Sutent 25 mg hard capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

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, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, even if the side effect is not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Sutent is and what it is used for

Sutent contains the active substance sunitinib, which is a protein kinase inhibitor. It is used for the treatment of cancer and works by blocking 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 tumour (GIST), a type of cancer of the stomach and intestine, when imatinib (another anticancer medicine) has already failed or cannot be used.
• Metastatic renal cell carcinoma (mRCC), a type of kidney cancer that has spread to other parts of the body.
• Pancreatic neuroendocrine tumours (pNET) (tumours of hormone-secreting cells in the pancreas) that have progressed or cannot be surgically removed.

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

2. What you need to know before starting Sutent

Do not take Sutent

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

Warnings and precautions

Talk to your doctor before starting Sutent:

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

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

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

• If you have abnormal heart rhythms. Sutent may cause irregularities in heart rhythm. Your doctor may perform electrocardiograms (ECGs) to assess these issues during treatment with Sutent. Consult your doctor if, during treatment with Sutent, you feel dizzy, weak, or have irregular heartbeats.

• If you have recently had blood clots in veins and/or arteries (types of blood vessels), including stroke, myocardial infarction, 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, difficulty speaking, headache, or dizziness while on Sutent treatment.

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

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

• If you have thyroid gland problems. Sutent may cause thyroid-related issues. Contact your doctor if you feel unusually tired, feel colder than others, or your voice becomes deeper while taking Sutent. Thyroid function should be checked before starting Sutent and periodically during treatment. If your thyroid gland does not produce enough thyroid hormone, you may be treated with replacement thyroid hormone.

• If you have or have had pancreatic or gallbladder disorders. Contact your doctor if you develop any of the following signs or symptoms: stomach pain (upper abdomen), nausea, vomiting, or 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 or symptoms of liver problems during treatment with Sutent: itching, yellowing of the eyes or skin, dark urine, or pain or discomfort in the upper right part of the stomach. Your doctor should perform blood tests to monitor liver function before and during treatment with Sutent, as well as whenever clinically indicated.

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

• If you are scheduled for surgery or have recently had an operation. Sutent may affect wound healing. If you are undergoing surgery, you will generally need to stop taking Sutent. Your doctor will decide when you can restart Sutent.

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

• If you have or have had mouth, teeth, and/or jaw pain, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loose teeth, inform your doctor and dentist immediately.

• If you require invasive dental treatment or dental surgery, inform your dentist that you are being treated with Sutent, especially if you are also receiving or have received intravenous bisphosphonates. Bisphosphonates are medications used to prevent bone complications that may occur due to other medical conditions.

• If you have or have had skin and subcutaneous tissue disorders. During treatment with this medicine, "pyoderma gangrenosum" (painful skin ulceration) or "necrotizing fasciitis" (a rapidly spreading skin/soft tissue infection that can be fatal) may occur. Contact your doctor immediately if you notice signs of infection around a skin lesion, such as fever, pain, redness, swelling, or pus or blood discharge. This reaction is generally reversible after stopping sunitinib. Serious skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported with sunitinib use, initially appearing as red, target-like spots or circular lesions, often with central blisters, typically on the trunk. This rash may progress to widespread blistering or skin peeling and can be life-threatening. Contact your doctor immediately if you develop a skin rash or the described skin symptoms.

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

• If you have diabetes. Blood glucose levels in diabetic patients should be checked regularly to determine whether the dose of antidiabetic medication needs adjustment 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, or loss of consciousness).

Children and adolescents

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

Other medicines and Sutent

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

Some medicines may affect the levels of Sutent in your body. You should inform your doctor if you are taking medicines containing 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 conditions (such as allergic/respiratory disorders or skin diseases)
• phenytoin, carbamazepine, phenobarbital – used to treat epilepsy and other neurological conditions
• herbal medicines containing St. John’s wort or Hypericum perforatum – used for the treatment of depression and anxiety

Taking Sutent with food and drink

You should avoid drinking grapefruit juice while being treated with Sutent.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

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

Driving and using machines

If you experience dizziness or unusual tiredness, take special care when driving or operating machinery.

Sutent contains sodium

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

3. How to take Sutent

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor again.

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

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

Your doctor will instruct you on the appropriate dose you need to take, as well as whether you need to interrupt treatment with Sutent and when.

Sutent may be taken with or without food.

If you take more Sutent than you should

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

If you forget to take Sutent

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

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

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

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

Kidney problems. Consult your doctor if you experience changes in the frequency or absence of urination, as these may be symptoms of kidney failure.

