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:
- You should talk with your healthcare provider about the risks of Erivedge to your unborn child
- Your healthcare provider will do a pregnancy test within 7 days before you start taking Erivedge
- In order to avoid pregnancy, you should use birth control during treatment and for 24 months after your final dose of Erivedge. Talk with your healthcare provider about what birth control method is right for you during this time
- Talk to your healthcare provider right away if you have unprotected sex or if you think that your birth control has failed
- Tell your healthcare provider right away if you become pregnant or think that you may be pregnant
- 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 Erivedge, and for 3 months after your final dose to protect your female partner from being exposed to Erivedge
- Tell your healthcare provider right away if your partner becomes pregnant or thinks she is pregnant while you are taking Erivedge
Pregnancy Exposure Registry:
There is a Pregnancy Exposure Registry for females taking Erivedge who become pregnant. The purpose of this registry is to monitor the health of you and your unborn baby. If you think that you or your female partner may have been exposed to Erivedge during pregnancy, talk to your healthcare provider right away. If you become pregnant during treatment with Erivedge, you or your healthcare provider should report your pregnancy to Genentech at (888) 835- 2555.
Before taking Erivedge, tell your healthcare provider about all of your medical conditions, including:
- If you are pregnant or plan to become pregnant
- If you are breastfeeding or plan to breastfeed. It is not known if Erivedge passes into your breast milk. You should not breastfeed during treatment and for 24 months after your final dose of Erivedge. Talk to your healthcare provider about the best way to feed your baby during this time
- About all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements
What should I avoid while taking Erivedge?
- Do not donate blood or blood products while you are taking Erivedge and for24 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?
- Severe skin reactions: Severe skin reactions have happened in some people taking Erivedge. You may need to be treated in a hospital because these severe skin reactions can be life-threatening or lead to death.
Tell your healthcare provider right away if you develop any of the following signs or symptoms of a severe skin reaction, including:
- blisters or peeling of your skin
- high fever or flu-like symptoms
- blisters on your lip, or around your mouth or eyes
- enlarged lymph nodes
- mouth sores or genital sores
- skin pain and burning
Your healthcare provider may permanently stop Erivedge if you develop a severe skin reaction.
- Muscle Problems: Muscle problems are common with Erivedge, but can also sometimes be serious. Erivedge can increase your risk of muscle spasms or muscle pain. Tell your healthcare provider right away if you develop any new or worsening muscle pain, tenderness, or weakness during or after treatment with Erivedge. Your healthcare provider should do a blood test to check for muscle problems and to check your kidney function before you start taking Erivedge, and as needed during treatment if you develop muscle problems
- 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.