Vismodegib (Erivedge)

General information

Class/mechanism: Hedgehog pathway inhibitor. Vismodegib binds to and inhibits the transmembrane protein Smoothened (SMO), which is part of the Hedgehog signal transduction pathway that is clinically relevant in diseases such as basal cell cancer.
Route: PO
Extravasation: n/a

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.

Diseases for which it is used

• Cutaneous basal cell carcinoma
• Hedgehog pathway-mutated tumors (tissue-agnostic)

Patient drug information

• Erivedge manufacturer side effect tips
• Vismodegib (Erivedge) patient drug information (UpToDate)

History of changes in FDA indication

• 2012-01-30: Initial FDA approval for the treatment of adults with metastatic basal cell carcinoma. (Based on ERIVANCE BCC)
• 2012-01-30: Initial FDA approval for the treatment of adults with locally advanced basal cell carcinoma that has recurred following surgery. (Based on ERIVANCE BCC)
• 2012-01-30: Initial FDA approval for the treatment of adults with locally advanced basal cell carcinoma who are not candidates for surgery, and who are not candidates for radiation. (Based on ERIVANCE BCC)

History of changes in EMA indication

• 2013-04-26: Initial authorization

History of changes in Health Canada indication

• 2013-07-12: Initial notice of compliance

Also known as

• Code name: GDC-0449
• Brand name: Erivedge