Sonidegib, Oral

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KEY POINTS

• This medicine is taken by mouth to treat basal cell carcinoma.
• This medicine must NOT be taken by a pregnant woman.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: anticancer

Generic and brand names: sonidegib, oral; Odomzo

What is this medicine used for?

This medicine is taken by mouth to treat basal cell carcinoma (a form of skin cancer) if it:

• Has spread to other parts of your body
• Has come back after surgery
• Cannot be treated with surgery or radiation

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Kidney or liver disease
• Muscle problems, including rhabdomyolysis

Females of childbearing age: Do not take this medicine during pregnancy because it may cause your baby to have severe birth defects or die before birth. You will need to have a negative pregnancy test before you start taking this medicine. Use effective birth control starting 1 month before you start taking this medicine and during treatment and for 20 months after you stop this medicine. Talk with your healthcare provider about effective methods of birth control. If you think you have become pregnant during this treatment or within 20 months after you stop this medicine, contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine or for 20 months after your final dose.

Males should always use a condom, even if you have had a vasectomy, during sex with female partners while you are taking this medicine and for 8 months after your last dose. If you think your female partner may have become pregnant while you are taking this medicine or within 8 months after you stop this medicine, contact your healthcare provider right away.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check with your healthcare provider before using this medicine in children under age 18.

Take this medicine exactly as your healthcare provider prescribes. Take this medicine for as long as your healthcare provider tells you. Do not stop taking this medicine without your healthcare provider's approval.

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

What if I miss a dose?

If you miss a dose, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

Do not donate blood or blood products while you are taking this medicine and for 20 months after your last dose. Males: Do not donate sperm while you are taking this medicine and for 8 months after your last dose.

Females: This medicine may cause you to stop having periods. Talk with your healthcare provider about this.

While you are taking this medicine, report any unusual or ongoing muscle pain, tenderness, or weakness to your healthcare provider right away, especially if you also have a fever or unusual tiredness. Also, contact your healthcare provider right away if these symptoms do not go away even after you stop taking this medicine.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

Your healthcare provider will want to check you regularly while you are taking this medicine. Keep all your appointments.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): New, worsening, or unexplained muscle pain, spasms, or weakness; dark urine; decreased or increased urination; unusual tiredness or weakness; fever, cough, or sore throat; confusion; severe drowsiness; increased thirst or hunger; severe stomach pain, nausea, or vomiting.

Other: Nausea, vomiting, diarrhea, stomach pain, change in sense of taste, decreased appetite, weight loss, tiredness, headache, hair loss, itching.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antifungal medicines such as fluconazole (Diflucan), isavuconazonium (Cresemba), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), eslicarbazepine (Aptiom), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira) and ombitasvir/paritaprevir/ritonavir (Technivie)
• Aprepitant (Emend)
• Bosentan (Tracleer)
• Cancer medicines such as ceritinib (Zykadia), crizotinib (Xalkori), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), mitotane (Lysodren), and nilotinib (Tasigna)
• Conivaptan (Vaprisol)
• Dexamethasone
• Heart medicines such as diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), efavirenz/emtricitabine/tenofovir (Atripla), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Lumacaftor/ivacaftor (Orkambi)
• Mifepristone (Korlym, Mifeprex)
• Nefazodone
• St. John's wort
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, and tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.