、OUTU、FUXIE、BIANMIHEZHUSHEBUWEIHONGBAN/FANYINGDENGBULIANGFANYINGDEFASHENGLVYOUZENGJIAQUSHI。PIXIAGEIYAOZHILIAODEQIAN1-2GEZHOUQIYUHOUXUZHOUQIXIANGBI,BULIANGFANYINGYOUGENGJIAXIANZHUDEQINGXIANG,BAOKUOXUEXIAOBANJIANSHAO、ZHONGXINGLIXIBAOJIANSHAO、PINXUE、EXIN、OUTU、ZHUSHEBUWEIHONGBAN/TENGTONG/CUOSHANG/FANYING、BIANMI、YUDIAN、TOUYUN、JIAOLV、DIJIAXUEZHENGHESHIMIAN。ZAIZHILIAOZHOUQIZHONGMEIYOUGUANCHADAORENHEBULIANGFANYINGPINLVZENGJIA。

ZONGTIERYAN,JINGMOYUPIXIAGEIYAOYANJIUZHIJIANBULIANGFANYINGMIAOSHUXIANGSI。YUJINGMOGEIYAOTUJINGTEBIEXIANGGUANDEBULIANGFANYINGBAOKUOSHUZHUBUWEIFANYING(LIRUHONGBANHUOTENGTONG)HEDAOGUANBUWEIFANYING(LIRUGANRAN、HONGBANHUOCHUXUE)。

阿扎胞苷給藥的臨床試驗中,報告了發生率<5%的以下嚴重不良反應(表1或2中未列出):

斗牛棋牌XUEYEHELINBAXITONGJIBING:LIXIBAOQUEFA,GUSUISHUAIJIE,QUANXUEXIBAOJIANSHAO,PIZHONGDA。

XINZANGJIBING:XINFANGZHANDONG,XINLISHUAIJIE,CHONGXUEXINGXINLISHUAIJIE,XINFEIZOUTING,CHONGXUEXINGXINJIBING。

YANBUJIBING:YANCHUXUE

斗牛棋牌WEICHANGDAOJIBING:QISHIYAN,WEICHANGDAOCHUXUE,HEIBIAN,ZHICHANGZHOUWEINONGZHONG。

QUANSHENXINGJIBINGHEGEIYAOBUWEIJIBING:DAOGUANBUWEICHUXUE,QUANSHENJIANKANGZHUANGTAIEHUA,QUANSHENYANZHENGFANYINGZONGHEZHENG。

斗牛棋牌GANDANXITONGJIBING:DANNANGYAN。

免疫系統疾病:過敏性休克,超敏反應。

GANRANHECHUANRAN:ZHITINONGZHONG,XIJUNGANRAN,FENGWOZHIYAN,YASHENGJUNBING,ZHUSHEBUWEIGANRAN,KELEIBOJUNBAIXUEZHENG,ZHONGXINGBAIXIBAOJIANSHAOXINGBAIXUEZHENG,LIANQIUJUNYANYAN,KELEIBOJUNFEIYAN,BAIXUEZHENG,GANRANXINGXIUKE,PUTAOQIUJUNJUNXUEZHENG,PUTAOQIUJUNGANRAN。

DAIXIEJIYINGYANGLEIJIBING:TUOSHUI。

斗牛棋牌JIROUGUGEHEJIEDIZUZHIJIBING:GUTONGJIAZHONG,JIWULI,JINGTONG。

LIANGXING、EXINGJIXINGZHIBUMINGDEZHONGLIU:PIFUBAIXUEBING。

SHENJINGXITONGJIBING:NAOCHUXUE,JINGJUE,LUNEICHUXUE。

斗牛棋牌SHENZANGHEMINIAOXITONGJIBING:YAOTONG,SHENSHUAIJIE。

斗牛棋牌HUXI、XIONGQIANGHEZONGGEXITONGJIBING:GEXUE,FEIJINRUN,FEIYAN,HUXIJIONGPO。

斗牛棋牌PIFUHEPIXIAZUZHIJIBING:HUAIJUXINGNONGPIBING,SAOYANGXINGPIZHEN,PIFUYINGJIE。

GEZHONGSHOUSHUJIYILIAOCAOZUO:DANNANGQIECHUSHU。

斗牛棋牌XUEGUANJIBING:ZHILIXINGDIXUEYA。

ZHONGGUOLINCHUANGSHIYAN(MDS-002)

