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Erivedge Approved For Advanced Basal Cell Carcinoma

On January 30, 2012, Erivedge™ (vismodegib) capsule was approved for the treatment of 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 their healthcare provider decides cannot be treated with surgery or radiation. It is not known if Erivedge is safe and effective in children.

Erivedge has been shown to shrink lesions in some adults with Advanced Basal Cell Carcinoma (BCC) (43% of patients (27/63) with locally Advanced Basal Cell Carcinoma (BCC) and 30% of patients (10/33) with metastatic BCC).

Read the press release

Full Prescribing Information Including Boxed WARNING

See Medication Guide (PDF)

Fact Sheets

• Erivedge Fact Sheet
• Skin Cancer Fact Sheet
• Erivedge Development Timeline

Important Safety Information and Serious Side Effects

• Erivedge can cause your baby to die before it is born (be stillborn) or cause your baby to have severe birth defects
• For females who can become pregnant, talk with your healthcare provider about the risks of Erivedge to your unborn child. Your healthcare provider should do a pregnancy test within 7 days before you start taking Erivedge to find out if you are pregnant. Avoid pregnancy by using highly effective birth control before starting Erivedge, and continue during treatment and for 7 months after your last dose. Tell your healthcare provider right away if you have unprotected sex or think that your birth control has failed. For males, always use a condom with a spermicide during sex with female partners while you are taking Erivedge and for 2 months after your last dose, even if you have had a vasectomy
• Tell your healthcare provider right away if you or your female partner could be pregnant or thinks she is pregnant while you 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.

What should I tell my healthcare provider before taking Erivedge?

• If you are pregnant or plan to become pregnant
• If you are breast-feeding or plan to breast-feed

What should I avoid while taking Erivedge?

Do not donate blood or blood products while you are taking Erivedge and for 7 months after your last dose.

What are the possible side effects of Erivedge?

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 
• Joint aches

These are not all of the possible side effects of Erivedge. For more information, ask your healthcare provider or pharmacist. Because everyone is different, it is not possible to predict what side effects any one person will have or how severe they may be. If you have questions or concerns about side effects, you should talk to your doctor.

Please see the full Prescribing Information and the Medication Guide that come with this [booklet, letter, etc] for serious side effects and additional important safety information.