Erbitux
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Uses
Erbitux® is indicated in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck. [See临床研究（14.1）。]
Erbitux is indicated in combination with platinum-based therapy with 5-FU for the first-line treatment of patients with recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck. [See临床研究（14.1）。]
Erbitux作为单一药物，用于治疗头部和颈部的复发或转移性鳞状细胞癌患者，其先前基于铂的治疗失败了。[看临床研究（14.1）。]
Erbitux已指示治疗K-Raswild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) as determined by FDA-approved tests for this use [seeDosage and Administration (2.2), Warnings and Precautions (5.7), Clinical Studies (14.2)]：
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- in combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) for first-line treatment,
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- in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy,
- •
- as a single agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan. [See警告和预防措施（5.7），临床药理学（12.1），临床研究（14.2）。]
使用的限制：未指示Erbitux的治疗拉斯突变的结直肠癌或何时拉斯突变测试未知[看警告和预防措施（5.7），临床研究（14.2）]。
Erbitux® is indicated in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck. [See临床研究（14.1）。]
Erbitux is indicated in combination with platinum-based therapy with 5-FU for the first-line treatment of patients with recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck. [See临床研究（14.1）。]
Erbitux作为单一药物，用于治疗头部和颈部的复发或转移性鳞状细胞癌患者，其先前基于铂的治疗失败了。[看临床研究（14.1）。]
1.2K-Ras野生型，表达EGFR的结直肠癌Erbitux已指示治疗K-Raswild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) as determined by FDA-approved tests for this use [seeDosage and Administration (2.2), Warnings and Precautions (5.7), Clinical Studies (14.2)]：
- •
- in combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) for first-line treatment,
- •
- in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy,
- •
- as a single agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan. [See警告和预防措施（5.7），临床药理学（12.1），临床研究（14.2）。]
使用的限制：未指示Erbitux的治疗拉斯突变的结直肠癌或何时拉斯突变测试未知[看警告和预防措施（5.7），临床研究（14.2）]。
历史
目前，该药物没有药物史。
其他信息
Erbitux®（西妥昔单抗）是一种重组，人/小鼠嵌合单克隆抗体，该抗体特异性与人表皮生长因子受体（EGFR）的细胞外域结合。西妥昔单抗由鼠抗EGFR抗体的FV区域组成，该抗体具有人IgG1重型和喀巴轻链恒定区域，并且近似于152 kDa的分子量。西妥昔单抗在哺乳动物（鼠髓瘤）细胞培养中产生。
Erbitux is a sterile, clear, colorless liquid of pH 7.0 to 7.4, which may contain a small amount of easily visible, white, amorphous cetuximab particulates. Erbitux is supplied at a concentration of 2 mg/mL in either 100 mg (50 mL) or 200 mg (100 mL), single-use vials. Cetuximab is formulated in a solution with no preservatives, which contains 8.48 mg/mL sodium chloride, 1.88 mg/mL sodium phosphate dibasic heptahydrate, 0.41 mg/mL sodium phosphate monobasic monohydrate, and Water for Injection, USP.
来源
Erbitux制造商
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Imclone LLC
![Erbitux（Cetuximab）溶液[IMCLONE LLC]](//www.lbxkm.com/wp-content/themes/bootstrap/assets/img/loading2.gif)
Erbitux |Imclone LLC
2.1 Squamous Cell Carcinoma of the Head and NeckErbitux与放射治疗或与5-FU的基于铂的治疗结合使用：
推荐的初始剂量为400毫克/平方米administered one week prior to initiation of a course of radiation therapy or on the day of initiation of platinum-based therapy with 5-FU as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min). Complete Erbitux administration 1 hour prior to platinum-based therapy with 5-FU. The recommended subsequent weekly dose (all other infusions) is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) for the duration of radiation therapy (6–7 weeks) or until disease progression or unacceptable toxicity when administered in combination with platinum-based therapy with 5-FU. Complete Erbitux administration 1 hour prior to radiation therapy or platinum-based therapy with 5-FU.Erbitux单一疗法：
推荐的初始剂量为400毫克/平方米administered as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min). The recommended subsequent weekly dose (all other infusions) is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity. 2.2 Colorectal Cancer Determine EGFR-expression status using FDA-approved tests prior to initiating treatment. Also confirm the absence of a Ras mutation prior to initiation of treatment with Erbitux. Information on FDA-approved tests for the detection of K-Ras mutations in patients with metastatic colorectal cancer is available at: http://www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/ucm301431.htm. The recommended initial dose, either as monotherapy or in combination with irinotecan or FOLFIRI (irinotecan, 5-fluorouracil, leucovorin), is 400 mg/m2 administered as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min). Complete Erbitux administration 1 hour prior to FOLFIRI. The recommended subsequent weekly dose, either as monotherapy or in combination with irinotecan or FOLFIRI, is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity. Complete Erbitux administration 1 hour prior to FOLFIRI. 2.3 Recommended Premedication与H1拮抗剂（例如50毫克的苯胺胺）进行预处理，在首次剂量前30-60分钟静脉注射；应根据临床判断和先前输注反应的存在/严重程度来对后续厄利剂剂量进行预处理。
2.4剂量修饰输注反应NCI CTC 1或2和非严重的NCI CTC 3级输注反应将输注率降低50％。
Immediately and permanently discontinue Erbitux for serious infusion reactions, requiring medical intervention and/or hospitalization. [See Warnings and Precautions (5.1).]
