For treatment of locally advanced or metastatic Non Small-Cell Lung Cancer (NSCLC) after failure of at least one prior chemotherapy regimen.
For use in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer
【药品名称】
商品名：Tarceva
别名称：它赛瓦,埃罗替尼
通用名：盐酸厄洛替尼片
英文商品名：Tavceva
英文通用名：Erlotinib HCL Tablets
份子结构名：盐酸厄洛替尼片
【成份】每片内含150mg厄洛替尼（以盐酸厄洛替尼形式存在）
【性状】圆形、双凸、白色包衣片，一面印有棕色"T"和"150"，另一面空白。
【作用机制】Tarceva的抗肿瘤作用机制主要为抑制表皮生长因子（EGFR）酪氨酸激酶胞内磷酸化。
【药代动力学】Tarceva口服后60%吸收，半衰期约36小时，主要由CYP3A4代谢清除。口服Tarceva150mg的生物利用度约60%，4小时后达血浆峰浓度。对591例接受单药Tarceva治疗的药代动力学分析显示，达到稳定血药浓度需7-8 天，患者的年龄、体重、性别与药物的清除速率无显著关系，吸烟可使药物清除率增加24%。
【适应症】Tarceva用于两个或两个以上化疗方案失败的局部晚期或转移的非小细胞肺癌的三线治疗。
【禁忌症】对本品及成份过敏者禁用。
【不良反应】最常见的不良反应是皮疹和腹泻，3/4度皮疹和腹泻的发生率分别为9%和6%，皮疹的中位出现时间是8天，腹泻中位出现时间为12天。
发生率大于10%的不良反应有：皮疹、腹泻、食欲减低、疲劳、呼吸困难、咳嗽、恶心、感染、呕吐、口腔炎、瘙痒、皮肤干燥、结膜炎、角膜结膜炎、腹痛。
【肺 毒 性】有较少的报道提示在接受Tarceva治疗的NSCLC患者或其他实体瘤患者中可出现严重的间质性肺病（ILD），甚至导致死亡。在随机对照研究中，ILD的发生率是0.8%，并且这一发生率在Tarceva治疗组和安慰剂组是相同的。报道的ILD包括：肺炎、间质性肺炎、间质性肺病、闭塞性细支气管炎、肺纤维化、急性呼吸应激综合征和肺渗出。症状发生于治疗后5天~超过9个月，中位发生时间为47天。多数患者常有混杂因素导致ILD发生，如：之前有化疗/放疗、原有实质性肺疾病、肺转移或肺部感染。当有新出现的、难以解释的肺部症状，例如：呼吸困难、咳嗽、发热等，需进行检查评价，一旦诊断ILD，应停止继续使用Tarceva，并采取适当治疗。
【肝 毒 性】Tarceva治疗可引起无症状的肝转氨酶升高，因此，治疗期间应定期复查肝功能，包括：转氨酶、胆红素、碱性磷酸酶等，如果肝功能损害严重应减量或停药。肝功能损害常为暂时性的或伴有肝转移。较少报道有胃肠道出血，常发生于同时应用华法林的患者，所以，同时服用华法林或其他抗凝剂的患者应监测凝血酶原时间。
【老年患者】安全性和药代动力学在年轻人和老年患者中无明显差异，因此，应用于老年患者时不建议调整剂量。
【注意事项】本品必须在有此类药物使用经验的医生指导下使用，并仅在国家肿瘤药物临床试验基地或三级甲等医院使用。
【用法与用量】本品必须在有此类药物使用经验的医生指导下使用，并仅在国家肿瘤药物临床试验基地或三级甲等医院使用。
　厄洛替尼单药用于非小细胞肺癌的推荐剂量为150mg/日，至少在进食前1小时或进食后2小时服用。持续用药直到疾病进展或出现不能耐受的毒性反应。无证据表明进展后继续治疗能使患者受益。

【原产地英文商品名】TARCEVA-25mg/tablet，30tablets
【原产地英文药品名】ERLOTINIB
【中文参考商品译名】
注：以下产品不同的规格和不同的价格，购买时请用电话咨询为准
·特罗凯-25毫克/片，30片/盒（罗氏）
·特罗凯-150毫克/片 30片/盒（罗氏）
·特罗凯-100毫克/片 30片/盒（罗氏）
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·ORLICERT (孟加拉特罗凯 它赛瓦 埃罗体) 150毫克/片 30片/瓶
·Erlocip (印度特罗凯) 150毫克x30片/盒
·Eloti (秘鲁特罗凯 它赛瓦 埃罗体) 150毫克x30片/盒
·Erlonat (印度特罗凯) 150毫克x30片/盒
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【中文参考药品译名】盐酸厄洛替尼片
【曾用名】它赛瓦,埃罗替尼
【生产厂家中文参考译名】罗氏控股的美国基因泰克

Tarceva® (erlotinib) tablets

Tarceva^® (erlotinib), a once-a-day pill, was one of the first targeted treatments approved by the U.S. Food and Drug Administration (FDA) specifically designed to target the epidermal growth factor receptor (EGFR) pathway. Tarceva has been shown to help some people with advanced NSCLC and advanced pancreatic cancer live longer.

