About Odomzo
Odomzo (sonidegib, formerly LDE225) is an oral, selective smoothened (SMO) inhibitor approved by the European Commission for the treatment of adult patients with laBCC who are not amenable to curative surgery or radiation therapy. SMO is a molecule that regulates the hedgehog (Hh) signaling pathway, which plays a critical role in stem cell maintenance and tissue repair, as well as in advanced basal cell carcinoma-[11]. Odomzo is currently in clinical development in other diseases.

Outside of the European Union, Odomzo is approved in the United Sates for laBCC that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy; in Australia for the treatment of laBCC that is not amenable to curative surgery or radiation therapy, or for those with mBCC; and in Switzerland for the treatment of advanced BCC that is not amenable to curative surgery or radiotherapy. Additional regulatory submissions are being reviewed by health authorities worldwide.

IMPORTANT SAFETY INFORMATION
Important note: please see the locally approved full prescribing information.

Odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy. Dosage and administration for adults is one 200 mg dose taken orally once daily on an empty stomach, at the same time each day.

Odomzo is contraindicated in women who are pregnant or breast-feeding.

Creatine phosphokinase (CK) levels should be checked prior to starting treatment and as clinically indicated thereafter, for example, if muscle related symptoms are reported. If clinically notable elevation of CK is detected, renal function should be assessed. Dose modification or interruption guidelines should be followed. Patients should be closely monitored for muscle related symptoms if Odomzo is used in combination with certain medications that may increase the potential risk of developing muscle toxicity. Doctors should closely monitor patients with neuromuscular disorders due to an increased risk of muscle toxicity.

Patients should be instructed not to donate blood while taking Odomzo and for at least 20 months after ending treatment.

Women of childbearing potential must use highly effective contraception while receiving Odomzo. Contraception must be continued for 20 months after ending treatment. Negative pregnancy status must be confirmed by a test performed by a healthcare provider prior to initiation of Odomzo treatment. Odomzo must not be used during pregnancy. Women must not breast feed while taking Odomzo and for at least 20 months after ending treatment.

Men should not father a child or donate semen while taking Odomzo and for at least 6 months after ending treatment. Sexually active males must use a condom, regardless of vasectomy status, during intercourse and for at least 6 months after ending treatment.

Male and female fertility may be compromised with Odomzo. Fertility preservation strategies should be discussed prior to starting treatment with Odomzo.