Odomzo
sonidegib
sonidegib
Odomzo may cause severe birth defects. It may lead to the death of a baby before it is born or shortly after being born. You must not become pregnant while taking this medicine. You must follow the contraception instructions contained in this leaflet.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Odomzo is and what it is used for
What you need to know before you take Odomzo
How to take Odomzo
Possible side effects
How to store Odomzo
Contents of the pack and other information
Odomzo contains the active substance sonidegib. It is an anti-cancer medicine.
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.
The normal growth of cells is controlled by various chemical signals. In patients with basal cell carcinoma, changes occur to genes controlling a part of this process known as the “hedgehog pathway”. This switches on signals that make the cancer cells grow out of control. Odomzo works by blocking this process, stopping cancer cells from growing and making new cells.
Read the specific instructions given to you by your doctor, particularly on the effects of Odomzo on unborn babies.
Read carefully and follow the instructions of the patient brochure and reminder card given to you by your doctor.
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 may be pregnant. This is because Odomzo may cause harm or death to your unborn baby (see section “Pregnancy”).
if you are breast-feeding. This is because it is not known whether Odomzo can pass into your breast milk and cause harm to your baby (see section “Breast-feeding”).
if you are able to become pregnant but are unable or unwilling to follow the necessary pregnancy prevention measures that are listed in the Odomzo Pregnancy Prevention Programme.
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.
Additional information on the above points can be found in the sections “Pregnancy”, “Breast-feeding”, “Fertility” and “Contraception for women and men”.
Odomzo may cause muscle problems. Tell 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) might increase the risk for muscle problems. Tell your doctor or pharmacist immediately if your muscles hurt or you have unexplained muscle cramps or weakness during treatment with Odomzo. Your doctor may need to change your dose, or stop your treatment
temporarily or permanently.
You should not donate blood while on treatment with Odomzo and for 20 months after ending your treatment.
If you are male, you should not donate semen at any time during treatment and for 6 months after the
final dose.
Your doctor will check your skin regularly for another type of cancer called cutaneous squamous cell carcinoma (SCC). It is not known whether SCC can be related to treatment with Odomzo. Usually this type of cancer appears on sun-damaged skin, does not spread and can be cured. Tell your doctor if you notice any changes in your skin.
Never give this medicine to anyone else. You should return unused capsules at the end of your treatment. Talk to your doctor or pharmacist regarding where to return the capsules.
Your doctor will perform blood tests before treatment, and possibly during treatment as well. These tests will
check the health of your muscles by measuring the levels of an enzyme in your blood called creatine phosphokinase.
Odomzo should not be used in children and adolescents below the age of 18. Problems with growing teeth
and bones were seen with this medicine. Odomzo may cause bones to stop growing in children and adolescents. This can also happen after discontinuation of the treatment.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This
includes medicines obtained without a prescription and herbal medicines. This is because Odomzo can affect the way some medicines work. Some other medicines can also affect how Odomzo works, or make it more likely that you will have side effects.
In particular tell your doctor or pharmacist if you are taking any of the following:
medicines such as statins and fibric acid derivatives used to treat high cholesterol and lipids
vitamin B3, also known as niacin
medicines such as methotrexate, mitoxantrone, irinotecan, or topotecan used to treat certain types of cancers or other diseases 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 and 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 diseases such as rheumatoid arthritis or lupus erythematosus
medicines such as ritonavir, saquinavir or zidovudine used to treat AIDS or HIV
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 rheumatoid arthritis
a 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 you are not sure, talk to your doctor or pharmacist before taking Odomzo.
These medicines should be used with caution or may need to be avoided during your treatment with Odomzo. If you are taking any of these, your doctor might need to prescribe an alternative medicine for you.
During your treatment with Odomzo, you should also tell your doctor or pharmacist if you are prescribed another medicine that you were not taking before.
Do not take Odomzo if you are pregnant, think you may be pregnant, or are planning to become pregnant during your treatment or during the 20 months after your treatment has finished. You must stop taking
Odomzo and talk to your doctor immediately if you become pregnant or suspect you could be pregnant. Odomzo may cause your baby to have severe birth defects or lead to the death of your unborn baby. Specific instructions (the Odomzo Pregnancy Prevention Programme) given to you by your doctor contain
information particularly on the effects of Odomzo on unborn babies.
