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.

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 should do a pregnancy test within 7 days before you start taking Erivedge to find out if you are pregnant
  • In order to avoid pregnancy, you should start using highly effective birth control before you start Erivedge, and continue during treatment and for 7 months after your last dose. 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:
  • You should always use a condom with a spermicide, even if you have had a vasectomy, during sex with female partners while you are taking Erivedge and for 2 months after your last 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. Pregnant women are encouraged to participate in a program that collects information about exposure to Erivedge during pregnancy, and the effects on the mother and her unborn child. This program is called the Erivedge pregnancy pharmacovigilance program. You may participate in this program by calling the Genentech Adverse Event Line 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 breast-feeding or plan to breast-feed. It is not known if Erivedge passes into your breast milk. You and your healthcare provider should decide if you will take Erivedge or breast-feed. You should not do both
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 last 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
  • Vomiting
  • Joint aches

These are not all the possible side effects of Erivedge. For more information, ask your healthcare provider or pharmacist.

Because everyone is different, it is not possible to predict what side effects any one person will have or how severe they may be. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

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, 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, talk with your healthcare provider about the risks of Erivedge to your unborn child. Your healthcare provider should do a pregnancy test within 7 days before you start taking Erivedge to find out if you are pregnant. Avoid pregnancy by using highly effective birth control before starting Erivedge, and continue during treatment and for 7 months after your last dose. Tell your healthcare provider right away if you have unprotected sex or think that your birth control has failed
  • For males, always use a condom with a spermicide during sex with female partners while you are taking Erivedge and for 2 months after your last dose, even if you have had a vasectomy
  • 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:
  • Pregnant women are encouraged to participate in a program that collects information about exposure and the effects on the mother and her unborn child by calling the Genentech Adverse Event Line 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 breast-feeding or plan to breast-feed
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 last 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
  • Vomiting
  • Joint aches

These are not all the possible side effects of Erivedge. For more information, ask your healthcare provider or pharmacist.

Because everyone is different, it is not possible to predict what side effects any one person will have or how severe they may be. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

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 accompanying full Prescribing Information, including serious side effects and the Medication Guide.


Download the full Prescribing Information

View full safety information