Vismodegib (Oral route)
Vismodegib can result in embryo-fetal death or severe birth defects when administered to a pregnant woman. Animal data indicate vismodegib is embryotoxic, fetotoxic, and teratogenic. Pregnancy status should be verified 7 days prior to treatment initiation. Advise pregnant women of the potential risks to a fetus. Advise female patients to use effective contraception during and after vismodegib therapy. Advise male patients of the potential risk of vismodegib exposure through semen and recommend use of condoms with a pregnant partner or female partner of reproductive potential .
Hedgehog Pathway Inhibitor
Uses of This Medicine:
Vismodegib is used to treat metastatic basal cell carcinoma, a certain type of skin cancer that has already spread through the body. It also treats advanced basal cell carcinoma that has come back after surgery or cannot be treated with radiation or surgery.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of vismodegib in the pediatric population. Safety and efficacy have not been established.
Although appropriate studies on the relationship of age to the effects of vismodegib have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aluminum Carbonate, Basic
- Aluminum Hydroxide
- Aluminum Phosphate
- Calcium Carbonate
- Dihydroxyaluminum Aminoacetate
- Dihydroxyaluminum Sodium Carbonate
- Magnesium Carbonate
- Magnesium Hydroxide
- Magnesium Oxide
- Magnesium Trisilicate
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Proper Use of This Medicine:
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
You may take this medicine with or without food.
Swallow the capsule whole. Do break, crush, or open it.
Take this medicine at the same time each day.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (capsules):
- For advanced or metastatic basal cell carcinoma:
- Adults—150 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For advanced or metastatic basal cell carcinoma:
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits for any unwanted effects or problems that may be caused by this medicine.
Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor will give you a pregnancy test 7 days before you start using this medicine to make sure you are not pregnant. Use a highly effective form of birth control during treatment and for 24 months after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
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 and spermicides as forms of birth control during treatment with this medicine and for 3 months after the last dose.
Do not donate blood or blood products during treatment with this medicine and for 24 months after the last dose.
For male patients: Do not donate semen during treatment with this medicine and for 3 months after the last dose.
Side Effects of This Medicine:
- Less common
- Bloody or cloudy urine
- decreased urine output
- dry mouth
- fast or irregular heartbeat
- increased thirst
- loss of consciousness
- muscle pain or cramps
- pain in the lower back or side
- swelling of the face, ankles, or hands
- unusual tiredness or weakness
- More common
- Absent, missed, or irregular menstrual periods
- change in taste
- decreased appetite
- difficulty having a bowel movement
- difficulty with moving
- hair loss or thinning of the hair
- loss of taste
- muscle spasm or stiffness
- pain in the joints
- stopping of menstrual bleeding
- weight loss
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 9/5/2019