• Melanoma and other skin cancers

Odomzo Generic Name & Formulations

General Description

Sonidegib 200mg; caps.

Pharmacological Class

Hedgehog pathway inhibitor.

How Supplied


Generic Availability


Mechanism of Action

Sonidegib is an inhibitor of the Hh pathway. Sonidegib binds to and inhibits Smoothened, a transmembrane protein involved in Hh signal transduction.

Odomzo Indications


Treatment of adults with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation, or those who are not candidates for surgery or radiation therapy.

Odomzo Dosage and Administration


Take on empty stomach. 200mg once daily until disease progression or unacceptable toxicity. Dose modifications: see full labeling.


Not established.

Odomzo Contraindications

Not Applicable

Odomzo Boxed Warnings

Boxed Warning

Embryo-fetal toxicity.

Odomzo Warnings/Precautions


Risk of embryo-fetal death or severe birth defects in pregnant women. Verify pregnancy status of females of reproductive potential prior to initiation. Advise females to use effective contraception during therapy and for at least 20 months after the last dose; male patients must use condoms and not to donate semen during therapy and for at least 8 months after last dose. Advise patients not to donate blood or blood products during therapy and for at least 20 months after last dose. Risk of musculoskeletal adverse reactions accompanied by serum creatine kinase (CK) elevations; temporarily interrupt or discontinue based on severity of reactions. Obtain baseline serum CK and creatinine (SCr) levels prior to initiation; periodically during treatment and as clinically indicated. Obtain serum CK and SCr levels at least weekly in those with musculoskeletal adverse reactions with concurrent serum CK elevation >2.5×ULN until symptoms resolve. Risk of premature fusion of the epiphyses in children (not approved use). Pregnancy. Nursing mothers: not recommended (during therapy and for 20 months after last dose).

Odomzo Pharmacokinetics


Median time-to-peak concentration (Tmax) was 2–4 hours.


Estimated apparent steady-state volume of distribution (Vss/F): 9,166 L. Plasma protein bound: >97%.


Hepatic (primarily CYP3A). 


Fecal (~70%), renal (30%). Half-life: ~28 days.

Odomzo Interactions


Avoid concomitant strong CYP3A inhibitors (eg, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone) or moderate CYP3A inhibitors (eg, atazanavir, diltiazem, fluconazole); if moderate CYP3A inhibitor use necessary, administer for <14 days and monitor closely. Avoid concomitant strong or moderate CYP3A inducers (eg, carbamazepine, efavirenz, modafinil, phenobarbital, phenytoin, rifabutin, rifampin, St. John’s Wort).

Odomzo Adverse Reactions

Adverse Reactions

Muscle spasms, alopecia, dysgeusia, fatigue, nausea, musculoskeletal pain, diarrhea, decreased weight, decreased appetite, myalgia, abdominal pain, headache, pain, vomiting, pruritus; anemia, hyperglycemia, increased SCr, CK, and LFTs.

Odomzo Clinical Trials

See Literature

Odomzo Note


To report exposure to Odomzo during pregnancy, call Novartis at (888) 669-6682.

Odomzo Patient Counseling

See Literature