Erivedge Approved For Advanced Basal Cell Carcinoma
January 30th, 2012
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 effe
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).
Important Safety Information
What is the most important information I should know about Erivedge?
- 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 Your healthcare provider will do a pregnancy test before you start taking Erivedge. Avoid pregnancy by using birth control during treatment and for 24 months after your final dose. Tell your healthcare provider right away if you have unprotected sex or think that your birth control has failed
- For males, Erivedge is present in semen. Do not donate semen while you are taking Erivedge and for 3 months after your final dose. You should always use a condom, even if you have had a vasectomy, during sex with female partners who are pregnant or who are able to become pregnant, during treatment with Erivedgeandfor 3monthsafteryourfinaldose to protect your female partner from being exposed to Erivedge.
- 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:
If you become pregnant during treatment with Erivedge, you or your healthcare provider should report your pregnancy to Genentech 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 breastfeeding or plan to breastfeed
- About all the medicines you take
What should I avoid while taking Erivedge?
- Do not donate blood or blood products while you are taking Erivedge and for 24 months after your final dose
- Do not donate semen while you are taking Erivedge and for 3 months after your final dose
What are the possible side effects of Erivedge?
- Bone growth problems. Bone growth problems have happened in children who have been exposed to ERIVEDGE. These problems may continue even after stopping treatment with ERIVEDGE
The most common side effects of Erivedge are:
- Muscle spasms
- Hair loss
- Change in how things taste or loss of taste
- Weight loss
- Decreased appetite
- Joint pain
Erivedge can cause absence of menstrual periods (amenorrhea) in females who are able to become pregnant. It is not known if amenorrhea is permanent. Talk to your healthcare provider if you have concerns about fertility.
These are not all of the possible side effects of Erivedge. Because everyone is different, it is not possible to predict what side effects any one person will have or how severe they may be.
Call your doctor for medical advice about side effects.
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.
Please see the full Prescribing Information for additional Important Safety Information, including serious side effects, and the Medication Guide.