Do not breast-feed during your treatment or during the 20 months after your treatment has finished. It is not known whether Odomzo can pass into your breast milk and cause harm to your baby.
Odomzo may have an impact on fertility in men and women. Talk to your doctor if you plan to have children in the future.
Women
Before starting Odomzo treatment, 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.
If you are able to become pregnant:
you must take precautions so that you do not become pregnant while taking Odomzo,
you must use 2 methods of contraception, one highly effective method and one barrier method (see the examples below) while you are taking Odomzo,
you must keep using this contraception for 20 months after you have stopped taking Odomzo because traces of the medicine remain in the body for a long time.
Your doctor will discuss with you the best method of contraception for you.
You must use one highly effective method, such as:
an intra-uterine device (“the coil” or IUD)
surgical sterilisation.
You must also use one barrier method, such as:
a condom (with spermicide, if available)
a diaphragm (with spermicide, if available).
Your doctor will test you for pregnancy:
at least 7 days before starting treatment – to make sure that you are not already pregnant
every month during treatment.
During treatment and during the 20 months after your treatment has finished, tell your doctor straight away if:
you think your contraception has not worked for any reason
your periods stop
you stop using contraception
you need to change contraception
Men
While you are taking Odomzo, always use a condom (with spermicide, if available) when you have sex with
a female partner, even if you have had a vasectomy. You must keep doing this for 6 months after your treatment has finished.
Tell your doctor straight away if your partner becomes pregnant while you are taking Odomzo and for 6 months after your treatment has finished.
You should not donate semen during your treatment and for 6 months after your treatment has finished.
Odomzo is not likely to affect your ability to drive or use any tools or machines. Talk to your doctor if you
are unsure.
Odomzo contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is 200 mg (1 capsule) a day.
Do not eat for 2 hours before taking Odomzo and for 1 hour afterwards.
Take your capsule at about the same time each day. This will help you to remember when to take your medicine.
Swallow the capsule whole. Do not open, chew or crush the capsule. Any contact with the content of the capsules should be avoided, as it may have harmful effects.
Do not change your dose without talking to your doctor. Do not exceed the recommended dose prescribed by your doctor. If you vomit after you swallow the capsule, do not take any more capsules until your next scheduled dose.
Keep taking Odomzo for as long as your doctor tells you. If you have questions about how long to take
Odomzo, talk to your doctor or pharmacist.
If you take more Odomzo than you should, or if someone else accidentally takes your medicine, talk to a doctor or go to a hospital straight away. Take the medicine and its packaging and leaflet with you.
If you forget to take a dose of Odomzo, take it as soon you realise. If more than six hours have passed since
the dose was due to be taken, skip the missed dose, then take the next dose at the scheduled time. Do not take
a double dose to make up for a forgotten dose.
Do not stop taking Odomzo without talking to your doctor first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Odomzo may cause severe birth defects, You must not become pregnant while taking this medicine (see “Pregnancy”, “Breast-feeding”, “Fertility” and “Contraception for women and men” in section 2 for more information).
Stop taking Odomzo and tell your doctor straight away if you notice any of the following as these could be signs of an allergic reaction:
difficulty breathing or swallowing
swelling of the face, lips, tongue or throat
severe itching of the skin, with a red rash or raised bumps.
Tell your doctor or pharmacist straight away if you notice any of the following:
severe muscle cramps, muscle pain or muscle weakness. These could be signs of a problem called rhabdomyolysis, which involves the breakdown of muscle tissue.
dark urine, decreased urine output or no urine output. These could be signs that your muscle fibre is breaking down, which is harmful to your kidneys.
If any of these side effects become severe, tell your doctor or pharmacist.
muscle cramps, muscle pain, pain in the bones, ligaments and tendons
absence of menstrual periods
diarrhoea or heartburn
decreased appetite
headache
disturbed sense of taste or strange taste in the mouth
pain in the belly
feeling sick
vomiting
itching
hair loss
tiredness
pain
weight loss.
upset stomach or indigestion
constipation
rash
abnormal hair growth
thirst, not passing much urine, weight loss, dry flushed skin, irritability (possible symptoms of low level of fluids in the body, known as dehydration).
