For all patients:

Sonidegib should not be taken by women who are pregnant or who may become pregnant. There is a high risk that sonidegib will cause loss of the pregnancy or will cause the baby to be born with birth defects (physical problems that are present at birth).

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with sonidegib and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or visit the manufacturer’s web site to obtain the Medication Guide.

Do not donate blood or blood products while you are taking sonidegib and for at least 20 months after your treatment.

Talk to your doctor about the risks of taking sonidegib.

For female patients:

If you can become pregnant, you will need to avoid becoming pregnant during your treatment with sonidegib. You must have a negative pregnancy test before the start of your treatment. You must use acceptable forms of birth control during your treatment and for at least 20 months after your treatment is completed. Your doctor will tell you which forms of birth control are acceptable.

If you think you are pregnant, miss a menstrual period, or have sex without using birth control while taking sonidegib or within 20 months after your treatment, call your doctor immediately.

For male patients:

You must use a condom, even if you have had a vasectomy (surgery to prevent sperm from leaving your body and causing pregnancy), every time you have sexual contact with a female who is pregnant or able to become pregnant while you are taking sonidegib, and for at least 8 months after your treatment. Tell your doctor immediately if you have had unprotected sex with a woman who can become pregnant or if you think for any reason that your partner is pregnant. Do not donate semen while you are taking sonidegib or within 8 months after your treatment.

Sonidegib is used to treat basal cell carcinoma (BCC; a type of skin cancer) in adults with cancer that has come back after surgery or radiation, or in adults that cannot be treated with surgery or radiation. Sonidegib is in a class of medications called hedgehog pathway inhibitors. It works by blocking the action of a protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells and may help shrink tumors.

Sonidegib comes as a capsule to take by mouth. It is usually taken once a day on an empty stomach, at least 1 hour before or 2 hours after a meal. Take sonidegib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take sonidegib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may need to interrupt or stop your treatment depending on your response to sonidegib and any side effects that you experience.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking sonidegib,

• tell your doctor and pharmacist if you are allergic to sonidegib, any other medications, or any of the ingredients in sonidegib capsules. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: atazanavir (Reyataz); certain antifungals such as fluconazole (Diflucan), itraconazole (Onmel, Sporanox), ketoconazole, posaconazole (Noxafil), and voriconazole (Vfend); diltiazem (Cardizem, Cartia, Tiazac, others); efavirenz (Sustiva, in Atripla); modafinil (Provigil); nefazodone; rifabutin (Mycobutin); rifampin (Rifadin, Rifamate, Rifater, Rimactane); saquinavir (Invirase); certain medications for seizures such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril), phenobarbital, and phenytoin (Dilantin, Phenytek); and telithromycin (Ketek). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with sonidegib, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor what herbal products you are taking, especially St. John’s wort. Your doctor will probably tell you not to take St. John’s wort while taking sonidegib.
• tell your doctor if you have or have ever had muscle disease.
• tell your doctor if you are breastfeeding. Your doctor may tell you not to breastfeed while you are taking sonidegib and for 20 months after your treatment.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Sonidegib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• abdominal pain
• loss of appetite
• weight loss
• nausea
• vomiting
• change in ability to taste food
• hair loss
• itching
• weakness
• extreme tiredness
• pain
• missed menstrual periods

Some side effects can be serious. If you experience any of these symptoms, stop taking sonidegib and call your doctor immediately:

• muscle spasms
• unexplained muscle pain, tenderness or weakness
• dark or cola colored urine
• decreased urination
• inability to urinate

Sonidegib may decrease fertility in women. Talk to your doctor about the risks of taking sonidegib if you have concerns about fertility.

Sonidegib may cause growth to stop early in children. This medication is not recommended for use in children.

Sonidegib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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