Sunitinib malate
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about SUTENT.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking SUTENT against the benefits it is expected to have for you.
If you have any concerns about this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What SUTENT is used for
SUTENT is used in the treatment of renal cell carcinoma, a type of kidney cancer.
SUTENT is used to treat gastrointestinal stromal tumour (GIST). GIST is a cancer of the stomach and bowels. It is caused by the uncontrolled growth of cells in the wall of the stomach or bowel. SUTENT slows down the growth of these cells.
SUTENT is also used to treat pancreatic neuroendocrine tumours. This is a rare cancer in the cells of the pancreas that release hormones.
Ask your doctor if you have any questions about why SUTENT has been prescribed for you.
Your doctor may have prescribed it for another purpose.
SUTENT is only available with a doctor's prescription. It is not addictive.
Use in children
The safety and efficacy of SUTENT have not been established in children.
Before you take SUTENT
When you must not take it
Do not take SUTENT if you have ever had an allergic reaction to sunitinib (the active ingredient in SUTENT) or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
Do not use SUTENT after the expiry date printed on the pack.
Do not use SUTENT if the packaging shows signs of tampering.
Before you start to take it
You must tell your doctor if:
you have high blood pressure
you have problems with your heart
you have or have ever had problems with your liver or kidneys
you are pregnant or planning to become pregnant.
SUTENT should not be used during pregnancy. Your doctor will discuss the risks with you.
you are breastfeeding.
You should not breastfeed while taking SUTENT.
You should have a dental check up before taking SUTENT.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines and SUTENT may interfere with each other. Some of these medicines include:
ketoconazole, a medicine to treat fungal infections
itraconazole, a medicine to treat fungal infections
ritonavir, a medicine to treat HIV infection
erythromycin, a medicine to treat infections
clarithromycin, a medicine to treat infections
rifampicin, a medicine to treat tuberculosis and some other infections
dexamethasone, a medicine to treat dermatitis, asthma and some other conditions
phenytoin, a medicine to treat seizures
carbamazepine, a medicine to treat seizures
phenobarbitone, a medicine to treat seizures
St. John's wort (a herbal medicine, also called Hypericum perforatum) to treat anxiety
medicines used to treat irregular heart beat
medicines called bisphosphonates, such as zoledronic acid, alendronate pamidronate or ibandronate to treat osteoporosis and some types of cancers
medicines to treat diabetes.
You may need to take different amounts of your medicines or you may need to use different medicines. Your doctor will advise you.
How to take SUTENT
Follow all directions given to you by your doctor carefully.
These directions may differ from the information contained in this leaflet.
If you do not understand the instructions on the label, ask your doctor or pharmacist for help.
How much to take
Your doctor will tell you the dose that you should take. The dose depends on the type of cancer.
For renal cell carcinoma and GIST, the usual dose is 50 mg taken once a day for 4 weeks followed by no medicine for 2 weeks, making a 6-week cycle. Your doctor will let you know how many cycles of treatment you will need.
For pancreatic neuroendocrine tumours, the usual recommended dose is 37.5 mg taken once daily.
Your doctor may change your dose during treatment.
How to take it
Swallow the capsules with a glass of water.
Take the capsules at about the same time each day.
Taking them at the same time each day will help you to remember to take them.
SUTENT can be taken with or without food.
How long to take it
Continue taking SUTENT for as long as your doctor prescribes it.
If you forget to take it
If you miss a dose, do not take an additional dose. Take your usual dose on the next day.
Do not take a double dose to make up for the one that you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you take too much (overdose)
Immediately telephone your doctor or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have taken too much SUTENT. Do this even if there are no signs of discomfort or poisoning.
Keep the telephone numbers for these places handy.
While you are taking SUTENT
Things you must do
Make sure you follow your doctor's instructions and keep all appointments.
You will need regular follow-up to make sure the treatment is working.
Your doctor will measure your blood pressure. You will also have blood tests to check for side effects.
Use a proven method of birth control (contraception) to prevent pregnancy while being treated with SUTENT and for at least 4 weeks after finishing treatment with SUTENT.
Tell your doctor immediately if you become pregnant while taking SUTENT.
Tell your doctor if you are going to have surgery, an operation or dental treatment while taking SUTENT.
