Erivedge (vismodegib)

Erivedge® (vismodegib) is used to treat certain aggressive cases of basal cell carcinoma (BCC). Metastatic BCC is cancer that has spread to distant parts of the body. Locally advanced BCC is cancer that still confined to the skin tumor, but it is large, recurrent, or difficult to treat.1

Erivedge is approved to treat:2

  • Metastatic BCC.
  • Locally advanced BCC that has recurred (come back) after surgery, if radiation is not an option.
  • Locally advanced BCC that cannot be treated with surgery or radiation.

Erivedge does not come in generic form. Erivedge is similar to Odomzo® (sonidegib), another drug that is approved to treat certain kinds of advanced basal cell carcinoma.

How does Erivedge work?

Erivedge blocks a cell signaling pathway called Hedgehog.2 This pathway has a role in the development of hair follicles and glands. It also helps to control skin growth.

Key players in the Hedgehog pathway are two receptors called PTCH1 (“Patched”) and SMO (“Smoothened”).3 In normal cells, PTCH1 acts like an off-switch for SMO. It prevents SMO from sending signals for cell division and survival.

In about 40% of BCC tumors, PTCH1 is mutated.4 Mutated PTCH1 does not turn SMO off, so SMO starts sending out signals. This leads to uncontrolled cell growth and survival.

Erivedge works by blocking the SMO receptor.2 It is called a targeted therapy, because it targets one feature that makes cancer cells different from normal cells.

How effective is Erivedge?

Erivedge was studied in 104 people. Study participants had metastatic BCC or locally advanced BCC.

The researchers used a measure called “objective response rate” to determine if the medication worked.2 Objective response rate has to do with how the tumor changes during treatment. It includes several factors, including tumor size and ulceration. (Ulceration is when the top layer of cells breaks down. This causes a hole to form in the skin, and the tissue below shows through.5) Response to treatment can be partial or complete. Complete response means no BCC was found on a follow-up biopsy. Partial response is when the tumor shrinks or the ulceration heals. The objective response rate does not measure whether you—as a whole patient—have improved.

Long-term results from the study showed:1

  • 22.2% of patients with locally advanced BCC had a complete response.
  • 25.4% of patients with locally advanced BCC had a partial response.
  • 33.3% of patients with metastatic BCC had a partial response to treatment.
  • No patients with metastatic BCC had a complete response.

Cancer can become resistant to treatment.6 When this happens, the cancer stops responding to treatment and begins to progress.6 Progression is when the tumor grows or ulcerates, or a new lesion develops. The median duration of response for people with metastatic cancer was 7.6 months. The median duration of response for people with locally advanced cancer was 9.5 months.

How do I take Erivedge?

Before taking Erivedge, read the Medication Guide that comes in the package. Follow your doctor’s instructions for dosing and duration.

Take Erivedge once a day. Erivedge comes as a capsule that is taken by mouth. Swallow the capsule whole. You can take it with or without food.2

You will continue taking Erivedge until the cancer progresses or the side effects are unacceptable.2

What are the side effects of Erivedge?

Nearly all patients experience at least one side effect.6 Most are mild or moderate. About 25% to 32% are serious. The most common side effects of Erivedge are:2

  • Muscle spasms
  • Hair loss
  • Taste changes, loss of appetite, weight loss
  • Fatigue
  • Gastrointestinal problems (nausea, vomiting, diarrhea or constipation)

Women may stop having a menstrual period while taking Erivedge. It is not known whether this change is permanent.

Who should not take Erivedge?

Erivedge can cause stillbirth or severe birth defects.2 Pregnant women should not take Erivedge. Women who could become pregnant should use effective birth control during treatment and for 24 months after the last dose. Do not breastfeed while taking Erivedge or for 24 months after the last dose.

Erivedge is present in semen.2 Men should always use a condom during sex with a partner who is or could become pregnant. Use a condom during treatment and for 3 months after the last dose of Erivedge. Do not donate semen during this time.

What precautions are needed when taking Erivedge?

During treatment with Erivedge and for 24 months after the last dose:2

  • Do not donate blood or blood products.
  • Women should use effective birth control.
  • Women should not breastfeed.

During treatment with Erivedge and for 3 months after the last dose, men whose sexual partners are pregnant or could become pregnant should use a condom.

Written by: Sarah O'Brien | Last reviewed: May 2017.
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