Sutent (sunitinib)

How does it work?

Sutent capsules contain the active ingredient sunitinib, which is a type of medicine called a multikinase inhibitor. It works by interfering with the pathways that signal certain cancer cells to grow.

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

Sunitinib works by inhibiting the action of various tyrosine kinase enzymes. This stops the signals that tell the cancer cells to grow and multiply. It also stops blood vessels growing into the tumour. This reduces the tumour's blood supply and with it, its supply of oxygen and nutrients. Both these effects stop the tumour from growing.

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

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

Sunitinib is licensed to treat inoperable or advanced GIST tumours that have either not responded to treatment with a similar medicine called imatinib, or in people who can't take imatinib.

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 as the cancer is responding to the treatment.

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.

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

People who have had a heart attack, severe angina, heart bypass surgery, heart failure, stroke, mini-stroke, or blood clot in the lung in the last 12 months

Heart disease

Slow heart rate (bradycardia)

History of an abnormal heart rhythm, seen on a heart monitoring trace 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

Allergy to any ingredient

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 or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

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

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, 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 individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Fatigue

Feeling weak

Disturbances of the gut, such as diarrhoea, nausea and vomiting, constipation, indigestion

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

Underactive thyroid gland (hypothyroidism)

Bleeding, particularly nosebleeds

Pain in the joints or muscles

Swelling due to fluid retention (oedema)

Dizziness

Pins and needles sensations

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

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

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