Tarceva in Advanced Non-Small Cell Lung Cancer
Tarceva is approved for use in people with advanced NSCLC in two settings:

• As a treatment for people whose lung cancer has not worsened following initial treatment with chemotherapy (maintenance therapy).
• As a treatment for people whose lung cancer has worsened after receiving one or more courses of chemotherapy (second- or third-line therapy).

Tarceva is not intended to be used at the same time as chemotherapy for advanced NSCLC.

Tarceva in Advanced Pancreatic Cancer
Tarceva, used with gemcitabine chemotherapy, is also FDA-approved for treating people with advanced pancreatic cancer who had not received prior chemotherapy (first-line treatment). Tarceva was the first FDA-approved medicine in more than a decade for advanced pancreatic cancer and is the only targeted therapy approved for this devastating disease with few treatment options.

OSI, together with our partners Genentech and Roche, continues to invest in the future development of Tarceva. Our longer-term strategy for Tarceva is to evaluate its efficacy and safety in the front-line and adjuvant settings in NSCLC, other cancers, and in combination with other targeted therapies.

For more information on Tarceva clinical trials, please go to *.

Proposed Mechanism of Action

Tarceva is designed to inhibit signaling of the epidermal growth factor receptor (EGFR) pathway. Tarceva works inside the tumor cell by inhibiting the tyrosine kinase activity of the EGFR pathway, which is one of the critical growth factors in NSCLC and pancreatic cancer.

By blocking this activity, it is thought that Tarceva may help slow or stop the growth of tumors. The way Tarceva works to treat cancer is not fully known.

Safety Information

There have been infrequent reports of serious Interstitial Lung Disease (ILD)-like events including deaths in patients taking Tarceva. Serious side effects (including deaths) in patients taking Tarceva include liver and/or kidney problems; gastrointestinal (GI) perforations (the development of a hole in the stomach, small intestine, or large intestine); and severe blistering skin reactions including cases similar to Stevens-Johnson syndrome. Patients taking Tarceva plus gemcitabine were more likely to experience bleeding and clotting problems such as heart attack or stroke. Eye irritation and damage to the cornea have been reported in patients taking Tarceva. Women should avoid becoming pregnant and avoid breastfeeding while taking Tarceva. Patients should call their doctor right away if they have these signs or symptoms: new or worsening skin rash; serious or ongoing diarrhea, nausea, loss of appetite, vomiting or stomach pain; new or worsening shortness of breath or cough; fever; eye irritation. Rash and diarrhea were the most common side effects associated with Tarceva in the NSCLC clinical studies. Fatigue, rash, nausea, loss of appetite and diarrhea were the most common side effects associated with Tarceva plus gemcitabine therapy in the pancreatic cancer clinical study.

View full prescribing information for additional safety information.

Non-Small Cell Lung Cancer

According to the American Cancer Society, lung cancer is the leading cause of cancer death in the United States and approximately 159,000 Americans died from the disease in 2009. NSCLC is the most common type of lung cancer. Most people are diagnosed with advanced stage disease and only one to five percent of people with advanced stage (IIIB/IV) NSCLC survive five years.

Pancreatic Cancer

Pancreatic cancer is the fourth leading cause of cancer deaths in the United States. In 2009, the American Cancer Society estimated that more than 42,000 people were diagnosed and about 35,000 people died from the disease. Pancreatic cancer tends to spread quickly in the body, leading to high mortality and short life expectancy.

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Indication and Usage for Lung Cancer Patients
Tarceva monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
Results from two, multicenter, placebo-controlled, randomized, Phase 3 trials conducted in first-line patients with locally advanced or metastatic NSCLC showed no clinical benefit with the concurrent administration of Tarceva with platinum-based chemotherapy [carboplatin and paclitaxel or gemcitabine and cisplatin] and its use is not recommended in that setting.
Indication and Usage for Pancreatic Cancer Patients
Tarceva in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
Important Information to Know
In clinical studies, there were infrequent reports of serious lung injuries similar to Interstitial Lung Disease (ILD)-like events. Reports of ILD-like events have been serious and have included deaths in patients receiving Tarceva.
Liver and/or kidney problems (including deaths) have been reported in some patients taking Tarceva. Let your doctor know if you have a history of liver or kidney disease.
Patients receiving Tarceva plus gemcitabine were more likely to experience bleeding and clotting problems such as heart attack or stroke.
Tarceva may cause harm to an unborn baby or may cause possible risk of pregnancy loss. Women should avoid becoming pregnant and avoid breastfeeding while taking Tarceva.
You should call your doctor right away if you have these signs or symptoms: new or worsening skin rash; serious or ongoing diarrhea, nausea, loss of appetite, or vomiting; new or worsening shortness of breath or cough; fever; eye irritation.
If you smoke, you should stop smoking while taking Tarceva, as it may affect how well Tarceva works for you. If you continue to smoke, you should speak to your doctor before taking Tarceva.
Let your doctor know if you are taking other prescription or over-the-counter drugs or herbal supplements before you start taking Tarceva. While taking Tarceva, do not start taking any new drugs or herbal supplements before talking to your doctor.
Rash and diarrhea were the most common side effects associated with Tarceva in the non-small cell lung cancer clinical study.
Fatigue, rash, nausea, loss of appetite, and diarrhea were the most common side effects associated with Tarceva plus gemcitabine therapy in the pancreatic cancer clinical study.
Tarceva is not right for everyone. Ask your doctor if once-daily Tarceva is right for you.