During Odomzo treatment, you may also have some abnormal blood test results. These can alert your doctor to possible changes in the function of some parts of your body, for example:
high levels of the following enzymes: creatine phosphokinase (muscle function), lipase and/or amylase (pancreas function), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) (liver function)
high level of creatinine (kidney function)
high level of sugar in the blood (known as hyperglycaemia)
low level of haemoglobin (needed to transport oxygen in the blood)
low level of white blood cells.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via the national reporting system listed in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and the blister after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is sonidegib (as phosphate). Each capsule contains 200 mg sonidegib.
The other ingredients are:
Capsule contents: crospovidone type A, lactose monohydrate (see section 2, ‘Odomzo contains lactose’), magnesium stearate, poloxamer 188, silica, colloidal anhydrous, sodium laurilsulfate.
Capsule shell: gelatin, iron oxide red (E172), titanium dioxide (E171).
Printing ink: iron oxide black (E172), propylene glycol (E1520), shellac.
Odomzo 200 mg capsules are pink and opaque. They are imprinted with “SONIDEGIB 200MG” and “NVR”.
Odomzo is provided in perforated unit-dose blisters containing 10 x 1 capsule. It is available in pack sizes of 10 and 30 capsules.
Not all pack sizes may be marketed.
Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87
2132JH Hoofddorp
Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Sun Pharmaceutical Industries Europe B.V.
Tél/Tel: +31 23 568 55 01
Sun Pharmaceutical Industries Europe B.V.
Tel: +31 23 568 55 01
Sun Pharmaceutical Industries Europe B.V.
Тел: +31 23 568 55 01
Sun Pharmaceutical Industries Europe B.V. Tél/Tel: +31 23 568 55 01
Sun Pharmaceutical Industries Europe B.V.
Tel: +31 23 568 55 01
Sun Pharmaceutical Industries Europe B.V.
Tel.: +31 23 568 55 01
Sun Pharmaceutical Industries Europe B.V.
Tlf: +31 23 568 55 01
Sun Pharmaceutical Industries Europe B.V.
Tel: +31 23 568 55 01
Sun Pharmaceuticals Germany GmbH Tel: +49 21 440 39 90
Sun Pharmaceutical Industries Europe B.V.
Tel: +31 23 568 55 01
Sun Pharmaceutical Industries Europe B.V. Tel: +31 23 568 55 01
Sun Pharmaceutical Industries Europe B.V.
Tlf: +31 23 568 55 01
Sun Pharmaceutical Industries Europe B.V.
Τηλ: +31 23 568 55 01
Astro-Pharma GmbH
Tel: +43 (1) 97 99 860
Sun Pharma Laboratorios S.L. Tel: +34 93 342 78 90
Ranbaxy (Poland) Tel.: +48 22 642 07 75
Sun Pharma France
Tél:+33 1 41 44 44 50
Sun Pharmaceutical Industries Europe B.V.
Tel: +31 23 568 55 01
Sun Pharmaceutical Industries Europe B.V. Tel.: +31 23 568 55 01
Terapia S.A.
Tel:+40 264 50 15 00
Sun Pharmaceutical Industries Europe B.V.
Tel: +31 23 568 55 01
Sun Pharmaceutical Industries Europe B.V.
Tel: +31 23 568 55 01
Sun Pharmaceutical Industries Europe B.V.
Sími: +31 23 568 55 01
Sun Pharmaceutical Industries Europe B.V.
Tel: +31 23 568 55 01
Sun Pharma Italia S.r.l. Tel: +39 02 33 49 07 93
Sun Pharmaceutical Industries Europe B.V. Puh/Tel: +31 23 568 55 01
Sun Pharmaceutical Industries Europe B.V.
Τηλ: +31 23 568 55 01
Sun Pharmaceutical Industries Europe B.V. Tel: +31 23 568 55 01
Sun Pharmaceutical Industries Europe B.V. Tel: +31 23 568 55 01
Ranbaxy UK Ltd
Tel: +44 (0) 208 848 8688
As part of the Odomzo Pregnancy Prevention Programme, all patients will receive a:
Patient Brochure
Patient Reminder Card
Please refer to these documents for further information.