200 mg Hard capsules
sonidegib
What Odomzo is and what it is used for
What Odomzo is
Odomzo contains the active substance sonidegib. It is a cancer 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 by surgery or radiation.
How Odomzo works
The normal growth of cells is controlled by various chemical signals. In patients with basal cell carcinoma, changes occur in the genes that control part of this process known as the “hedgehog signaling pathway”. This connects to signals that cause the cancer cells to grow out of control. Odomzo works by blocking this process and preventing the cancer cells from growing and multiplying.
What you need to know before taking Odomzo
Read the specific instructions given to you by your doctor, especially about the effect of Odomzo on the fetus.
Read carefully and follow the instructions in the patient brochure and reminder card for patients that you received from your doctor.
Do not use Odomzo
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 may be pregnant. This is because Odomzo can harm or kill your unborn baby (see section “Pregnancy”).
- if you are breast-feeding. It is not known whether Odomzo can pass into breast milk and harm the baby (see section “Breastfeeding”).
- if you may be pregnant but are unable or unwilling to take 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 not sure, talk to your doctor or pharmacist before taking Odomzo.
Further information on the above points can be found in the sections “Pregnancy, breast-feeding and fertility” and “Contraceptive methods for women and men”.
Warnings and cautions
- Odomzo can cause muscle problems. Tell your doctor before taking Odomzo if you have previously had muscle cramps or muscle weakness, or if you are taking any other medicines. Some medicines (eg medicines for high cholesterol) may increase the risk of muscle problems. Talk to your doctor or pharmacist immediately if you experience muscle pain or if you experience unexplained muscle cramps or muscle weakness during treatment with Odomzo. Your doctor may need to change your dose or stop treatment temporarily or permanently.
- You should not donate blood during treatment with Odomzo and for 20 months after the end of treatment.
- If you are a man, do not donate semen at any time during treatment or for 6 months after the last dose .
- Your doctor will examine your skin regularly for another type of cancer called cutaneous squamous cell carcinoma . It is unknown whether cutaneous squamous cell carcinoma may be associated with Odomzo treatment. This type of cancer is most commonly found on sun-damaged skin. It does not spread and can be cured. Tell your doctor if you notice any skin changes.
- Never give this medicine to anyone else. You must return unused capsules after the treatment has ended. Talk to your doctor or pharmacist where the capsules are to be returned.
Blood tests during treatment with Odomzo
The doctor takes blood samples before starting treatment and possibly also during the treatment period. These tests are done to check your muscles by measuring the amount of enzyme and creatine phosphokinase in your blood.
Children and adolescents (under 18 years)
Odomzo should not be given to children and adolescents under 18 years of age. Problems with growing teeth and bones have been noted for this medication. Odomzo can make bones stop growing in children and adolescents. This can also occur even at the end of treatment.
Other drugs and Odomzo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This also applies to over-the-counter medicines and herbal medicines. Odomzo may affect the way other medicines work. Some medicines can in turn affect the way Odomzo works, or increase the likelihood of you getting side effects.
You must tell your doctor or pharmacist if you are taking any of the following medicines:
- drugs such as statins and fibric acid derivatives used to treat high cholesterol and fats
- Vitamin B3, also called niacin
- drugs such as methotrexate, mitoxantrone, irinotecan or topotecan used to treat certain types of cancer or other diseases such as severe joint problems ( rheumatoid arthritis ) and psoriasis
- drugs such as telithromycin, rifampicin or rifabutin used to treat bacterial infections
- medicines such as ketoconazole (excluding shampoos and creams ), itraconazole, posaconazole and voriconazole used to treat fungal infections 32
- drugs such as chloroquine and hydroxychloroquine used to treat parasitic infections as well as other diseases such as rheumatoid arthritis or lupus erythematosus
- drugs such as ritonavir, saquvinavir and zidovudine used to treat AIDS or HIV
- drugs such as carbamazepine, phenytoin and phenobarbital used to treat acute seizures
- the drug nefazodone, which is used to treat depression
- the drug penicillamine, which is used to treat rheumatoid arthritis
- an herbal remedy called St. John ‘s wort (Hypericum perforatum) which is used to treat mild depression and mild anxiety
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 altogether during treatment with Odomzo. If you are taking any of these, your doctor may need to prescribe you another alternative medicine.
During treatment with Odomzo, you should also tell your doctor or pharmacist if you have been prescribed any other medicines that you have not taken before.
Pregnancy, breastfeeding and fertility
Pregnancy
Do not take Odomzo if you are pregnant, think you may be pregnant or are planning to have a baby during treatment or within 20 months of stopping treatment. You must stop taking Odomzo and talk to your doctor immediately if you become pregnant or suspect you may be pregnant. Odomzo can cause severe birth defects and can even lead to fetal death. Special instructions (Odomzo Pregnancy Prevention Program) will be given to you by your doctor with information specifically regarding the effect of Odomzo on the fetus
Breast-feeding You should not breast-feed during treatment or within 20 months after the end of treatment. It is unknown if Odomzo can pass into breast milk and harm the baby.
Fertility
Odomzo can affect the fertility of men and women. Talk to your doctor if you plan to have children in the future.
Contraceptive methods for women and men
Women
Before starting treatment with Odomzo, ask your doctor if you may become pregnant even though you are no longer menstruating (menopause). You must check with your doctor if there is a risk that you may become pregnant.
If you can get pregnant:
- you need to take precautions so that you do not get pregnant while taking Odomzo,
- you must use two methods of contraception: a very effective method and a barrier method (see example below) while taking Odomzo,
- You must continue to use these contraceptives for 20 months after stopping Odomzo because traces of the medicine remain in the body for a long time.
