FDA Approves Odomzo

Odomzo (sonidegib) Capsules

Company: Novartis Pharmaceuticals Corporation
Date of Approval: July 24, 2015
Treatment for: Basal Cell Carcinoma

Odomzo is the second hedgehog pathway inhibitor approved for the treatment of basal cell carcinoma.

The U.S. Food and Drug Administration (FDA) has approved Odomzo (sonidegib), an oral hedgehog pathway inhibitor for the treatment of locally advanced basal cell carcinoma (laBCC) that has returned after surgery or radiation therapy, or for patients who cannot undergo surgery or radiation therapy. It joins Erivedge (vismodegib) as the second hedgehog pathway inhibitor approved for the treatment of basal cell carcinoma.

MEDICATION GUIDE

Read this Medication Guide before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

IMPORTANT INFORMATION

Odomzo can cause your baby to die before it is born (be stillborn) or cause your baby to have severe birth defects.

For females who can become pregnant:

• You should talk to your healthcare provider about the risks to your unborn child.
• Your healthcare provider will do a pregnancy test before you start treatment.
• In order to avoid pregnancy, you should use birth control during treatment, and for at least 20 months after your final dose. Talk to your healthcare provider about what birth control method is right for you during this time.
• Talk to your healthcare provider right away if you have unprotected sex or if you think your birth control has failed.
• Tell your healthcare provider right away if you become pregnant or think that you may be pregnant.

For males:

• It is not known if Odomzo is present in semen. Do not donate semen while you are taking Odomzo and for at least 8 months after your final dose.
• You should always use a condom, even if you have had a vasectomy, during sex with female partners who are pregnant or who are able to become pregnant, during treatment and for at least 8 months after your final dose to protect your female partner from being exposed to Odomzo.
• Tell your healthcare provider right away if your partner becomes pregnant or thinks she is pregnant while you are taking Odomzo.

Exposure to Odomzo during pregnancy:

If you think that you or your female partner may have been exposed to Odomzo during pregnancy, talk to your healthcare provider right away. If you become pregnant during treatment, you or your healthcare provider should report your pregnancy to Novartis Pharmaceuticals Corporation at 1-888-669-6682.

WHAT IS ODOMZO?

Odomzo is a prescription medicine used to treat adults with a type of skin cancer, called basal cell carcinoma, that has come back following surgery or radiation or that cannot be treated with surgery or radiation.

It is not known if it is safe and effective in children.

BEFORE TAKING ODOMZO

Before you take Odomzo, tell your healthcare provider if you:

• have muscle pain or spasms, or have a history of a muscle disorder called rhabdomyolysis or myopathy
• have any other medical conditions
• are pregnant or plan to become pregnant. See Important information.
• are breastfeeding or plan to breastfeed. It is not known if Odomzo passes into your breast milk. Do not breastfeed during treatment and for 20 months after your final dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

HOW SHOULD I TAKE ODOMZO?

• Take this medicine exactly as your healthcare provider tells you.
• Take Odomzo one time each day, at least one hour before or two hours after a meal.
• If you miss a dose, skip the missed dose. Take your next dose as scheduled.

WHAT SHOULD I AVOID WHILE TAKING ODOMZO?

• Do not donate blood or blood products during treatment and for 20 months after your final dose.
• Do not donate semen during treatment and for at least 8 months after your final dose.

ODOMZO SIDE EFFECTS

Odomzo can cause serious side effects, including:

• See Important information.
• Muscle Problems. Muscle spasms and muscle pain are common with Odomzo, but can also sometimes be symptoms of serious muscle problems. Odomzo can increase your risk of muscle pain and, rarely a serious condition caused by injury to the muscles (rhabdomyolysis) that can lead to kidney damage. Tell your healthcare provider right away if you develop any new or worsening muscle spasms, pain or tenderness, dark urine, or decreased amount of urine during treatment.

Your healthcare provider should do a blood test to check for muscle problems and to check your kidney function before you start taking Odomzo, during treatment, and if you develop muscle problems.

The most common side effects include:

• hair loss
• change in taste
• tiredness
• nausea
• diarrhea
• weight loss
• decreased appetite
• vomiting
• stomach area (abdominal pain)
• itching
• headache

Odomzo can cause absence of menstrual periods (amenorrhea) in females who are able to become pregnant. It is not known if amenorrhea is permanent. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

HOW SHOULD I STORE ODOMZO?

• Store at room temperature between 68°F to 77°F (20°C to 25°C).

Keep all medicines out of the reach of children.

GENERAL INFORMATION ABOUT THE SAFE AND EFFECTIVE USE OF ODOMZO

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information that is written for health professionals.

WHAT ARE THE INGREDIENTS IN ODOMZO?

Active ingredient: sonidegib

Inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, poloxamer, and sodium lauryl sulfate. The capsule shell contains gelatin, red iron oxide, and titanium dioxide. The black printing ink contains ammonium hydroxide, black iron oxide, propylene glycol, and shellac.