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Class: Biological Therapy

Generic Name: Odomzo®

Trade Name: Sonidegib

For which conditions is Odomzo® approved for? Odomzo is approved for the treatment of adults with a type of skin cancer called basal cell carcinoma (BCC). Specifically, Odomzo is used in BCC that has come back following surgery or radiation or that cannot be treated with surgery or radiation.

What is the mechanism of action? Odomzo works by blocking the activity of a cell-signaling pathway known as the hedgehog pathway, which plays a role in the growth and spread of BCC.

How is Odomzo typically given (administered)? Odomzo is a pill that you’ll take by mouth once daily. Take Odomzo on an empty stomach at least one hour before or two hours after a meal.

How are patients typically monitored? Before you start taking Odomzo, your doctor will do a blood test to make sure you don’t have any muscle problems and that your kidneys are functioning normally. Your doctor will also perform these tests during treatment and if you develop muscle problems.

What are the common (occur in 30% or more of patients) side effects of treatment with Odomzo?

  • Muscle spasms
  • Musculoskeletal pain
  • Alopecia (hair loss)
  • Changes in sense of taste
  • Fatigue
  • Nausea
  • Diarrhea
  • Decreased weight

What are the less common (occur in 10% to 29% of patients) side effects of treatment with Odomzo?

  • Joint pain
  • Headache
  • Itching
  • Abdominal pain
  • Vomiting
  • Decreased appetite
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This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

  • Take Odomzo exactly as your healthcare provider tells you.
  • If you miss a dose, skip the missed dose and take your next dose as scheduled.
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • Tell your doctor if you have: muscle pain or spasms; a history of a muscle disorder called rhabdomyolysis or myopathy; any other medical conditions.
  • Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Are there any special precautions patients should be aware of before starting treatment?

  • For women: You should avoid getting pregnant while taking Odomzo and make sure you’re not pregnant when you start treatment. Odomzo can cause your baby to die before it is born (be stillborn) or cause your baby to have severe birth defects. If you can become pregnant, your doctor should perform a pregnancy test before you start treatment with Odomzo. If you can become pregnant, you should use birth control during treatment and for at least 20 months after your final dose. If you have unprotected sex or if you think your birth control has failed during treatment, tell your doctor right away.
  • For men: Even though it’s not known if Odomzo is present in semen, men should also take precautions during treatment. You should not donate semen during treatment and for at least eight months after completing treatment. You should always use a condom while taking Odomzo and for at least eight months after treatment during sex with female partners who are pregnant or who are able to become pregnant—even if you who have had a vasectomy, you should use a condom.
  • For women and men: Do not donate blood or blood products while you are taking Odomzo and for 20 months after your final dose.

When should patients notify their physician?

  • Female patients: Tell your doctor if you are pregnant, think you may be pregnant, have had unprotected sex, or think your birth control may have failed.
  • If you become pregnant during treatment with Odomzo, you or your healthcare provider should report your pregnancy to Novartis Pharmaceuticals Corporation at 1-888-669-6682.
  • Male patients: Tell your healthcare provider right away if your partner becomes pregnant or thinks she is pregnant while you are taking Odomzo.

If you think that you or your female partner may have been exposed to Odomzo during pregnancy, talk to your doctor right away.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.