Tratamento com Sutent

As informações a seguir foram tiradas de um site australiano: http://www.nps.org.au/__data/assets/pdf_file/0019/16282/pfcsutec.pdf

SUTENT(R)
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.
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 reathing; 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:
1. you have high blood pressure.
2. you have problems with your heart.
3. you are pregnant or planning to become pregnant.
SUTENT should not be used during pregnancy. Your doctor will discuss the risks with you.
4. you are breastfeeding.
You should not breastfeed while taking SUTENT.
5. you have or have ever had problems with your liver or kidneys.

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
* ritonavir
* itraconazole
* erythromycin
* clarithromycin
* rifampicin
* dexamethasone
* phenytoin
* carbamazepine
* phenobarbitone
* St. John's Wort (a herbal medicine, also called Hypericum perforatum)
* medicines used to treat irregular heart beat

You may need to take different amounts of your medicines or you may need to use different edicines. 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 is usually taken once a day for 4 weeks followed by no medicine for 2 weeks, making a 6-week cycle. Your doctor will let you now how many cycles of treatment you will need.
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 Poisons Information Centre (Phone Australia 13 11 26 or New Zealand 0800 POISON or 0800 764 766) for advice 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 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 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 use 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 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, blister
* headache
* constipation
* sore tongue, sore mouth, dry mouth
* 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
* swelling, weight gain
* 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 or eyelids
* bleeding or bruising under the skin; coughing blood
* flu-like symptoms (chills, fever, sore throat, swollen glands)
* high blood pressure
* very bad stomach pain
* fits, seizures
* infection
* muscle pain, weakness or wasting

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 use 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 an orange cap and body, and are printed with "Pfizer" on the cap and "STN 12.5 mg" on the body in white ink.
SUTENT 25 mg capsules have a caramel-coloured cap and orange body, and are printed with "Pfizer" on the cap and "STN 25 mg" on the body in white ink.
SUTENT 50 mg capsules have a caramel-coloured cap and body, and are printed with "Pfizer" n the cap and "STN 50 mg" 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 or 50 mg of sunitinib.
The capsules also contain:

* mannitol
* croscarmellose sodium
* povidone
* magnesium stearate
* gelatin
* titanium dioxide (E171)
* red iron oxide CI77491 (E172)
* yellow iron oxide CI77492 (E172) (25 mg and 50 mg only)
* black iron oxide CI77499 (E172) (25 mg and 50 mg only)

SUTENT capsules do not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.