Generic Name and Formulations:
Vismodegib 150mg; caps.

Company:
Genentech, Inc.
Indications for ERIVEDGE:
Treatment of adults with metastatic basal cell carcinoma, or locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.

Adult:
Swallow whole. 150mg once daily, until disease progression or unacceptable toxicity.

Children:
Not established.

Pharmacological Class:
Hedgehog pathway inhibitor.

Warnings/Precautions:
Risk of embryo-fetal death and severe birth defects in pregnant women. Verify pregnancy status prior to initiation of therapy. Counsel patients (males and females) on the need for contraception during and after treatment. Advise patients not to donate blood or blood products while on therapy and for at least 7 months after last dose. Pregnancy (Cat.D). Nursing mothers: not recommended.

Interactions:
May be potentiated by P-gp inhibitors (eg, clarithromycin, erythromycin, azithromycin). May be antagonized by drugs that affect gastric pH (eg, proton pump inhibitors, H2-receptor antagonists, antacids).

Adverse Reactions:
Muscle spasms, alopecia, dysgeusia, weight loss, fatigue, GI upset, decreased appetite, constipation, arthralgias, ageusia.

Note:
Report immediately exposure to Erivedge during pregnancy by contacting the Genentech Adverse Event Line at (888) 835-2555.

How Supplied:
Caps—28

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。