Main use Active ingredient Manufacturer
Advanced kidney cancer Sunitinib malate Pfizer

How does it work?
Sutent capsules contain the active ingredient sunitinib, whichis a type of medicine called a multikinase inhibitor. It works by interferingwith the pathways that signal certain cancer cells to grow.

The way that cells in the body work and grow is regulated byvarious enzymes called tyrosine kinases. In cancerous cells, these kinases makethe cells grow and multiply abnormally. They also stimulate nearby bloodvessels to grow into the tumour. The new blood vessels allow the cancer cellsto grow and multiply by supplying them with oxygen and nutrients. They alsoallow the cancerous cells to spread into other areas of the body through theblood circulation.

Sunitinib works by inhibiting the action of various tyrosinekinase enzymes. This stops the signals that tell the cancer cells to grow andmultiply. It also stops blood vessels growing into the tumour. This reduces thetumour’s blood supply and with it, its supply of oxygen and nutrients. Boththese effects stop the tumour from growing.

Sunitinib is licensed to treat advanced kidney cancer. It isalso used to treat a rare kind of cancer that occurs in the wall of the stomachand small intestine. This cancer is called a gastrointestinal stromal tumour(GIST).

GIST tumours are caused by a particular abnormal tyrosinekinase, called c-kit. Sunitinib blocks the action of this enzyme, which stopsthe GIST cells from multiplying uncontrollably.

Sunitinib is licensed to treat inoperable or advanced GISTtumours that have either not responded to treatment with a similar medicinecalled imatinib, or in people who can’t take imatinib.

When treating kidney cancer or GIST, Sutent capsules are taken by mouth once a day for four weeks,followed by a two week break. This six week cycle may be repeated as long asthe cancer is responding to the treatment.

Sunitinib is also licensed to treat another rare type of cancer that originates in the hormone-producing cells in the pancreas. When treating this type of cancer the capsules are taken once a day on a continuous basis.

What is it used for?
Kidney cancer that is advanced or has spread to other parts of the body.
A rare cancer that occurs in the wall of the stomach and small intestine (gastrointestinal stromal tumour or GIST) that is inoperable or has spread to other parts of the body.
A rare cancer that starts in the hormone-producing cells of the pancreas (pancreatic neuroendocrine tumour or pNET) that is inoperable or has spread to other parts of the body.
Warning!
You should not drink grapefruit juice while you are taking this medicine, as it may increase the amount of this medicine in the blood and could therefore increase the risk of side effects.
This medicine can sometimes cause heart problems. Tell your doctor straight away if you experience breathlessness, tiredness, or swollen feet or ankles while taking this medicine.
Your blood pressure should be regularly monitored while you are taking this medicine. If your blood pressure increases you may need to take medicines to reduce it.
You will need to have a blood test at the beginning of each cycle of treatment with this medicine so that the levels of blood cells in your blood can be checked.
This medicine could be harmful to a developing baby. Women who could get pregnant must use a reliable method of contraception to avoid getting pregnant while taking this medicine. Seek further medical advice from your doctor. Tell your doctor immediately if you get pregnant during treatment.
Your ability to get pregnant or father a child may be affected by treatment with this medicine. It is important to discuss fertility with your doctor before starting treatment.
Use with caution in
Decreased liver function.
Decreased kidney function.
High blood pressure (hypertension).
Heart disease.
People who have had a heart attack, severe angina, heart bypass surgery, heart failure, stroke, mini-stroke (TIA), or blood clot in the lung (pulmonary embolism) in the last 12 months.
Slow heart rate (bradycardia).
History of an abnormal heart rhythm, seen on a heart monitoring trace (ECG) as a ‘prolonged QT interval’.
People taking medicines for abnormal heartbeats (antiarrhythmics – see end of factsheet for more details).
Disturbances in the levels of electrolytes (salts such as potassium and sodium) in the blood.
People with blood clotting problems or at increased risk of bleeding.
Not to be used in
Breastfeeding.
This medicine is not recommended for children and adolescents under 18 years of age.
This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such an allergy.

If you feel you have experienced an allergic reaction, stopusing this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

This medicine could be harmful to a developing baby. It should not be used during pregnancy unless considered essential by your doctor, and only if the potential benefit to the mother outweighs any risks to the developing baby. Women who could get pregnant must use a reliable method of contraception to avoid getting pregnant while taking this medicine. Seek further medical advice from your doctor. Tell your doctor immediately if you get pregnant during treatment.
It is not known if this medicine passes into breast milk. Mothers who need to take this medicine should not breastfeed, because if the medicine does pass into the breast milk it could be harmful to a nursing infant. Seek medical advice from your doctor.
Side effects
Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere, it does not mean that all people using this medicine will experience thator any side effect.

Fatigue.
Disturbances of the gut, such as diarrhoea, nausea and vomiting, constipation, indigestion.
Feeling weak
Sore mouth.
Alteration in taste.
Loss of appetite.
Skin discolouration.
Changes in hair colour.
Rash, dryness, thickening, cracking or blistering of the skin on the palms of the hands and soles of the feet (hand-foot syndrome).
Skin reactions such as dry or red skin, rash.
Increased blood pressure.
Headache.
Hair loss.
Decreased levels of red blood cells, white blood cells or platelets in the blood.
Overactive or underactive thyroid gland.
Bleeding, particularly nosebleeds.
Pain in the joints or muscles.
Swelling due to fluid retention (oedema).
Dizziness.
Pins and needles sensations.
Blood clot in a vein (deep vein thrombosis) or the lungs (pulmonary embolism).
Inflammation of the pancreas (pancreatitis).
Liver or kidney problems.
Heart failure.
The side effects listed above may not include all of the sideeffects reported by the medicine's manufacturer.

For more information about any other possible risks associatedwith this medicine, please read the information provided with the medicine orconsult your doctor or pharmacist.

How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before you start treatment with this medicine. Similarly,check with your doctor or pharmacist before taking any new medicines whiletaking this one, to ensure that thecombination is safe.

The following medicines may decrease the breakdown of sunitinibby the body and so could increase the amount of sunitinib in theblood:

azole-type antifungals, eg itraconazole, ketoconazole
macrolide antibiotics, eg clarithromycin, erythromycin
protease inhibitors for HIV, eg ritonavir.
As these medicines could increase the risk of side effects dueto sunitinib, they should be avoided where possible while you are taking thismedicine. If your doctor needs to prescribe you any of these medicines, yourdose of sunitinib may need to be decreased.

The following medicines may increase the breakdown of sunitinibby the body and so could decrease the amount of sunitinib in the blood:

barbiturates, eg phenobarbital, amobarbital
carbamazepine
dexamethasone
phenytoin
rifampicin
the herbal remedy St John's wort (Hypericum perforatum).
As these medicines could make sunitinib less effective theyshould be avoided where possible while you are taking this medicine. If yourdoctor needs to prescribe you any of these medicines, your dose of sunitinibmay need to be increased.

Bleeding has been reported with this medicine. If you are takinga medicine to prevent or treat blood clots (anticoagulant medicines such aswarfarin), your doctor may want to perform extra monitoring of your blood cellsand blood clotting time (INR) while you are taking this medicine.

There may be an increased risk of an abnormal heart rhythm seenon an ECG as a ‘prolonged QT interval’ if this medicine is taken in combinationwith medicines to treat irregular heart beats (antiarrhythmics) such asamiodarone, disopyramide, flecainide, procainamide, propafenone, quinidine orsotalol.

Other medicines containing the same active ingredient
There are currently no other medicines available in the UK thatcontain sunitinib as the active ingredient.