Sonidegib

Odomzo®

A selective Smoothened (Smo) antagonist with antitumor and antiproliferative properties. Its effect is based on the inhibition of the Hedgehog signaling pathway through binding to the membrane protein Smo, which results in reduced transcription of growth-promoting genes.

March 2018

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

Differential blood count, blood chemistry panel with glucose, pregnancy test if applicable, weight measurement, 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).

200 mg once daily orally, two hours after a meal and at least one hour before the next meal.

Patients must not donate blood during treatment or for up to 20 months after treatment ends.

Male patients must use a condom during sexual intercourse throughout treatment and for at least 8 months after treatment ends (even after a vasectomy) and must not father a child or donate sperm. Female patients must not become pregnant during treatment or for up to 20 months after treatment.

Concomitant administration of potent CYP3A4 inhibitors or inducers may significantly increase or decrease sonidegib concentrations.

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

See medical literature, guidelines, and study results.