Erivedge

Erivedge (vismodegib) belongs to a class of medications called hedgehog pathway inhibitors. Vismodegib works by blocking the action of a protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells and may help shrink tumors.

Erivedge is used to treat basal cell carcinoma (a type of skin cancer) in people with cancer that has spread to other parts of the body.

Erivedge is also used to treat basal cell carcinoma that cannot be treated with surgery or radiation or has come back after surgery.

Take Erivedge exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

You may take Erivedge once a day with or without food.

Swallow the capsule whole and do not crush, chew, break, or open it.

Your doctor will perform tests to check for side effects during treatment with Erivedge.

Your treatment with Erivedge may be temporarily or permanently discontinued if you have certain side effects.

Do not stop taking this medicine without your doctor's advice.

Store tightly closed at room temperature, away from moisture and heat.

Do not use Erivedge if you are pregnant. Both men and women using this medicine should use effective birth control to prevent pregnancy. Vismodegib can harm an unborn baby if the mother or father is using this medicine.

For Women: Use effective birth control to prevent pregnancy while you are using this medicine and for at least 24 months after your last dose. Call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant.

For Men: Always use a latex condom and spermicide when having sex, even if you have had a vasectomy. Continue using condoms and spermicide for at least 3 months after you stop taking Erivedge.

Call your doctor at once if a pregnancy occurs while either sexual partner is taking Erivedge.

You should not use Erivedge if you are allergic to vismodegib.

To make sure Erivedge is safe for you, tell your doctor if you have ever had:

• a muscle disorder; or
• kidney disease.

Vismodegib can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you will need a pregnancy test within 7 days before starting Erivedge to make sure you are not pregnant. Use birth control while using this medicine and for at least 24 months after your last dose.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of vismodegib on the baby.

Do not breastfeed while using this medicine, and for at least 24 months after your last dose.

Get emergency medical help if you have signs of an allergic reaction to Erivedge (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Erivedge may cause serious side effects. Call your doctor at once if you have:

• muscle spasms or muscle pain.

Vismodegib can affect bone growth in children. Tell your doctor if your child is not growing at a normal rate while using and after stopping this medicine.

Call your doctor at once if you miss a menstrual period. This could be a side effect, or it may be a sign that you are pregnant.

Common Erivedge side effects may include:

• nausea, vomiting, loss of appetite;
• diarrhea, constipation;
• tired feeling;
• joint pain, muscle spasms;
• hair loss;
• weight loss; or
• decreased sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Basal Cell Carcinoma:

150 mg orally once a day until disease progression or unacceptable toxicity Comments: -Withhold therapy for up to 8 weeks for intolerable adverse reactions until improvement or resolution. -Treatment durations shorter than 8 weeks prior to interruptions have not been studied. Use: Treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not donate blood while taking Erivedge and for 24 months after your treatment ends.

Do not donate semen while taking this medicine and for 3 months after your treatment ends.

Other drugs may interact with vismodegib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Active ingredient: vismodegib Inactive ingredients: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, povidone, sodium starch glycolate, talc, and magnesium stearate (non-bovine). The capsule shell contains gelatin, titanium dioxide, red iron oxide, and black iron oxide. The black printing ink contains shellac and black iron oxide.

Manufactured by: Patheon, Inc. Mississauga, Canada Distributed by: Genentech USA, Inc.

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