What is Erivedge
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Erivedge is approved for the treatment of advanced basal cell carcinoma

What is Erivedge?

Erivedge is a prescription medicine used to treat adults with a type of skin cancer, called basal cell carcinoma (BCC), 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.

Erivedge is

  • The first medicine approved by the Food and Drug Administration (FDA) for adults with advanced BCC who can't have surgery or radiation therapy
  • A capsule you take by mouth once a day

Erivedge is only approved for use in adults. It is not known if Erivedge is safe and effective in children.

Erivedge may cause BCCs to shrink, or it may help control disease

In a medical study, 96 adult patients took Erivedge for advanced BCC and were evaluated by doctors. There are 2 kinds of advanced BCC and patients in the study had one or the other:

  • Locally advanced BCC: when BCC grows deep into the skin
  • Metastatic BCC: when BCC spreads to other parts of the body

After taking Erivedge for 24 weeks, some of these patients had less BCC.

  • In locally advanced BCC, the BCC shrank or was no longer visible in 4 of 10 patients
  • In metastatic BCC, the BCC shrank in 3 out of 10 patients

How does Erivedge work?

Erivedge is a unique treatment that works inside the body to treat advanced BCC. This includes advanced BCC that has grown over a large area or has spread to other parts of the body.

What happens in the body that could cause BCC to grow?

Approximately 9 out of 10 basal cell carcinomas involve a signal in certain cells of the body. This signal is found in a pathway in the cells called the "Hedgehog pathway." Problems with this signal can cause BCC to grow.

How does Erivedge work inside the body to treat advanced BCC?

Erivedge was designed to interrupt the Hedgehog pathway signal inside the cells. This may slow down the growth of BCC. Because Erivedge targets the Hedgehog pathway, it is called a "Hedgehog pathway inhibitor."

Safety First

Before you start exploring, take the time to read the side effects information.

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Indication

Erivedge 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.

Indication

Erivedge 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
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 7 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 7 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 7 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?

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.

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Safety

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 before you start taking Erivedge
  • In order to avoid pregnancy, you should use birth control during treatment and for 7 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 7 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 7 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?

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.


Download the full Prescribing Information

View full safety information