Prospect: information for the user

Sutent 12.5 mg hard capsules

Sutent 25 mg hard capsules

Sutent 37.5 mg hard capsules

Sutent 50 mg hard capsules

sunitinib

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, even if they are not listed in this prospect. See section 4.

1.What Sutent is and for what it is used

2.What you need to know before starting to take Sutent

3.How to take Sutent

4.Possible adverse effects

5.Storage of Sutent

6.Contents of the package and additional information

Sutent contains the active ingredient sunitinib, which is a protein-tyrosine kinase inhibitor. It is used for the treatment of cancer and acts by preventing the activity of a specific group of proteins involved in the growth and proliferation of cancer cells.

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

• Gastrointestinal stromal tumor (GIST), a type of stomach and intestinal cancer, when imatinib (another anticancer medication) has failed or cannot be taken.
• Metastatic renal cell carcinoma (mRCC), a type of kidney cancer that has spread to other parts of the body.
• Progressive or unresectable pancreatic neuroendocrine tumors (pNET) (tumors of hormone-secreting cells in the pancreas).

If you have any doubts about how Sutent works or why this medication has been prescribed for you, consult your doctor.

Do not take Sutent

-if you are allergic to sunitinib or any of the other ingredients in this medicine (listed in section 6).

Warnings and precautions

Consult your doctor before starting to take Sutent:

• If you have high blood pressure.Sutent may increase blood pressure. Your doctor may monitor your blood pressure during treatment with Sutent, and if necessary, you may be treated with medications that reduce blood pressure.

• If you have or have had blood disorders, bleeding problems or bruising.Treatment with Sutent may lead to a high risk of bleeding or produce changes in the number of certain blood cells, which may cause anemia or affect blood clotting. If you are taking warfarin or acenocoumarol, medications that thin the blood to prevent clots, there may be a higher risk of bleeding. If you experience any bleeding during treatment with Sutent, consult your doctor.

• If you have heart problems.Sutent may cause heart problems. Consult your doctor if you feel extremely tired, short of breath, or have swollen feet and ankles.

• If you have abnormal heart rhythm.Sutent may cause abnormal heart rhythm. Your doctor may obtain electrocardiograms to evaluate these problems during treatment with Sutent. Consult your doctor if you experience dizziness, weakness, or abnormal heartbeats during treatment with Sutent.

• If you have had recent blood clots in veins and/or arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis.Contact your doctor immediately if you experience symptoms such as chest pain or pressure, pain in the arms, back, neck, or jaw, shortness of breath, numbness or weakness on one side of the body, speech problems, headache, or dizziness while on treatment with Sutent.

• If you have or have had an aneurysm(enlargement and weakening of the wall of a blood vessel) or tearing of the wall of a blood vessel.

• If you have or have had damage to smaller blood vessels known as microangiopathic thrombosis (MAT).Contact your doctor if you experience fever, fatigue, tiredness, bruising, bleeding, swelling, confusion, loss of vision, and seizures.

• If you have thyroid problems.Sutent may cause thyroid problems. Contact your doctor if you feel tired more easily, are usually colder than others, or your voice becomes deeper while taking Sutent. Before starting treatment with Sutent, your thyroid function should be checked and monitored periodically while on treatment. If your thyroid gland does not produce enough thyroid hormone, you may be treated with thyroid hormone replacement.

• If you have or have had pancreatic disorders or gallbladder problems.Contact your doctor if you develop any of the following signs and symptoms: stomach pain (upper abdominal area), nausea, vomiting, and fever. These may be caused by inflammation of the pancreas or gallbladder.

• If you have or have had liver problems.Contact your doctor if you develop any of the following signs and symptoms of liver problems during treatment with Sutent: itching, yellow eyes or skin, dark urine, and pain or discomfort in the upper right abdominal area. Your doctor should perform blood tests to monitor liver function before and during treatment with Sutent, as well as when clinically indicated.

• If you have or have had kidney problems.Your doctor will monitor your renal function.

• If you are about to undergo surgery or have had a recent operation.Sutent may affect wound healing. If you are about to undergo surgery, you will usually stop taking Sutent. Your doctor will decide when to start Sutent again.

