SUTENT 50 mg hard capsules

 

What is it and how is it used?

SUTENT is a medicine used to treat cancer by preventing the activity of a special group of proteins which are known to be involved in the growth and spread of cancer cells.

SUTENT will only be prescribed to you by a doctor with experienced in the use of anti-cancer medicinal products.

Gastrointestinal stromal tumour (GIST)
SUTENT is indicated for the treatment of unresectable and/or metastatic malignantgastrointestinal stromal tumour (GIST) in adults after failure of imatinib mesilate treatment due to resistance or intolerance. GIST is a cancer of the stomach and bowels, originating from uncontrolled cell growth of the supporting tissues of these organs. SUTENT inhibits the growth of these cells.

Metastatic renal cell carcinoma (MRCC)
SUTENT is indicated for the treatment of advanced metastatic renal cell carcinoma (MRCC) in adults. MRCC is a form of kidney cancer that involves cancerous changes in the cells of the renal tubule.

Pancreatic neuroendocrine tumours (pNET)
SUTENT is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults. pNET is a rare cancer originating in the hormone-secreting cells of the pancreas.
Experience with SUTENT as first-line treatment is limited.

If you have any questions about how SUTENT works or why this medicine has been prescribed for you, ask your doctor.

What do you have to consider before using it?

Follow all your doctor’s instructions carefully, even if they differ from the general information contained in this leaflet.

Do not take SUTENT

  • If you are allergic to sunitinib or any of the other ingredients of SUTENT.

Before you take SUTENT or while you are being treated with SUTENT:
You may be advised to have a dental check-up before you start treatment with SUTENT.

  • if you have or have had pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth tell your doctor and dentist immediately.
  • if you need to undergo an invasive dental treatment or dental surgery, tell your dentist that you are being treated with SUTENT in particular when you are also receiving or have received i.v. bisphosphonates.

Take special care with SUTENT

  • If you have or have had liver or kidney problems.
  • If you have high blood pressure.
  • If you have an under-active thyroid gland before starting treatment with SUTENT, or if your thyroid gland becomes less active during treatment.
  • If you have an abnormality of your heart trace known as Prolonged QT interval.
  • If you are pregnant or think you may be (see below).
  • If you are breast-feeding (see below).
  • If you are going to have surgery or if you had an operation recently. SUTENT may affect the way your wounds heal. You will usually be taken off SUTENT if you are having an operation. Your doctor will decide when to start SUTENT again. If any of those apply to you, tell your doctor before you take SUTENT.

Tell your doctor if you develop any of the following signs and symptoms of liver problems during SUTENT treatment: itching, -yellow eyes or skin, dark urine, and -pain or discomfort in the right upper stomach area.
Your doctor should do blood tests to check your liver function before and during treatment with Sutent, and as clinically indicated.

Before taking SUTENT
Tell your doctor if you need to undergo surgery.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription even those not prescribed.

Some medicines can affect the levels of SUTENT in your body. You should inform your doctor if you are taking medicines containing the following active substances:
ketoconazole, itraconazole – used to treat fungal infections
erythromycin, clarithromycin, rifampicin – medicines used to treat infections ritonavir – medicines used to treat HIV
dexamethasone – a corticosteroid used for various conditions
phenytoin, carbamazepine phenobarbital – treatments for epilepsy and other conditions herbal preparations containing St. John’s Wort (Hypericum perforatum) – used to treat depression and anxiety

Taking SUTENT with food and drink
SUTENT can be taken with or without food; however, you should avoid drinking grapefruit juice while on treatment with SUTENT.

Pregnancy and breast-feeding
If you are pregnant or think you may be, tell your doctor.
SUTENT is not to be used during pregnancy unless clearly necessary. Your doctor will discuss with you the potential risk of taking SUTENT during pregnancy.
If you might get pregnant, you should use effective contraception during treatment with SUTENT.

If you are breast-feeding, tell your doctor. Do not breast-feed during treatment with SUTENT.

Driving and using machines
If you experience dizziness or you feel unusually tired, take special care when driving or using machines.

How is it used?

