ODOMZO

What it is

ODOMZO is a hard gelatin capsule containing 200 mg of sonidegib (as diphosphate). Sonidegib is a selective and orally bioavailable Smoothened (Smo) antagonist. Smo is a G protein-coupled receptor-like molecule that positively regulates the Hedgehog (Hh) signal transduction pathway, which is linked to the pathogenesis of basal cell carcinoma. Sonidegib binds Smo with high affinity to inhibit Hh signalling.

Approved indications —

Locally advanced basal cell carcinoma (BCC) in adult patients who are not amenable to curative surgery or radiation therapy — Metastatic BCC in adult patients

Dosing overview

The recommended dose of ODOMZO is 200 mg taken orally once daily on an empty stomach, at the same time each day. ODOMZO should be taken at least 1 hour before, or two hours after a meal. ODOMZO capsules must be swallowed whole and must not be chewed or crushed. Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity develops.

Key safety warnings

All patients starting therapy with ODOMZO should be advised of the risk of muscle-related adverse events including the potential for rhabdomyolysis, and should report promptly any new unexplained muscle pain, tenderness or weakness occurring during treatment or if symptoms persist after discontinuing treatment. CK levels should be checked prior to starting treatment and as clinically indicated thereafter, such as if muscle-related symptoms are reported. If clinically notable elevation of CK is detected, renal function should be assessed. ODOMZO may cause embryo-fetal death or severe birth defects when administered to pregnant women. Based on the mechanism of action, in animal studies, sonidegib has been shown to be teratogenic and fetotoxic. Women who have received ODOMZO should not become pregnant for at least 20 months following their last ODOMZO dose. Sexually active males being treated with ODOMZO must use a condom with spermicide during intercourse and for 6 months after ending treatment. They should not father a child or donate semen while taking ODOMZO or for at least 6 months after ending treatment.

Contraindications

ODOMZO is contraindicated in women who are pregnant or breast-feeding. Women of child-bearing potential are contraindicated unless two reliable methods of contraception are used during treatment and for 20 months after the last dose.

PBS listing

ODOMZO 200 mg capsule is listed on the PBS with authority required restriction at an ex-manufacturer price of A$7430.36.

Regulatory history

ODOMZO was first included in the Australian Register of Therapeutic Goods on 10 August 2015. In November 2017, the PBAC recommended listing for metastatic or locally advanced BCC inappropriate for surgery and curative radiotherapy on an authority required basis, on a cost-minimisation basis against vismodegib, with clinical claims of non-inferior efficacy and safety to vismodegib adequately supported.