Odomzo 200 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Odomzo 200 mg hard capsules

sonidegib

Odomzo can cause severe birth defects. It may cause death of the foetus or newborn. You must not become pregnant while taking this medicine. You must follow the contraception instructions included in this leaflet.

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Odomzo is and what it is used for
2. What you need to know before taking Odomzo
3. How to take Odomzo
4. Possible side effects
5. How to store Odomzo
6. Contents of the pack and other information

1. What Odomzo is and what it is used for

What is Odomzo

Odomzo contains the active substance sonidegib. It is an anticancer medicine.

What Odomzo is 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 locally and cannot be treated with surgery or radiation.

How Odomzo works

Normal cell growth is controlled by various chemical signals. In patients with basal cell carcinoma, changes occur in genes that regulate a part of this process known as the "hedgehog pathway". These genetic changes cause cancer cells to grow uncontrollably. Odomzo works by blocking this pathway, thereby inhibiting the growth of cancer cells and preventing the formation of new cancer cells.

2. What you need to know before starting Odomzo

Read the specific instructions provided by your doctor, particularly regarding the effects of Odomzo on the fetus.

Carefully read and follow the instructions in the patient leaflet and reminder card provided by your doctor.

Do not take Odomzo

• if you are allergic to sonidegib or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or think you might be pregnant. This is because Odomzo can cause harm or death to your fetus (see section “Pregnancy”).
• if you are breastfeeding. This is because it is unknown whether Odomzo can pass into breast milk and cause harm to the newborn (see section “Breast-feeding”).
• if you could become pregnant but are unable or unwilling to follow the necessary pregnancy prevention measures listed in the Odomzo Pregnancy Prevention Program.

Do not take Odomzo if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Odomzo.

Additional information on the points above can be found in the sections “Pregnancy”, “Breast-feeding”, “Fertility”, and “Contraception in women and men”.

Warnings and precautions

• Odomzo may cause muscle problems. Inform your doctor before taking Odomzo if you have a history of muscle cramps or weakness, or if you are taking other medicines. Some medicines (e.g., medicines used to treat high cholesterol) may increase the risk of muscle problems. Inform your doctor or pharmacist immediately if you experience unexplained muscle pain, cramps, or weakness during treatment with Odomzo. Your doctor may need to adjust your dose or temporarily or permanently stop your treatment.
• You must not donate blood while being treated with Odomzo or for 20 months after stopping treatment.
• If you are male, you must not father a child or donate semen at any time during treatment or for 6 months after your last dose.
• Your doctor will regularly monitor your skin for another type of cancer called cutaneous squamous cell carcinoma (cSCC). It is not known whether cSCC is related to treatment with Odomzo. This type of cancer usually appears on sun-damaged skin, does not spread, and can be cured. Inform your doctor if you notice any changes in your skin.
• Never give this medicine to anyone else. You must return any unused capsules at the end of your treatment. Ask your doctor or pharmacist where to return the capsules.

Blood tests during treatment with Odomzo

Your doctor will perform blood tests before starting treatment and possibly also during treatment. These tests will assess your muscle health by measuring the levels of an enzyme in your blood called creatine phosphokinase.

Children and adolescents (under 18 years of age)

Odomzo must not be used in children and adolescents under 18 years of age. Problems with developing teeth and bones have been observed with this medicine. Odomzo may cause bones to stop growing in children and adolescents. This may also occur after stopping treatment.

Taking Odomzo with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Odomzo may affect how other medicines work. Likewise, some medicines may affect how Odomzo works or make it more likely that you experience side effects.

