How does this medication work? What will it do for me?

Vismodegib belongs to the class of medications called antineoplastics . It is used to treat advanced basal cell carcinoma, a form of skin cancer, which has spread or cannot be treated with surgery or radiation.

Most people see an improvement in the condition within 16 weeks of starting this medication. If no improvement has occurred after 16 weeks of treatment, discuss with your doctor whether continuing with the medication will help your condition.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

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 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.

How should I use this medication?

The recommended dose of 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 this medication 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 this medication 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.

Who should NOT take this medication?

Do not take vismodegib if you:

  • are allergic to 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"

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • back or joint pain
  • constipation
  • dehydration
  • diarrhea
  • difficulty swallowing
  • fatigue
  • hair loss
  • irregular or stopped menstrual periods
  • loss of appetite
  • loss of taste or a change in how things taste
  • muscle spasm
  • nausea
  • vomiting
  • weight loss

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • blood pressure changes (increased or decreased)
  • broken hip
  • fainting
  • signs of bleeding (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
  • signs of a blood clot in the arm, leg, (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (difficulty breathing, sharp chest pain that is worst when breathing in, coughing, coughing up blood, sweating, or passing out)
  • signs of heart failure (e.g., shortness of breath, fatigue, swelling in legs, ankles, feet)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • signs of a skin infection (redness, warmth, swelling, or painful skin)
  • signs of skin cancer, such as unusual moles or warts; small pearl-coloured bumps on the skin that may bleed easily; or red, raised, scaly patches of skin
  • symptoms of pneumonia (e.g., fever or chills, shortness of breath, fatigue, chest pain, cough)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
  • signs of heart attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)
  • signs of severe skin reactions (e.g., blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort)
  • signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

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 this medication.

Anemia: 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 vismodegib, while taking the medication (including dose interruptions), and for 24 months after stopping vismodegib. Your doctor will perform pregnancy tests throughout the time that you are taking vismodegib.

There is a high risk of harm to a developing baby that is fathered by a man who is taking vismodegib. Men who take 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 vismodegib.

Blood clots: This medication 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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, 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 vismodegib may not donate blood while taking the medication and for 24 months after stopping the treatment.

Heart problems: Rarely, 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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Infection: As well as slowing or stopping the growth of cancer cells, 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 this medication if you have reduced kidney function has not been established. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

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

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 vismodegib. It is important to have your skin examined before starting this medication 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: Vismodegib may cause severe birth defects to the developing baby, including death, if this medication is taken during pregnancy. This medication should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.

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

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with this medication?

For a full list of interactions, use the Drug Interaction Checker available on the website.

If you are taking other 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.

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.

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