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Overview: Erivedge is used to treat a common type of skin cancer. It works by blocking certain signals that help cancer cells grow. Common Erivedge side effects may include muscle spasms, hair loss, taste changes, weight loss, tiredness, nausea, and diarrhea. It may also cause menstrual periods to stop. Contact your health care provider right away if you have new or worsening muscle pain, skin peeling, or blisters. Erivedge can cause fetal harm and requires strict use of birth control or condoms to prevent pregnancy.

Uses

What is Erivedge used for?

Erivedge (vismodegib) is commonly used to treat a certain 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 cannot be treated with surgery or radiation.

BCC is a cancer that grows on parts of your skin that get a lot of sun. BCC is the most common type of skin cancer. It usually starts as small shiny bumps on your nose or other parts of your face, but it can be found on any part of your body. People with fair skin are more likely to get this type of skin cancer.

Erivedge may also be used for other conditions as determined by your health care provider.

How does Erivedge work (mechanism of action)?

Erivedge blocks a pathway in your body called the Hedgehog pathway. Abnormal signals from this pathway may cause basal cell cancer to grow. Blocking the signals from the Hedgehog pathway may slow down the growth of the cancer.

How is Erivedge supplied (dosage forms)?

Erivedge is available in 150 mg oral capsules.

How should I store Erivedge?

Erivedge should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C), for shorter periods of time, such as when transporting it. Store in a cool, dry place.  Keep the bottle tightly closed to protect from moisture.

Side Effects

What are the most common side effects of Erivedge?

The most common side effects of Erivedge are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Muscle spasms (see below)
  • Hair loss
  • Loss of taste or change in how things taste
  • Decreased appetite and weight loss
  • Tiredness
  • Nausea or vomiting
  • Diarrhea or constipation
  • Joint pain

There may be other side effects of Erivedge that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Erivedge?

While less common, the most serious side effects of Erivedge are described below, along with what to do if they happen.

Severe Skin Reactions. Erivedge may cause severe skin reactions, including Stevens-Johnson Syndrome (SJS),Toxic Epidermal Necrolysis (TEN), or DRESS, which stands for Drug Reaction with Eosinophilia and Systemic Symptoms. These reactions can be life-threatening or result in death. Stop Erivedge and get emergency help if you have any of the following symptoms of a severe skin reaction.

  • Blisters or peeling of your skin
  • Blisters on your lips or around your mouth or eyes
  • Mouth sores or genital sores
  • High fever or flu-like symptoms
  • Swollen lymph nodes
  • Skin pain and burning

Muscle Problems. Erivedge may cause muscle problems, including muscle spasms or muscle pain. Sometimes these problems can be serious. Tell your health care provider if you have any new muscle pain, tenderness, or weakness, or if these get worse while taking Erivedge. 

Bone Growth Problems. Using Erivedge in children may cause permanent bone growth problems which can affect the child’s height. Erivedge is not approved for children. 

Severe Allergic Reactions.Erivedge may cause allergic reactions, which can be serious. Stop taking Erivedge and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Warnings & Precautions

Who should not take Erivedge?

Allergies to Ingredients. People who are allergic to any of the following should not take Erivedge.

  • Erivedge
  • Vismodegib
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Erivedge.

What should I know about Erivedge before taking it?

Do not take Erivedge unless it has been prescribed to you by a health care provider. Take it as prescribed. 

Swallow Erivedge whole. Do not open or crush the capsules.

Do not share Erivedge with other people, even if they have the same condition as you. It may harm them.

Keep Erivedge out of the reach of children.

Erivedge can cause your menstrual periods to stop (amenorrhea). It is not known if this is permanent. Talk to your health care provider if you are concerned about fertility.

Do not donate blood or blood products while taking Erivedge or for 2 years after your last dose. Erivedge may cause harm if a fetus is exposed to blood donated from a person taking Erivedge. See the Pregnancy section below for more details.

Do not donate semen while you are taking Erivedge or for 3 months after your last dose. Erivedge passes into semen. See the Pregnancy section below for more details.

What should I tell my health care provider before taking Erivedge?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Erivedge is right for you.

In particular, make sure that you discuss any of the following.

Pregnancy. Erivedge may cause harm to a fetus or pregnancy loss. Tell your health care provider if you are pregnant or plan to become pregnant. A negative pregnancy test is necessary within 7 days before starting Erivedge. If you can become pregnant, use birth control while you are taking Erivedge and for 24 months after your last dose. Talk to your health care provider about your birth control options. 

Tell your health care provider right away if you have unprotected sex or if you think your birth control has failed. Tell your health care provider right away if you become pregnant or think you might be pregnant. 

Erivedge passes into semen. Use condoms, even after a vasectomy, with partners who are pregnant or may become pregnant during treatment with Erivedge and for 3 months after your final dose. Do not donate semen while taking Erivedge or for 3 months after your final dose. Tell your health care provider right away if your partner becomes pregnant or thinks they are pregnant while you are taking Erivedge.

A Pregnancy Exposure Registry monitors the use of Erivedge during pregnancy.  Talk to your health care provider right away if you think you or your partner may have been exposed to Erivedge during pregnancy. If you become pregnant during treatment with Erivedge, you or your health care provider should report your pregnancy to the registry by calling 888-835-2555.

Breastfeeding. It is not known if Erivedge passes into breast milk. You should not breastfeed during treatment with Erivedge or for 24 months after your final dose. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Erivedge?

For more information about Erivedge, you can visit the drugmaker's website at www.erivedge.com or call them at 855-737-4833.

Interactions

Does Erivedge interact with foods or drinks?

There are no known interactions between Erivedge and foods or drinks.

It is unknown if drinking alcohol will affect Erivedge.

Does Erivedge interact with other medicines (drug interactions)?

There are no known interactions between Erivedge and other medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally take too much Erivedge?

If you or someone else has used too much Erivedge, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Erivedge?

If you miss a dose, skip the missed dose and only take the next scheduled dose. Do not take double or extra doses.