What is Odomzo (sonidegib) for?

Odomzo (sonidegib) is a prescription medication used to treat basal cell carcinoma (BCC) in adults. BCC is the most common type of skin cancer. Odomzo is specifically used to treat locally advanced BCC, which means that the cancer has grown into surrounding tissues and cannot be treated with surgery or other types of radiation. Odomzo belongs to a class of drugs called Hedgehog pathway inhibitors, which work by blocking the abnormal signaling pathway associated with BCC. It is typically taken orally as a capsule.

How does Odomzo (sonidegib) work?

Odomzo (sonidegib) works by blocking the Hedgehog signaling pathway which is a molecular pathway that plays a crucial role in the development of basal cell carcinoma (BCC). Normally, the Hedgehog signaling pathway is responsible for regulating the growth and differentiation of cells during embryonic development, but when this pathway becomes overactive in adults, it can lead to the abnormal growth and division of cells, leading to BCC.

Sonidegib inhibits this pathway by binding to and blocking a protein called Smoothened, which is located on the surface of cancer cells and is part of the Hedgehog signaling pathway. By blocking Smoothened, Sonidegib prevents the abnormal activation of the pathway and slows or stops the growth of BCC.

How is Odomzo (sonidegib) taken?

Odomzo (sonidegib) is available in the form of capsules for oral administration. The usual recommended dose is 200 milligrams (mg) once daily. It should be taken with food, specifically a meal that has a moderate amount of fat because this helps the body absorb the medication more effectively.

It is important to follow the prescribed dosage and schedule given by the healthcare provider. Do not take more or less than the prescribed dose, and do not change the dosing frequency without first consulting your doctor.

Also, do not crush, chew, or break the capsule. Swallow it whole with a glass of water. If a dose is missed, take it as soon as you remember it. If it is almost time for the next dose, skip the missed dose and take the next one at the scheduled time.

Are there any known side effects of Odomzo (sonidegib)?

Yes, there are known side effects associated with the use of Odomzo (sonidegib), some of which can be serious. Common side effects include muscle spasms, hair loss, changes in taste, nausea, vomiting, diarrhea, and fatigue.

More serious side effects that may require immediate medical attention include muscle pain, weakness, or tenderness; severe stomach pain; fever, chills, or flu-like symptoms; skin blistering or peeling; and vision problems.

In addition to these side effects, Odomzo may also cause developmental defects or harm to a developing fetus, so it is contraindicated in pregnancy. Women who are pregnant should not take Odomzo, and women who may become pregnant should use effective birth control during treatment with this medication and for at least 20 months after stopping treatment.

As with any medication, it is important to discuss any potential side effects with your healthcare provider before beginning treatment with Odomzo.

Clinical trials

Odomzo (sonidegib) received approval for the treatment of locally advanced basal cell carcinoma (BCC) based on a study involving 230 patients with either locally advanced or metastatic BCC. Patients were given two different doses of sonidegib – 200mg or 800mg once daily. The study found that the response rate on metastatic BCC was less than 20%, while patients with locally advanced BCC had a response rate of 56% (95% CI: 43.3, 68.3) on the 200mg dosage with 5% complete responses and 45% (95% CI: 43.3, 68.3) on the 800mg dosage. The time to tumor response was 4.0 months (95% CI: 3.8, 5.6) on the 200mg dose, and the median duration of response was 26.1 months.