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  药店国别: 德国药房
产地国家: 德国
所属类别: 抗癌药物->治疗肠癌药物
处方药:处方药
包装规格: 500毫克/100毫升/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
默克
生产厂家英文名:
Merck
该药品相关信息网址1:
http://www.erbitux.com/
原产地英文商品名:
ERBITUX 500mg/100ml/vial
原产地英文药品名:
Cetuximab
中文参考商品译名:
爱必妥 500毫克/100毫升/瓶
中文参考药品译名:
西妥昔单抗
原产地国家批准上市年份:
2004/02/12
英文适应病症1:
EGFR-expressing meta
英文适应病症2:
Colorectal Carcinoma
英文适应病症3:
Cancer
临床试验期:
完成
中文适应病症参考翻译1:
表皮生长因子受体转移
中文适应病症参考翻译2:
结肠直肠癌
中文适应病症参考翻译3:
癌症
药品信息:

---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件(20113920485716.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------
部分中文爱必妥处方资料(仅供参考)

药品名称:爱必妥 注射 (Erbitux)       
通用名: 西妥昔单抗
英文名: cetuximab
制造商: 德国默克勃林格殷格翰
性状 
本品除活性成分外,还含有以下成分 :磷酸二氢钠20 mg、磷酸氢二钠66 mg、氯化钠424 mg、注射用水加至50 mL。
本品为注射用溶液,无色,可能含有与产品相关的白色可见的无定形颗粒。 

药理作用   
作用机制 :西妥昔单抗属于嵌合型IgG1单克隆抗体,分子靶点为表皮因子受体(EGFR)。EGFR信号途径参与控制细胞的存活、增殖、血管生成、细胞运动、细胞的入侵及转移等。本品可以以高出内源配体约5-10倍的亲和力与EGFR特异结合,可阻碍内源EGFR配体的结合,从而抑制受体的功能,进一步诱导EGFR内吞,从而导致受体数量的下调。西妥昔单抗可以靶向诱导细胞毒免疫效应细胞作用于表达EGFR的肿瘤细胞(抗体依赖的细胞介质的细胞毒作用,ADCC)。
药效学:体内、体外研究均表明,西妥昔单抗可以抑制表达EGFR的人类肿瘤细胞的增殖并诱导其凋亡。在体外,本品能抑制肿瘤细胞分泌的血管生成因子并阻遏内皮细胞的移动。在体内,本品可以抑制肿瘤细胞血管生成因子的表达以减少肿瘤血管的新生和转移。
免疫原性:单克隆嵌合抗体进入人体内引发抗原抗体反应,从而产生人抗嵌合抗体(HACA),但目前有关HACA产生过程的数据有限。在所有已进行的目标适应症的研究中,3.7%的患者检测到了HACA的滴度,其发生率为0-8.5%。到目前为止,尚无HACA中和西妥昔单抗的结论性数据。HACA的产生与超敏反应或其他不良反应的发生无关。
临床疗效 :通过免疫组化方法检测肿瘤组织的EGFR表达(EGFR pharm Dx)。如果检测到一个染色细胞,即认定该肿瘤为EGFR阳性。已有的临床试验中,约80%的转移性结直肠癌患者经筛查为EGFR阳性,适合应用西妥昔单抗进行治疗。尚无本品对EGFR阴性肿瘤患者的有效性及安全性数据。在欧洲和美国已进行了2项西妥昔单抗与伊立替康联合用药的临床试验。共有365个近期经含伊立替康细胞毒治疗方案治疗失败的EGFR阳性的转移性结直肠癌患者入选,其KPS不低于60。但在接受联合治疗后,大部分患者的KPS都大于等于80。
EMR 62 202-007 :本项随机试验是比较西妥昔单抗加伊立替康联合治疗(218例有效病例)和西妥昔单抗单药治疗(111例有效病例)的疗效和安全性。在联合治疗组中,伊立替康的用药方案为:125 mg/m2体表面积,连续4周每周给药1次,随后停药2周 ;或每2周的给药剂量为180 mg/m2体表面积 ;或每3周的给药剂量为350 mg/m2体表面积 ;或参照伊立替康的使用说明书推荐的剂量进行调整。其中半数以上的患者采用的给药剂量为每2周180 mg/m2体表面积。西妥昔单抗单药治疗组的患者如发生疾病进展,则继续采用西妥昔单抗加伊立替康(伊立替康的给药剂量与进入本试验之前患者的使用剂量相同)的方案进行联合治疗。
IMCL CP02-9923 :本实验为单组开放试验,共入选138例有效病例接受联合治疗。其中约90%的患者伊立替康用用药方案为125 mg/m2体表面积,连续4周每周给药1次,随后停药2周。
以上2项试验中,西妥昔单抗的给药剂量见"用法用量"。
CI=可信区间,DCR=疾病控制率(完全缓解、部分缓解或疾病稳定至少6周),ORR=客观有效率(完全缓解或部分缓解),OS=总生存期,PFS=无进展生存期。
西妥昔单抗与伊立替康联合治疗组的客观有效率(ORR)、疾病控制率(DCR)和无进展生存期(PFS)均优于西妥昔单抗单药治疗组。在EMR 62 202-007试验中没有观察到两组之间总生存期的统计学差异(风险比0.91,p=0.48)。
目前尚缺乏本品在中国人进行的临床研究资料。但一项在亚太地区完成的西妥昔单抗与卡铂联合治疗含铂方案化疗失败的复发或转移性鼻咽癌研究中(EMR 62 202-003),本品显示出良好的安全性和有效性(疾病控制率为60% ;中位生存期为8个月)。
EMR 62 202-003 :本项国际、多中心、开放试验共入选60例复发或转移性鼻咽癌患者。本试验用药方案为:西妥昔单抗的初始剂量为400 mg/m2的体表面积,其后每周维持剂量为250 mg/m2体表面积 ;此外 ,在每个治疗周期(3周)的第1天给予卡铂AUC5。治疗持续时间 :至少完成一个治疗周期(3周)。如果出现疾病缓解或疾病稳定,则继续治疗8个周期(24周)。  

