Sonidegib is used to treat basal cell carcinoma (a type of skin cancer).

Sonidegib is usually given when surgery or radiation cannot be used, or have been used without success.

Sonidegib may also be used for purposes not listed in this medication guide.

Tell your doctor if you have ever had:

• kidney disease; or
• a muscle disorder called rhabdomyolysis or myopathy.

You will need to have a negative pregnancy test before you start taking sonidegib.

Sonidegib can cause severe birth defects or stillbirth if the mother or father is taking this medicine at the time of conception or during pregnancy. Both men and women using this medicine should use effective birth control to prevent pregnancy.

• If you are a woman, do not use sonidegib if you are pregnant. Use effective birth control to prevent pregnancy while you are taking this medicine and for at least 20 months after your last dose. Stop using sonidegib and call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant.
• If you are a man, always use a condom during sex with a woman who is pregnant or is able to get pregnant, even if you have had a vasectomy. Keep using condoms while you are taking sonidegib and for at least 8 months after your last dose.

Call your doctor if you have unprotected sex or if you believe your form of contraception has failed, whether you are a man or a woman.

Do not breastfeed while using this medicine, and for at least 20 months after your last dose.

Use Odomzo (Sonidegib) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Sonidegib can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have:

• severe or unexplained muscle pain or weakness (even if this occurs after you have stopped taking sonidegib);
• little or no urinating; or
• dark colored urine.

Common side effects may include:

• stomach pain, nausea, vomiting, diarrhea;
• loss of appetite, weight loss;
• tiredness;
• itchy skin, hair loss; or
• changes in your sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Do not donate blood while you are taking sonidegib and for at least 20 months after your final dose of sonidegib.

Do not donate semen (sperm) while taking sonidegib and for at least 8 months after your final dose.