Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Sunitinib contains the active substance sunitinib, which is a protein kinase inhibitor. It is 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.
Sunitinib 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 imatinib (another anticancer medicine) no longer works or you cannot take imatinib.
• 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 the hormone-producing cells in the pancreas) that have progressed or cannot be removed with surgery.
If you have any questions about how Sunitinib works or why this medicine has been prescribed for you, ask your doctor.
Do not take Sunitinib • If you are allergic to sunitinib or any of the other ingredients of Sunitinib (listed in section 6).
Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Sunitinib:
• If you have high blood pressure . Sunitinib can raise blood pressure. Your doctor may check your blood pressure during treatment with Sunitinib, and you may be treated with medicines to reduce the blood pressure, if needed.
• If you have or have had blood disease, bleeding problems, or bruising. Treatment with Sunitinib may lead to a higher risk of bleeding or lead to changes in the number of certain cells in the blood which may lead to anaemia or affect the ability of your blood to clot. If you are taking warfarin or acenocoumarole, medicines which thin the blood to prevent blood clots, there may be a greater risk of bleeding. Tell your doctor if you have any bleeding while on treatment with Sunitinib.
• If you have heart problems . Sunitinib can cause heart problems. Tell your doctor if you feel very tired, are short of breath, or have swollen feet and ankles.
• If you have abnormal heart rhythm changes . Sunitinib can cause abnormality of your heart rhythm. Your doctor may obtain electrocardiograms to evaluate for these problems during your treatment with Sunitinib. Tell your doctor if you feel dizzy, faint, or have abnormal heartbeats while taking Sunitinib.
• If you have had a recent problem with blood clots in your veins and/or arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis. Call your doctor immediately if you get symptoms such as chest pain or pressure, pain in your arms, back, neck or jaw, shortness of breath, numbness or weakness on 1 side of your body, trouble talking, headache, or dizziness while on treatment with Sunitinib.
• If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
• If you have or have had damage to the smallest blood vessels known as thrombotic
• microangiopathy (TMA). Tell your doctor if you develop fever, fatigue, tiredness, bruising, bleeding, swelling, confusion, vision loss, and seizures.
• If you have thyroid glands problems . Sunitinib can cause thyroid gland problems. Tell your doctor if you get tired more easily, generally feel colder than other people, or your voice deepens whilst taking Sunitinib. Your thyroid function should be checked before you take Sunitinib and regularly while you are taking it. If your thyroid gland is not producing 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: pain in the area of the stomach (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 Sunitinib 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 Sunitinib, and as 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 if you had an operation recently. Sunitinib may affect the way your wounds heal. You will usually be taken off Sunitinib if you are having an operation.
Your doctor will decide when to start Sunitinib again.
• You may be advised to have a dental check-up before you start treatment with Sunitinib.
• 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 Sunitinib in particular when you are also receiving or have received intravenous bisphosphonates. Bisphosphonates are medicines used to prevent bone complications that may have been given for another medical condition.
• If you have or have had skin and subcutaneous tissue disorders. While you are on this medicine “pyoderma gangrenosum” (painful skin ulceration) or “necrotising fasciitis” (rapidly spreading infection of the skin/soft tissue that may be life-threatening) may occur. Contact your doctor immediately if symptoms of infection occur around a skin injury, including fever, pain, redness, swelling, or drainage of pus or blood. This event is generally reversible after sunitinib discontinuation.
Severe skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported with the use of sunitinib, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. The rash may progress to widespread blistering or peeling of the skin and may be life-threatening. If you develop a rash or these skin symptoms, seek immediate advice from a doctor.
• If you have or have had seizures. Notify your doctor as soon as possible if you have high blood pressure, headache, or loss of sight.
• If you have diabetes. Blood sugar levels in diabetic patients should be checked regularly in order to assess if antidiabetic medicine’s dosage needs to be adjusted to minimise the risk of low blood sugar. Notify your doctor as soon as possible if you experience any signs and symptoms of low blood sugar (fatigue, palpitations, sweating, hunger and loss of consciousness).
Children and adolescents Sunitinib is not recommended for people aged under 18.
Other medicines and Sunitinib Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription and even those not prescribed. Some medicines can affect the levels of Sunitinib 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 –used to treat infections
• ritonavir –used to treat HIV
• dexamethasone – a corticosteroid used for various conditions (such as allergic/breathing disorders or skin diseases)
• phenytoin, carbamazepine, phenobarbital – used to treat epilepsy and other neurological conditions
• herbal preparations containing St. John’s Wort ( Hypericum perforatum ) – used to treat depression and anxiety
Sunitinib with food and drink You should avoid drinking grapefruit juice while on treatment with Sunitinib.