皮肤病毒性表1中指定了重度（NCI CTC 3或4级）的建议（NCI CTC 3或4级）的建议修饰。[请参见警告和预防措施（5.4）。
表1：皮疹严重痤疮状的Erbitux剂量修饰指南beplay体验
皮疹Erbitux结果Erbitux剂量
修改第一次发生
Delay infusion 1 to 2 weeks
改进
继续以250 mg/m2
No Improvement
停止厄立曲
2nd occurrence
Delay infusion 1 to 2 weeks
改进
将剂量降低到200 mg/m2
No Improvement
停止厄立曲
第三次出现
Delay infusion 1 to 2 weeks
改进
Reduce dose to 150 mg/m2
No Improvement
停止厄立曲
第四次发生
停止厄立曲
2.5管理准备请勿将Erbitux作为静脉推动或推注。
Administer via infusion pump or syringe pump. Do not exceed an infusion rate of 10 mg/min.
通过低蛋白结合0.22微米的在线滤波器进行管理。
肠胃外药物应在溶液和容器允许的情况下在给药前视觉检查颗粒物和变色。
该溶液应清晰无色，并且可能包含少量易于可见的，白色，无定形的西妥昔单抗颗粒物。不要摇动或稀释。
2.1 Squamous Cell Carcinoma of the Head and NeckErbitux与放射治疗或与5-FU的基于铂的治疗结合使用：
推荐的初始剂量为400毫克/平方米administered one week prior to initiation of a course of radiation therapy or on the day of initiation of platinum-based therapy with 5-FU as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min). Complete Erbitux administration 1 hour prior to platinum-based therapy with 5-FU. The recommended subsequent weekly dose (all other infusions) is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) for the duration of radiation therapy (6–7 weeks) or until disease progression or unacceptable toxicity when administered in combination with platinum-based therapy with 5-FU. Complete Erbitux administration 1 hour prior to radiation therapy or platinum-based therapy with 5-FU.Erbitux单一疗法：
推荐的初始剂量为400毫克/平方米administered as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min). The recommended subsequent weekly dose (all other infusions) is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity. 2.2 Colorectal Cancer Determine EGFR-expression status using FDA-approved tests prior to initiating treatment. Also confirm the absence of a Ras mutation prior to initiation of treatment with Erbitux. Information on FDA-approved tests for the detection of K-Ras mutations in patients with metastatic colorectal cancer is available at: http://www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/ucm301431.htm. The recommended initial dose, either as monotherapy or in combination with irinotecan or FOLFIRI (irinotecan, 5-fluorouracil, leucovorin), is 400 mg/m2 administered as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min). Complete Erbitux administration 1 hour prior to FOLFIRI. The recommended subsequent weekly dose, either as monotherapy or in combination with irinotecan or FOLFIRI, is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity. Complete Erbitux administration 1 hour prior to FOLFIRI. 2.3 Recommended Premedication与H1拮抗剂（例如50毫克的苯胺胺）进行预处理，在首次剂量前30-60分钟静脉注射；应根据临床判断和先前输注反应的存在/严重程度来对后续厄利剂剂量进行预处理。
2.4剂量修饰输注反应NCI CTC 1或2和非严重的NCI CTC 3级输注反应将输注率降低50％。
Immediately and permanently discontinue Erbitux for serious infusion reactions, requiring medical intervention and/or hospitalization. [See Warnings and Precautions (5.1).]
皮肤病毒性表1中指定了重度（NCI CTC 3或4级）的建议（NCI CTC 3或4级）的建议修饰。[请参见警告和预防措施（5.4）。
表1：皮疹严重痤疮状的Erbitux剂量修饰指南beplay体验
皮疹Erbitux结果Erbitux剂量
修改第一次发生
Delay infusion 1 to 2 weeks
改进
继续以250 mg/m2
No Improvement
停止厄立曲
2nd occurrence
Delay infusion 1 to 2 weeks
改进
将剂量降低到200 mg/m2
No Improvement
停止厄立曲
第三次出现
Delay infusion 1 to 2 weeks
改进
Reduce dose to 150 mg/m2
No Improvement
停止厄立曲
第四次发生
停止厄立曲
输注反应NCI CTC 1或2和非严重的NCI CTC 3级输注反应将输注率降低50％。
Immediately and permanently discontinue Erbitux for serious infusion reactions, requiring medical intervention and/or hospitalization. [See Warnings and Precautions (5.1).]
皮肤病毒性表1中指定了重度（NCI CTC 3或4级）的建议（NCI CTC 3或4级）的建议修饰。[请参见警告和预防措施（5.4）。
表1：皮疹严重痤疮状的Erbitux剂量修饰指南beplay体验
皮疹Erbitux结果Erbitux剂量
修改第一次发生
Delay infusion 1 to 2 weeks
改进
继续以250 mg/m2
No Improvement
停止厄立曲
2nd occurrence
Delay infusion 1 to 2 weeks
改进
将剂量降低到200 mg/m2
No Improvement
停止厄立曲
第三次出现
Delay infusion 1 to 2 weeks
改进
Reduce dose to 150 mg/m2
No Improvement
停止厄立曲
第四次发生
停止厄立曲
2.5管理准备请勿将Erbitux作为静脉推动或推注。
Administer via infusion pump or syringe pump. Do not exceed an infusion rate of 10 mg/min.
通过低蛋白结合0.22微米的在线滤波器进行管理。
肠胃外药物应在溶液和容器允许的情况下在给药前视觉检查颗粒物和变色。
该溶液应清晰无色，并且可能包含少量易于可见的，白色，无定形的西妥昔单抗颗粒物。不要摇动或稀释。
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