商品名：Erivedge 　　 通用名：vismodegib 　　 生产商：罗氏的基因技术公司（Genentech） 批准日期：2012年1月30日；公司：Genentech 应证和用途 ERIVEDGE™ (vismodegib)胶囊是一种刺猬[hedgehog]通路抑制剂适用于手术后复发或不是手术备选者，和不是放疗备选者有转移基底细胞癌，或有局部晚期基底细胞癌成年的治疗。 剂量和给药方法 推荐剂量是150 mg口服每天1次。 剂型和规格 150 mg胶囊。 禁忌证 无。   警告和注意事项 （1）胚胎-胎儿死亡和严重出生缺陷：ERIVEDGE可能致胚胎-胎儿死亡或严重出生缺陷。 （2）献血：建议患者当接受ERIVEDGE和末次ERIVEDGE剂量后至少7个月不要献血或血液产品。 不良反应 最常见不良反应(发生率≥10%)是肌肉痉挛，脱发，味觉障碍，体重减轻，疲乏，恶心，腹泻，食欲减退，便秘，关节痛，呕吐，和完全丧失味觉。 特殊人群中使用 （1）妊娠：可能引起胎儿危害。忠告生殖潜能女性对胎儿潜在风险。 （2）哺乳母亲：终止药物或哺乳考虑药物对母亲的重要性。 （3）女性生殖潜能和男性：咨询男性和女性对预防妊娠和计划。.暴露于ERIVEDGE期间妊娠立即报告Genentech不良反应在线电话1-888-835-2555。鼓励患者通过在线电话1-888-835-2555联系Genentech不良反应参加ERIVEDGE妊娠药物监察计划。 如何供应/贮存和处置 每个ERIVEDGE(vismodegib)胶囊有粉红色不透明体和灰色不透明帽黑色墨水将“150 mg”印在胶囊体上和“VISMO” 印在胶囊帽上。在28胶囊瓶装可得到ERIVEDGE胶囊(NDC 50242-140-01). 贮存在室温20°C至25°C(68°F至77°F)；外出允许15°C至30°C(59°F至86°F)间[见USP控制室温]。 患者咨询资料 见FDA-批准的患者说明书(用药指南). 忠告患者妊娠期间ERIVEDGE暴露可致胚胎-胎儿死亡或严重出生缺陷。 指导女性患者的生殖潜能当服用ERIVEDGE时使用一种高效避孕形式(失败率小于1%)和末次ERIVEDGE后至少7个月。 指导所有男性患者，当服用ERIVEDGE时，和末次剂量ERIVEDGE后至少2个月，当与女性伴侣性交时，使用避孕套与杀精药，即使输精管切除术前。 指导患者暴露于ERIVEDGE后如她们(或，对男性，他们的女伴侣)成为怀孕或如怀疑妊娠时立即联系其卫生保健提供者。 指导暴露于ERIVEDGE患者立即报告任何妊娠和鼓励参加ERIVEDGE妊娠药物监察计划通过与Genentech不良事件线1-888-835-2555打电话联系。 告知女性患者哺乳婴儿来自ERIVEDGE严重不良反应潜能，考虑到药物对母亲的重要性。 忠告患者当服用ERIVEDGE和末次ERIVEDGE后至少7个月不要献血或血液制品。 忠告患者整个吞服ERIVEDGE胶囊和不要压碎或打开胶囊。 INDICATION Erivedge™ (vismodegib) capsule is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation. BOXED WARNING AND ADDITIONAL IMPORTANT SAFETY INFORMATION EMBRYO-FETAL DEATH AND SEVERE BIRTH DEFECTS Erivedge capsule can cause fetal harm when administered to a pregnant female based on its mechanism of action. Erivedge is embryotoxic and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations Verify pregnancy status prior to the initiation of Erivedge. Advise male and female patients of these risks. Advise female patients of the need for contraception during and after treatment and advise male patients of the potential risk of Erivedge exposure through semen Advise patients to contact their healthcare provider immediately if they suspect they (or, for males, their female partner) may be pregnant. Female and male patients of reproductive potential should be counseled regarding pregnancy prevention and planning Immediately report exposure to Erivedge during pregnancy and encourage women who may have been exposed to Erivedge during pregnancy, either directly or through seminal fluid, to participate in the Erivedge pregnancy pharmacovigilance program by contacting the Genentech Adverse Event Line at (888) 835-2555 FEMALE PATIENTS Determine