• Before starting treatment with Sutent, you may be advised to have a dental check-up

• If you have or have had mouth pain, tooth pain, or gum pain, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or if you feel that a tooth is loose, inform your doctor and dentist immediately.
• If you need to have invasive dental treatment or dental surgery, inform your dentist that you are taking Sutent, particularly if you are also taking or have been treated with bisphosphonates intravenously. Bisphosphonates are medications used to prevent bone complications that may occur due to another medical condition.

• If you have or have had skin and subcutaneous tissue disorders.During treatment with this medication, you may develop "pyoderma gangrenosum" (painful skin ulceration) or "necrotizing fasciitis" (infection of the skin/soft tissues that spreads quickly and can be fatal). Contact your doctor immediately if you experience symptoms of infection around a skin lesion, such as fever, pain, redness, swelling, or pus or blood discharge. This reaction is usually reversible after stopping sunitinib. Cases of severe skin rash (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported, which initially appeared as red spots resembling targets or circular spots, often accompanied by central blisters on the trunk. This rash may progress to form widespread blisters or cause skin peeling, and may be life-threatening. Consult your doctor immediately if you develop a skin rash or the indicated skin symptoms.

• If you have or have had seizures.If you have high blood pressure, headache, or loss of vision, inform your doctor as soon as possible.

• If you have diabetes.Your blood glucose levels should be checked regularly to assess whether your diabetes medication needs to be adjusted to minimize the risk of low blood sugar. Inform your doctor as soon as possible if you experience signs and symptoms of low blood sugar (fatigue, palpitations, sweating, hunger, and loss of consciousness).

Children and adolescents

Sutent is not recommended for use in patients under 18 years of age.

Other medications and Sutent

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Some medications may affect the levels of Sutent in your body. You should inform your doctor if you are taking medications that contain any of the following active ingredients:

• ketoconazole, itraconazole – used to treat fungal infections
• erythromycin, clarithromycin, rifampicin – used to treat infections
• ritonavir – used to treat HIV/AIDS
• dexamethasone – a corticosteroid used to treat various diseases (such as allergic/respiratory disorders or skin diseases)
• phenytoin, carbamazepine, phenobarbital – used to treat epilepsy and other neurological disorders
• herbal remedies containing St. John's Wort or hypericum (Hypericum perforatum)– used to treat depression and anxiety

Taking Sutent with food and drinks

You should avoid taking grapefruit juice while on treatment with Sutent.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

If you can become pregnant, you should use a reliable contraceptive method during treatment with Sutent.

If you are breastfeeding, inform your doctor. You should not breastfeed your child during treatment with Sutent.

Driving and operating machinery

If you experience dizziness or unusual fatigue, exercise special caution when driving or operating machinery.

Sutent contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

Your doctor will establish the correct dose for you depending on the type of cancer being treated. If you are to receive treatment for:

• GIST or CCRM: the usual dose is 50 mg once a day for 28 days (4 weeks), followed by 14 days (2 weeks) of rest (no medication) in 6-week cycles.
• pNET: the usual dose is 37.5 mg once a day without a rest period.

Your doctor will inform you of the appropriate dose you need to take, as well as whether you need to suspend Sutent treatment and when.

Sutent can be taken with or without food.

If you take more Sutent than you should

If you have accidentally taken too many capsules, consult your doctor immediately. You may require medical attention.

If you forget to take Sutent

Do not take a double dose to make up for the missed doses.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

You should contact your doctor immediately if you experience any of the following serious side effects (see alsoWhat you need to know before starting to take Sutent):

Heart problems.Consult your doctor if you are very tired, short of breath, or have swollen feet and ankles. These may be symptoms of heart problems that can include heart failure and heart muscle problems (cardiomyopathy).

Lung or respiratory problems.Consult your doctor if youdevelop a cough, chest pain, sudden onset of breathing difficulties, or cough up blood.This may be a sign of a condition called pulmonary embolism that occurs when blood clots travel to the lungs.

Changes in the kidney.Consult your doctor ifyou experience a change in the frequency or absence of urination, as this may be a sign of kidney failure.

