12.5 mg, 25 mg, 37.5 mg, 50 mg hard capsules
sunitinib
What Sutent is and what it is used for
Sutent contains the active substance sunitinib, which is a protein kinase inhibitor. It is used in the treatment of cancer to prevent the activity of a certain type of protein known to be active in the growth and spread of cancer cells.
Sutent is used to treat the following cancers:
- Gastrointestinal stromal cell tumor ( GIST ), is a type of cancer of the stomach and intestines. Sutent is used if imatinib (another cancer medicine) is no longer working or if you cannot take imatinib.
- Metastatic renal cell carcinoma (MRCC), is a type of kidney cancer that has spread to other parts of the body.
- Pancreatic neuroendocrine tumor ( pNET ) (tumor of the hormone-producing cells of the pancreas), when cancer has worsened or cannot be operated on.
If you have any questions about how Sutent works or why this medicine has been prescribed for you, contact your doctor.
What you need to know before taking Sutent
Do not take Sutent
- if you are allergic to sunitinib or any of the other ingredients of Sutent (listed in section 6).
Warnings and precautions
Talk to your doctor before taking Sutent:
- If you have high blood pressure. Sutent can raise blood pressure et. Your doctor may want to check your blood pressure during treatment with Sutent and you may receive treatment to lower your blood pressure if needed.
- If you have or have had a blood disorder or problems with bleeding or bruising. Treatment with Sutent can lead to a higher risk of bleeding or a change in the number of certain cells in the blood, which can cause anemia ( lack of blood ) or affect the blood’s ability to be livered. If you take medicines that thin the blood to prevent blood clots, e.g. warfarin or acenocoumarol, the risk of bleeding may be increased. Tell your doctor if you bleed while being treated with Sutent.
- If you have heart problems. Sutent can cause heart problems. Tell your doctor if you feel very tired, short of breath, or have swollen feet and ankles.
- If the heart rhythm becomes abnormal. Sutent can cause abnormal heart rhythm. Your doctor may take an EKG to assess these problems during treatment with Sutent. Tell your doctor if you feel dizzy, faint, or have an abnormal heartbeat while taking Sutent.
- If you have recently had problems with blood clots in your veins and/or arteries (different types of blood vessels), including stroke, heart attack, embolism, or thrombosis. Contact your doctor immediately if you experience any symptoms such as chest pain or tightness in the chest, pain in the arms, back, neck, or jaw, shortness of breath, numbness or weakness on one side of the body, trouble speaking, headache or dizziness while being treated with Sutent.
- If you have or have had an aneurysm (enlargement and weakening of a vessel wall) or a rupture in a vessel wall.
- If you have or have had damage to the smallest blood vessels, which is called thrombotic microangiopathy (TMA). Tell your doctor if you develop fever, fatigue, tiredness, bruising, bleeding, swelling, confusion, vision loss, and seizures.
- If you have thyroid problems. Sutent can cause thyroid problems. Tell your doctor if you get tired more easily, get colder than others or if your voice gets deeper when you take Sutent. Thyroid function should be checked before taking Sutent and regularly 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 a disease of the pancreas or gallbladder. Tell your doctor if you get any of the following signs or symptoms: pain in the area around your stomach (upper abdomen), nausea, vomiting, and fever. These can be caused by an inflammation of the pancreas or gall bladder.
- If you have or have had liver problems. Tell 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, and pain or discomfort in the upper right part of the abdomen. Your doctor should take blood tests to check liver function before and during treatment with Sutent, as needed.
- Suppose you have or have had kidney problems. Your doctor will monitor your kidney function.
- If you are going to have surgery or have recently had surgery. Sutent can affect wound healing. Most often, you stop using Sutent before an operation. Your doctor will decide when you can start taking Sutent again.
- You may be advised to have a check-up with the dentist before starting treatment with Sutent
- If you have or have had pain in your mouth, teeth, and/or jaw, swelling or sores in your mouth, if you feel numbness or heaviness in your jaw, or if a tooth is loose – contact your doctor and dentist immediately.
- If you need to undergo invasive dental treatment or dental surgery. Tell the dentist that you are being treated with Sutent, especially if you are also receiving or have received bisphosphonates intravenously (in a vessel ). Bisphosphonates are used to prevent bone complications and may have been given to you to treat another condition.