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 might get pregnant, you should use a reliable method of contraception during treatment with Sunitinib.
If you are breast-feeding, tell your doctor. You should not breast-feed during treatment with Sunitinib.
Driving and using machines If you experience dizziness or you feel unusually tired, take special care when driving or using machines.
Sunitinib contains sodium This medicine contains less than 1 mmol (23 mg) sodium per capsule, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. 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 MRCC: the usual dose is 50 mg once daily taken for 28 days (4 weeks), followed by 14 days (2 weeks) of rest (no medicine), in 6-week cycles.
• pNET: the usual dose is 37.5 mg once daily without a rest period.
Your doctor will determine the appropriate dose you need to take, as well as if and when you need to stop treatment with Sunitinib. Sunitinib can be taken with or without food.
If you take more Sunitinib 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 Sunitinib Do not take a double dose to make up for a forgotten dose.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must immediately contact your doctor if you experience any of those serious side effects (see also What you need to know before you take Sunitinib ):
Heart problems. Tell your doctor if you feel very tired, are short of breath, or have swollen feet and ankles. These may be symptoms of heart problems that may include heart failure and heart muscle problems (cardiomyopathy).
Lung or breathing problems. Tell your doctor if you develop cough, chest pain, sudden onset of shortness of breath, or coughing up blood. These may be symptoms of a condition called pulmonary embolism that occurs when blood clots travel to your lungs.
Kidney disorders. Tell your doctor if you experience altered frequency or absence of urination which may be symptoms of kidney failure.
Bleeding. Tell your doctor if you have any of these symptoms or a serious bleeding problem during treatment with Sunitinib: painful, swollen stomach (abdomen); vomiting blood; black, sticky stools; bloody urine; headache or change in your mental status; coughing up of blood or bloody sputum from the lungs or airway.
Tumour destruction leading to hole in the intestine. Tell your doctor if you have severe abdominal pain, fever, nausea, vomiting, blood in your stool, or changes in bowel habits.
Other side effects with Sunitinib 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).
• Shortness of breath.
• High blood pressure.
• Extreme tiredness, loss of strength.
• Swelling caused by fluid under the skin and around the eye, deep allergic rash.
• Mouth pain/irritation, mouth sores/inflammation/dryness, taste disturbances, upset stomach, nausea, vomiting, diarrhoea, constipation, abdominal pain/swelling, loss/decrease of appetite.
• Decreased activity of thyroid gland (hypothyroidism).
• Dizziness.
• Headache.
• Nose bleeding.
• Back pain, joint pain.
• Pain in arms and legs.
• Yellow skin/skin discoloration, excess pigmentation of the skin, hair colour change, rash on the palms of the hands and soles of the feet, rash, dryness of the skin.
• Cough.
• Fever.
• Difficulty in falling asleep.
Common: may affect up to 1 in 10 people
• Blood clots in the blood vessels.
• Deficiency of blood supply 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 severe infection (infection is present in the bloodstream) that can lead to tissue damage, organ failure, and death.
• Decreased blood sugar level (see section 2).
• Loss of protein in the urine sometime resulting in swelling.
• Influenza-like syndrome.
• Abnormal blood tests including pancreatic and liver enzymes.
• High level of uric acid in the blood.
• Haemorrhoids, pain in the rectum, gingival bleeding, difficulty in swallowing or inability to swallow.
• Burning or painful sensation in the tongue, inflammation of the digestive tract lining, excessive gas in the stomach or intestine.
• Weight loss.
• Musculoskeletal pain (pain in muscles and bones), muscular weakness, muscular fatigue, muscle pain, muscle spasms.
• Nasal dryness, congested nose.
• Excessive tear flow.
• Abnormal sensation of the skin, itching, flaking and inflammation of the skin, blisters, acne, nail discolouration, hair loss.
• Abnormal sensations in extremities.
• Abnormally decreased/increased sensitivity, particularly to touch.
• Acid heartburn.
• Dehydration.
• Hot flushes.
• Abnormally coloured urine.
• Depression.
• Chills.
Uncommon: may affect up to 1 in 100 people
• Life-threatening infection of the soft tissue including the ano-genital region (see section 2).
• Stroke.
• Heart attack caused by an interrupted or decreased blood supply to the heart.