Tell any doctor, dentist or pharmacist who treats you that you are taking SUTENT.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking SUTENT.
Things you must not do
Do not take SUTENT to treat any other complaints unless your doctor tells you to.
Do not give SUTENT to anyone else, even if their condition seems similar to yours.
Things to be careful of
Avoid drinking grapefruit juice while you are being treated with SUTENT.
Grapefruit juice may interact with SUTENT and affect how your body uses this medicine.
Be careful driving, operating machinery or doing jobs that require you to be alert, until you know how SUTENT affects you.
SUTENT may make some people feel very tired or dizzy.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking SUTENT.
All medicines can have unwanted side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. Medicines can affect people in different ways.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
tiredness
diarrhoea
nausea (feeling sick) or vomiting
change in sense of taste, loss of taste
loss of appetite, weight loss
change in skin colour
change in hair colour
tingling or rash on palms of hands or soles of feet
rash, dry skin, skin redness, scaly skin, itchy skin, blisters; skin infections, pus formation, skin ulcers
headache
constipation
sore tongue, sore mouth, dry mouth, difficulty swallowing, cold sores
cough
upset stomach, stomach pain, wind, heart burn, indigestion
pain in fingers, arms or legs
weakness
muscle pain, joint pain, back pain
dizziness
hair loss
nose bleed
increased tears, watery eyes
tingling or numbness of hands or feet; pins and needles
difficulty sleeping
depression
unusual urine colour, frequency or pain passing urine
swelling, weight gain, enlargement of thyroid gland
feeling overheated, increased sweating
fast or irregular heart beat.
These are the more common side effects.
Tell your doctor immediately if you get any of the following side effects:
shortness of breath, wheezing or trouble breathing, chest pain
swelling of feet or legs, leg pain
swollen face, eyelids, lip, tongue or voice box; swelling under the skin
bleeding or bruising under the skin; coughing blood
flu-like symptoms (chills, fever, sore throat, swollen glands)
high blood pressure
very bad stomach pain
leaking or discharge near anus
fits, seizures
infection
swelling, dark marks or blisters on any part of the body
muscle pain, weakness or wasting
decrease in amount of urine
yellowing of skin and eyes (jaundice)
numbness or tingling on one side of the body; weakness of face, arm or leg; trouble speaking, seeing or swallowing; headache, confusion, dizziness, loss of co-ordination or balance
pain or numbness in the jaw, teeth or gums
decreased blood sugar level, feeling hungry, shaky or anxious
pain in the neck, shoulder or arm
pressure in the chest.
The above side effects may be serious. You may need urgent medical attention.
Tell your doctor if you notice anything else that is making you feel unwell.
Other side effects not listed above may also occur in some patients.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
After using SUTENT
Storage
Keep your capsules in the original container until it is time to take them.
Store SUTENT in a cool dry place.
Do not leave SUTENT or any other medicine in the car or on window sills.
Do not store SUTENT or any other medicine in the bathroom or near a sink.
Heat and dampness can destroy some medicines.
Keep the capsules where children cannot reach them.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any capsules you have left.
Product description
What it looks like
SUTENT 12.5 mg capsules have a Swedish Orange (a brownish red colour) cap and body and are printed with "Pfizer" on the cap and "STN 12.5mg" on the body in white ink.
SUTENT 25 mg capsules have a caramel-coloured cap and Swedish Orange (a brownish red colour) body and are printed with "Pfizer" on the cap and "STN 25mg" on the body in white ink.
SUTENT 37.5 mg capsules have a yellow cap and body and are printed with "Pfizer" on the cap and "STN 37.5mg" on the body in black ink.
SUTENT 50 mg capsules have a caramel-coloured cap and body and are printed with "Pfizer" on the cap and "STN 50mg" on the body in white ink.
Each bottle or blister pack contains 28 capsules.
Ingredients
Sutent capsules contain sunitinib malate equivalent to 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib.
The capsules also contain:
mannitol
croscarmellose sodium
povidone
magnesium stearate
gelatin
titanium dioxide (E171)
red iron oxide CI77491 (E172) (12.5 mg, 25 mg and 50 mg)
yellow iron oxide CI77492 (E172) (25 mg and 50 mg)
black iron oxide CI77499 (E172) (25 mg and 50 mg).
SUTENT capsules do not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.