斗牛棋牌MDS-002SHIYIXIANGZAIZHONGGUOGAOFENGXIANGUSUIZENGSHENGYICHANGZONGHEZHENGCHENGNIANSHOUSHIZHEZHONGPINGGUPIXIAZHUSHEAZHABAOGANYOUXIAOXING、ANQUANXINGHEYAODAIDONGLIXUEDE2QI、KAIFANGBIAOQIAN、DANBEISHIYAN。

所有受試者均接受阿扎胞苷皮下注射(SC)劑量75mg/m2/day,連續7天,每28天為一個周期。共有72名患者使用阿扎胞苷,包括56名(77.8%)受試者完成至少4個治療周期,50名(69.4%)受試者完成至少5個治療周期,46名(63.9%)受試者完成6個治療周期,39名(54.2%)受試者完成>6個治療周期。平均治療周期數為8,每個治療周期平均給藥天數中位值為7天。平均每日處方劑量的中位值為75mg/m2

SUOYOU72MINGSHOUSHIZHEJUNBAOGAOLEZHISHAO1LIZHILIAOZHONGBULIANGSHIJIAN(TEAE)。ANSHOUXUANSHUYU,ZUICHANGJIANDEZHILIAOZHONGBULIANGSHIJIAN(≥20%DEHUANZHE)BAOKUOXUEXIAOBANJIANSHAO、BAIXIBAOJIANSHAO、ZHONGXINGLIXIBAOJIANSHAO、PINXUE、SHANGHUXIDAOGANRAN、BIANMI、FARE、FEIYAN、EXIN、YAYINYAN、FUXIEHEOUTU。

BIAO3:ZAIZHISHAO20%HUANZHEZHONGBAOGAODEZHILIAOZHONGBULIANGSHIJIAN(ANQUANXINGRENQUN)

\

斗牛棋牌70/72MING(97.2%)HUANZHEBAOGAOLEZHISHAOYILI3JIHUO4JITEAE。ANSHOUXUANSHUYU,ZUIJIANDEZHILIAOZHONG3JIHUO4JIBULIANGSHIJIAN(≥10%DEHUANZHE)BAOKUOXUEXIAOBANJIANSHAO、ZHONGXINGLIXIBAOJIANSHAO、BAIXIBAOJIANSHAO、PINXUE、FEIYANHESHANGHUXIDAOGANRAN。

BIAO4:ZAIZHISHAO10%DEMDS-002HUANZHEZHONG3JIHUOGENGGAOJIBIEZHILIAOZHONGBULIANGSHIJIAN(ANQUANXINGRENQUN)

\

52.8%(38/72)SHOUSHIZHEFASHENGZHISHAO1LIZHILIAOZHONGYANZHONGBULIANGSHIJIAN。ANSHOUXUANSHUYU,ZUICHANGJIANDEZHILIAOZHONGCHUXIANDEYANZHONGBULIANGSHIJIAN(ZHISHAO2LIHUANZHEFASHENG)RUXIA:FEIYAN(15.3%)、FAREXINGZHONGXINGLIXIBAOJIANSHAO(6.9%)、LIXIBAOQUEFA、XUEXIAOBANJIANSHAOHESHANGHUXIDAOGANRAN(5.6%),KOUQIANGCHUXUEHEFARE(4.2%)、GUSUISHUAIJIE,XINLISHUAIJIE,FENGWOZUZHIYANHEFEIBUGANRAN(2.8%)。

ZONGZHI,ZHONGGUOSHOUSHIZHEZHONGAZHABAOGANDEZONGTIANQUANXINGTEZHENGYUYIZHIDEAZHABAOGANANQUANXINGTEZHENGYIZHI。

2.SHANGSHIHOUJINGYAN

BENPINQUANQIUSHANGSHIHOUBAOGAOLEYIXIAYAOWUBULIANGFANYING。YOUYUZHEXIEBAOGAOLAIZIYUYIGEWEIZHIRENQUNGUIMODEZIFABAOGAO,SUOYIJIAONANKEKAODIPINGGUQIFASHENGLVHUOQUELIYUYAOWUBAOLUZHIJIANDEYINGUOGUANXI。