Your doctor will prescribe a dose that is right for you, depending on the type of cancer to be treated. If you are being treated for GIST or renal cancer, the usual dose is 50 mg once daily taken for 28 days (4 weeks), followed by 14 days (2 weeks) of rest (no medicine), given as a 6-weeks cycle. If you are being treated for pNET, the usual dose is 37.5 mg once daily without a rest period. Your doctor will determine how many cycles of treatment you will need as well as the appropriate dose you need to take.
Always take SUTENT exactly as your doctor has told you. You should check with your doctor if you are not sure.

If you take more SUTENT than you should
If you have accidentally taken too many capsules, talk to your doctor straight away. You may require medical attention.

If you forget to take SUTENT
Do not take a double dose to make up for a forgotten dose.

What are possible side effects?

Like all medicines, SUTENT can cause side effects, although not everybody gets them.

These side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated from the available data.

Very common side effects

  • Mouth pain/irritation, mouth sores/inflammation/dryness, taste disturbances, burning or painful sensation in the tongue, upset stomach, nausea, vomiting, diarrhoea, inflammation of the digestive tract lining, excessive gas in the stomach or intestine, constipation, abdominal pain, loss/decrease of appetite, loss of strength, weight loss.
  • Yellow skin/skin discoloration, hair colour change, hair loss, rash on the palms of the hands and soles of the feet, blisters, rash, dryness of the skin.
  • Nose bleeding.
  • Extreme tiredness.
  • High blood pressure, migraine.
  • Reduced/abnormal ability of the heart to pump blood.
  • Headache.
  • Reduction in the number of platelets, red blood cells and/or neutrophils (type of white blood cells.
  • Reduction in the number of white blood cells.
  • Decreased activity of the thyroid gland (hypothyroidism).
  • Pain in arms and legs.

Common side effects

  • Chills, fever, influenza-like syndrome.
  • Cough, nasal dryness, congested nose.
  • Difficulty in speaking.
  • Abnormally coloured urine.
  • Haemorrhoids, pain in the rectum, rectal bleeding, gingival bleeding, difficulty in swallowing or inability to swallow, acid heartburn.
  • Excessive tear flow.
  • Back pain, joint pain, muscle pain.
  • Chest pain.
  • Abnormal sensations in extremities.
  • Swelling of the limbs or around the eyes.
  • Abnormal sensation of the skin, dry skin, itching, flaking and inflammation of the skin, blisters, acne, excess pigmentation of the skin.
  • Hot flushes.
  • Nail discolouration.
  • Abnormally decreased/increased sensitivity, particularly to touch.
  • Shortness of breath.
  • Depression.
  • Difficulty in falling asleep.
  • Abnormal blood tests including pancreatic and liver enzymes.

Uncommon side effects

  • Pain in the stomach (abdomen) caused by inflammation of the pancreas.
  • Heart failure.
  • Liver failure.

Rare side effect

  • Tumour destruction leading to hole in the intestine (perforation).
  • Changes in the electrical activity or abnormal rhythm of the heart.

Non Known

  • Abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis).
  • Infections.
  • Blood clots in the blood vessels.
  • Loss of protein in the urine sometime resulting in swelling.
  • Fluid retention including around the lungs.
  • Inappropriate and excessive reaction to an allergen.
  • Rapid tissue swelling characterized by large circumscribed areas of fluid under the skin.
  • Overproduction of thyroid hormones which increases the amount of energy the body uses at rest.
  • Abnormal tube like passage from one normal body cavity to another body cavity or the skin.
  • Inflammation of the liver (hepatitis).
  • Severe disorder of heart muscle that may be associated with an increased risk of death (cardiomyopathy).
  • Fluid around the heart (pericardial effusion).
  • Kidney failure.
  • Problems with wound healing after surgery.
  • Pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. These could be signs and symptoms of bone damage in the jaw (osteonecrosis). Tell you doctor and dentist immediately if you experience any of them.

If any of the side effect gets serious or if you notice any side effect not listed in this leaflet, please tell your doctor.

How should it be stored?