• Changes in the electrical activity or abnormal rhythm of the heart.
• Fluid around the heart (pericardial effusion).
• Liver failure.
• Pain in the stomach (abdomen) caused by inflammation of the pancreas.
• Tumour destruction leading to hole in the intestine (perforation).
• Inflammation (swelling and redness) of the gallbladder with or without associated gallstones.
• Abnormal tube like passage from one normal body cavity to another body cavity or 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 loosening of a tooth. These could be signs and symptoms of bone damage in the jaw (osteonecrosis), see section 2.
• Overproduction of thyroid hormones which increases the amount of energy the body uses at rest.
• Problems with wound healing after surgery.
• Increased blood level of enzyme (creatine phosphokinase) from muscle.
• Excessive reaction to an allergen including hay fever, skin rash, itchy skin, hives, swelling of body parts, and trouble breathing.
• Inflammation of the colon (colitis, colitis ischaemic).
Rare: may affect up to 1 in 1,000 people
• Severe reaction of the skin and/or mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• Tumour lysis syndrome (TLS) – TLS consists of a group of metabolic complications that can occur during treatment of cancer. These complications are caused by the break-down products of dying cancer cells and may include the following: nausea, shortness of breath, irregular heartbeat, muscular cramps, seizure, clouding of urine and tiredness associated with abnormal laboratory test results (high potassium, uric acid and phosphorous levels and low calcium levels in the blood) that can lead to changes in kidney function and acute renal failure.
• Abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis).
• Abnormal changes in the brain that can cause a collection of symptoms including headache, confusion, seizures, and vision loss (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).
Not known (frequency cannot be estimated from available data):
• An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
• Lack of energy, confusion, sleepiness, unconsciousness/coma-these symptoms may be signs of brain toxicity caused by high blood levels of ammonia (hyperammonaemic encephalopathy).
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
What Sunitinib contains Sunitinib 12.5 mg Hard Capsules
The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 12.5 mg sunitinib. The other ingredients are:
• Capsule content: mannitol, croscarmellose sodium, povidone (K-25) and magnesium stearate.
• Capsule shell (cap and body): titanium dioxide (E171), iron oxide red (E172) and gelatin
• Printing ink: shellac (E904), titanium dioxide (E171), black iron oxide (E172) and potassium hydroxide (E525)
Sunitinib 25 mg Hard Capsules The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 25 mg sunitinib. The other ingredients are:
• Capsule content: mannitol, croscarmellose sodium, povidone (K-25) and magnesium stearate.
• Cap of the capsules contains: titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), FD & C Blue 2 (E132) and gelatin
• Body of the cap contains: titanium dioxide (E171), iron oxide red (E172) and gelatin
• Printing ink: shellac (E904), titanium dioxide (E171), black iron oxide (E172) and potassium hydroxide (E525)
Sunitinib 50 mg Hard Capsules The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 50 mg sunitinib. The other ingredients are:
• Capsule content: mannitol, croscarmellose sodium, povidone (K-25) and magnesium stearate.
• Cap of the capsules contains: titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), FD & C Blue 2 (E132) and gelatin
• Body of the cap contains: titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), FD & C Blue 2 (E132) and gelatin
• Printing ink: shellac (E904), titanium dioxide (E171), black iron oxide (E172) and potassium hydroxide (E525)
What Sunitinib looks like and contents of the pack Sunitinib 12.5mg Hard Capsules contains red opaque cap and red opaque body, size ‘4’, hard gelatin capsule shells imprinted with ‘S12.5’ on body with white ink, filled with Yellow to orange granules.
Sunitinib 25mg Hard Capsules contains olive green opaque cap and red opaque body, size ‘3’, hard gelatin capsule shells imprinted with ‘S25’ on body with white ink, filled with Yellow to orange granules.
Sunitinib 50mg Hard Capsules contains olive green opaque cap and olive green opaque body, size ‘2’, hard gelatin capsule shells imprinted with ‘S50’ on body with black ink, filled with Yellow to orange granules.
The capsules are available in blister packs and plastic bottles. Pack size of 28 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder Eugia (UK) Limited
1 Roundwood Avenue
Stockley Park
Uxbridge
UB11 1AF
United Kingdom
Manufacturer APL Swift Services (Malta) Limited
HF26
Hal Far Industrial Estate
Hal Far
Birzebbugia
BBG 3000
Malta
Milpharm Limited
1 Roundwood Avenue
Stockley Park
Uxbridge
UB11 1AF
United Kingdom
This leaflet was last revised in 02/2026.