- JIANZHIXINGFEIBING

- ZHONGLIURONGJIEZONGHEZHENG

- ZHUSHEBUWEIHUAISI

- Sweet 綜合征(急性發熱性嗜中性皮膚病

- HUAISIXINGJINMOYAN(BAOKUOSIWANGBINGLI)

- HUAIJUXINGNONGPIBING

【ZHUYISHIXIANG】

1.PINXUE,ZHONGXINGLIXIBAOJIANSHAOHEXUEXIAOBANJIANSHAO

AZHABAOGANDAOZHIPINXUE、ZHONGXINGLIXIBAOJIANSHAOHEXUEXIAOBANJIANSHAO。DUOCIJIANCEQUANXUEXIBAOJISHU,YIPINGGUHUANJIEHE/HUODUXING,ZHISHAOZAIMEIGEGEIYAOZHOUQIQIANJINXINGJIANCE。SHOUGEZHOUQIYITUIJIANJILIANGGEIYAOHOU,JIYUXUEXIBAOZUIDIZHIJISHUHEXUEYEYINGDADIAOZHENGHOUXUZHOUQIDEJILIANG(JIAN【YONGFAYONGLIANG】)。

斗牛棋牌2.JIWANGHUANYOUZHONGDUGANSUNHAIHUANZHEZHONGDEAZHABAOGANDUXING

由于在既往患有重度肝損害的患者中阿扎胞苷具有潛在肝毒性,因而肝疾病患者用藥需謹慎。由于疾病的轉移性導致患者具有廣泛腫瘤負擔,據報告此類患者在阿扎胞苷治療期間曾發生進行性肝昏迷和死亡,特別是在基線白蛋白<30g/L的此類患者中。阿扎胞苷禁用于晚期惡性肝腫瘤患者(見【禁忌】)。

SHANGWEIZAIGANSUNHAIDEMDSHUANZHEZHONGYANJIUAZHABAOGANDEANQUANXINGHEYOUXIAOXING,YINWEILINCHUANGSHIYANZHONGPAICHULEZHEXIEHUANZHE。

3.SHENDUXING

在接受阿扎胞苷靜脈給藥與用于非MDS的其它化療藥物聯合治療的患者中曾報告了不同程度的毒性反應,從血肌酐升高至腎衰竭和死亡。另外,阿扎胞苷和依托泊苷治療的5名CML患者中發生了腎小管酸中毒,定義為血清碳酸氫鹽降低至<20mEq/L伴堿性尿和低血鉀(血清鉀<3mEq/L)。如果發生無法解釋的血清碳酸氫鹽降低<20mEq/L或BUN或血肌酐升高,則應當減小劑量或暫停給藥(見【用法用量】)。

SHENSUNHAIHUANZHEFASHENGSHENDUXINGDEFENGXIANKENENGZENGJIA。CIWAI,AZHABAOGANJIQIDAIXIECHANWUZHUYAOJINGSHENZANGPAIXIE。YINER,YINGDANGMIQIEJIANCESHENDUXING(JIAN【YONGFAYONGLIANG】)。LINCHUANGSHIYANZHONGPAICHULESHENSUNHAIDEMDSHUANZHE。

4.RENSHENQIYONGYAO

斗牛棋牌RENSHENFUNVSHIYONGBENPINSHI,KENENGHUIGEITAIERDAILAISHANGHAI。AZHABAOGANZAIDONGWUZHONGDAOZHIXIANTIANJIXING。YINGJIANYIYULINGNVXINGZAIJIESHOUAZHABAOGANZHILIAOQIJIANBIMIANRENSHEN。MUQIANSHANGWEIKAIZHANDUIRENSHENNVXINGSHIYONGAZHABAOGANDECHONGFENDEQIELIANGHAODUIZHAODEYANJIU。RUGUOHUANZHEZAIRENSHENQISHIYONGBENPINHUOZHEZAIYONGYAOQIJIANRENSHEN,YINGGAOZHIHUANZHEBENPINDUITAIERDEQIANZAIWEIHAI(JIAN【YUNFUJIBURUQIFUNVYONGYAO】)。

