When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to sonidegib, or if you are pregnant.

How to Use This Medicine:
Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Take this medicine on an empty stomach, at least 1 hour before or 2 hours after a meal. Swallow the capsule whole.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Skip the missed dose and go back to your regular dosing schedule. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how sonidegib works. Tell your doctor if you are using any of the following:
  
  • Atazanavir, carbamazepine, diltiazem, efavirenz, fluconazole, itraconazole, ketoconazole, modafinil, nefazodone, phenobarbital, phenytoin, posaconazole, rifabutin, rifampin, saquinavir, St John's wort, telithromycin, voriconazole

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Women should use an effective form of birth control during treatment and for at least 20 months after the last dose. Men should use a condom during sex while they are taking this medicine and for at least 8 months after the last dose, even if they had a vasectomy.
• Women should not breastfeed during treatment and for 20 months after the last dose.
• This medicine may cause serious muscle problems that can lead to kidney damage.
• Do not donate blood or blood products while you are taking this medicine and for 20 months after treatment ends. Men should not donate semen while taking this medicine and for 8 months after the last dose.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Decrease in how much you urinate, dark urine
• Muscle pain, tenderness, or weakness, muscle spasms

If you notice these less serious side effects, talk with your doctor:

• Change in or loss of sense of taste
• Decreased appetite, weight loss
• Diarrhea, nausea
• Hair loss
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088