Use

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.

The information below about others' experiences may not be representative of yours, as each individual patient's experience may differ.

Meet Mitch Meet Mitch

"I’m a native Californian. I spent most of my life in southern California, growing up."

"I was adopted at birth into a family that tanned really well. So I grew up being the pale one, the redhead, who got sunburns all the time."

From a small spot to a serious problem

"When I was 20, I had my first Mohs surgery to remove a larger lesion next to my nose. And that was a very significant thing."

"Afterwards, there were many factors that perhaps caused me to deprioritize taking care of my skin. I took a leave of absence from working to help take care of my mother when she was very sick, and I decided to go back to school to pursue my calling of becoming a chiropractor."

"One time, someone walked up to me and said, 'Are you contagious? Should I be anywhere near you?' It was extremely painful and difficult to hear. And, you know, what do you say in a situation like that?"

"So at some point, I decided that I had to do something about it."

Searching for an option

"My doctor and I talked about the fact that surgery and radiation therapy were not appropriate courses of action to treat my basal cell carcinoma."

"I was really surprised one day when my doctor told me that she had a drug called Erivedge that might be able to help me."

"I was very interested to learn that Erivedge works beneath the skin to potentially shrink tumors."

"My doctor told me there would be side effects. And the side effects that I experienced the most were hair loss, loss of taste, and muscle cramps and spasms."

Feeling Grateful

"I was really anxious for Erivedge to work for me."

"Every day when I looked in the mirror, I wanted to see changes in the size of my lesions. And over time, I did see them. The lesions began to shrink in size."

"For me, having Erivedge as a treatment option – it's hard to even come up with the right words."

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 of 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

Ask your doctor if Erivedge may be able to help you. Keep in mind, everyone's results are different and there are possible side effects with Erivedge. Be sure to talk to your doctor about both the benefits and risks of Erivedge.

Important Safety Information/Use

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 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

Exposure to Erivedge during pregnancy:

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?

  • 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.

Meet Nancy Meet Nancy

"I'm from beautiful Colorado. I live there with my husband. We've been married 54 years. I'm real happy to say that, because we were very young when we started."

"I've golfed for about 30 years. I love to golf, and my husband hates it when I outdrive him."

"We have five beautiful grandchildren, and we spend all the time we can with them. They are a great joy to us."

"As a young girl, you do young, foolish thing. I did; I was a sun worshipper. The important thing to me at that young age was to have a wonderful tan, and I did."

Putting others first

"I first noticed that I had something wrong with my head. I noticed that it looked like I had a bug bite or a product allergy or something."

"I didn't really pay too much attention to it; I basically ignored it. I did that for quite a while. I did that for longer than I should have."

"Even though I sensed that I had a problem, I didn't seek help right away. I always found that I was too busy. I had things to do with my son. I had to care for my mother. I had my husband and household responsibilities. It was always the excuse I used not to go see my doctor."

"But one day I stepped out of the shower, and I noticed that this little thing had become a big thing. It just absolutely scared me to death."

Finally seeking help

"My doctor walked in the room, and I said, 'Doctor, I have something to show you.' I looked him right in the eyes and told him, 'I need your help.' And he just said, 'You've got it.'"

"After much discussion, my doctor explained radiation and surgery and that I was not a candidate for those two options."

"When he told me about Erivedge, he told me that I could take a pill once a day. So Erivedge became a routine part of my day. That's the first thing I did in the morning."

"When he explained it to me, he did say that there would possibly be some side effects and that it was different for everybody."

"I did experience side effects. I had leg cramps, my hair was falling out, and my taste buds were changing. I couldn't taste salty or spicy foods."

A visit to remember

"The first time I went back to the doctor's office, he looked at it. It had actually started to shrink."

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 of 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

Ask your doctor if Erivedge may be able to help you. Keep in mind, everybody's results are different and there are possible side effects with Erivedge. Be sure to talk to your doctor about the benefits and the risks of Erivedge.

Important Safety Information and Indication

Use

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.

Important Safety Information/Use

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 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

Exposure to Erivedge during pregnancy:

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?

  • 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.