What is the most important information I should know about vismodegib?
Do not use if you are pregnant.Both men and women using this medicine should use effective birth control to prevent pregnancy. Vismodegib can harm an unborn baby if the mother or father is using this medicine.
What is vismodegib?
Vismodegib is used in adults to treat basal cell carcinoma that has spread to other parts of the body (metastatic), or that has come back after surgery, or cannot be treated with surgery or radiation.
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.
Tell your doctor if you have ever had:
- a muscle disorder; or
- kidney disease.
Vismodegib can harm an unborn baby if the mother or the father is using this medicine.
- If you are a woman, you will need a pregnancy test within 7 days before starting vismodegib to make sure you are not pregnant. Use birth control while using this medicine and for at least 24 months after your last dose.
- If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
- Tell your doctor right away if a pregnancy occurs.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of vismodegib on the baby.
Do not breastfeed while using this medicine, and for at least 24 months after your last dose.
How should I take vismodegib?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
You may take vismodegib once a day with or without food.
Swallow the capsule whole and do not crush, chew, break, or open it.
Your doctor will perform tests to check for side effects during treatment with vismodegib.
Your treatment with vismodegib may be temporarily or permanently discontinued if you have certain side effects.
Do not stop taking vismodegib without your doctor's advice.
Store tightly closed at room temperature, away from moisture and heat.
What happens if I miss a dose?
Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.
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 24 months after your treatment ends.
Do not donate semen while taking vismodegib and for 3 months after your treatment ends.
What are the possible side effects of vismodegib?
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.
Call your doctor at once if you have:
- muscle spasms or muscle pain.
Vismodegib can affect bone growth in children. Tell your doctor if your child is not growing at a normal rate while using and after stopping this medicine.
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, loss of 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 affect vismodegib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.
Where can I get more information?
Your doctor or 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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