药代动力学   
临床试验中,对西妥昔单抗单药治疗及其与化疗药物或放疗联合治疗的药代动力学特性都进行了研究。当静脉滴注剂量为5-500 mg/m2体表面积/周时,本品表现出剂量依赖的药代动力学特性。
当本品的初始剂量为400 mg/m2体表面积时,平均分布容积大致与血容量(2.9 L/m2 :1.5-6.2 L/m2)相同,平均Cmax(±标准偏差)为185±55 ug/mL,平均清除率为0.022 L/h/m2体表面积。本品在靶剂量时具有较长的清除半衰期,为70-100小时。
本品的血清浓度在单药治疗3周后达到稳态水平。第3周时平均峰浓度为155.8 ug/mL,第8周时为151.6 ug/mL,相应的平均谷浓度为41.3 ug/mL和55.4 ug/mL。本品与伊立替康联合用药,第12周时平均谷浓度为50.0 ug/mL,第36周时平均谷浓度为49.4 ug/mL。
抗体的代谢可能受多种途径的影响,这些途径可以将抗体降解为小分子,如短肽和氨基酸等。
特殊人群的药代动力学 :对目前所有临床试验进行综合分析发现,西妥昔单抗的药代动力学性质不会受到种族、年龄、性别、肝肾状况的影响。到目前为止,仅对肝肾功能正常的患者(血清肌酐≤ (smaller than or equal to) 正常值上限的1.5倍,转氨酶≤ (smaller than or equal to) 正常值上限的5倍,胆红素≤ (smaller than or equal to) 正常值上限的1.5倍进行过本品的相关研究。  

毒理研究   
采用临床相应剂量的西妥昔单抗对恒河猴进行了长期毒理性研究,结果主要观察到皮肤毒性。当猴体内浓度达到人临床标准治疗时体内血药浓度的17倍时,本品能引起猴的严重皮肤毒性及致命的综合症。
偶然通过非静脉给药的其它途径应用西妥昔单抗并分析其遗传毒性及局部耐受性,发现本品对人没有特殊毒性。
尚未进行正式的西妥昔单抗致癌性、生殖毒性及潜在致畸毒性的动物试验。
尚未进行西妥昔单抗与伊立替康联合用药的毒性研究。
到目前为止,尚无抗EGFR抗体对伤口愈合的非临床数据。然而,非临床伤口愈合模型显示EGFR选择性酪氨酸激酶抑制剂能延迟伤口愈合。  

