Description
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.
This product is available in the following dosage forms:
- Capsule
Before Using
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:
Allergies
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.
Pediatric
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. This medicine is not indicated for use in children because it may cause bone growth problems.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bacillus of Calmette and Guerin Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine
- Typhoid Vaccine
- Varicella Virus Vaccine
- Yellow Fever Vaccine
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.
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Aluminum Carbonate, Basic
- Aluminum Hydroxide
- Aluminum Phosphate
- Calcium Carbonate
- Cholera Vaccine
- Cimetidine
- Dexlansoprazole
- Dihydroxyaluminum Aminoacetate
- Dihydroxyaluminum Sodium Carbonate
- Ebola Zaire Vaccine, Live
- Esomeprazole
- Famotidine
- Influenza Virus Vaccine, Live
- Lansoprazole
- Magaldrate
- Magnesium Carbonate
- Magnesium Hydroxide
- Magnesium Oxide
- Magnesium Trisilicate
- Nizatidine
- Omeprazole
- Pantoprazole
- Rabeprazole
- Ranitidine
- Rotavirus Vaccine, Live
Other Interactions
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
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.
Dosing
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:
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
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
It is very important that your doctor check your progress at regular visits. Blood and urine tests may be needed to check 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.
This medicine may cause serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), which maybe life-threatening. Check with your doctor right away if you have black, tarry stools, blistering, peeling, loosening of the skin, chills, cough, diarrhea, itching, muscle or joint pain, irritated eyes, red skin lesions, often with a purple center, painful or difficult urination, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, trouble breathing, unusual bleeding or bruising, unusual tiredness or weakness.
This medicine may cause muscle problems. Check with your doctor right away if you have difficulty in moving, joint pain, or muscle pain, cramps, spasm, stiffness, tenderness, or weakness.
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
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:
More common
- Difficulty in moving
- joint pain
- muscle pain, cramps, spasm, stiffness, tenderness, or weakness
Less common
- Bloody or cloudy urine
- confusion
- decreased urine output
- dizziness
- dry mouth
- fast or irregular heartbeat
- headache
- increased thirst
- loss of consciousness
- nausea
- pain in the lower back or side
- seizures
- swelling of the face, ankles, or hands
- thirst
- unusual tiredness or weakness
- vomiting
Incidence not known
- Black, tarry stools
- blistering, peeling, loosening of the skin
- chest pain
- chills
- cough
- diarrhea
- itching skin
- painful or difficult urination
- red irritated eyes
- red skin lesions, often with a purple center
- sores, ulcers, or white spots in the mouth or on the lips
- sore throat
- swollen glands
- trouble breathing
- unusual bleeding or bruising
- yellow eyes or skin
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:
More common
- Absent, missed, or irregular menstrual periods
- change in taste
- constipation
- decreased appetite
- diarrhea
- difficulty having a bowel movement
- hair loss or thinning
- loss of taste
- stopping of menstrual bleeding
- weight loss
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.
DRG-20075421
