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Odomzo® (Sonidegib)

Reviewed by: HU Medical Review Board | Last reviewed: April 2023

Odomzo® (sonidegib) is a treatment option for adults with certain forms of advanced basal cell carcinoma (BCC). It can be used to treat locally advanced BCC that has come back after surgery or radiation, or that cannot be treated with surgery or radiation. "Locally advanced" means the cancer has not spread far from its original location.1

Odomzo is often one of the first drugs used for locally advanced BCC. It reduces tumor growth by blocking skin cell growth and division. Talk to your doctor about the risks and benefits of Odomzo.1-5

What are the ingredients in Odomzo?

The active ingredient in Odomzo is sonidegib.1,2

How does Odomzo work?

Odomzo works by blocking a cell process called the Hedgehog pathway. This process helps control hair follicle development and skin growth.3,4

A key part of the Hedgehog pathway is a protein called “Smoothened” (SMO). When SMO is active, it sends signals for cells to grow and divide. Normally, SMO is turned off by another protein called “Patched” (PTCH1) when necessary.3,4

But many people with BCC have changes (mutations) to PTCH1. This prevents it from turning off SMO. SMO is then free to send unlimited signals to cells that tell them to grow. This can lead to uncontrolled cell division and tumor growth.3,4

Odomzo is designed to block SMO to prevent or slow cancer cell growth. Odomzo is an example of a targeted therapy for BCC. It targets a unique feature of cancer cells – in this case, active SMO proteins.5

What are the possible side effects?

The most common side effects of Odomzo include:1,5

  • Hair loss
  • Nausea, vomiting, or diarrhea
  • Low appetite and weight loss
  • Change in taste
  • Stomach pain
  • Itching
  • Tiredness
  • Headache

Odomzo has a boxed warning, the strictest warning from the US Food and Drug Administration (FDA). It has this warning because it can cause severe birth defects or cause babies to die before they are born.1

If you are pregnant, plan to become pregnant, or are breastfeeding or plan to breastfeed, talk with your doctor. Odomzo should not be taken by people who are pregnant or are breastfeeding.1

Odomzo can also cause muscle spasms and muscle pain. In rare cases, Odomzo can increase your risk of a muscle injury called rhabdomyolysis. This can lead to kidney damage. Talk to your doctor if you notice symptoms of muscle problems or kidney damage, including:1

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

Odomzo can also cause menstrual periods to stop in people who can become pregnant. Experts do not yet know if this change is permanent.1

These are not all the possible side effects of Odomzo. Talk to your doctor about what to expect when taking Odomzo. Call your doctor if you have any changes that concern you when taking Odomzo.

Other things to know

Take Odomzo as your doctor prescribes. It is available as an oral capsule.5

Talk to your doctor about how to prevent pregnancy and pregnancy complications while taking Odomzo. They may suggest that you:1

  • Use birth control during treatment and for some time after treatment if you can become pregnant
  • Use a condom during sex throughout treatment and for some time after treatment if your partner is pregnant or can become pregnant
  • Talk to your doctor if you have unprotected sex or if you think contraceptives have failed
  • Talk to your doctor if you or your partner become pregnant or may be pregnant

Your doctor may monitor your muscle and kidney function while you are taking Odomzo. They will perform certain blood tests before and during treatment.1

Talk to your doctor about what to avoid while taking Odomzo. They may suggest that during treatment and for some time after your last dose, you should:1

  • Not donate any blood or blood products
  • Not donate semen
  • Not breastfeed

Other medical conditions or medicines may make Odomzo less safe. Before taking Odomzo, tell your doctor your full health history. Talk to them about:1

  • History of muscle disorders, spasms, or pain
  • Pregnancy or plans to become pregnant
  • Breastfeeding or plans to breastfeed
  • Any allergies you have
  • Any other medical conditions you have
  • Any medicines you take, including over-the-counter drugs, vitamins, and supplements

For more information, read the full prescribing information of Odomzo.

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