5.NANXINGYONGYAO

YINGJIANYINANXINGHUANZHEZAIJIESHOUAZHABAOGANZHILIAOQIJIANBUYISHENGYU)。DONGWUYANJIUZHONG,XIONGXINGXIAOSHUHEDASHUSHOUYUNQIANJINGAZHABAOGANCHULIHUIDAOZHIJIAOPEIDECIXINGDONGWUPEITAILIUCHANLVZENGJIA(JIAN【YAOLIDULI】)。

6.ZHONGLIURONGJIEZONGHEZHENG

JUYOUZHONGLIURONGJIEZONGHEZHENGFENGXIANDEHUANZHESHIZHIZHILIAOQIANGAOZHONGLIUFUHEDEHUANZHE。DUIZHEXIEHUANZHEYINGJINXINGYANMIJIANCEBINGCAIQUSHIDANGDEYUFANGCUOSHI。

斗牛棋牌7.DUIJIASHIHUOCAOZUOJIQINENGLIDEYINGXIANG

WEIYANJIUBENPINDUIJIASHIHUOCAOZUOJIQINENGLIDEYINGXIANG。

【JINJI】

JINYONGYUWANQIEXINGGANZHONGLIUHUANZHE(JIAN【ZHUYISHIXIANG】)。

JINYONGYUYIZHIDUIAZHABAOGANHUOGANLUCHUNGUOMINDEHUANZHE。

【YUNFUJIBURUQIFUNVYONGYAO】

1.RENSHEN

RENSHENFUNVAZHABAOGANGEIYAOSHI,KENENGHUIGEITAIERDAILAISHANGHAI。AZHABAOGANZAIDONGWUZHONGJUYOUZHIJIXING。BENPINDUIRENSHENQIFUNVMEIYOUJINXINGCHONGFENHEYANGEDUIZHAODEYANJIU。YINGJIANYIYULINGNVXINGZAIJIESHOUBENPINZHILIAOQIJIANBIMIANRENSHEN。RUGUOHUANZHEZAIRENSHENQISHIYONGBENPINHUOZHEZAIGEIYAOQIJIANRENSHEN,YINGGAOZHIHUANZHEBENPINDUITAIERDEQIANZAIWEIHAI。

斗牛棋牌JIESHOUAZHABAOGANZHILIAODENANXINGHUANZHEDENVXINGBANLVBUYINGRENSHEN(JIAN【YAOLIDULI】)。

小鼠早期胚胎毒性研究顯示,妊娠第10天6mg/m2(基于mg/m2,約為推薦人用每日劑量的8%)阿扎胞苷單次腹膜內注射后,子宮內胚胎死亡(吸收增加)發生率為44%。妊娠第15天時或之前給予3-12mg/m2劑量(基于mg/m2,約為推薦人用每日劑量的4%-16%)阿扎胞苷的小鼠中,曾檢出大腦發育異常。

大鼠中,妊娠第4-8天(植入后)以6mg/m2劑量(基于mg/m2,約為推薦人用每日劑量的8%)IP給藥時,阿扎胞苷具有明顯胚胎毒性,而植入前期(妊娠第1-3天)處理對胚胎沒有不良影響。大鼠妊娠第9、10、11或12天3-12mg/m2劑量(基于mg/m2,約為推薦人用每日劑量的8%)單次腹膜內給藥后,阿扎胞苷導致多種胚胎異常。本研究中,當在妊娠第9和10天以3-12mg/m2劑量給藥時,阿扎胞苷導致胚胎死亡:妊娠第9天使用最高劑量時,每窩的平均存活動物減少至對照的9%。胚胎異常包括:中樞神經系統(CNS)異常(露腦/腦疝),肢體異常(短肢,畸形足,并趾癥,少趾畸形),以及其它異常(小頜,腹裂,水腫和肋骨異常)。

2.BURUQIFUNV

斗牛棋牌SHANGBUQUEDINGAZHABAOGANHUOQIDAIXIECHANWUSHIFOUTONGGUORENDERUZHIFENMI。KAOLVDAOXUDUOYAOWUHUITONGGUORENDERUZHIFENMI,HEAZHABAOGANDONGWUYANJIUZHONGXIANSHIDEZHILIUXINGKENENG,YIJIAZHABAOGANYONGYAODUIYUBURUQIYINGERQIANZAIDEYANZHONGBULIANGFANYING,YINGQUANHENGYAOWUDUIMUQINDEZHONGYAOXINGLAIJUEDINGZHONGZHIBURUHUANSHIZHONGZHIYONGYAO。

