Vismodegib

Erivedge®

Inhibitor of the Sonic Hedgehog (Shh) signaling pathway. When Shh binds to Patched, Smoothened is activated and an intracellular signal is transmitted. This signal is inhibited by vismodegib. In Hedgehog-dependent tumor cells, this leads to apoptosis and tumor regression.

June 2013

Advanced basal cell carcinoma (BCC) when surgery or radiation therapy are not options.

Differential blood count, blood chemistry panel including glucose, pregnancy test if applicable, weight, dermatological examination (including photographic documentation) every 4 weeks (initial laboratory tests after 2 weeks).

Differential blood count, blood chemistry panel (Na, K, chloride, calcium, phosphate, urea, creatinine, uric acid, bilirubin, AST, ALT, gamma-GT, alkaline phosphatase, LDH, pancreatic amylase, total protein, CRP, CK, Mg), glucose, pregnancy test if applicable, weight, dermatological examination (including photographic documentation).

150 mg once daily orally, regardless of food intake.

Under no circumstances should the capsules be opened or crushed. Patients must not donate blood during treatment or for up to 24 months after the end of treatment.

Male patients must use condoms during sexual intercourse with women and for up to two months after the end of treatment with vismodegib, and must not donate semen. Women of childbearing potential must agree to use two reliable forms of contraception during treatment and for up to 24 months after the end of treatment.

Treatment with vismodegib should be continued until disease progression or the occurrence of unacceptable toxicities.

See medical literature, guidelines, and study results.