Erivedge

Vismodegib is used to treat basal cell carcinoma that has spread to other parts of the body.

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

You should not use vismodegib if you are allergic to it, or:

• if you are pregnant or breast-feeding.

You will need to have a negative pregnancy test within 7 days before you start taking vismodegib.

You must prevent pregnancy while you are taking vismodegib, whether you are a man or a woman. This medicine can cause severe birth defects or death of a baby.

For Women: Use effective birth control while taking vismodegib and for 24 months after your last dose. The birth control method you use must be proven highly effective (at least 99%), such as: hormonal birth control (pills, vaginal ring, implants, or injections), an intrauterine device (IUD), or a tubal ligation. Call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant.

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

For Men: While you are taking vismodegib you must not have unprotected sex with a pregnant woman, or cause a woman to become pregnant. Vismodegib can affect your sperm and may cause harm to the baby at conception or during pregnancy. Always use a latex condom and spermicide when having sex, even if you have had a vasectomy. Continue using condoms and spermicide for at 3 months after you stop taking vismodegib.

Call your doctor right away if a pregnancy occurs while either the mother or the father is using vismodegib.

Tell your doctor if you have ever had:

• liver disease; or
• kidney disease.

You should not breast-feed while you are using vismodegib and for 7 months after your last dose.

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 with or without food.

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

Store at room temperature away from moisture and heat.

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.

Do not donate blood while taking vismodegib and for 7 months after your treatment ends.

Do not donate sperm (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 of your face, lips, tongue, or throat.

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 may include:

• nausea, vomiting, decreased 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 your current medicines and any medicine you start or stop using.

Your pharmacist can provide more information about vismodegib.