ST LOUIS (MD Consult) - On May 8, 2009, the US Food and Drug Administration (FDA) announced that new safety information is being added to the prescribing information for Tarceva. The new information was derived from routine pharmacovigilance activities of clinical study and postmarketing reports.

Tarceva monotherapy is indicated for the treatment of patients with locally advanced or metastatic non–small cell lung cancer after failure of at least 1 prior chemotherapy regimen. In combination with gemcitabine, Tarceva is also indicated for the first-line treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer.

Gastrointestinal perforation (including fatalities) has been reported in patients receiving Tarceva. The manufacturers warn that patients receiving concomitant antiangiogenic agents, corticosteroids, nonsteroidal antiinflammatory drugs, and/or taxane-based chemotherapy or who have a history of peptic ulceration or diverticular disease are at increased risk. Tarceva should be permanently discontinued in patients who experience gastrointestinal perforation.

Bullous, blistering, and exfoliative skin conditions including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, in some cases fatal, have also been reported in some patients receiving Tarceva. Drug treatment with Tarceva may need to be interrupted or discontinued in patients who experience severe cases of the detailed skin conditions.

In addition to gastrointestinal and dermatologic adverse events, some patients receiving Tarceva have experienced ocular disorders including corneal perforation or ulceration. Other ocular disorders including abnormal eyelash growth, keratoconjunctivitis sicca, and keratitis have been observed. In patients who present with manifestations of acute or worsening eye disorders (eg, eye pain), the manufacturers recommend that Tarceva therapy be interrupted or discontinued.

圣路易斯(MD Consult)——2009年5月8日，美国食品药品管理局(FDA)宣布，目前正着手在Tarceva的处方上添加新的安全信息。该安全信息来源于临床研究的常规药物警戒活动和上市后报告。

Tarceva单药疗法适用于化疗(至少1次)失败的局部晚期或转移性非小细胞肺癌患者。Tarceva+吉西他滨联合疗法也可作为针对局部晚期、不能切除或转移性胰腺癌的一线治疗。

研究报告显示，Tarceva可引起胃肠道穿孔(可能致死)。生产厂家警告说，合并应用血管生成抑制剂、皮质类固醇、非甾类抗炎药和/或基于紫杉烷的化疗、或有消化性溃疡或憩室病病史，均可导致风险增加。患者如果出现胃肠道穿孔，则应永久停用Tarceva。

研究报告还显示，一些接受Tarceva治疗的患者出现大疱性、发疱性和剥脱性皮肤病变，包括Stevens-Johnson综合征/中毒性表皮坏死松解症，部分患者因此出现死亡。 如果患者出现上述严重皮肤病变，则需中断Tarceva治疗。

接受Tarceva治疗的一些患者除了出现上述胃肠道和皮肤不良事件之外，还出现诸如角膜穿孔或眼部溃疡病变。其他眼部病变还包括睫毛生长异常、干燥性角结膜炎和角膜炎。生产厂家建议，如果患者出现急性或加重性眼部病变(如眼痛)，则应停用Tarceva。

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