Bleeding.Consult your doctor if you have any of these symptomsor a severe bleeding problem during treatment with Sutent: stomach (abdomen) pain or swelling; vomit blood; have black, sticky stools; urinate with blood; have a headache or any change in your mental state;cough up blood or sputum with blood from the lungs or respiratory tract.

Tumor destruction causing a perforation in the intestine.Consult your doctor if you have severe abdominal pain, fever, nausea, vomiting, blood in stools, or changes in bowel habits.

Other side effects with Sutent may include:

Very common: may affect more than 1 in 10 people

• Reduction in the number of platelets, red blood cells, and/or white blood cells (e.g., neutrophils).
• Difficulty breathing.
• High blood pressure.
• Extreme tiredness, loss of strength.
• Fast swelling of tissues caused by fluid under the skin and around the eye, severe allergic rash.
• Mouth pain/irritation, mouth sores/inflammation/dryness, taste disturbances, stomach discomfort, nausea, vomiting, diarrhea, constipation, abdominal pain/swelling, loss/reduced appetite.
• Decreased activity of the thyroid gland (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleed.
• Back pain, joint pain.
• Arm and leg pain.
• Yellow skin/decoloration of the skin, excessive skin pigmentation, change in hair color, skin rash on the palms of the hands and soles of the feet, rash, dry skin.
• Cough.
• Fever.
• Difficulty falling asleep.

Common: may affect up to 1 in 10 people

• Blood clots in blood vessels.
• Lack of blood flow to the heart muscle due to obstruction or constriction of coronary arteries.
• Chest pain.

• Decreased amount of blood pumped by the heart.

• Retention of fluid including around the lungs.

• Infections.
• Complication of a severe infection (the infection is present in the bloodstream) that can cause tissue damage, organ failure, and death.
• Low blood sugar (see section 2).

• Loss of protein in the urine that can cause swelling.

• Flu-like syndrome.
• Alteration of blood tests including pancreatic and liver enzymes.
• Elevated blood uric acid levels.
• Hemorrhoids, rectal pain, gum bleeding, difficulty swallowing or inability to swallow.
• Burning sensation or pain in the tongue, inflammation of the lining of the digestive tract, excess gas in the stomach or intestine.
• Weight loss.

• Musculoskeletal pain (pain in muscles and bones),weakness, muscle fatigue, muscle pain, muscle spasms.
• Runny nose, nasal congestion.

• Excessive tear production.

• Abnormal sensation in the skin, itching, scaly and inflamed skin, blisters, acne, change in nail color, hair loss.
• Abnormal sensation in the extremities.
• Abnormally decreased/increased sensitivity, especially to touch.
• Heartburn.
• Dehydration.
• Hot flashes.
• Abnormal urine color.
• Depression.
• Chills.

Uncommon: may affect up to 1 in 100 people

• Potentially fatal soft tissue infection, including the anogenital region (see section 2).

• Stroke.
• Myocardial infarction caused by interruption or reduction of blood flow to the heart.

• Abnormal heart rhythm or abnormal heart rate.
• Fluid around the heart (pericardial effusion).
• Liver failure.
• Abdominal pain (stomach) caused by inflammation of the pancreas.
• Tumor destruction causing a perforation in the intestine (perforation).
• Inflammation (swelling and redness) of the gallbladder, associated or not with gallstones.
• Abnormal tube like a conduit from a normal body cavity to another body cavity or to the skin.
• Pain in the mouth, teeth, and/or jaw,swelling or sores inside the mouth,numbness or a feeling of heaviness in the jaw, or that a tooth is loose. All of these may be signs and symptoms of jaw bone damage (osteonecrosis), see section 2.
• Overproduction of thyroid hormones that increase the amount of energy the body consumes at rest.
• Problems with wound healing after surgery.
• Elevated blood levels of an enzyme (creatine phosphokinase) of the muscle.

• Excessive reaction to an allergen, including pollen, skin rash, itching, urticaria, swelling of parts of the body, and difficulty breathing.
• Inflammation of the colon (colitis, ischemic colitis).

