Vismodegib (By mouth)

Introduction

Vismodegib (vis-moe-DEG-ib)

Treats metastatic or locally advanced basal cell carcinoma.

Brand Name(s)

Erivedge

When This Medicine Should Not Be Used

How to Use This Medicine

Capsule

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• Swallow the capsule whole. Do not break, crush, or open it.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not take more than one dose at a time.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

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

• Make sure your doctor knows if you also use medicine to treat infection, such as azithromycin, clarithromycin, erythromycin, Biaxin®, Ery-Tab®, or Zithromax®.

Warnings While Using This Medicine

• You can harm your unborn baby if you use this medicine while you are pregnant. Your doctor may give you a pregnancy test 7 days before you start this medicine. Use a highly effective form of birth control to avoid pregnancy. You should not become pregnant while you take this medicine and for 7 months after you stop taking it. Tell your doctor right away if you think you have become pregnant while using the medicine.
• This medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Male patients (including those who had a vasectomy) should use condoms with spermicides during sexual intercourse while taking vismodegib and for at least 2 months after the last dose.
• Make sure your doctor knows if you are breastfeeding.
• Do not donate blood or blood products while you take this medicine and for 7 months after you stop taking it.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.

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

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

• Change in taste or decreased appetite
• Diarrhea, constipation, nausea, or vomiting
• Hair loss
• Muscle spasms or joint or muscle pain
• Tiredness or weakness
• Weight loss

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