适应症   
西妥昔单抗与伊立替康联合用药治疗表达表皮生长因子受体(EGFR)、经含伊立替康细胞毒治疗失败后的转移性结直肠癌。 
 
用法用量   
建议在经验丰富的试验室按照验证后的方法检测EGFR(见"药理毒理")。
西妥昔单抗必须在有使用抗癌药物经验的医师指导下使用。在用药过程中及用药结束后1小时内,需密切监测患者的状况,并必须配备复苏设备。
首次滴注本品之前,患者必须接受抗组胺药物的治疗。建议在随后每次使用本品之前都对患者进行这种治疗。
本品每周给药1次。初始剂量为400 mg/m2体表面积,其后每周的给药剂量为250 mg/m2体表面积。
与本品联合使用的伊立替康的给药剂量,请参照伊立替康的使用说明书。通常情况下,伊立替康的给药剂量与患者上次用药时最后1个周期的使用剂量相同,但同时须参照伊立替康的使用说明书对其剂量进行必要的调整。伊立替康的使用必须在本品滴注结束1小时之后开始。
建议本品的疗程持续至患者的病情进展为止。
本品可使用输液泵、重力滴注或注射器泵经一串联过滤器进行静脉给药(使用方法详见"操作指南")。
初次给药时,建议滴注时间为120分钟,随后每周给药的滴注时间为60分钟,最大滴注速率不得超过5 mL/分。
特殊人群 :迄今为止,本品只在肝肾功能正常的患者中进行过研究(详见"注意事项")。尚未对有血液疾病的患者进行过本品的研究(详见"注意事项")。 
不良反应   
西妥昔单抗的安全性不会受到伊立替康的影响,反之亦然。与伊立替康合用时,本品的其它一些不良反应为已知的伊立替康的不良反应(包括腹泻72%、恶心55%、呕吐41%、粘膜炎如口腔炎等26%、发热33%、白细胞减少症25%,和脱发22%)。因此,请同时参阅伊立替康的使用说明书。
临床上未观察到本品的性别差异。
免疫系统紊乱 :常见(>1/100,<1/10) - 约5%的患者在接受西妥昔单抗治疗时发生超敏反应;其中约半数为严重反应。
轻中度(1级或2级 ;美国国立癌症中心 - 常见毒性标准,NCI-CTC)反应包括发热、寒战、恶心、皮疹和呼吸困难等症状。严重的超敏反应(3级或4级)多发于初次滴注过程中或初次滴注结束1小时内,症状包括急性气道阻塞(如支气管痉挛、喘鸣、嘶哑、说话困难)风疹和/或低血压。
以上不良反应的临床处置,请参见"注意事项"。
眼部疾病 :常见(>1/100,<1/10) - 约5%的患者会发生结膜炎。
呼吸、胸部及纵隔紊乱 :易见(>1/10) - 有报道25%的终末期结直肠癌患者发生呼吸困难。老年患者、体能状况低下者或伴有肺部疾病的患者中,呼吸困难的发生率较高,有时症状严重(见"注意事项")。
皮肤及皮下组织紊乱 :易见(>1/10) - 80%以上的患者可能发生皮肤反应,其中约15%症状严重。主要症状为粉刺样皮疹,其次为指甲病(如甲床炎)。这些不良反应大多在治疗的第1周内出现。通常中断治疗后上述症状可以自行消退,并无后遗症。随后可以按照推荐的调整剂量继续进行治疗(见"注意事项 ")。按照NCI-CTC,2级皮肤反应为50%的体表出现皮疹,3级为大于等于50%的体表出现皮疹。
代谢及营养紊乱 :有低血镁症的报道。 