Rare: may affect up to 1 in 1,000 people

• Severe skin and/or mucous membrane reaction (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• Tumor lysis syndrome (TLS)– TLS includes a series of metabolic complications that can occur during cancer treatment. These complications are caused by the products released by dying cancer cells and may include: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, dark urine, and fatigue, associated with abnormal laboratory test results (high levels of potassium, uric acid, and phosphorus, and low levels of calcium in the blood) that can lead to kidney function changes and acute kidney failure.
• Abnormal muscle breakdown that can lead to kidney problems (rhabdomyolysis).
• Abnormal changes in the brain that can cause a range of symptoms including headache, confusion, seizures, and vision loss (posterior reversible encephalopathy syndrome).
• Painful skin ulceration (pyoderma gangrenosum).
• Liver inflammation (hepatitis).
• Thyroid gland inflammation.
• Damage to the smallest blood vessels known as microangiopathic thrombosis (MAT).

Frequency not known (cannot be estimated from available data):

• Increased and weakened wall of a blood vessel or tearing of the wall of a blood vessel (aneurysms and arterial dissections).
• Low energy, confusion, drowsiness, loss of consciousness/coma: these symptoms may be signs of brain toxicity caused by high levels of ammonia in the blood (hyperammonemic encephalopathy).

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keepthis medicationout of the sight and reach of children.

• Do notuse this medication after the expiration datethat appears on the packaging, bottle, and blisterafterCAD.The expiration date is the last day of the month indicated.
• This medication does not require special storage conditions.
• Do not use this medication if you observe that the packaging is damaged or shows signs of having been opened.

• Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Sutent

Sutent 12.5 mg hard capsules

The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 12.5 mg of sunitinib. The other components are:

• Capule content: mannitol (E421), sodium croscarmellose, povidone (K-25) and magnesium stearate.
• Capule coating: gelatin, iron oxide red (E172) and titanium dioxide (E171).
• Printing ink: shellac, propylene glycol, sodium hydroxide, povidone and titanium dioxide (E171).

Sutent 25 mg hard capsules

The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 25 mg. The other components are:

• Capule content: mannitol (E421), sodium croscarmellose, povidone (K-25) and magnesium stearate.
• Capule coating: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and black iron oxide (E172).
• Printing ink: shellac, propylene glycol, sodium hydroxide, povidone and titanium dioxide (E171).

Sutent 37.5 mg hard capsules

The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 37.5 mg. The other components are:

• Capule content: mannitol (E421), sodium croscarmellose, povidone (K-25) and magnesium stearate.
• Capule coating: gelatin, titanium dioxide (E171), yellow iron oxide (E172).
• Printing ink: shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).

Sutent 50 mg hard capsules

The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 50 mg. The other components are:

• Capule content: mannitol (E421), sodium croscarmellose, povidone (K-25) and magnesium stearate.
• Capule coating: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and black iron oxide (E172).
• Printing ink: shellac, propylene glycol, sodium hydroxide, povidone and titanium dioxide (E171).

Appearance of the product and contents of the pack

Sutent 12.5 mg is presented in hard gelatin capsules with an orange cap and an orange body, with the word “Pfizer” printed in white ink on the cap and “STN 12.5 mg” on the body, containing yellow to orange coloured granules.

Sutent 25 mg is presented in hard gelatin capsules with a caramel coloured cap and an orange body, with the word “Pfizer” printed in white ink on the cap and “STN 25 mg” on the body, containing yellow to orange coloured granules.

Sutent 37.5 mg is presented in hard gelatin capsules with a yellow cap and a yellow body, with the word “Pfizer” printed in black ink on the cap and “STN 37.5 mg” on the body, containing yellow to orange coloured granules.

Sutent 50 mg is presented in hard gelatin capsules with a caramel coloured cap and a caramel coloured body, with the word “Pfizer” printed in white ink on the cap and “STN 50 mg” on the body, containing yellow to orange coloured granules.

It is available in plastic bottles of 30 capsules and in blister packs of 28 x 1 capsules.

Only some pack sizes may be marketed.

Marketing authorisation holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Bélgica

Responsible for manufacturing

Pfizer Italia S.r.l.

Via del Commercio – Zona Industriale

63100 Marino del Tronto (Ascoli Piceno)

Italia

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder.

Last update of the summary of product characteristics:{MM/AAAA}.

Further information on this medicinal product is available on the website of the European Medicines Agency:https://www.ema.europa.eu.