  • Keep out of reach and sight of children.
  • Do not use after the expiry date (EXP) which is stated on the outer pack and label.
  • This medicine does not require any special storage conditions.
  • Do not use any pack that is damaged or shows signs of tampering.

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.

What is it?

Sutent is a medicine that contains the active substance sunitinib. It is available as capsules (orange: 12.5 mg; caramel and orange: 25 mg; yellow: 37.5 mg; caramel: 50 mg).

What is it used for?

Sutent is used to treat adults with the following types of cancer:

gastrointestinal stromal tumour GIST, a type of cancer of the stomach and bowel where there is uncontrolled growth of cells in the supporting tissues of these organs. Sutent is used in patients with GISTs that cannot be removed with surgery or have spread to other parts of the body. It is used after treatment with imatinib another anticancer medicine has failed

metastatic renal cell carcinoma, a type of kidney cancer, that has spread to other parts of the body

pancreatic neuroendocrine tumours tumours of the hormone-producing cells in the pancreas that have spread or cannot be removed with surgery. Sutent is used if the disease is getting worse and the tumour cells are well-differentiated similar to normal cells in the pancreas.

The medicine can only be obtained with a prescription.

How is it used?

Treatment with Sutent should be started by doctors who have experience in administering anticancer medicines.

For GIST and metastatic renal cell carcinoma, Sutent is given in six-week cycles, at a dose of 50 mg once a day for four weeks, followed by a two-week ‘rest period’. The dose can be adjusted according to the patient’s response to the treatment, but should be kept within the range of 25 to 75 mg.

For pancreatic neuroendocrine tumours, Sutent is given at a dose of 37.5 mg once a day without a rest period. This dose may also be adjusted.

How does it work?

The active substance in Sutent, sunitinib, is a protein kinase inhibitor. This means that it blocks some specific enzymes known as protein kinases. These enzymes can be found in some receptors at the surface of cancer cells, where they are involved in the growth and spread of cancer cells and in the blood vessels that supply the tumours, where they are involved in the development of new blood vessels. By blocking these enzymes, Sutent can reduce the growth and spread of the cancer and cut off the blood supply that keeps cancer cells growing.

How has it been studied?

Sutent was compared with placebo (a dummy treatment) in 312 patients with GIST whose previous treatment with imatinib had failed and in 171 patients with worsening pancreatic neuroendocrine tumours that could not be removed with surgery.. Sutent was also compared with another anticancer medicine, interferon alfa, in 750 patients with metastatic renal cell carcinoma whose cancer had not been treated before.

The main measure of effectiveness in all of the studies was how long the patients lived without their tumours getting worse.

What benefits has it shown during the studies?

Sutent was more effective than placebo in treating GIST and pancreatic neuroendocrine tumours. Patients with GIST taking Sutent lived for an average of 27.3 weeks without the disease getting worse, compared with 6.4 weeks in the patients taking placebo. For pancreatic neuroendocrine tumours the figures were 11.4 months in the Sutent group and 5.5 months in the placebo group.

In metastatic renal cell carcinoma, patients taking Sutent lived for an average of 47.3 weeks without their disease worsening, compared with 22.0 weeks in the patients receiving interferon alfa.

What is the risk associated?

The most common side effects with Sutent (seen in more than 20% of patients) include fatigue (tiredness), gastrointestinal disorders (such as diarrhoea, feeling sick, inflammation of the lining of the mouth, indigestion and vomiting), skin discoloration, dysgeusia (taste disturbances) and loss of appetite. For the full list of all side effects reported with Sutent, see the package leaflet.

Sutent should not be used in people who may be hypersensitive (allergic) to sunitinib or any of the other ingredients.

Why has it been approved?

The CHMP decided that Sutent’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Sutent was originally given ‘conditional approval’. This means that there was more evidence to come about the medicine, in particular in the treatment of renal cell carcinoma. As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.

Further information

The European Commission granted a conditional marketing authorisation valid throughout the European Union for Sutent to Pfizer Ltd on 19 July 2006. This was switched to a full marketing authorisation on 11 January 2007. The marketing authorisation is valid for five years, after which it can be renewed. europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Sutent, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 11-2010.