Odomzo

Brand Name

Odomzo

Common Name

sonidegib

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

How does this medication work? What will it do for me?

Sonidegib belongs to the class of medications called antineoplastic agents. It is used to treat locally advanced basal cell carcinoma, a type of skin cancer, when it cannot be treated with surgery or radiation. This medication works by blocking a protein involved in signaling the growth of cancer cells.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The recommended adult dose of this medication is 200 mg taken by mouth once daily, on an empty stomach, either 1 hour before or 2 hours after a meal.

Swallow the capsules whole with some water. Do not open, crush, or chew the capsules. Do not take this mediation with grapefruit juice or Seville oranges or juice.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you vomit after taking a dose, do not take another dose. Take the next dose as scheduled.

If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

Each opaque pink capsule with "SONIDEGIB 200MG" printed on the capsule body and "NVR" printed on the cap in black ink, contains 200 mg of sonidegib. Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, poloxamer, and sodium lauryl sulfate; hard-capsule shell: gelatin, red iron oxide, and titanium dioxide; printing ink: ammonium hydroxide, black iron oxide, propylene glycol, and shellac.

Who should NOT take this medication?

Do not take this medication if you:

• are allergic to sonidegib or any ingredients of the medication
• are pregnant or may become pregnant
• are breast-feeding
• are a woman who could become pregnant and you are unable to comply with birth control measures
• are a man with a partner who could become pregnant and you are unable to comply birth control measures

Do not give this medication to children or adolescents under the age of 18.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• acid reflux
• changed sense of taste
• constipation
• decreased appetite
• diarrhea
• dizziness
• dry eyes
• dry mouth
• hair loss
• headache
• heartburn
• nausea
• tiredness
• unusual hair growth
• weight loss
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abdominal pain
• dizziness when rising from a sitting or lying position
• interruption of menstrual periods
• muscle pain, spasms, or weakness
• numbness and tingling in the extremities
• rash
• signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• trigger finger (condition where one of your fingers gets stuck in a bent position)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of muscle damage (e.g., unexplained muscle pain, tenderness, or weakness; or brown or discoloured urine)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Birth control: This medication appears in the sperm of men taking this medication. To protect your partner, as well as prevent pregnancy, all men who are taking sonidegib and have a partner who could become pregnant must use a condom while taking the medication and for 6 months after the last dose.

Women who are taking this medication must use 2 reliable forms of birth control, beginning at least 4 weeks before starting sonidegib, while taking this medication, and for 20 months after the last dose. At least one of these methods must be a highly effective method of birth control and one must be a barrier method, such as condom or diaphragm with spermicide.

Your doctor will have you do a pregnancy test monthly starting the week before the first dose of the medication, while you are taking sonidegib, and for 20 months after the last dose.

Blood donation: Avoid donating blood for at least 20 months after taking the last dose of sonidegib.

Liver function:  Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Muscle effects: Muscle damage has been associated with the use of sonidegib. Report any unexplained muscle pain, tenderness, weakness, or cramps, or any brown or discoloured urine to your doctor immediately, particularly if you are also experiencing malaise (a general feeling of being unwell) or fever.

Other cancers: There have been reports of squamous cell carcinoma, another form of skin cancer, developing after taking this medication. This type of skin cancer may appear as scaly red patches; open sores; or rough, thickened, or wart-like skin. It may also appear as raised growths on the skin. Report any changes to your skin to your doctor as soon as possible.

Pregnancy: This medication can cause severe birth defects affecting the baby if the mother takes this medication during pregnancy. Two forms of effective birth control must be used while taking sonidegib and for 20 months after the last dose. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if sonidegib passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: It is likely that people over the age of 65 will experience more side effects and more severe side effects.

What other drugs could interact with this medication?

There may be an interaction between sonidegib and any of the following:

• apalutamide
• aprepitant
• "azole" antifungals (e.g., fluconazole, itraconazole, ketoconazole, voriconazole)
• bosentan
• cobicistat
• conivaptan
• deferasirox
• diltiazem
• dronedarone
• efavirenz
• enzalutamide
• estradiol and norethindrone
• etravirine
• grapefruit juice
• HIV protease inhibitors (atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir)
• lumacaftor and ivacaftor
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• mifepristone
• mitotane
• modafinil
• protein kinase inhibitors (e.g., ceritinib, crizotinib, dabrafenib, idelalisib, imatinib, nilotinib, ribociclib)
• rifabutin
• rifampin
• St. John's wort
• sarilumab
• seizure medications (e.g., carbamazepine, eslicarbazepine. phenobarbital, phenytoin, primidone)
• tocilizumab
• verapamil

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Odomzo