Specifically, inform your doctor or pharmacist if you are taking any of the following:

• medicines such as statins and fibrates used to treat high cholesterol and lipid levels.
• vitamin B3, also known as niacin.
• medicines such as methotrexate, mitoxantrone, irinotecan, or topotecan used to treat certain types of cancer, as well as other conditions such as severe joint problems (rheumatoid arthritis) and psoriasis.
• medicines such as telithromycin, rifampicin, or rifabutin used to treat bacterial infections.
• medicines such as ketoconazole (not including shampoos or creams), itraconazole, posaconazole, or voriconazole used to treat fungal infections.
• medicines such as chloroquine and hydroxychloroquine used to treat parasitic infections, as well as other conditions such as rheumatoid arthritis or lupus erythematosus.
• medicines such as ritonavir, saquinavir, or zidovudine used to treat HIV/AIDS.
• medicines such as carbamazepine, phenytoin, or phenobarbital used to treat acute seizures.
• a medicine called nefazodone used to treat depression.
• a medicine called penicillamine used to treat severe joint problems (rheumatoid arthritis).
• an herbal medicine called St. John’s wort (also known as Hypericum perforatum) used to treat depression.

If any of the above apply to you or if you are unsure, consult your doctor or pharmacist before taking Odomzo.

These medicines should be used with caution or may need to be discontinued during your treatment with Odomzo. If you are taking any of them, your doctor may need to prescribe an alternative medicine.

During your treatment with Odomzo, inform your doctor or pharmacist if you are prescribed any other medicine you have not taken before.

Pregnancy

Do not take Odomzo if you are pregnant, think you might be pregnant, or plan to become pregnant during your treatment or within 20 months after stopping treatment. You must stop treatment with Odomzo and inform your doctor immediately if you become pregnant or suspect you might be pregnant. Odomzo may cause severe birth defects or lead to fetal death. The specific instructions (the Odomzo Pregnancy Prevention Program) provided by your doctor contain information mainly about the effects of Odomzo on the fetus.

Breast-feeding

Do not breast-feed during your treatment or for 20 months after stopping treatment. It is unknown whether Odomzo can pass into breast milk and cause harm to the newborn.

Fertility

Odomzo may have an impact on male and female fertility. Inform your doctor if you plan to have children in the future.

Contraception in women and men

Women

Before starting treatment with Odomzo, consult your doctor if you could become pregnant, even if your periods have stopped (menopause). It is important to confirm with your doctor whether there is a risk that you could become pregnant.

If you could become pregnant:

• you must take precautions to avoid becoming pregnant while taking Odomzo,
• you must use 2 forms of contraception: one highly effective method and one barrier method (see examples below) while taking Odomzo,
• you must continue using these contraceptive methods for 20 months after stopping treatment with Odomzo, because traces of the medicine remain in the body for a long time.

Your doctor will discuss with you the best contraceptive method for you.

You must use a highly effective method such as:

• an intrauterine device (IUD)
• surgical sterilization.

In addition, you must use a barrier method such as:

• a condom (with spermicide, if available)
• a diaphragm (with spermicide, if available).

Your doctor will perform a pregnancy test:

• at least 7 days before starting treatment – to ensure you are not already pregnant
• every month during treatment.

During treatment and for 20 months after stopping treatment, inform your doctor immediately if:

• you think your contraceptive method has failed for any reason
• your periods have stopped
• you have stopped using contraception
• you need to change your contraceptive method

Men

While taking Odomzo, always use a condom (with spermicide, if available) when having sexual intercourse with a female partner, even if you have had a vasectomy. You must continue using condoms for 6 months after your treatment has ended.

Inform your doctor immediately if your partner becomes pregnant while you are being treated with Odomzo or within 6 months after your treatment has ended.

You must not father a child or donate semen at any time during treatment or for 6 months after stopping treatment.

Driving and using machines

Odomzo is unlikely to affect your ability to drive or use tools or machinery. If in doubt, consult your doctor.

Odomzo contains lactose

Odomzo contains lactose (milk sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Odomzo

Follow exactly the instructions for using this medicine as provided by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Taking this medicine

The recommended dose is 200 mg (1 capsule) daily.

• Do not eat for 2 hours before taking Odomzo and for 1 hour after taking it.
• Take your capsule at approximately the same time each day. This will help you remember when to take your medicine.
• Swallow the capsule whole. Do not open, chew, or crush the capsule. You must avoid any contact with the capsule contents, as they may have harmful effects.