- If you have or have had problems with the skin and subcutaneous tissue. When taking this medicine, the condition “pyoderma gangrenosum” (painful sores on the skin) or “necrotizing fasciitis” (rapidly progressing skin/soft tissue infection that can be life-threatening) may occur. Contact a doctor immediately if you develop symptoms of infection around a skin injury, including fever, pain, redness, swelling, or if a sore or blood oozes from the wound. This side effect usually disappears when treatment with sunitinib is stopped. Severe skin rashes (Steven-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported with sunitinib treatment. These occur initially as reddish circular target-like spots or as round spots with a central blister, on the trunk. The rash can develop into widespread blistering or scaling of the skin and can be life-threatening. If you develop a rash or these skin symptoms, seek medical advice immediately.
- If you have or have had convulsions. Tell your doctor as soon as possible if you have high blood pressure, headaches, or vision loss.
- If you have diabetes. In diabetic patients, blood sugar levels should be checked regularly to determine if the dosage of one of the diabetes medicines needs to be adjusted, to minimize the risk of low blood sugar. Tell your doctor as soon as possible if you experience any signs and symptoms of low blood sugar (fatigue, palpitations, sweating, hunger, and fainting).
Children and young people
Sutent is not recommended for people under the age of 18.
Other medicines and Sutent
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those without a prescription.
Some medicines can affect the concentration of Sutent in the body. Tell the doctor if you are using medicines containing the following active substances:
- ketoconazole, itraconazole – for the treatment of fungal infections
- erythromycin, clarithromycin, rifampicin – to treat infection er
- ritonavir – for treating HIV
- dexamethasone – a corticosteroid used for various medical conditions (medical conditions (such as allergies/respiratory problems or skin diseases)
- phenytoin, carbamazepine, phenobarbital – for the treatment of epilepsy and other neurological conditions
- herbal preparations containing St. John’s wort (Hypericum perforatum) – used for mild depression and mild anxiety
Sutent with food and drink
Avoid drinking grapefruit juice while being treated with Sutent.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
If there is a risk of you becoming pregnant, you must use reliable contraception during treatment with Sutent.
If you are breastfeeding, talk to your doctor. You should not breastfeed while you are being treated with Sutent.
Driving ability and use of machinery
If you feel dizzy or unusually tired, take special care when driving or using machinery.
Sutent contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is almost ‘sodium-free’.
How to take Sutent
Always take this medicine as directed by your doctor. Consult a doctor if you are unsure.
The doctor will prescribe an appropriate dose for you, depending on the type of cancer you have. If you are being treated for:
- GIST or renal cell carcinoma (MRCC) is the most common dose of 50 mg once daily, taken for 28 days (four weeks), followed by 14 days (two weeks) off (no medication), for 6-week periods.
- pNET is the usual dose of 37.5 mg once daily without any breaks.
The doctor decides which dose is suitable for you and when and if you need to stop Sutent.
Sutent can be taken with or without food.
If you have taken too much Sutent
If you accidentally take too many capsules, contact your doctor immediately. You may need medical attention.
If you forget to take Sutent
Do not take a double dose to make up for a missed dose.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must contact your doctor immediately if you experience any of these serious side effects (see also What you need to know before taking Sutent):
Heart problems. Tell your doctor if you feel very tired, short of breath, or have swollen feet and ankles. These can be symptoms of heart problems such as heart failure and problems with the heart muscle ( cardiomyopathy ).
Problems with lungs or breathing. Tell your doctor if you develop a cough, chest pain, sudden shortness of breath, or if you cough up blood. These can be symptoms of pulmonary embolism, which occurs when blood clots travel to the lungs.
Kidney diseases. Tell your doctor if you notice any changes in how often you urinate or if you do not urinate. This may be a symptom of kidney failure.
Bleeding. Tell your doctor if you get any of these symptoms or if you have a serious bleed during treatment with Sutent: painful and swollen abdomen, vomiting blood, black and sticky stools, blood in the urine, headache, altered consciousness or mental state, or coughing of blood or bloody mucus from the lungs or airways.
Tumor breakdown leads to holes in the intestine. Tell your doctor if you develop severe abdominal pain, fever, nausea, vomiting, blood in the stool, or changes in bowel habits.
Other side effects that can occur with Sutent are:
Very common side effects (may affect more than 1 in 10 people)
- Decreased number of platelets, red blood cells, and/or white blood cells (eg neutrophils ).
- Shortness of breath.
- High blood pressure.
- Extreme fatigue, weakness.
- Swelling due to fluid accumulation under the skin and around the eyes, deep allergic rash.
- Pain/irritation in the mouth, mouth ulcers, inflammation of the mouth, dry mouth, taste disturbance, upset stomach, nausea, vomiting, diarrhea, constipation, abdominal pain/swelling, and decreased appetite.
