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| 特罗凯(Tarceva)与两件致命性肝毒性病例有关 | |
| 美国食品药物管理局（FDA）今天警告健康照护专家们，erlotinib（Tarceva，OSI药厂与Genentech公司製造），已经被报导与致命性肝毒性有关。 根据一篇由美国FDA的安全资讯与不良反应通报系统MedWatch发出的警讯，肝臟功能不全病患在使用erlotinib时应该要特别注意监测，特别是那些胆红素高於正常上限值三倍（ULN）的病患。 如果肝臟功能严重变化，应该中止或是停止用药，例如总胆红素浓度加倍，以及/或是转氨脢浓度上升超过治疗前的三倍。 这项警讯是根据一项上市后药物动力学研究（共有15位受试者），这些病患罹患固体肿瘤，且有中度肝臟功能受损（Child-Pugh分级B级），其中十件死亡事件中有两件与肝毒性有关，一位病患死於肝肾症候群，而另一位死於快速恶化的肝臟衰竭。 该公司於一项对临床医师的通讯中表示，十位死亡的病患中有六位治疗前总胆红素就已经超过ULN 三倍，暗示这是严重而非中度肝臟功能不佳，突显了使用Child-Pugh分级於肝臟功能不全肿瘤病患的限制。 Erlotinib适用於局部恶化或是转移性非小细胞肺癌，过去至少使用一个以上的化学治疗，且与gemcitabine HCl（Gemzar注射剂，礼来药厂製造）併用於第一线治疗局部恶化、无法切除、或是转移的胰臟癌。 与erlotinib有关的不良反应应该通报到製造商，以电话1-877-TARCEVA（1-877-827-2382），或是透过电话1-800-FDA-1088通报、传真到1-800-FDA-0178、线上通报http://www.fda.gov/medwatch或是邮件到5600 Fishers Lane，Rockville, MD 20852-9787。 Tarceva Linked to 2 Fatal Cases of Hepatotoxicity Cases of fatal hepatotoxicity have been reported with use of erlotinib (Tarceva, OSI Pharmaceuticals, Inc, and Genentech, Inc), the US Food and Drug Administration (FDA) warned healthcare professionals today. Patients with hepatic impairment should be closely monitored during erlotinib therapy, and particular caution is advised for those with total bilirubin levels greater than 3 times the upper limit of normal (ULN), according to an alert issued by MedWatch, the FDA\'s safety information and adverse event reporting program. Dosing should be interrupted or discontinued for severe changes in liver function, such as doubling of total bilirubin and/or tripling of transaminases in baseline levels outside the normal range. The warning was based on findings from a postapproval pharmacokinetic study (n = 15) of patients with solid tumors and moderate hepatic impairment (Child-Pugh class B), in which 2 of 10 deaths were attributed to hepatotoxicity. One patient died from hepatorenal syndrome, and the other from rapidly progressing liver failure. \"Six out of the 10 patients who died had baseline total bilirubin > 3 × ULN suggesting severe, rather than moderate, hepatic impairment,\" the company said in a communication to clinicians, highlighting the limitations of using Child-Pugh criteria in oncology patients with liver involvement. Erlotinib is indicated as monotherapy for locally advanced or metastatic non-small cell lung cancer after failure of at least 1 prior chemotherapy regimen and in combination with gemcitabine HCl (Gemzar injection, Eli Lilly and Co) for the first-line treatment of locally advanced, unresectable, or metastatic pancreatic cancer. Adverse events related to use of erlotinib should be reported to the manufacturer by telephone at 1-877-TARCEVA (1-877-827-2382). Alternatively, case data may be relayed to the FDA\'s MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787. 发布时间：2008年10月02日 |
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