Full Prescribing Information including Boxed WARNING

Medication Guide

Erivedge™ (vismodegib) capsule is a Hedgehog pathway inhibitor indicated for the 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. It is not known if Erivedge is safe and effective in children.

Important Safety Information for Erivedge

Erivedge can cause a baby to die before it is born (be stillborn) or cause a baby to have severe birth defects based on how the medicine interacts with the body.

• Female patients who can become pregnant should speak with their healthcare provider about the risks of Erivedge to their unborn child. Their healthcare provider should do a pregnancy test within seven days before they start taking Erivedge to find out if they are pregnant. Women should avoid pregnancy by using highly effective birth control before starting Erivedge, and continue during treatment and for seven months after their last dose. They should tell their healthcare provider right away if they have unprotected sex or think that their birth control has failed. Female patients must tell their healthcare provider right away if they become pregnant or think that they may be pregnant. Pregnant women are encouraged to participate in a program called the Erivedge pregnancy pharmacovigilance program by calling 1-888-835-2555.
• Male patients should always use a condom with a spermicide during sex with female partners while they are taking Erivedge and for two months after their last dose, even if they have had a vasectomy. Male patients should tell their healthcare provider right away if their female partner could be pregnant or thinks she is pregnant while they are taking Erivedge.
• Patients must not donate blood or blood products while they are taking Erivedge and for seven months after their last dose.
• The most common side effects of Erivedge are muscle spasms, hair loss, change in how things taste or loss of taste, weight loss, tiredness, nausea, diarrhea, decreased appetite, constipation, vomiting and joint aches. Another side effect may include missed monthly periods in females who can become pregnant.
• Patients should tell their healthcare provider if they have any side effect that bothers them or that does not go away.
• These are not all the possible side effects of Erivedge. For more information, please see the Full Prescribing Information for Erivedge, including the Boxed WARNING and Medication Guide at http://www.Erivedge.com.