禁忌症   
已知对西妥昔单抗有严重超敏反应(3级或4级)的患者禁用本品。
伊立替康的有关禁忌,请参阅其使用说明书。 
 
警告   
注意事项   
超敏反应 :如病人出现轻中度(1级或2级)超敏反应,应减慢西妥昔单抗的滴注速率,建议在此后的所有滴注过程均采用该调整后的速率。
有报道使用本品会发生严重的超敏反应(3级或4级),症状多发于初次滴注过程中或初次滴注结束后1小时内,也可能在结束后数小时发生。建议医生告知患者这种超敏反应延迟发生的可能性,并要求患者出现超敏反应症状时立即联系医生。一旦发生严重超敏反应,应立即并永久停用本品,并进行紧急处理。
建议体能状况低下或伴有心肺疾病的患者应特别注意。
呼吸困难 :呼吸困难为超敏反应的一部分,给药当时可能与本品密切相关。但如果在治疗数周后发生呼吸困难,则可能与患者本身所患疾病有关(参见"不良反应")。老年患者、体能状况低下或伴有肺部疾病的患者,可能存在更高的与呼吸困难相关的风险,这种风险可能更严重和/或持续时间更长。
使用本品治疗过程中患者如发生呼吸困难,建议医生观察患者的肺部疾病进展情况。此外,个别患者使用本品时发生间质性肺病,但尚未确定与本品的因果关系。
皮肤反应 :患者发生严重的(3级)皮肤反应,必须中断西妥昔单抗的治疗。只有当反应缓解到2级,才能重新进行治疗(参见"不良反应")。如果严重的皮肤反应属首次发生,不须调整本品的剂量。
如严重的皮肤反应为第2次或第3次出现,必须再次中断使用本品。只有当反应缓解到2级,才能重新开始以较低剂量(第2次发生 :200 mg/m2体表面积 ;第3次发生 :150 mg/m2体表面积)继续进行治疗。
如严重的皮肤反应为第4次发生,或停药后皮肤反应无法缓解至2级,则须永久停止应用本品进行治疗。
特殊人群 :到目前为止,仅对肝肾功能正常的患者(血清肌酐≤ (smaller than or equal to) 正常值上限的1.5倍,转氨酶≤ (smaller than or equal to) 正常值上限的5倍,胆红素≤ (smaller than or equal to) 正常值上限的1.5倍进行过本品的相关研究。
尚无本品对以下一项或多项实验室指标异常的患者的用药经验 :血红蛋白<9 /dl,白血球计数<3000/mm3,绝对嗜中性粒细胞计数<1500/mm3,血小板计数<10万/mm3。
西妥昔单抗与放疗联合应用治疗结直肠癌的经验有限。
其它 :建议检测血清中镁的水平。需要时应补充镁。
驾车与操作机器 尚未进行本品对驾车和操作机器影响的研究。如果患者发生与治疗相关的症状而影响其注意力和反应,建议在症状消退前不要驾车或操作机器。
 
孕妇及哺乳期妇女用药   
EGFR参与胎儿的发育,已有的研究发现其它的IgG1抗体可以通过胎盘屏障,故虽然没有进行西妥昔单抗相关的动物研究,且没有孕妇或哺乳期妇女应用本品的足够数据,但仍强烈建议孕妇仅在其可能获得利益大于对胎儿的潜在风险时才能接受本品的治疗。
由于未知西妥昔单抗是否会分泌到乳汁中,建议哺乳期妇女在使用本品治疗期间和最后1次用药后1个月内不要哺乳。 

儿童用药   
尚无儿童患者使用西妥昔单抗的安全性和有效性数据。 

老年患者用药   
老年患者无需调整剂量。75岁以上患者的用药经验有限。
 
药物相互作用   
伊立替康不会影响西妥昔单抗的安全性,反之亦然。一项正式的药物相互作用研究显示,单剂量(350 mg/m2体表面积)伊立替康不会影响本品的药代动力学性质。同样,本品也不会影响伊立替康的药代动力学性质。
尚未进行本品与其它药物相互作用的人体研究。 

药物过量   
尚无药物过量的报道。无西妥昔单抗单次给药剂量超过500 mg/m2体表面积的经验。 

用药须知   
操作指南 :西妥昔单抗可通过输液泵、重力滴注或注射器泵给药,必须使用单独的输液管。滴注快结束时必须使用9 mg/mL(0.9%)的无菌氯化钠溶液冲洗输液管。
本品为无色溶液,可能含有与产品有关的白色可见的无定形颗粒,这些颗粒不会影响产品的质量,但是,本品在给药期间必须使用0.2 um或0.22 um微孔径过滤器进行过滤。
本品可与以下物品配伍 :聚乙烯、乙烯基乙酸乙酯或聚氯乙烯塑料袋 ;聚乙烯、乙烯基乙酸乙酯、聚氯乙烯、聚丁二烯或聚氨基甲酸酯输注装置;聚醚砜、聚酰氨或聚砜串联过滤器。
准备输液过程中必须确保无菌操作。
必须按照以下要求准备本品 :
与输液泵或重力滴注串联过滤 :取一支适当的无菌注射器(最小50 mL)并装上匹配的针头。从药瓶中抽取所需体积的西妥昔单抗,转入真空容器或塑料袋中,并重复该操作直至达到所需体积。输液管上串联一上述过滤器,并在滴注前向过滤器中注入本品,然后开始给药。滴注速率的设定和控制如前所述。
与注射器泵串联过滤 :取一支适当的无菌注射器(最小50 mL)并装上匹配的针头,从药瓶中抽取所需体积的西妥昔单抗,除去针头后将注射器放入注射器泵,注射器泵上再串联一上述过滤器,并在滴注前向过滤器中注入本品,然后开始给药。滴注速率的设定和控制如前所述。重复该操作直至达到所需体积。
在滴注期间,过滤器可能会偶尔发生堵塞。如发生堵塞,必须更换过滤器。
 
贮藏/有效期   
本品应贮藏在冰箱(2-8°C),禁止冷冻。开启后应立即使用。有效期24个月。

Indications
Head & Neck Cancer:
ERBITUX® (cetuximab), in combination with radiation therapy, is indicated for the initial treatment of a certain type of locally or regionally advanced head and neck cancer.

