sonidegib

Sonidegib (odomzo) is a prescription oral medication used to treat a type of skin cancer called basal cell carcinoma that has recurred following surgery or radiation treatment. It also is used for treating basal cell carcinoma that cannot be treated with surgery or radiation.

Sonidegib is an inhibitor of the hedgehog biological signaling pathway, a pathway that promotes the growth of both normal and cancer cells. Sonidegib binds to and inhibits smoothened, a protein involved in hedgehog signaling. Inhibiting smoothened disrupts cell signaling and growth of cancer cells. Sonidegib was approved by the FDA in July, 2015.

The most common side effects of sonidegib include

• hair loss,
• weakness,
• nausea,
• decreased appetite,
• vomiting,
• taste changes,
• diarrhea,
• weight loss,
• stomach pain,
• headache,
• pain,
• muscle pain and spasms, and
• itching.

Women taking sonidegib may experience an absence of menstrual periods (amenorrhea). It is not known if amenorrhea is permanent. Women who wish to get pregnant in the future should talk to their doctor for advice.

The recommended dose of sonidegib is 200 mg orally once daily on an empty stomach, at least 1 hour before or 2 hours after a meal. Sonidegib may be taken until the cancer progresses or unacceptable toxicity develops.

Sonidegib is broken down by a group of liver enzymes known as cytochrome P4503A (CYP3A). Sonidegib should not be combined with drugs that inhibit the activity of these enzymes because enzyme inhibition may result in high blood levels of sonidegib, leading to increased side effects. Examples of such inhibitors include

• ketoconazole (Nizoral),
• itraconazole (Sporanox),
• voriconazole (VFEND),
• certain HIV medications,
• telithromycin (Ketek), and
• others.

Similarly, sonidegib should be combined with drugs that induce (increase the activity) of CYP3A enzymes. Strong CYP3A inducers may decrease blood levels of sonidegib causing treatment failure. Examples of CYP3A inducers include

• carbamazepine (Tegretol),
• efavirenz (Sustiva),
• modafinil (Provigil),
• phenobarbital (Luminal),
• phenytoin (Dilantin),
• rifampin (Rimactane),
• St. John's Wort, and
• others.

Use of sonidegib during pregnancy is not recommended because it may cause death and severe birth defects. Female patients who have been exposed to sonidegib during pregnancy should report their pregnancy to Novartis Pharmaceuticals Corporation by calling 1-888-669-6682.

It is not known whether sonidegib is excreted in breast milk. It should not be used while nursing because there is a potential for serious side effects in the breast fed baby. Additionally, women should not breast feed for at least 20 months after the last dose of sonidegib.

What preparations of sonidegib are available?

Oral capsules: 200 mg

How should I keep sonidegib stored?

Sonidegib capsules should be stored at room temperature between 15 C and 30 C (59 F and 86 F).