Genentech - A Member of the Roche Group

Information for Healthcare Providers / Patients / Our Medicines

Erivedge® (vismodegib)

Side Effect Reporting

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to Genentech at (888) 835-2555.

What it Treats

Erivedge® is a prescription medicine used to treat adults with a type of skin cancer, called basal cell carcinoma, that has spread to other parts of the body or that has come back after surgery or that your healthcare provider decides cannot be treated with surgery or radiation.

Important Safety Information

Erivedge can cause a baby to die before it is born (be stillborn) or cause a baby to have severe birth defects.

Female patients who can become pregnant should talk with their healthcare provider about the risks of Erivedge to their unborn child. Their healthcare provider should do a pregnancy test within 7 days before the patient starts taking Erivedge to find out if the patient is pregnant. Patients must avoid pregnancy by using highly effective birth control before starting Erivedge, and continue during treatment and for 7 months after their last dose. Patients must tell their healthcare provider right away if they have unprotected sex or think that their birth control has failed.

Male patients should always use a condom with a spermicide during sex with female partners while they are taking Erivedge and for 2 months after their last dose, even if they have had a vasectomy.

Patients must tell their healthcare provider right away if they or their female partner could be pregnant or thinks she is pregnant while they are taking Erivedge.

Exposure to Erivedge during pregnancy:

Pregnant women are encouraged to participate in a program that collects information about exposure and the effects on the mother and her unborn child by calling the Genentech Adverse Event Line at (888) 835 2555.

Patients must tell their healthcare provider before taking Erivedge if they are pregnant or plan to become pregnant, and if they are breast-feeding or plan to breast-feed.

Patients must not donate blood or blood products while they are taking Erivedge and for 7 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.

These are not all of the possible side effects of Erivedge. For more information, patients should ask their healthcare providers or pharmacists.

Because everyone is different, it is not possible to predict what side effects any one person will have or how severe they may be. Patients should tell their healthcare provider if they have any side effect that bothers them or that does not go away.

Please see the full Prescribing Information and the Medication Guide for serious side effects and additional important safety information at www.erivedge.com.

Patient Access

Genentech Access Solutions offers coverage support, patient assistance, other useful information needed for Erivedge.