ERBITUX, in combination with platinum-based chemotherapy with 5-fluorouracil, is indicated for the initial treatment of patients with a certain type of head and neck cancer whose tumor has returned in the same location or spread to other parts of the body.

ERBITUX is also indicated for use alone to treat patients with a certain type of head and neck cancer whose tumor has returned in the same location or spread to other parts of the body and whose disease has progressed following platinum-based chemotherapy.

Colorectal Cancer:
ERBITUX is indicated for the treatment of patients who have colorectal cancer that has spread to other parts of the body and whose tumor expresses a protein called an Epidermal Growth Factor Receptor (EGFR). Treatment with ERBITUX is given in the following two ways:
■As a single agent:
for patients whose disease has progressed after receiving both irinotecan and oxaliplatin
for patients who are unable to tolerate chemotherapy with irinotecan
■In combination with another chemotherapy drug, irinotecan, for patients whose disease has progressed after receiving chemotherapy with irinotecan. The effectiveness of ERBITUX in this combination is based on data regarding patients in clinical studies whose tumors became smaller. At present, there is no proof in this setting that ERBITUX improves the symptoms that a patient feels or helps a patient live longer

The results of certain clinical trials of patients with advanced or metastatic colorectal cancer were reviewed. It was found that ERBITUX did not work in patients whose tumors had mutations of the K-ras gene. ERBITUX is not recommended for the treatment of patients whose colorectal cancer tumors have mutations of the K-ras gene.

ERBITUX is available by prescription only.

Important Safety Information including Boxed WARNINGS
Allergic Reaction
■Severe allergic reactions due to ERBITUX® (cetuximab) therapy have occurred in 42 of 1373 patients (3%) receiving ERBITUX during clinical studies, resulting in death in less than 1 in 1000 patients
Symptoms can include trouble with breathing (including tightening of the airways, wheezing, or hoarseness), low blood pressure, shock, loss of consciousness, and/or heart attack
Most (90%) of the severe allergic reactions occurred with the first dose of ERBITUX, although some patients experienced their first severe allergic reaction during a subsequent dose of ERBITUX
Your doctor or nurse should watch you closely for these symptoms during treatment and may need to stop therapy in the event of an allergic reaction
Severe allergic reactions require that treatment with ERBITUX be stopped immediately and not started again

Heart Attack
■Heart attack and/or sudden death occurred in 4 of 208 patients (2%) with head and neck cancer treated with radiation therapy and ERBITUX (cetuximab) as compared to none of 212 patients treated with radiation therapy alone
■Heart problems resulting in death and/or sudden death occurred in 7 of 219 patients (3%) with head and neck cancer treated with platinum-based chemotherapy with 5-fluorouracil and cetuximab compared to 4 of 215 patients (2%) treated with chemotherapy alone, based on a study conducted in Europe using European cetuximab
■Notify your doctor if you have a history of any heart disease

Lung Disease
■Lung disease, which resulted in 1 death, occurred in 4 of 1570 patients (<0.5%) receiving ERBITUX in several clinical trials in colorectal cancer and head and neck cancer
Notify your doctor if you develop shortness of breath while receiving ERBITUX
ERBITUX treatment should be stopped if symptoms worsen or lung disease is confirmed

Skin Problems
■In several clinical trials in colorectal cancer and head and neck cancer with ERBITUX, skin problems including an acne-like rash, skin drying and cracking, infections (including infections of the blood, skin, eyes, and lips), and abnormal hair growth were seen
Sun exposure may worsen these effects
Patients taking ERBITUX should wear sunscreen and hats to limit sun exposure
A related nail disorder that causes painful swelling of the skin around the nails—most often of the large toes and thumbs—also was reported
Notify your doctor if you develop any of these symptoms while receiving ERBITUX

