Sonidegib Capsules

What is this medication?

SONIDEGIB (soe ni DEG ib) treats skin cancer. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

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

COMMON BRAND NAME(S): ODOMZO

What should I tell my care team before I take this medication?

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

• History of a muscle disorder
• An unusual or allergic reaction to sonidegib, other medications, foods, dyes, or preservatives
• If you or your partner are pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with a glass of water. Do not cut, crush, or chew this medication. Swallow capsules whole. Take it on an empty stomach, at least 1 hour before or 2 hours after food. Do not take with food. Keep taking it unless your care team tells you to stop.

Do not take this medication with grapefruit juice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

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 you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

• Atazanavir
• Certain medications for fungal infections, such as ketoconazole, itraconazole, fluconazole, posaconazole, voriconazole
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Diltiazem
• Efavirenz
• Erythromycin
• Modafinil
• Nefazodone
• Rifabutin
• Rifampin
• Saquinavir
• Stomach acid blockers, such as cimetidine, famotidine, ranitidine, 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 medication?

Your condition will be monitored carefully while you are receiving this medication. You may need blood work while taking this medication.

This medication may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 20 months after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 20 months after the last dose. Your care team can help you find the option that works for you.

If your partner can get pregnant, use a condom during sex while taking this medication and for 8 months after the last dose.

Do not donate sperm while taking this medication and for 8 months after the last dose.

Do not breastfeed while taking this medication and for 20 months after the last dose.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

Do not donate blood while you are taking this medication and for 20 months after the last dose. Donated blood may contain enough of this medication to cause birth defects if transfused to someone who is pregnant.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Muscle injury—unusual weakness or fatigue, muscle pain, dark yellow or brown urine, decrease in amount of urine

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Change in taste
• Diarrhea
• Fatigue
• Hair loss
• Loss of appetite with weight loss
• Nausea

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 medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.