Odomzo: Uses, Side Effects and Dosage

What is ODOMZO used for?

ODOMZO is used to:

• treat adults with a type of skin cancer, called basal cell carcinoma. It is used when the cancer has spread to surrounding areas (called “locally advanced” basal cell carcinoma (BCC)) and it cannot be treated with surgery or radiation.

How does ODOMZO work?

The DNA in skin cells can become damaged. This damage can change how certain proteins in your cell work and it can turn these damaged cells into skin cancer. ODOMZO works by controlling a key protein involved in cancer. This may stop the cancer cells from growing or may kill them. As a result, your skin cancer may shrink.

What are the ingredients in ODOMZO?

Medicinal ingredients: sonidegib

Non-medicinal ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, poloxamer, and sodium lauryl sulfate. The capsule shell contains gelatin, red iron oxide, and titanium dioxide. The black printing ink contains ammonium hydroxide, black iron oxide, propylene glycol, and shellac.

ODOMZO comes in the following dosage forms:

Capsules: 200 mg sonidegib (as phosphate)

Serious Warnings and Precautions ODOMZO should only be prescribed to you under the supervision of a doctor:

• who is qualified in the use of cancer therapies and
• has a full understanding of the risks of ODOMZO therapy and the patient monitoring requirements for this medicine
• ODOMZO can cause your baby to die before it is born (be stillborn) or cause your baby to have severe birth defects.

• ODOMZO is only available under a controlled distribution program called the

  ODOMZO Pregnancy Prevention Program (OPPP).

• ODOMZO has not been studied in patients with severe kidney problems.
• In children, ODOMZO can cause bones to stop growing. This is called epiphyses premature fusion. It can happen even after stopping ODOMZO. This is a permanent condition.

Do not use ODOMZO if:

• You are pregnant or think you may be pregnant
• You are breast-feeding
• You are able to become pregnant but you are unable or unwilling to follow the necessary pregnancy prevention measures that are listed in the ODOMZO Pregnancy Prevention Program
• You are a male and you are unwilling to follow the necessary contraceptive measures listed in the ODOMZO Pregnancy Prevention Program
• You are under the age of 18 years
• You are allergic to sonidegib. This medicine contains lactose and other ingredients – see

What are the ingredients in ODOMZO? for the complete list of ingredients.

Do not take ODOMZO if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking ODOMZO.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ODOMZO. Talk about any health conditions or problems you may have, including if you:

• Have muscle pain or spasms, or have a history of a muscle disorder called rhabdomyolysis or myopathy. Your doctor should do a blood test to check for muscle problems and to check how well your kidneys are working:

  • before you start taking ODOMZO
  • during treatment and
  • if you develop muscle problems
• Have kidney problems
• Have any other medical conditions
• Are pregnant or plan to become pregnant
• Are breast-feeding

Other warnings you should know about:

Cutaneous squamous cell carcinoma (cuSCC): Patients with advanced BCC have an increased risk of developing cutaneous squamous cell carcinoma (cuSCC). Your doctor should monitor you regularly while you are taking ODOMZO.

Donating Blood: You should not donate blood or blood products while taking ODOMZO and for 20 months after you have stopped taking ODOMZO.

Abnormal test results: ODOMZO can cause abnormal blood test results. Your doctor will do a blood test before you start taking ODOMZO and periodically during treatment and will interpret the results.

For female patients who can become pregnant (are of childbearing age):

Pregnancy:

• Before starting ODOMZO, ask your doctor if you are able to become pregnant, even if your periods have stopped (menopause). It is important to check with your doctor whether there is a risk that you could become pregnant.
• ODOMZO may cause your baby to have severe birth defects or lead to the death of your unborn baby.
• Do not take ODOMZO if you are pregnant, think you may be pregnant, or are planning to become pregnant while taking ODOMZO and for 20 months after you have taken your last dose.

• You must stop taking ODOMZO and talk to your doctor right away if while taking ODOMZO or within 20 months after you have taken your last dose you:

  • become pregnant
  • think you could be pregnant
  • miss your menstrual period

Pregnancy Testing:

Your doctor will do pregnancy tests:

• within 7 days before you start treatment to make sure you are not pregnant
• every month while you are taking ODOMZO (including if there is an interruption in your treatment)
• every month for 20 months after you stop taking ODOMZO

Breast-feeding:

• Do not breast-feed while taking ODOMZO and for 20 months after you have taken your last dose. It is not known whether ODOMZO can pass into your breast milk and cause harm to your baby.

Fertility:

• ODOMZO may affect your ability to have children. Some women taking ODOMZO have stopped having their menstrual period. If this happens to you, it is not known if your period will come back. Talk to your doctor if you wish to have children in the future.

Contraception:

Your healthcare provider will talk to you about what contraceptive methods are right for you and will give you educational materials on the contraception requirements and risks of ODOMZO in pregnancy.

