Vismodegib is used in adults to treat basal cell carcinoma that has spread to other parts of the body (metastatic), or that has come back after surgery, or cannot be treated with surgery or radiation.

Vismodegib may also be used for purposes not listed in this medication guide.

Do not use if you are pregnant. Both men and women using this medicine should use effective birth control to prevent pregnancy. Vismodegib can harm an unborn baby if the mother or father is using this medicine.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take vismodegib once a day with or without food.

Swallow the capsule whole and do not crush, chew, break, or open it.

Your doctor will perform tests to check for side effects during treatment with vismodegib.

Your treatment with vismodegib may be temporarily or permanently discontinued if you have certain side effects.

Do not stop taking vismodegib without your doctor's advice.

Store tightly closed at room temperature, away from moisture and heat.

Usual Adult Dose for Basal Cell Carcinoma:

150 mg orally once a day until disease progression or unacceptable toxicity

Comments:
-Withhold therapy for up to 8 weeks for intolerable adverse reactions until improvement or resolution.
-Treatment durations shorter than 8 weeks prior to interruptions have not been studied.

Use: Treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation

You should not use vismodegib if you are allergic to it.

Tell your doctor if you have ever had:

• a muscle disorder; or

• kidney disease.

Vismodegib can harm an unborn baby if the mother or the father is using vismodegib.

• If you are a woman, you will need a pregnancy test within 7 days before starting vismodegib to make sure you are not pregnant. Use birth control while using this medicine and for at least 24 months after your last dose.

• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of vismodegib on the baby.

Do not breastfeed while using this medicine, and for at least 24 months after your last dose.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

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

Do not donate blood while taking vismodegib and for 24 months after your treatment ends.

Do not donate semen while taking vismodegib and for 3 months after your treatment ends.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Vismodegib may cause serious side effects. Call your doctor at once if you have:

• muscle spasms or muscle pain.

Vismodegib can affect bone growth in children. Tell your doctor if your child is not growing at a normal rate while using and after stopping vismodegib.

Call your doctor at once if you miss a menstrual period. This could be a side effect, or it may be a sign that you are pregnant.

Common side effects of vismodegib may include:

• nausea, vomiting, loss of appetite;

• diarrhea, constipation;

• tired feeling;

• joint pain, muscle spasms;

• hair loss;

• weight loss; or

• decreased sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect vismodegib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

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.