Sonidegib (Oral route)
Use of sonidegib during pregnancy can cause embryofetal death or severe birth defects. Verify pregnancy status prior to initiating treatment and advise females of reproductive potential to use adequate contraception during treatment and for at least 20 months after discontinuation. Male patients with a female partner of reproductive potential must be advised to use adequate contraception during treatment for at least 8 months after discontinuation .
Hedgehog Pathway Inhibitor
Uses of This Medicine:
Sonidegib is used to treat adults with locally advanced basal cell carcinoma, a certain type of skin cancer. It is used in patients with skin cancer 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 sonidegib in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sonidegib in the elderly. However, elderly patients are more likely to have unwanted effects, which may require caution in patients receiving sonidegib.
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.
- St John's Wort
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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Myopathy (muscle problem), history of or
- Rhabdomyolysis (muscle problem), history of—Use with caution. May increase risk for more serious side effects.
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.
Take this medicine on an empty stomach, at least 1 hour before or 2 hours after a meal.
Swallow the capsule whole. Do break, crush, or open it.
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 basal cell carcinoma:
- Adults—200 milligrams (mg) once a day.
- Children—Use and dose must be determined by your doctor.
- For advanced 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. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use a highly effective form of birth control to keep from getting pregnant. You should not become pregnant while you are taking this medicine and for 20 months after stopping it. 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 sexual intercourse while taking sonidegib and for 8 months after the last dose of this medicine.
Do not donate blood or blood products while taking this medicine and for 20 months after stopping it. Men should not donate semen while taking this medicine and for 8 months after the last dose.
This medicine may increase your risk of serious muscle problems called rhabdomyolysis, that can lead to kidney damage. Tell your doctor right away if you develop new or worsening muscle spams, pain, or tenderness, dark urine, or decreased amount of urine while taking sonidegib.
If you plan to have children, talk with your doctor before using this medicine. Some women using this medicine have become infertile (unable to have children).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St John's wort) or vitamin supplements.
Side Effects of This Medicine:
- More common
- Difficulty with moving
- joint pain
- muscle aching or cramping
- muscle pains or stiffness
- muscle spasms
- swollen joints
- Dark-colored urine
- muscle stiffness
- unusual tiredness or weakness
- More common
- Abdominal or stomach pain
- change in taste
- decreased appetite
- decreased weight
- hair loss or thinning of the hair
- itching skin
- loss of taste
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: 8/2/2019