Erivedge

The recommended dose of Erivedge (Vismodegib) is 150 mg taken once daily. It may be taken with food or on an empty stomach. The capsules should be swallowed whole. Do not open or crush the capsules.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that Erivedge (Vismodegib) be taken exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Erivedge (Vismodegib) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each grey and pink, two-piece hard gelatin capsule with "VISMO" printed in black ink on the grey opaque cap and "150 mg" printed in black ink on the pink opaque body, contains 150 mg of Erivedge (Vismodegib). Nonmedicinal ingredients: microcrystalline cellulose PH101, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, povidone K29/32, sodium starch glycolate and talc; capsule: gelatin, titanium dioxide, iron oxide black, iron oxide red, and shellac.

Do not take Erivedge (Vismodegib) if you:

• are allergic to Erivedge (Vismodegib) or any ingredients of the medication
• are breast-feeding
• are pregnant or may become pregnant
• will be unable to follow the pregnancy precautions of the medication's "Pregnancy Prevention Program"

Do not give Erivedge (Vismodegib) to children and adolescents less than 18 years of age.

There may be an interaction between Erivedge (Vismodegib) and any of the following:

• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Erivedge (Vismodegib). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Erivedge (Vismodegib).

Anemia: Erivedge (Vismodegib) may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired or pale skin, contact your doctor as soon as possible.

Birth control: Women who may become pregnant must use two forms of birth control, for at least four weeks before starting Erivedge (Vismodegib), while taking the medication (including dose interruptions), and for 24 months after stopping Erivedge (Vismodegib). Your doctor will perform pregnancy tests throughout the time that you are taking Erivedge (Vismodegib).

There is a high risk of harm to a developing baby that is fathered by a man who is taking Erivedge (Vismodegib). Men who take Erivedge (Vismodegib) must use condoms with spermicide while taking the medication, during dose interruptions, and for at least 2 months after stopping the medication to prevent their partner from becoming pregnant.

Your health care provider will discuss the possible risks to an unborn baby when either of the parents is taking Erivedge (Vismodegib).

Blood Clots: Erivedge (Vismodegib) may increase the chance of blood clot formation.

If you have a history of clotting, you may be at increased risk of experiencing blood clot-related problems such as heart attack, stroke, or clots in the lungs or deep veins of your leg. Discuss with your doctor how Erivedge (Vismodegib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Erivedge (Vismodegib), and whether any special monitoring is needed.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision, or difficulty speaking, contact your doctor immediately.

Blood donation: People who take Erivedge (Vismodegib) may not donate blood while taking the medication and for 24 months after stopping the treatment.

Heart problems: Rarely, Erivedge (Vismodegib) may cause heart-related side effects such as a change in heart rhythm, heart failure, heart attack, and Angina. If you have heart problems, discuss with your doctor how Erivedge (Vismodegib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Erivedge (Vismodegib), and whether any special monitoring is needed.

Infection: As well as slowing or stopping the growth of cancer cells, Erivedge (Vismodegib) can reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness.

Kidney function: The safety and effectiveness of using Erivedge (Vismodegib) if you have reduced kidney function has not been established. If you have reduced kidney function or Kidney Disease, discuss with your doctor how Erivedge (Vismodegib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Erivedge (Vismodegib), and whether any special monitoring is needed.

Liver function: If you have reduced liver function or liver disease, discuss with your doctor how Erivedge (Vismodegib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Erivedge (Vismodegib), and whether any special monitoring is needed. Erivedge (Vismodegib) is not recommended for people with severely decreased liver function.

Erivedge (Vismodegib) may cause reduced liver function or liver damage. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Other cancers: New cancerous lesions on the skin, such as squamous cell cancer, can occur while you are taking Erivedge (Vismodegib). It is important to have your skin examined before starting Erivedge (Vismodegib) and while you are taking it. If you notice any skin changes such as moles with an irregular shape, border, or colour that are changing shape or are growing, contact your doctor as soon as possible.

Pregnancy: Erivedge (Vismodegib) may cause severe birth defects to the developing baby, including death, if Erivedge (Vismodegib) is taken during pregnancy. Erivedge (Vismodegib) should not be used during pregnancy. If you become pregnant while taking Erivedge (Vismodegib), contact your doctor immediately.

Breast-feeding: It is not known if Erivedge (Vismodegib) passes into breast milk. Because it has the potential to cause serious defects to a child's development, women should not breast-feed while taking Erivedge (Vismodegib) and for 24 months after stopping the medication.

Children: The safety and effectiveness of using Erivedge (Vismodegib) have not been established for children.