Sonidegib

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 tried without success.

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

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

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

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

Store at room temperature, away from moisture and heat.

Sonidegib can cause serious birth defects or stillbirth if either parent is taking sonidegib at the time of conception or during pregnancy. Both men and women using this medicine must use effective birth control to prevent pregnancy.

If you are a woman, do not take 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.

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

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.

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

Sonidegib can cause a condition that leads to the breakdown of skeletal muscle tissue, which can result in 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.

Usual Adult Dose for Basal Cell Carcinoma:

200 mg orally once a day until disease progression or unacceptable toxicityComments:-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

Take the medicine as soon as possible, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at once.

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

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.

Sometimes it is not safe to use certain medications together. Some drugs can change how much of other drugs is in your blood, 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 the medicines you are currently taking and any medicine you begin or stop using.