Vismodegib (vis-moe-DEG-ib)

Treats basal cell carcinoma (skin cancer).

Brand Name(s):

Erivedge

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the capsule whole. Do not break, crush, or open it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Your doctor will give you a pregnancy test 7 days before using this medicine to make sure you are not pregnant. Women should use an effective form of birth control during treatment and for 24 months after the last dose. Men (including those who had a vasectomy) should use an effective barrier method (including condoms, spermicides) during treatment with this medicine and for 3 months after the last dose.
• Do not breastfeed during treatment and for 24 months after your last dose.
• Do not donate blood or blood products while you are using this medicine and for 24 months after treatment ends. Men should not donate semen while using this medicine and for 3 months after the last dose.
• This medicine may cause the following problems:
  • Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), which may be life-threatening
  • Muscle problems
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• High fever or flu-like symptoms
• Joint pain, muscle pain, spasm, tenderness, or weakness

If you notice these less serious side effects, talk with your doctor:

• Absent, missed, or irregular menstrual periods
• Change in taste, decreased appetite, weight loss
• Diarrhea, constipation, nausea, vomiting
• Hair loss
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088