ERBITUX With Chemotherapy and Radiation
■Death and serious heart problems were seen in a clinical trial that studied the combination of ERBITUX, radiation therapy, and cisplatin (a cancer drug) treatment in patients with head and neck cancer
Two out of 21 patients died and four patients stopped treatment due to side effects
The safety and effectiveness of this regimen has not been established

Electrolyte Depletion
■Low levels of magnesium and accompanying low calcium and potassium levels have been reported with ERBITUX when given by itself and in combination with other cancer drugs
Your doctor or nurse should periodically monitor your blood electrolyte levels and administer intravenous replacement as needed

Late Radiation Side Effects
■The percentage of late radiation side effects was higher in patients given ERBITUX with radiation therapy compared with patients given radiation therapy alone
The following sites were affected: organs that produce saliva (65%/56%), voice box (52%/36%), tissue below the skin (49%/45%), lining of the mouth and some organs (48%/39%), food pipe (44%/35%), and skin (42%/33%) in the patients given ERBITUX and radiation versus patients given radiation alone, respectively
■The percentage of severe late radiation side effects was similar among patients given radiation therapy alone and patients given ERBITUX plus radiation therapy

Pregnancy and Nursing
■Notify your doctor if you are pregnant or if you become pregnant while receiving ERBITUX. Contraception must be used, in both males and females, during ERBITUX therapy and for six months following the last dose of ERBITUX. ERBITUX may be passed from the mother to the developing fetus, and may cause harm to the fetus. ERBITUX should only be used during pregnancy if the potential benefit is greater than the potential risk to the fetus
■ERBITUX may be passed through human breast milk. Because of the potential for serious side effects in nursing infants from ERBITUX, nursing is not recommended during ERBITUX therapy and for two months following the last dose of ERBITUX

Additional Side Effects
In studies of ERBITUX:
■The most serious side effects associated with ERBITUX across all clinical studies were: allergic reactions, heart attack, skin problems, skin irritation in the radiation area, infection, kidney failure, lung disease, and blood clots in the lung
■The most frequent side effects associated with ERBITUX (reported in at least 25% of patients) are skin problems (including rash, itching, and nail changes), headache, diarrhea, and infection

In a study of ERBITUX and radiation therapy given to 208 people with head and neck cancer versus radiation therapy alone given to 212 people with head and neck cancer:
■The most frequent side effects were: acne-like rash (87% versus 10%), skin irritation in the radiation area (86% versus 90%), weight loss (84% versus 72%), and feeling weak (56% versus 49%)
■Serious side effects reported by at least 10% of patients that received ERBITUX in combination with radiation therapy versus radiation therapy alone included: skin irritation in the radiation area (23% versus 18%), acne-like rash (17% versus 1%), and weight loss (11% versus 7%)

In a study of European cetuximab in combination with platinum-based chemotherapy with 5-fluorouracil given to 219 people with head and neck cancer versus chemotherapy alone given to 215 people with head and neck cancer:
■The most frequent side effects were: acne-like rash (70% versus 2%), nausea (54% versus 47%), and infection (44% versus 27%).
■Serious side effects reported by at least 10% of patients in either arm were: infection (11% versus 8%).
■ERBITUX yields approximately 22% higher blood levels of cetuximab relative to European cetuximab. It is possible that U.S. patients receiving ERBITUX may experience more frequent or severe side effects than patients in the study conducted in Europe.

In a study where ERBITUX and supportive care were given to 288 people with metastatic colorectal cancer:
■The most frequent side effects reported were: feeling tired (89%), rash or shedding of the outer layer of the skin (89%), stomach pain (59%), and other pain (51%)
■Serious side effects reported by at least 10% of patients included: fatigue (33%), other pain (16%), shortness of breath (16%), stomach pain (14%), infection without abnormal decrease in white blood cell count (13%), rash or shedding of the outer layer of skin (12%), and other intestinal problems (10%)
In studies where ERBITUX and irinotecan were given to 354 people with metastatic colorectal cancer:

■The most frequent side effects reported were: acne-like rash (88%), feeling weakness or discomfort (73%), diarrhea (72%), and nausea (55%)
■Serious side effects reported by at least 10% of patients included: diarrhea (22%), decrease in white blood cell count (17%), feeling weakness or discomfort (16%), and acne-like rash (14%)

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 详细处方信息以本药内容附件PDF文件(20113920485716.pdf)的“原文Priscribing Information”为准
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更新日期: 2013-09-28
附件:
20113920485716.pdf    

 
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