Class: Biological Therapy

Generic Name: vismodegib

Trade Name: Erivedge™

How is this drug used? Erivedge is approved for the treatment of adults with basal cell carcinoma of the skin that has spread to other parts of the body or that has come back after surgery or cannot be treated with surgery or radiation. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than for which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Erivedge targets a specific biological pathway (the Hedgehog pathway) that is thought to play a role in more than 90% of cases of basal cell carcinoma. Erivedge inhibits the abnormal signaling in this pathway that contributes to cancer growth.

How is Erivedge given (administered)? Erivedge is taken orally (by mouth).

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Erivedge.  Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems. Patients may undergo physical examinations and other tests to assess side effects and response to therapy.

What are the most common side effects of treatment with Erivedge?

• Muscle spasms
• Hair loss
• Taste changes or loss of taste
• Weight loss
• Fatigue
• Nausea
• Diarrhea
• Decreased appetite
• Constipation
• Joint pain
• Vomiting

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions, and discuss side effects with your physician.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. Erivedge can cause severe birth defects and fetal death. Women should have a pregnancy test prior to starting Erivedge and should talk with their doctor about choice and duration of birth control.
• Men treated with Erivedge should use a condom and spermicide during sex (even if they’ve had a vasectomy) to avoid exposing their partner to Erivedge through semen.
• During treatment and for several months afterwards, patients should not donate blood or blood products.
• Patients should inform their physician about all other medical conditions.
• Patients should inform their physician of any other medication or supplement they are taking (whether prescription or over-the-counter).

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away.

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Copyright © 2016 CancerConnect Last updated 01/12.

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