【ERTONGYONGYAO】

斗牛棋牌SHANGWEIMINGQUEBENPINZAIERTONGHUANZHEZHONGDEANQUANXINGHEYOUXIAOXING。

【LAONIANYONGYAO】

研究AZAPHGL2003CL001中隨機化接受阿扎胞苷的179名患者中,65歲及以上的為68%,75歲及以上的為21%。65歲及以上患者的生存期數據與總體生存期結果一致。<65歲患者與65歲及以上患者之間大多數不良反應的發生率相似。

斗牛棋牌LAONIANHUANZHEGENGYOUKENENGFASHENGSHENGONGNENGJIANTUI。YINGJIANCEZHEXIEHUANZHEDESHENGONGNENG(JIAN【YONGFAYONGLIANGLI】HE【ZHUYISHIXIANG】)。

【YAOWUXIANGHUZUOYONG】

斗牛棋牌SHANGWEIJINXINGAZHABAOGANYUQITAYAOWUZHIJIANYAOWU-YAOWUXIANGHUZUOYONGDEZHENGSHILINCHUANGSHIYAN。

【YAOWUGUOLIANG】

臨床試驗過程中報告了1例阿扎胞苷過量。一名患者在接受約290mg/m2斗牛棋牌劑量單次靜脈給藥后發生腹瀉、惡心和嘔吐,該劑量接近推薦起始劑量的4倍。以上不良事件恢復后未留后遺癥,第二天重新開始正確劑量治療。如果發生用藥過量,應適當監測血細胞計數,必要時,給予支持治療。本品過量用藥后沒有已知專門的解毒劑。

【ZHUZANG】25℃YIXIABAOCUN。

斗牛棋牌【BAOZHUANG】BOLIPINGBAOZHUANG,1PING/HE。

【YOUXIAOQI】24GEYUE

斗牛棋牌【SHENGCHANQIYE】ZHENGDATIANQINGYAOYEJITUANGUFENYOUXIANGONGSI

注射用阿扎胞苷的功效與作用

ZHUSHEYONGAZHABAOGANZHUSHEYONGAZHABAOGANSHIYONGYUZHILIAOYIXIACHENGNIANHUANZHE:GUOJIYUHOUPINGFENXITONG(IPSS)ZHONGDEZHONGWEI-2JIGAOWEIGUZENGSHENGYICHANGZONGHEZHENG(MDS),MANXINGLI-DANHEXIBAOBAIXUEBING(CMML)ANZHAOSHIJIEWEISHENGZUZHI(WHO)FENLEIDEJIXINGSUIXIBAIXUEBING(AML)、GUSUIYUANSHIXIBAOWEI20-30%BANDUOXIFAYUYICHANG。BAOZHILINDAYAOFANGZHUSHEYONGAZHABAOGANYEMIANTIGONGZHENGDATIANQINGYAOYEJITUANGUFENYOUXIANGONGSISHENGCHANDEZHUSHEYONGAZHABAOGAN,ZHUSHEYONGAZHABAOGANSHUOMINGSHUHANZHUSHEYONGAZHABAOGANJIAGE、ZHUSHEYONGAZHABAOGANDEGONGXIAOYUZUOYONG、ZHUSHEYONGAZHABAOGANDEYONGFAYONGLIANG、ZHUSHEYONGAZHABAOGANDEFUZUOYONGYUBULIANGFANYING、ZHUSHEYONGAZHABAOGANDEZHUYISHIXIANGYUJINJIDENGXINXI。

  • 腫瘤用藥
  • 肝膽用藥
  • 神經精神
  • 免疫用藥
  • 胃腸用藥
  • 心腦血管
  • 風濕骨病
  • 泌尿用藥

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規格:100mg
十三味菥蓂丸
規格:0.3g*18丸*3小盒
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規格:80mg*30片
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規格:0.3g*72片
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規格:0.45g*24粒

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