- Decreased activity of the thyroid gland ( hypothyroidism ).
- Dizziness.
- Headache.
- Nosebleed.
- Back pain, joint pain.
- Pain in arms and legs.
- Yellow or discolored skin, increased pigmentation of the skin, change in hair color, rash on the palms of the hands and the soles of the feet, rash, dry skin.
- Cough.
- Fever.
- Difficulty falling asleep.
Common (may affect up to 1 in 10 people)
- Clots in the blood vessels.
- Lack of blood supply to the heart muscle due to blockage or narrowing of the heart’s coronary arteries.
- Chest pain.
- Decrease in the amount of blood that the heart pumps.
- Fluid accumulation around the lungs.
- Infection you.
- A complication of severe infection ( infection in the blood) which can lead to tissue damage, organ failure, and death.
- Low blood sugar (see section 2).
- Protein leakage in the urine sometimes leads to swelling.
- Flu-like symptoms.
- Abnormal blood values, i.a. for pancreatic and liver enzymes.
- Increased level of uric acid in the blood.
- Hemorrhoids, pain in the rectum, bleeding gums, difficulty or inability to swallow.
- Burning sensation or pain on the tongue, inflammation of the mucous membrane of the gastrointestinal tract, and increased amount of gas in the stomach or intestines.
- Weight loss.
- Musculoskeletal pain (pain in muscles and bones), muscle weakness, muscle fatigue, muscle pain, muscle spasm.
- Dryness of the nose, and nasal congestion.
- Increased tear flow.
- Abnormal sensation in the skin, itching, scaly and inflamed skin, blisters, acne, discoloration of the nails, and hair loss.
- Abnormal sensation in arms and legs.
- Abnormally decreased or increased sensitivity, especially to touch.
- Heartburn.
- Dehydration.
- Flushing.
- Discolored urine.
- Depression.
- Overindulge.
Uncommon (may affect up to 1 in 100 people))
- Life-threatening soft tissue infection, including around the rectum and genitals (see section 2).
- Stroke.
- Heart attack is caused by interrupted or reduced blood supply to the heart.
- Changes in the heart’s electrical activity or abnormal heart rhythm.
- Fluid around the heart (pericardial effusion).
- Liver failure.
- Abdominal pain is caused by inflammation of the pancreas.
- Tumor breakdown leads to holes in the intestine ( perforation ).
- Inflammation (swelling and redness ) of the gallbladder, with or without gallstones.
- Abnormal channel from one normal body cavity to another or the skin ( fistula ).
- Pain in the mouth, teeth, and/or jaw, swelling and sores inside the mouth, numbness or a feeling of heaviness in the jaw, or tooth loss. These may be symptoms of bone damage in the jaw ( osteonecrosis ), see section 2.
- Overproduction of thyroid hormone increases the body’s energy consumption at rest.
- Problems with wound healing after surgery.
- Increased levels of a muscle enzyme (creatine phosphokinase) in the blood.
- Strong reaction to any allergen including hay fever, 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 reactions on the skin and/or mucous membranes ( Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
- Tumor lysis syndrome (TLS) – TLS is a group of metabolic complications that can occur during cancer treatment. They are caused by the breakdown products of dying cancer cells and may include: nausea, shortness of breath, irregular pulse, muscle cramps, seizures, cloudy urine, and fatigue combined with abnormal laboratory values (high potassium, uric acid, and phosphate levels and low calcium levels in the blood). The complications can lead to altered kidney function and acute kidney failure.
- Abnormal breakdown of muscle tissue can lead to kidney problems ( rhabdomyolysis ).
- Abnormal changes in the brain can cause several symptoms, including headache, confusion, seizures, and loss of vision (reversible posterior leukoencephalopathy syndrome).
- Painful sores on the skin (pyoderma gangrenosum).
- Inflammation of the liver ( hepatitis ).
- Inflammation of the thyroid gland.
- Damage to the smallest blood vessels is called thrombotic microangiopathy (TMA).
Frequency not known (cannot be estimated from available data)
- An enlargement and weakening of a vessel wall or a rupture in a vessel wall ( aneurysms and arterial dissections).
How Sutent should be stored
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date which is stated on the carton, can, and blister card after EXP. The expiration date is the last day of the specified month.
- No special storage instructions.
- Do not use this medicine if you see that the package is damaged or appears to have been opened.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
Sutent 12.5 mg hard capsules
The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 12.5 mg sunitinib.
Other ingredients are:
– Capsule contents: mannitol (E421), croscarmellose sodium, povidone (K-25), and magnesium stearate.
