Sonidegib is used to treat basal cell carcinoma (a type of skin cancer).

Sonidegib is usually given when surgery or radiation cannot be used, or have been used without success.

Sonidegib may also be used for purposes not listed in this medication guide.

Sonidegib can cause severe birth defects or stillbirth if the mother or father is taking sonidegib at the time of conception or during pregnancy. Both men and women using this medicine should use effective birth control to prevent pregnancy.

If you are a woman, do not use sonidegib if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 20 months after your last dose.

If you are a man, always use a condom during sex with a woman who is pregnant or is able to get pregnant, even if you have had a vasectomy. Keep using condoms while you are taking sonidegib and for at least 8 months after your last dose.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take sonidegib on an empty stomach, at least 1 hour before or 2 hours after a meal.

You will need frequent medical tests to be sure sonidegib is not causing harmful effects. Your cancer treatments may be delayed based on the results of these tests.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Basal Cell Carcinoma:

200 mg orally once a day until disease progression or unacceptable toxicity

Comments:
-Prior to therapy initiation, serum creatinine kinase (CK) levels and renal function tests should be obtained.
-Verify pregnancy status in all patients of reproductive potential.

Use: For adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy

Tell your doctor if you have ever had:

• kidney disease; or

• a muscle disorder called rhabdomyolysis or myopathy.

You will need to have a negative pregnancy test before you start taking sonidegib.

Sonidegib can cause severe birth defects or stillbirth if the mother or father is taking this medicine at the time of conception or during pregnancy. Both men and women using this medicine should use effective birth control to prevent pregnancy.

• If you are a woman, do not use sonidegib if you are pregnant. Use effective birth control to prevent pregnancy while you are taking this medicine and for at least 20 months after your last dose. Stop using sonidegib and call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant.

• If you are a man, always use a condom during sex with a woman who is pregnant or is able to get pregnant, even if you have had a vasectomy. Keep using condoms while you are taking sonidegib and for at least 8 months after your last dose.

Call your doctor if you have unprotected sex or if you believe your form of contraception has failed, whether you are a man or a woman.

Do not breastfeed while using this medicine, and for at least 20 months after your last dose.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Do not donate blood while you are taking sonidegib and for at least 20 months after your final dose of sonidegib.

Do not donate semen (sperm) while taking sonidegib and for at least 8 months after your final dose.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Sonidegib can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have:

• severe or unexplained muscle pain or weakness (even if this occurs after you have stopped taking sonidegib);

• little or no urinating; or

• dark colored urine.

Common side effects of sonidegib may include:

• stomach pain, nausea, vomiting, diarrhea;

• loss of appetite, weight loss;

• tiredness;

• itchy skin, hair loss; or

• changes in your sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect sonidegib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.