What is the most important information I should know about vismodegib?
Do not use vismodegib if you are pregnant, or if you are a man and your sexual partner is pregnant. Vismodegib use by either parent may cause severe birth defects or death of a baby.
For Women: Use effective birth control to prevent pregnancy while you are using this medicine and for at least 7 months after your last dose. Call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant.
For Men:
Always use a latex condom and spermicide when having sex, even if you have had a vasectomy. Continue using condoms and spermicide for at least 3 months after you stop taking vismodegib.
What is vismodegib?
Vismodegib is a cancer medicine that interferes with the growth of certain cancer cells in the body.
Vismodegib is used to treat basal cell carcinoma that has spread to other parts of the body.
Vismodegib may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking vismodegib?
You should not use vismodegib if you are allergic to it, or:
- if you are pregnant or breast-feeding.
You will need to have a negative pregnancy test within 7 days before you start taking vismodegib.
Do not use vismodegib if you are pregnant, or if you are a man and your sexual partner is pregnant. Vismodegib can cause severe birth defects or death of a baby if either parent is using this medicine at the time of conception or during pregnancy.
You must prevent pregnancy while you are taking vismodegib, whether you are a man or a woman.
For Women: Use effective birth control while taking vismodegib and for 7 months after your last dose. The birth control method you use must be proven highly effective (at least 99%), such as: hormonal birth control (pills, vaginal ring, implants, or injections), an intrauterine device (IUD), or a tubal ligation. Call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant.
For Men: While you are taking vismodegib you must not have unprotected sex with a pregnant woman, or cause a woman to become pregnant. Vismodegib can affect your sperm and may cause harm to the baby at conception or during pregnancy. Always use a latex condom and spermicide when having sex, even if you have had a vasectomy. Continue using condoms and spermicide for at 3 months after you stop taking vismodegib.
Call your doctor at once if a pregnancy occurs while either sexual partner is taking vismodegib.
To make sure vismodegib is safe for you, tell your doctor if you have:
- liver disease; or
- kidney disease.
It is not known whether vismodegib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using vismodegib and for 7 months after your last dose.
How should I take vismodegib?
Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Vismodegib is usually taken once per day. You may take the medicine with or without food.
Do not crush, chew, break, or open a vismodegib capsule. Swallow it whole.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Skip the missed dose and wait until your next scheduled dose to take the medication. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking vismodegib?
Do not donate blood while taking vismodegib and for 7 months after your treatment ends.
Do not donate sperm (semen) while taking vismodegib and for 3 months after your treatment ends.
This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.
What are the possible side effects of vismodegib?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you miss a menstrual period. This could be a side effect, or it may be a sign that you are pregnant.
Common side effects may include:
- nausea, vomiting, decreased appetite;
- diarrhea, constipation;
- tired feeling;
- joint pain, muscle spasms;
- hair loss;
- weight loss; or
- decreased sense of taste.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect vismodegib?
Other drugs may interact with vismodegib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Where can I get more information?
Your pharmacist can provide more information about vismodegib.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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