For all patients:

Vismodegib should not be taken by women who are pregnant or who may become pregnant. There is a risk that vismodegib 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 vismodegib 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 while you are taking vismodegib and for 7 months after your treatment.

Do not share vismodegib with anyone else, even someone who has the same symptoms you have.

Talk to your doctor about the risk(s) of taking vismodegib.

For female patients:

If you can become pregnant, you will need to avoid becoming pregnant during your treatment with vismodegib. You must have a negative pregnancy test within 1 week of the start of your treatment. You must use acceptable forms of birth control during your treatment and for 7 months after your treatment is completed. Your doctor will tell you which forms of birth control are acceptable.

If you think you are pregnant, you miss a menstrual period, or you have sex without using birth control while taking vismodegib or within 7 months after your treatment, call your doctor immediately.

For male patients:

You must use a condom every time you have sexual contact with a female who is pregnant or able to become pregnant while you are taking vismodegib and for 3 months after your treatment. This is required even if you have had a vasectomy (surgery to prevent sperm from leaving your body and causing pregnancy). 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 vismodegib and for 3 months after your treatment.

Vismodegib is used to treat basal cell carcinoma (a type of skin cancer) in people with cancer that has spread to other parts of the body. Vismodegib is also used to treat basal cell carcinoma that cannot be treated with surgery or radiation or has come back after surgery. Vismodegib 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.

Vismodegib comes as a capsule to take by mouth. It is usually taken once a day with or without food. To help you remember to take vismodegib, take it 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 vismodegib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not split, chew, or crush them.

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

Before taking vismodegib,

• tell your doctor and pharmacist if you are allergic to vismodegib, any other medications, or any of the ingredients in vismodegib 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, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antacids; certain antibiotics such as azithromycin (Z-Pak, Zithromax), clarithromycin (Biaxin, in Prevpac), and erythromycin (E.E.S., Eryc, Ery-Tab, Erythrocin, PCE); a medication for indigestion, heartburn, or ulcers such as cimetidine (Tagamet), famotidine (Pepcid), and ranitidine (Zantac); and proton-pump inhibitors such as dexlansoprazole (Dexilant), lansoprazole (Prevacid, in Prevpac), omeprazole (Prilosec, Zegerid), pantoprazole (Protonix), and rabeprazole (AcipHex). 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 vismodegib, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• do not breast-feed while you are taking vismodegib and for 7 months after your treatment.

Unless your doctor tells you otherwise, continue your normal diet.

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

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

• muscle spasms
• joint pain
• tiredness
• hair loss
• change in how things taste or loss of taste
• decreased appetite
• weight loss
• nausea
• vomiting
• diarrhea
• constipation
• missed menstrual periods

Vismodegib 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.

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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