SUTENT 50 mg HARD CAPSULES

Introduction

Package Leaflet: 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 all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Sutent and what is it used for
2. What you need to know before you take Sutent
3. How to take Sutent
4. Possible side effects
5. Storage of Sutent
6. Contents of the pack and further information

1. What is Sutent and what is it used for

Sutent contains the active substance sunitinib, which is a protein-kinase inhibitor. It is used to treat cancer and works by preventing the activity of a special 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 intestine cancer, when imatinib (another anti-tumor medicine) has failed or when imatinib cannot be taken.
• Metastatic renal cell carcinoma (mRCC), a type of kidney cancer that has spread to other parts of the body.
• Pancreatic neuroendocrine tumors (pNET) (tumors of the hormone-producing cells in the pancreas) that have progressed or cannot be removed by surgery.

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

2. What you need to know before you take Sutent

Do not take Sutent

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

Warnings and precautions

Tell your doctor before you start taking Sutent:

• If you have high blood pressure.Sutent may increase your blood pressure. Your doctor may check your blood pressure during treatment with Sutent and, if necessary, treat you with medicines that lower 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 changes in the number of certain blood cells, which can cause anemia or affect the blood's ability to clot. If you are taking warfarin or acenocoumarol, medicines 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. Tell your doctor if you feel very tired, short of breath, or if your feet and ankles are swollen.

• If you have abnormal heart rhythms.Sutent may cause abnormal heart rhythms. Your doctor may perform electrocardiograms to evaluate these problems during treatment with Sutent. Tell your doctor if you feel dizzy, weak, or have 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, arm, back, neck, or jaw pain, shortness of breath, numbness or weakness on one side of the body, speech problems, headache, or dizziness while taking Sutent.

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

• If you have or have had damage to the small blood vessels known as thrombotic microangiopathy (TMA).Contact your doctor if you experience fever, fatigue, tiredness, bruising, bleeding, swelling, confusion, vision loss, and seizures.

• If you have thyroid problems.Sutent may cause thyroid problems. Tell your doctor if you feel more tired than usual, feel colder than others, or if your voice becomes hoarse while taking Sutent. Before treatment with Sutent, your thyroid function should be checked, and periodically while taking it. 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 or gallbladder disorders.Tell your doctor if you develop any of the following signs and symptoms: stomach pain (upper abdomen), nausea, vomiting, and fever. These may be caused by inflammation of the pancreas or gallbladder.

• If you have or have had liver problems.Tell 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 side of the stomach. 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 kidney function.

• If you are going to have surgery or have had a recent operation.Sutent may affect wound healing. If you are going to have an operation, 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 pain in your mouth, teeth, and/or jaw, swelling, or ulcers inside your mouth, numbness or a feeling of heaviness in your jaw, or if you have loose teeth, tell your doctor and dentist immediately.
• If you need to have invasive dental treatment or dental surgery, tell your dentist that you are taking Sutent, especially if you are also being treated with intravenous bisphosphonates. Bisphosphonates are medicines 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 medicine, "pyoderma gangrenosum" (painful skin ulceration) or "necrotizing fasciitis" (rapidly spreading skin/soft tissue infection that can be life-threatening) may occur. Contact your doctor immediately if you experience symptoms of infection around a skin lesion, such as fever, pain, redness, swelling, or discharge of pus or blood. This reaction is usually reversible after stopping sunitinib. Cases of severe skin rash (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported with sunitinib, which initially had the appearance of red patches resembling targets or circular patches, often accompanied by central blisters on the trunk. This rash may progress to widespread blisters or skin peeling and can be life-threatening. Contact your doctor immediately if you develop a skin rash or the skin symptoms mentioned.

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

• If you have diabetes.Blood glucose levels should be regularly checked in diabetic patients to assess whether it is necessary to adjust the dose of the anti-diabetic medicine to minimize the risk of low blood sugar. Tell 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 children and adolescents under 18 years of age.

Other medicines and Sutent

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

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

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

Taking Sutent with food and drinks

You should avoid taking grapefruit juice while taking Sutent.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

If you are breast-feeding, tell your doctor. You should not breast-feed while taking Sutent.

Driving and using machines

If you experience dizziness or unusual tiredness, be careful when driving or using machines.

Sutent contains sodium

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

3. How to take Sutent

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, ask your doctor again.

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

• GIST or mRCC: the usual dose is 50 mg once a day for 28 days (4 weeks), followed by 14 days (2 weeks) of rest (without medication) in 6-week cycles.
• pNET: the usual dose is 37.5 mg once a day without a rest period.