You and your doctor will discuss which method of contraception is best for you.
You need to use a very effective method such as:
- IUD or intrauterine (uterine) insert
- sterilization by surgery.
You must also use a barrier method such as:
- condom (if possible with spermicide)
- pessaries (if possible with spermicides).
The doctor will perform pregnancy tests:
- at least 7 days before starting treatment to see that you are not already pregnant
- every month during treatment.
During treatment and within 20 months after the end of treatment, tell your doctor immediately about:
- you think your contraceptives have not worked for some reason
- your periods stop
- you stop using contraception
- you need to change contraceptives.
Men
While taking Odomzo, always use a condom (with a spermicide, if available) during sexual intercourse with a female partner, even if you have undergone vasectomy. You must continue to do this for 6 months after the end of treatment.
Tell your doctor immediately if your partner becomes pregnant while you are taking Odomzo and for 6 months after your treatment has ended.
You should not donate semen during treatment or within 6 months after the end of treatment.
Driving and using machines
Odomzo is unlikely to affect your ability to drive or use tools or machines. Talk to your doctor if you are unsure.
Odomzo contains lactose
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.
How to take Odomzo
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
How to take this medicine
The recommended dose is 200 mg (1 capsule) per day.
- Do not eat for 2 hours before taking Odomzo and 1 hour afterwards.
- Take your capsule at about the same time each day. This will make it easier to remember when to take your medicine.
- The capsule should be swallowed whole. It must not be opened, chewed or crushed. All contact with the contents of the capsules should be avoided, as it can have harmful effects.
Do not change the dose without talking to your doctor. Do not take more medicines than your doctor prescribed. If you vomit after swallowing the capsule, do not take any more capsules until the next scheduled dose.
How long should you take Odomzo?
Continue to take Odomzo for as long as your doctor prescribes it. Talk to your doctor or pharmacist if you are wondering how long to take Odomzo.
If you take more Odomzo than you should
If you have taken too much Odomzo, or if someone else has accidentally taken your medicine, contact a doctor or go to the hospital immediately. Bring the medicine with the package and package leaflet.
If you forget to take Odomzo
If you forget to take a dose of Odomzo, take it as soon as you realize it. If more than six hours have passed since 34 dose one should have been taken, skip the missed dose one and then take the next dose at the appointed time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Odomzo
Do not stop taking Odomzo without talking to your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Odomzo can cause severe birth defects. You must not become pregnant while taking this medicine (see “Pregnancy, breast-feeding and fertility” and “Contraceptive measures for women and men” in section 2 for further information).
Stop taking Odomzo and tell your doctor immediately if you notice any of the following, as it may be a sign of an allergic reaction:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
- severely itchy skin with red rashes or lumps.
Some side effects can be serious
If you notice any of the following, tell your doctor or pharmacist immediately:
- Severe muscle cramps, muscle pain or muscle weakness. This can be a sign of a complication called rhabdomyolysis , which involves breaking down muscle tissue.
- Dark-colored urine, small amounts of urine or no urine at all. This can be a sign that the muscle fibers are being broken down, which is damaging the kidneys.
Other possible side effects
If any of these side effects gets worse, talk to your doctor or pharmacist.
Very common: may affect more than 1 in 10 people
- muscle cramps, muscle aches, pain in the skeleton, ligaments and tendons
- no menstruation
- diarrhea or heartburn
- reduced appetite
- headache
- altered taste experience or strange taste in the mouth
- abdominal pain
- feeling sick
- vomiting
- itching
- hair loss
- fatigue
- pains
- weight loss.
Common can occur in up to 1 in 10 people
- upset stomach or indigestion
- constipation
- rash
- abnormal hair growth
- thirst, small amounts of urine, weight loss, dry and reddened skin, irritability (possible symptoms of low fluid levels in the body, ie dehydration, also called dehydration ).
During treatment with Odomzo you may also get some abnormal blood counts. These can alert your doctor about possible changes in the function of various parts of your body, for example:
- high levels of the following enzymes: creatine phosphokinase (muscle function), lipase and / or amylase (pancreatic function), alanine aminotransferase ( ALT ) and / or aspartate aminotransferase ( ASAT ) (liver function)
- high creatinine value (renal function)
- high blood sugar ( hyperglycaemia )
- low hemoglobin value ( hemoglobin is needed to transport oxygen in the blood)
- low white blood cell count .
How to store Odomzo
- 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 carton and blister after EXP. The expiration date is the last day of the specified month.
- Do not store above 30 ° C.
- Store in the original package. Moisture sensitive.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is sonidegib (as phosphate ). Each capsule contains 200 mg of sonidegib.
- Other ingredients are:
- Capsule contents: crospovidone type A, lactose monohydrate (see section 2, ‘Odomzo contains lactose’), magnesium stearate, poloxamer (188), colloidal anhydrous silica, sodium lauryl sulphate.
- Capsule shell: gelatin, red iron oxide (E172), titanium dioxide (E171).
- Ink: black iron oxide (E172), propylene glycol (E1520), shellac.
What the medicine looks like and contents of the pack
Odomzo 200 mg capsules are pink and opaque, imprinted with “SONIDEGIB 200MG” and “NVR”.
Odomzo is packaged in perforated unit dose blisters containing 10 x 1 capsules. It is available in packs of 10 or 30 capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Sun Pharmaceutical Industries Europe BV
Polarisavenue 87
2132JH Hoofddorp
Netherlands
Contact the representative of the marketing authorization holder to find out more about this medicine:
Sun Pharmaceutical Industries Europe BV
Tel: +31 23 568 55 0