Sonidegib Oral capsule

What is this medicine?

SONIDEGIB (soe ni deg ib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat basal cell carcinoma, a type of skin cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• history of a muscle disorder

• an unusual or allergic reaction to sonidegib, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Do not cut, crush, or chew this medicine. Take this medicine on an empty stomach, at least 1 hour before or 2 hours after food. Do not take with food. Do not take with grapefruit juice. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If a dose is missed, skip the dose and take the dose the next day at the scheduled time.

What may interact with this medicine?

This medicine may interact with the following medications:

• atazanavir

• certain medicines for fungal infections like ketoconazole, itraconazole, fluconazole, posaconazole and voriconazole

• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin

• diltiazem

• efavirenz

• erythromycin

• modafinil

• nefazodone

• rifabutin

• rifampin

• saquinavir

• stomach acid blockers like cimetidine, famotidine, ranitidine, or omeprazole

• St. John’s Wort

• telithromycin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

This drug may make you feel generally unwell. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

Do not become pregnant while taking this medicine or for 20 months after stopping it. Women of child-bearing potential will need to have a negative pregnancy test before starting this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. This medicine can cause severe birth defects or death to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for 20 months after stopping it.

Men should not father a child while taking this medicine. Men must use a latex condom during sexual contact with a woman while taking this medicine and for 8 months after you stop taking this medicine. A latex condom is needed even if you have had a vasectomy. Contact your doctor right away if your partner becomes pregnant. Do not donate sperm while taking this medicine and for at least 8 months after you stop taking this medicine.

Do not give blood while taking the medicine and for 20 months after completion of treatment to avoid exposing pregnant women to the medicine through the donated blood.

You may need blood work done while you are taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• signs and symptoms of muscle injury like dark urine; trouble passing urine or change in the amount of urine; unusually weak or tired; muscle pain or side or back pain

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• diarrhea

• changes in taste

• hair loss

• headache

• itching

• loss of appetite

• nausea/vomiting

• stomach pain

• tiredness

• weight loss

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.