What is advanced basal cell carcinoma (BCC) and metastatic BCC?
BCC is the most common type of skin cancer. It starts in the top layer of the skin, and if it's found early, most BCC can be surgically removed.
Sometimes, BCC becomes more serious and can be called advanced BCC. When BCC is advanced, it's either locally advanced or metastatic.
BCC may be locally advanced if:
- It has grown large or deep below the skin, and surgery or radiation are not appropriate, or
- It's on a part of the body, such as the face or ear, where treatment may significantly change the way you look or cause functional damage, or
- It has come back after surgery, or cannot be treated with either surgery or radiation
BCC may be metastatic if:
- It has spread to other parts of the body, such as the lymph nodes, lungs, or bones
If you have advanced BCC and surgery or radiation aren't treatment options, then you and your doctor may decide that Erivedge is the right treatment for you.
How Erivedge is designed to work
Before starting treatment, it's important to understand how Erivedge may work inside the body.
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 child. Your healthcare provider will do a pregnancy test within 7 days 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 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 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.
How might Erivedge help?
Erivedge may cause your advanced BCC to shrink, or it may help control your disease.
In a clinical study, 104 adults took Erivedge for their advanced BCC. Of the 104 patients, 96 were evaluated for overall response rate (63 had locally advanced BCC and 33 had metastatic BCC).
Results at 24 weeks (6 months) of Erivedge treatment
- 27 of 63 patients with locally advanced BCC saw their
BCC shrink
- Out of those, 13 patients saw no visible sign of BCC
- 10 of 33 patients with metastatic
BCC saw their BCC shrink
- No patients in this group saw their BCC completely disappear
How long patients saw improvement:
Half of the patients who responded to Erivedge saw improvement for less than 7.6 months, and half saw improvement for more than 7.6 months.
For patients who responded, the length of improvement ranged from:
- 1 to 13 months for patients with locally advanced BCC
- 2 to 11 months for patients with metastatic BCC
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. You should not breastfeed during treatment and for 24 months after your final dose of Erivedge
- 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?
- Serious 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
- Blisters on your lip, or around your mouth or eyes
- Mouth sores or genital sores
- High fever or flu-like symptoms
- Enlarged lymph nodes
- Skin pain and burning
Your healthcare provider may permanently stop Erivedge if you develop a severe skin reaction.
- 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
- Tiredness
- Nausea
- Diarrhea
- Decreased appetite
- Constipation
- Joint pain
- Vomiting
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.
Indication and Important Safety Information
Indication
Erivedge® (vismodegib) capsule 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.
It is not known if Erivedge is safe and effective in children.
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.
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
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 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.
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. 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 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?
- Serious 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
- Blisters on your lip, or around your mouth or eyes
- Mouth sores or genital sores
- High fever or flu-like symptoms
- Enlarged lymph nodes
- Skin pain and burning
Your healthcare provider may permanently stop Erivedge if you develop a severe skin reaction.
- 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
- Tiredness
- Nausea
- Diarrhea
- Decreased appetite
- Constipation
- Joint pain
- Vomiting
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 full Prescribing Information, for additional Important Safety Information, including serious side effects, and the Medication Guide.