If you are able to become pregnant:

• You must take precautions so that you do not become pregnant while taking ODOMZO

• Unless you commit to not having sex (abstinence), you must use 2 methods of contraception, one highly effective method and one barrier method every time you have sex with a male:

  • for 4 weeks before you start taking ODOMZO
  • while you are taking ODOMZO (including if there is an interruption in your treatment)
  • for 20 months after you have taken your last dose because traces of the medicine remain in the body for a long time
• If your periods have stopped, are irregular or you have abnormal menstrual bleeding, you must continue to use 2 methods of contraception

• Talk to your doctor right away if while taking ODOMZO or within 20 months after you have taken your last dose you:

  • have stopped using contraception
  • previously chosen to not have sex as a way to prevent pregnancy but you have changed your mind
  • need to change the type of contraception you are using or
  • think your contraception has failed or had unprotected sex

For male patients:

ODOMZO is present in semen. You must let your female sexual partners know that you are taking ODOMZO and of the potential serious risks to an unborn baby if she becomes pregnant by you:

• while you are taking this medicine (including if there is an interruption in your treatment)

  and

• within 6 months after you have stopped taking ODOMZO

Contraception:

• To protect your female partner from being exposed to ODOMZO, you must always use a condom (with spermicide, if available) when you have sex with a female partner while taking ODOMZO. You must do this:

  • even if you have had a vasectomy
  • for at least 6 months after you have taken your last dose
• Your doctor will counsel you and give you educational materials on the contraception requirements and risks of ODOMZO in pregnancy.

• Talk to your doctor right away if while taking ODOMZO or for 6 months after you have taken your last dose:

  • your female partner gets pregnant or thinks she is pregnant
  • you think your contraception has failed or had unprotected sex

Sperm donation:

• You should not donate semen during your treatment and for at least 6 months after your treatment has finished.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with ODOMZO:

• Strong and moderate CYP3A inhibitors (such as ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole)
• Strong and moderate CYP3A inducers (such as carbamazepine, efavirenz, modafinil, phenobarbital, phenytoin, rifabutin, rifampin)
• St. John’s Wart (Hypericum perforatum)
• Warfarin (used to treat blood clots)
• Medicines used to treat too much acid in your stomach/heartburn (such as esomeprazole)
• Medicines used to treat other types of cancer (such as methotrexate, mitoxantrone, irinotecan, topotecan)
• Grapefruit products and juice
• Seville oranges and juice

How to take ODOMZO:

ONLY take this medicine if you are registered in and agreed to meet all the conditions set out in the ODOMZO Pregnancy Prevention Program. Information on the OPPP can be found:

• by calling 1-844-266-2974 or
• online at www.ODOMZO.ca

ODOMZO should only be prescribed to you under the supervision of a doctor who:

• is qualified in the use of cancer therapies
• has a full understanding of the risks of ODOMZO therapy and the patient monitoring requirements for this medicine

Before you start treatment with ODOMZO your doctor will do blood tests to verify that you are not pregnant and how well your kidneys are working.

• Take ODOMZO exactly as your healthcare provider tells you
• Swallow the capsule whole. Do not open, chew or crush the capsule.

Usual Adult dose: Take 1 capsule once a day on an empty stomach, at least 1 hour before or 2 hours after a meal.

Overdose:

If you think you have taken too much ODOMZO, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose, skip the missed dose. Take your next dose as scheduled.

What are possible side effects from using ODOMZO?

The most common side effects (those that may affect 1 or more in every 20 patients) include:

• a sensation of tingling or prickling (“pins and needles”)
• absence of menstrual period (amenorrhea) in females
• change in taste • hypotension
• constipation • itching
• decreased appetite • muscle pain
• decrease in weight • muscle spasms
• depression • muscle weakness
• diarrhea • rash
• dry mouth • stomach area (abdominal) pain
• feeling dizzy • upset stomach or indigestion
• feeling sick (nausea) • vomiting
• feeling tired • weight loss
• hair loss
• headache

Less common side effects include:

• abnormal hair growth
• acid reflux
• dry eye
• nerve damage (peripheral neuropathy)
• thirst, not passing much urine, weight loss, dry flushed skin, irritability (possible symptoms of low levels of fluids in the body, known as dehydration).
• trigger finger (condition in which one of your fingers gets stuck in a bent position)

These are not all the possible side effects you may feel when taking ODOMZO. If you experience any side effects not listed here, contact your healthcare professional.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting

  (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store ODOMZO at room temperature between 15°C to 30°C. Protect from moisture. Keep out of reach and sight of children.

If you want more information about ODOMZO:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.sunpharma.com/canada, or by calling 1-844-924-0656.

For more information about the ODOMZO Pregnancy Prevention Program, contact 1-844-266-2974 or visit website www.ODOMZO.ca.

Sun Pharmaceutical Industries Ltd.

Distributed by

Sun Pharma Canada Inc.

Last Revised December 31, 2021

ODOMZO^® is a registered trademark of Sun Pharmaceutical Industries Ltd.