Your doctor will tell you the dose you need to take and when you may need to stop treatment with Sutent.

Sutent can be taken with or without food.

If you take more Sutent than you should

If you have accidentally taken too many capsules, talk to your doctor immediately. You may need medical attention.

If you forget to take Sutent

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

You should contact your doctor immediately if you experience any of these serious adverse effects (see also What you need to know before taking Sutent):

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

Lung or respiratory problems. Consult your doctor if you develop a cough, chest pain, sudden breathing problems, or cough up blood. They can be symptoms of a condition called pulmonary embolism that occurs when blood clots travel to the lungs.

Kidney problems. Consult your doctor if you experience a change in the frequency or absence of urination, as they can be symptoms of kidney failure.

Bleeding.Consult your doctor if you have any of these symptoms or a serious bleeding problem during treatment with Sutent: painful or swollen stomach (abdomen); vomiting blood; having black, tarry stools; urinating with blood; having a headache or any change in your mental state; coughing up blood or bloody sputum from the lungs or airways.

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

Other adverse 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 fatigue, loss of strength.
• Rapid swelling of tissues caused by fluids under the skin and around the eye, severe allergic rash.
• Mouth pain/irritation, mouth sores/inflammation/dryness, taste disturbances, stomach upset, nausea, vomiting, diarrhea, constipation, abdominal pain/swelling, loss/decreased appetite.
• Decreased activity of the thyroid gland (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in arms and legs.
• Yellowing/discoloration of the skin, excessive skin pigmentation, hair color change, skin rash on the palms of the hands and soles of the feet, rash, dry skin.
• Cough.
• Fever.
• Difficulty sleeping.

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 the coronary arteries.
• Chest pain.

• Decrease in the amount of blood pumped by the heart.

• Fluid retention, including around the lungs.

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

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

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

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

• Excessive tear production.
• Abnormal sensation in the skin, itching, scaly and inflamed skin, blisters, acne, nail color change, hair loss.
• Abnormal sensation in the limbs.
• 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 life-threatening soft tissue infection, including the anogenital region (see section 2).

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

• Changes in the electrical activity or abnormal heart rhythm.
• Fluid around the heart (pericardial effusion).
• Liver failure.
• Abdominal pain caused by pancreas inflammation.
• Tumor destruction producing a hole in the intestine (perforation).
• Inflammation (swelling and redness) of the gallbladder, with or without gallstones.
• Abnormal tube-like structure 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 feeling like a tooth is moving. All of these can be signs and symptoms of bone damage in the jaw (osteonecrosis), see section 2.
• Overproduction of thyroid hormones that increase the amount of energy the body uses at rest.
• Problems with wound healing after surgery.
• High level of an enzyme (creatine phosphokinase) in the muscle.

• Excessive reaction to an allergen, including pollen allergy, skin rash, itching, hives, swelling of body parts, 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 encompasses a series of metabolic complications that can occur during cancer treatment. These complications are caused by products released by dying cancer cells and can include nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, darkening of the 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 changes in kidney function 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 loss of vision (posterior reversible leukoencephalopathy syndrome).
• Painful skin ulceration (pyoderma gangrenosum).
• Liver inflammation (hepatitis).
• Thyroid gland inflammation.
• Damaged small blood vessels known as thrombotic microangiopathy (TMA).

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

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

Reporting of adverse effects

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

5. Storage of Sutent

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiration date stated on the packaging, bottle, and blister pack after CAD. The expiration date is the last day of the month indicated.
• This medicine does not require special storage conditions.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of having been opened.

• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Sutent

Sutent 12.5 mg hard capsules

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

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

Sutent 25 mg hard capsules

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

• Capsule content: mannitol (E421), sodium croscarmellose, povidone (K-25), and magnesium stearate.
• Capsule shell: 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 ingredient is sunitinib. Each capsule contains sunitinib malate equivalent to 37.5 mg. The other ingredients are:

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

Sutent 50 mg hard capsules

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

• Capsule content: mannitol (E421), sodium croscarmellose, povidone (K-25), and magnesium stearate.
• Capsule shell: 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 and packaging of the product

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 granules.

Sutent 25 mg is presented in hard gelatin capsules with a caramel 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 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 granules.

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

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

Only certain pack sizes may be marketed.

Marketing authorization holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Brussels

Belgium

Manufacturer

Pfizer Italia S.r.l.

Via del Commercio – Zona Industriale

63100 Ascoli Piceno

Italy

You can obtain more information about this medicine by contacting the local representative of the marketing authorization holder.

Date of the last revision of this leaflet:{MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.