– Capsule shell: gelatin, red iron oxide (E172), and titanium dioxide (E171).
– Embossing 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 of sunitinib.
Other ingredients are:
– Capsule contents: mannitol (E421), croscarmellose sodium, povidone (K-25), and magnesium stearate.
– Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
– Embossing 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 of sunitinib.
Other ingredients are:
– Capsule contents: mannitol (E421), croscarmellose sodium, povidone (K-25), and magnesium stearate.
– Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172).
– Embossing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).
Sutent 50 mg hard capsules
The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 50 mg of sunitinib.
Other ingredients are:
– Capsule contents: mannitol (E421), croscarmellose sodium, 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).
– Embossing ink: shellac, propylene glycol, sodium hydroxide, povidone, and titanium dioxide (E171).
Appearance and package sizes of the medicine
Sutent 12.5 mg is supplied as hard gelatin capsules, containing yellow to orange colored granules. The gelatin capsules are orange, embossed in white with “Pfizer” on the cap and “STN 12.5 mg” on the bottom.
Sutent 25 mg is supplied as hard gelatin capsules, containing yellow to orange colored granules. The gelatin capsules have a caramel-colored cap and an orange-colored body, embossed with “Pfizer” in white on the cap and “STN 25 mg” on the body.
Sutent 37.5 mg is supplied as hard gelatin capsules, containing yellow to orange colored granules. The gelatin capsules are yellow, imprinted with “Pfizer” in black on the cap and “STN 37.5 mg” on the bottom.
Sutent 50 mg is supplied as hard gelatin capsules, containing yellow to orange colored granules. The gelatin capsules are caramel colored, embossed with “Pfizer” in white on the cap and “STN 50 mg” on the bottom.
Supplied in plastic bottles containing 30 capsules and in perforated unit dose blisters containing 28 x 1 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer
Pfizer Italia Srl
Via del Commercio – Zona Industriale
63100 Marino del Tronto (Ascoli Piceno)
Italy
| België/Belgique/BelgienLuxembourg/LuxembourgPfizer NV/SATel/Tel: +32 (0)2 554 62 11 | LithuaniaPfizer Luxembourg SARL branches in LithuaniaTel. + 370 52 51 4000 |
| BulgariaPfizer Luxembourg САРЛ, Клон БулгарияTel.: +359 2 970 4333 | MagyarországPfizer Kft.Tel.: +36-1-488-37-00 |
| Czech RepublicPfizer, coil. s roTel.: +420 283 004 111 | MaltaVivian Corporation Ltd.Phone: +356 21344610 |
| DenmarkPfizer ApSPhone: +45 44 20 11 00 | The NetherlandsPfizer BVPhone: +31 (0)10 406 43 01 |
| DeutschlandPFIZER PHARMA GmbHPhone: +49 (0)30 550055-51000 | NorwayPfizer iPhone: +47 67 52 61 00 |
| EstoniaPfizer Luxembourg SARL Eesti branches.: +372 666 7500 | AustriaPfizer Corporation Austria Ges.mbHPhone: +43 (0)1 521 15-0 |
| GreecePfizer Hellas AETel: +30 210 6785 800 | PolishPfizer Polska Sp.zooTel.: +48 22 335 61 00 |
| SpainPfizer, SLPhone: +34 91 490 99 00 | PortugalLaboratórios Pfizer, Lda.Phone: +351 21 423 5500 |
| FrancePfizerTel: +33 (0)1 58 07 34 40 | RomaniaPfizer România SRLPhone: +40 (0)21 207 28 00 |
| HrvatskaPfizer Croatia dooPhone: + 385 1 3908 777 | SlovenijaPfizer Luxembourg SARLPfizer, a branch of marketing, LjubljanaTel.: + 386 (0)1 52 11 400 |
| IrelandPfizer Healthcare IrelandPhone: 1800 633 363 (toll free)+44 (0)1304 616161 | Slovenian RepublicPfizer Luxembourg SARL, organizačná zložkaTel.: + 421 2 3355 5500 |
| IcelandIcepharma hf.Phone: +354 540 8000 | Finland/FinlandPfizer OyTel./Tel: +358 (0)9 43 00 40 |
| ItalyPfizer SrlPhone: +39 06 33 18 21 | SwedenPfizer phone: +46 (0)8 550 520 00 |
| CyprusPfizer Ελλάς AE (Cyprus Branch)Tel.: + 357 22 817690 | United Kingdom (Northern Ireland)Pfizer LimitedT10 |
| LatviaPfizer Luxembourg SARL filiale LatvijaTel.: + 371 670 35 775 |