Sonidegib

Sonidegib is a prescription medication used to treat basal cell carcinoma, a type of skin cancer.

Sonidegib belongs to a group of drugs called selective smoothened (SMO) inhibitors. These help to regulate tissue repair. 

This medication comes in capsule form. It is taken once daily taken on an empty stomach, at least 1 hour before or 2 hours after a meal. 

Common side effects include muscle spasms, hair loss, and change in the sense of taste.

Sonidegib is a prescription medication used to treat adults with basal cell carcinoma, a type of skin cancer, that has come back following surgery or radiation or that cannot be treated with surgery or radiation. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Sonidegib may be found in some form under the following brand names:

• Odomzo

Serious side effects have been reported with sonidegib. See the "Sonidegib Precautions" section. 

Common side effects of sonidegib include the following:

• hair loss
• change in taste
• tiredness
• nausea
• diarrhea
• weight loss
• decreased appetite
• vomiting
• stomach pain (abdominal pain)
• itching
• headache
• absence of menstrual periods (amenorrhea). Sonidegib can cause absence of menstrual periods (amenorrhea) in females who are able to become pregnant. It is not known if amenorrhea is permanent. Talk to your healthcare provider if you have concerns about fertility

Do not drive or operate heavy machinery until you know how this medication will affect you.

This is not a complete list of sonidegib side effects. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, and nimodipine (Nimotop)

This is not a complete list of sonidegib drug interactions. Ask your doctor or pharmacist for more information. 

Serious side effects have been reported with sonidegib including the following:

• Muscle Problems. Muscle spasms and muscle pain are common with sonidegib, but can also sometimes be symptoms of serious muscle problems. Sonidegib can increase your risk of muscle pain and, rarely a serious condition caused by injury to the muscles (rhabdomyolysis) that can lead to kidney damage. Tell your healthcare provider right away if you develop any new or worsening muscle spasms, pain or tenderness, dark urine, or decreased amount of urine during treatment with sonidegib. Your healthcare provider should do a blood test to check for muscle problems and to check your kidney function before you start taking sonidegib, during treatment, and if you develop muscle problems.
• Exposure to sonidegib during pregnancy: If you think that you or your female partner may have been exposed to sonidegib during pregnancy, talk to your healthcare provider right away.
• Sonidegib can cause absence of menstrual periods (amenorrhea) in females who are able to become pregnant. It is not known if amenorrhea is permanent. Talk to your healthcare provider if you have concerns about fertility.

Do not donate blood or blood products while you are taking sonidegib and for 20 months after your final dose.

Do not donate semen while taking sonidegib and for at least 8 months after your final dose.

Do not take sonidegib if you are allergic to sonidegib or any of its ingredients. 

Grapefruit and grapefruit juice may theoretically interact with sonidegib and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Sonidegib contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), talk to your doctor before taking sonidegib.

Before taking sonidegib, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to sonidegib or any of its ingredients
• have muscle pain or spasms, or have a history of a muscle disorder called rhabdomyolysis or myopathy
• have any other medical conditions
• are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if sonidegib passes into your breast milk. Do not breastfeed during treatment and for 20 months after your final dose of sonidegib. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Sonidegib can cause harm to your unborn baby, cause birth defects, or even result in death to to the fetus if used during pregnancy. Sonidegib should not be used by pregnant women. 

For females who can become pregnant: 

• You should talk to your healthcare provider about the risks of sonidegib to your unborn child.
•  Your healthcare provider will do a pregnancy test before you start taking sonidegib.
• In order to avoid pregnancy, you should use birth control during treatment, and for at least 20 months after your final dose of sonidegib. Talk to your healthcare provider about what birth control method is right for you during this time.
• Talk to your healthcare provider right away if you have unprotected sex or if you think your birth control has failed.
• Tell your healthcare provider right away if you become pregnant or think that you may be pregnant.

For males:

• It is not known if sonidegib is present in semen. Do not donate semen while you are taking sonidegib and for at least 8 months after your final dose.
• You should always use a condom, even if you have had a vasectomy, during sex with female partners who are pregnant or who are able to become pregnant, during treatment with sonidegib and for at least 8 months after your final dose to protect your female partner from being exposed to sonidegib.
• Tell your healthcare provider right away if your partner becomes pregnant or thinks she is pregnant while you are taking sonidegib.

Exposure to sonidegib during pregnancy: If you think that you or your female partner may have been exposed to sonidegib during pregnancy, talk to your healthcare provider right away. If you become pregnant during treatment with sonidegib, you or your healthcare provider should report your pregnancy to Novartis Pharmaceuticals Corporation at 1-888-669-6682

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if sonidegib is excreted in human breast milk or if it will harm your nursing baby. Because many drugs are present in human milk and because of the potential for serious adverse reactions in nursing infants from sonidegib, nursing is not recommended. Do not breastfeed during treatment and for 20 months after your final dose of sonidegib.

Talk to your healthcare provider about the best way to feed your baby during this time.

Take sonidegib exactly as your healthcare provider tells you.

• Take sonidegib 1 time each day.
• Take sonidegib at least 1 hour before or 2 hours after a meal.
• If you miss a dose, skip the missed dose. Take your next dose as scheduled.
• Do not donate blood or blood products while you are taking sonidegib and for 20 months after your final dose.
• Do not donate semen while taking sonidegib and for at least 8 months after your final dose.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the state of the condition being treated
• how you respond to this medication

The recommended usage of sonidegib to treat basal cell carcinoma, a type of skin cancer, is 200 mg orally once daily.

If you take too much sonidegib call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store sonidegib at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep this and all medications out of the reach of children. 

WARNING: EMBRYO-FETAL TOXICITY

Sonidegib can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. Sonidegib is embryotoxic, fetotoxic, and teratogenic in animals. Verify the pregnancy status of females of reproductive potential prior to initiating therapy. Advise females of reproductive potential to use effective contraception during treatment with sonidegib and for at least 20 months after the last dose. Advise males of the potential risk of exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential during treatment with sonidegib and for at least 8 months after the last dose.