Do not change your dose without discussing it with your doctor. Do not exceed the recommended dose prescribed by your doctor. If you vomit after swallowing the capsule, do not take another capsule until your next scheduled dose.

How long to take Odomzo

Continue taking Odomzo for as long as your doctor tells you to. If you have any doubts about how long you should take Odomzo, consult your doctor or pharmacist.

If you take more Odomzo than you should

If you take more Odomzo than you should, or if someone else accidentally takes your medicine, contact a doctor or go to the hospital immediately. Take the medicine, its packaging, and the leaflet with you.

If you forget to take Odomzo

If you forget to take a dose of Odomzo, take it as soon as you remember. If more than six hours have passed since you were supposed to take the dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Odomzo

Do not stop treatment with Odomzo without first discussing it with your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Odomzo may cause serious birth defects. You must not become pregnant while taking this medicine (for further information, see “Pregnancy”, “Breast-feeding”, “Fertility”, and “Contraception in women and men” in section 2).

Stop your treatment with Odomzo and inform your doctor immediately if you notice any of the following effects, as they may be signs of an allergic reaction:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• severe skin itching, with a red rash or lumps.

Some adverse effects may be serious

Inform your doctor or pharmacist immediately if you notice any of the following:

• muscle cramps, severe muscle pain, or severe muscle weakness. These may be signs of a condition called rhabdomyolysis, which involves breakdown of muscle tissue.
• dark-colored urine, reduced urine output, or no urine production. These may be signs of muscle breakdown, which can harm the kidneys.

Other possible adverse effects

If any of these adverse effects become severe, consult your doctor or pharmacist.

Very common: may affect more than 1 in 10 patients

• muscle cramps, muscle pain, bone pain, pain in ligaments and tendons
• absence of menstrual periods
• diarrhoea or heartburn
• decreased appetite
• headache
• altered sense of taste or a strange taste in the mouth
• stomach pain
• malaise
• vomiting
• itching
• hair loss
• fatigue
• pain
• weight loss.

Common: may affect up to 1 in 10 patients

• stomach discomfort or indigestion
• constipation
• skin rash
• abnormal hair growth
• thirst, low urine output, weight loss, dry and flushed skin, irritability (possible symptoms of low body fluid levels, known as dehydration).

During treatment with Odomzo, you may also have abnormal blood test results. These may alert your doctor to possible changes in the function of certain parts of your body, for example:

• elevated levels of the following enzymes: creatine phosphokinase (muscle function), lipase and/or amylase (pancreatic function), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) (liver function)
• elevated creatinine levels (kidney function)
• elevated blood sugar levels (known as hyperglycaemia)
• low haemoglobin levels (needed to carry oxygen in the blood)
• low white blood cell count.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Odomzo

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging and blister after CAD/EXP. The expiry date refers to the last day of the month indicated.
• Do not store above 30°C.
• Store in the original packaging to protect from moisture.
• Medicines should not be disposed of via wastewater drains or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Odomzo

• The active substance is sonidegib (as phosphate). Each capsule contains 200 mg of sonidegib.

• The other components are:

• Capsule contents: crospovidone type A, lactose monohydrate (see section 2, “Odomzo contains lactose”), magnesium stearate, poloxamer 188, colloidal anhydrous silica, sodium lauryl sulfate.

• Capsule shell: gelatin, red iron oxide (E172), titanium dioxide (E171).

• Printing ink: black iron oxide (E172), propylene glycol (E1520), shellac.

Appearance of Odomzo and contents of the pack

Odomzo 200 mg capsules are opaque and pink in colour. They are printed with “SONIDEGIB 200MG” and “NVR”.

Odomzo is supplied in perforated unit dose blisters containing 10 x 1 capsule. Packs of 10 and 30 capsules are available.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

The Netherlands

More information on this medicinal product is available by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu

As part of the Odomzo pregnancy prevention programme, all patients will receive:

• Patient leaflet
• Patient reminder card

For additional information, refer to these documents.