Odomzo

Read the Medication Guide provided by your pharmacist before you start taking sonidegib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily on an empty stomach, at least 1 hour before or 2 hours after a meal.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Tell your doctor if your condition does not get better or if it gets worse.

Sonidegib is not recommended for use during pregnancy because it may cause serious harm (possibly death) to an unborn baby. Women of childbearing age must have a pregnancy test before starting this medication. They must also use reliable forms of birth control while taking sonidegib and for 20 months after the last dose of this medication.

It is unknown if sonidegib passes into semen. Because of the possible risk of passing the drug on to a partner, men taking sonidegib (including men who have had a vasectomy) must use condoms during sex with women who are pregnant or of childbearing age, both during treatment with sonidegib and for 8 months after the last dose of this medication. Men should also not donate sperm during this time.

If you or your partner become pregnant or think you may be pregnant, tell your doctor right away.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Tiredness, abnormal taste, hair loss, headache, weight loss, nausea/vomiting, diarrhea, stomach/abdominal pain, mild itching, or decreased appetite may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: muscle pain/tenderness/weakness/spasms, signs of kidney problems (such as change in the amount of urine), missed periods.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking sonidegib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Do not donate blood while taking this drug and for 20 months after stopping treatment. This will prevent your blood being given to a pregnant woman.

Older adults may be more sensitive to the side effects of this drug.

This medication may stop normal bone growth and affect final height if it is used by children/young adults. Ask your doctor for more details.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor. Consult your doctor for more details. (See also Warning section.)

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 20 months after the last dose. Consult your doctor before breastfeeding.

Do not share this medication with others.

Lab and/or medical tests (such as a pregnancy test, kidney/liver function, creatine kinase levels, complete blood count, blood glucose) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of sonidegib from your body, which may affect how sonidegib works. Examples include azole antifungals (such as itraconazole, ketoconazole), efavirenz, modafinil, nefazodone, HIV protease inhibitors (such as saquinavir), rifamycins (such as rifabutin), ritonavir, St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), telithromycin, among others.