Odomzo (sonidegib)

Odomzo® (sonidegib) is used to treat certain cases of locally advanced basal cell carcinoma (BCC). Locally advanced BCC may generally be defined as cancer that is still confined to the skin tumor, but it is large, recurrent, or aggressive.1

Sonidegib is used to treat locally advanced BCC that:2

  • has recurred (come back) after surgery or radiation, or cannot be treated with surgery or radiation

Sonidegib does not come in generic form. Sonidegib is similar to Erivedge® (vismodegib), another drug that is approved to treat certain kinds of advanced basal cell carcinoma.

How does Sonidegib work?

Sonidegib blocks a cell signaling pathway called Hedgehog.2 This pathway has a role in the development of hair follicles and glands. It also helps to control skin growth.

Key players in the Hedgehog pathway are two receptors called PTCH1 (“Patched”) and SMO (“Smoothened”).3 In normal cells, PTCH1 acts like an off-switch for SMO. It prevents SMO from sending signals for cell division and survival.

In about 80% of BCC tumors, PTCH1 is mutated.4 Mutated PTCH1 does not turn SMO off, so SMO starts sending out signals. This leads to uncontrolled cell growth and survival.

Sonidegib works by blocking the SMO receptor.2 It is called a targeted therapy, because it targets one feature that makes cancer cells different from normal cells.

Receiving sonidegib

Before taking sonidegib, read the Medication Guide that comes in the package. Follow your doctor’s instructions for dosing and duration.

Sonidegib comes as a pink capsule that is taken by mouth.2 Patients should take their medication as prescribed by their doctor. Patients should talk to their doctor if they have any questions, or if they have questions regarding their sonidegib regimen.

Based on your doctor’s instructions, you will continue taking Sonidegib until the cancer progresses or the side effects are unacceptable.2

What are the side effects of Sonidegib?

Muscle spasms and muscle pain are common side effects of Sonidegib.2 In rare cases, taking Sonidegib increases your risk of a muscle injury called rhabdomyolysis. Rhabdomyolysis can lead to kidney damage. Symptoms of muscle problems and kidney damage include:

  • New or worsening muscle spasms
  • Pain or tenderness
  • Dark urine
  • Low urine output (production)

Nearly all patients experience at least one side effect.7 Most are mild or moderate. 2 The most common side effects of Sonidegib include:2

  • Muscle spasms and muscle pain
  • Hair loss
  • Taste changes, loss of appetite, weight loss
  • Fatigue
  • Gastrointestinal problems (nausea, vomiting, diarrhea)
  • Stomach pain
  • Headache
  • Itching

Women may stop having a menstrual period while taking Sonidegib. It is not known whether this change is permanent.

This is not an exhaustive list of all potential side effects of Sonidegib. Talk to your healthcare provider or pharmacist for further information.

Who should not take Sonidegib?

If you are pregnant, plan to become pregnant, or are breastfeeding or plan to breastfeed, talk with your doctor. Sonidegib can cause stillbirth or severe birth defects and should not be taken by women who are pregnant.2 While receiving Sonidegib, females who can become pregnant should use contraceptives during treatment and for a period of time after completing treatment (patients should discuss appropriate birth control methods, and how long they need to use them, with their doctor). Females should not breastfeed during Sonidegib treatment and for a period of time following the final dose (patients should discuss breastfeeding considerations with their doctor).

It is not known whether Sonidegib is present in semen.2 While receiving Sonidegib, males with female partners who are pregnant, or who can become pregnant, should always use a condom during sex throughout treatment and for a period of time after completing treatment (patients should discuss appropriate birth control methods, and how long they need to use them, with their doctor).

Tell your doctor about any medical conditions you have. In particular, tell your doctor if you have a history of a muscle disorder called rhabdomyolysis or myopathy. Blood tests can be done to check for muscle problems and kidney function. Your doctor will do this test before and during treatment with Sonidegib.

What precautions are needed when taking Sonidegib?

During treatment with Sonidegib and for 20 months after the last dose:2

  • Do not donate blood or blood products.

During treatment with Sonidegib and for at least 8 months after the last dose, male patients should not donate semen.

Before starting treatment with Sonidegib, patients should tell their doctor about all medications (prescription and over-the-counter), herbal supplements, and vitamins they are taking.

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Written by: Sarah O'Brien | Last reviewed: February, 2022.