pregnancy status within 7 days prior to initiation of treatment in females of reproductive potential. For females with a negative pregnancy test, initiate a highly effective form of contraception (failure rate of less than 1%) prior to the first dose. Continue highly effective contraception during therapy and for 7 months after the last dose of Erivedge MALE PATIENTS Male patients should use condoms with spermicide, even after a vasectomy, during sexual intercourse with female partners while being treated with Erivedge and for 2 months after the last dose to avoid exposing an embryo or fetus to vismodegib BLOOD DONATION Advise patients not to donate blood or blood products while receiving Erivedge and for at least 7 months after the last dose of Erivedge NURSING MOTHERS It is not known whether vismodegib is excreted in human breast milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Erivedge, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother ADVERSE REACTIONS The most common adverse reactions (≥10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia Amenorrhea has been observed in clinical trials in females of reproductive potential. Reversibility of fertility impairment is unknown. In clinical trials, a total of 3 of 10 premenopausal women developed amenorrhea while receiving Erivedge Treatment-emergent grade 3 laboratory abnormalities observed in clinical trials were hyponatremia in 6 patients (4%), hypokalemia in 2 patients (1%), and azotemia in 3 patients (2%) Please see the accompanying full Prescribing Information for a complete discussion of the risks associated with Erivedge, including the BOXED WARNING and the Medication Guide FDA批准Erivedge(vismodegib)治疗成人基底细胞癌 2012年1月30日，美国食品药品监督管理局（FDA）批准Erivedge(vismodegib)用于治疗成人最常见的皮肤癌--基底细胞癌。该药用于无法手术或放射治疗的局部晚期基底细胞癌和转移性基底细胞癌患者。 基底细胞癌通常始于表皮，是一种生长缓慢、无痛的皮肤癌。此种癌症多形成于经常日光照射或其他紫外辐射部位。 Erivedge是第一个获FDA批准用于转移性基底细胞癌的药物，按照优先审评程序进行加速审评。Erivedge是一日服用一次的片剂，通过抑制Hedgehog路径发挥药效。该路径作用于大部分基底细胞癌和少数正常组织，如表皮。 对96名局部晚期或转移性基底细胞癌患者进行多中心临床研究评估了Erivedge的安全性和有效性。该临床研究的主要终点是客观应答率（ORR）或治疗后癌症损伤完全或局部减少或消失。30%接受Erivedge的转移性患者产生局部应答，43%局部晚期患者产生完全或局部应答。 在接受Erivedge治疗的患者中观察到最常见副作用有：肌肉痉挛、脱发、体重减轻、恶心、腹泻、疲劳、味觉紊乱、食欲减退、便秘、呕吐、味觉丧失。 Erivedge在获批时附有黑框警告，提醒患者和医护专业人员其可能存在的死亡风险或对未出生胎儿的严重影响。使用Erivedge治疗前必须检验妊娠状态。男性和女性患者都应该了解这些风险，并控制生育。 关于基底细胞癌 基底细胞癌(basal cell carcinoma，BCC) 是皮肤癌最常见类型之一，又称基底细胞上皮瘤(basal cell epithelioma) 、基底样细胞瘤侵蚀性溃疡等，是源于表皮基底细胞或毛囊外根鞘的上皮性低度恶性肿瘤。典型的基底细胞癌的治疗方法包括冷冻或手术切除癌变区域。 每年大约有280万美国人罹患基底细胞癌。皮肤癌基金会称，基底细胞癌(BCCs)一般不致命，但如果任其继续生长将可能导致毁容。有少量的案例里基底细胞癌可能扩散到身体其他器官，并最后导致死亡。