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

Tumor destruction leading to intestinal perforation. Consult your doctor if you have severe abdominal pain, fever, nausea, vomiting, blood in stools, or changes in bowel habits.

Other adverse effects with Sutent may include:

Very common: may affect more than 1 in 10 people

• Decrease 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.
• Rapid swelling of tissues due to fluid accumulation under the skin and around the eye, severe allergic rash.
• Mouth pain/irritation, mouth sores/inflammation/dryness in the mouth, taste disturbances, stomach discomfort, nausea, vomiting, diarrhea, constipation, abdominal pain/swelling, loss/reduced appetite.
• Decreased activity of the thyroid gland (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in arms and legs.
• Yellow skin/skin discoloration, 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.
• Reduced blood flow to the heart muscle due to blockage or narrowing of the coronary arteries.
• Chest pain.
• Reduced amount of blood pumped by the heart.
• Fluid retention, including around the lungs.
• Infections.
• Complication of a severe infection (infection present in the bloodstream) that may cause tissue damage, organ failure, and death.
• Low blood sugar level (see section 2).
• Loss of protein in urine, which may cause swelling.
• Pseudoflu-like syndrome.
• Abnormal blood test results, including pancreatic and liver enzymes.
• High level of uric acid in blood.
• Hemorrhoids, rectal pain, bleeding gums, 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 intestines.
• Weight loss.
• Musculoskeletal pain (pain in muscles and bones), weakness, muscle fatigue, muscle pain, muscle spasms.
• Dry 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 limbs.
• Abnormally decreased/increased sensitivity, especially to touch.
• Indigestion.
• Dehydration.
• Hot flushes.
• 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 interruption or reduction of blood flow to the heart.
• Changes in the heart's electrical activity or abnormal heart rhythm.
• Fluid around the heart (pericardial effusion).
• Liver failure.
• Stomach (abdominal) pain due to inflammation of the pancreas.
• Tumor destruction leading to a hole in the intestine (perforation).
• Inflammation (swelling and redness) of the gallbladder, with or without gallstones.
• Abnormal tube-like connection from one 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 loose teeth. These may be signs and symptoms of jaw bone damage (osteonecrosis), see section 2.
• Overproduction of thyroid hormones, increasing the body's resting energy expenditure.
• Problems with wound healing after surgery.
• Elevated blood levels of a muscle enzyme (creatine phosphokinase).
• Severe allergic reaction, including pollen allergy, skin rash, skin itching, hives, swelling of body parts, and breathing difficulties.
• 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 may occur during cancer treatment. These complications are caused by substances released from 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 phosphate, and low calcium levels in blood), which may lead to changes in kidney function and acute kidney failure.
• Abnormal breakdown of muscles, which may lead to kidney problems (rhabdomyolysis).
• Abnormal changes in the brain that may cause a range of symptoms including headache, confusion, seizures, and loss of vision (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulceration (pyoderma gangrenosum).
• Inflammation of the liver (hepatitis).
• Inflammation of the thyroid gland.
• Damage to the smallest blood vessels known as thrombotic microangiopathy (TMA).

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

• Enlargement and weakening of a blood vessel wall or a tear in the blood vessel wall (aneurysms and arterial dissections).
• Lack of 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 adverse effects

If you experience any adverse effect, talk to your doctor, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide 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 expiry date stated on the pack, vial, and blister after EXP. The expiry date refers to the last day of the month indicated.

• This medicine does not require any special storage conditions.

• Do not use this medicine if the packaging is damaged or shows signs of prior opening.

• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

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:

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

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

• Capsule contents: mannitol (E421), sodium croscarmellose, povidone (K-25) and magnesium stearate.
• Capsule shell: 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:

• Capsule contents: 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).

Nature of the product and contents of the pack

Sutent 12.5 mg is presented as 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 as hard gelatin capsules with a caramel-colored 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 as 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 as hard gelatin capsules with a caramel-colored cap and a caramel-colored body, with the word “Pfizer” printed in white ink on the cap and “STN 50 mg” on the body, containing yellow to orange granules.

Available in plastic bottles containing 30 capsules and in unit dose blister packs containing 28 x 1 capsule.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Manufacturer

Pfizer Italia S.r.l.
Via del Commercio – Zona Industriale
63100 Marino del Tronto (Ascoli Piceno)
Italy

Further information on this medicinal product is available upon request to the local representative of the Marketing Authorization Holder.

Date of the most recent review of this summary: {MM/YYYY}.

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