Ref: Ver 2
P1540744
Eugia (UK) Limited
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1 Roundwood Avenue, Stockley Park, Uxbridge, UB11 1AF, UK
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+44 (0)208 845 8811
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Sunitinib Eugia 25 mg hard capsules comes as capsule containing 25 mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Sunitinib Eugia 25 mg hard capsules is sunitinib malate.
Medicines with the same active substance include: SUTENT 12.5mg Hard Capsules, SUTENT 25 mg hard capsules, SUTENT 50 mg hard capsules, Sunitinib 12.5 mg hard capsules, Sunitinib 25 mg hard capsules, Sunitinib 37.5 mg hard capsules. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Sunitinib Eugia 25 mg hard capsules, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Gastrointestinal stromal tumour (GIST)
Sunitinib is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance.
Metastatic renal cell carcinoma (MRCC)
Sunitinib is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.
Pancreatic neuroendocrine tumours (pNET)
Sunitinib is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults.
Therapy with Sunitinib should be initiated by a physician experienced in the administration of anticancer agents.
Posology
For GIST and MRCC, the recommended dose of Sunitinib is 50 mg taken orally once daily, for 4 consecutive weeks, followed by a 2-week rest period (Schedule 4/2) to comprise a complete cycle of 6 weeks.
For pNET, the recommended dose of Sunitinib is 37.5 mg taken orally once daily without a scheduled rest period.
Dose adjustments
Safety and tolerability
For GIST and MRCC, dose modifications in 12.5 mg steps may be applied based on individual safety and tolerability. Daily dose should not exceed 75 mg nor be decreased below 25 mg.
For pNET, dose modification in 12.5 mg steps may be applied based on individual safety and tolerability. The maximum dose administered in the Phase 3 pNET study was 50 mg daily.
Dose interruptions may be required based on individual safety and tolerability.
CYP3A4 inhibitors/inducers
Co-administration of sunitinib with potent CYP3A4 inducers, such as rifampicin, should be avoided (see sections 4.4 and 4.5). If this is not possible, the dose of sunitinib may need to be increased in 12.5 mg steps (up to 87.5 mg per day for GIST and MRCC or 62.5 mg per day for pNET) based on careful monitoring of tolerability.
Co-administration of sunitinib with potent CYP3A4 inhibitors, such as ketoconazole, should be avoided (see sections 4.4 and 4.5). If this is not possible, the dose of sunitinib may need to be reduced to a minimum of 37.5 mg daily for GIST and MRCC or 25 mg daily for pNET, based on careful monitoring of tolerability.
Selection of an alternative concomitant medicinal product with no or minimal potential to induce or inhibit CYP3A4 should be considered.
Special populations
Paediatric population
The safety and efficacy of Sunitinib in patients below 18 years of age have not been established.
Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Elderly
Approximately one-third of the patients in clinical studies who received sunitinib were 65 years of age or over. No significant differences in safety or efficacy were observed between younger and older patients.
Hepatic impairment
No starting dose adjustment is recommended when administering sunitinib to patients with mild or moderate (Child-Pugh class A and B) hepatic impairment. Sunitinib has not been studied in subjects with severe (Child-Pugh class C) hepatic impairment and therefore its use in patients with severe hepatic impairment cannot be recommended (see section 5.2).
Renal impairment
No starting dose adjustment is required when administering sunitinib to patients with renal impairment (mild-severe) or with end-stage renal disease (ESRD) on haemodialysis. Subsequent dose adjustments should be based on individual safety and tolerability (see section 5.2).
Method of administration
Sunitinib is for oral administration. It may be taken with or without food.
If a dose is missed, the patient should not be given an additional dose. The patient should take the usual prescribed dose on the following day.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Interaction studies have only been performed in adults.
Medicinal products that may increase sunitinib plasma concentrations
Effect of CYP3A4 inhibitors
In healthy volunteers, concomitant administration of a single dose of sunitinib with the potent CYP3A4 inhibitor ketoconazole resulted in an increase of the combined [sunitinib + primary metabolite] maximum concentration (Cmax) and area under the curve (AUC0- ∞) values of 49% and 51%, respectively.
Administration of sunitinib with potent CYP3A4 inhibitors (e.g., ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice) may increase sunitinib concentrations.
Combination with CYP3A4 inhibitors should therefore be avoided, or the selection of an alternate concomitant medicinal product with no or minimal potential to inhibit CYP3A4 should be considered.
If this is not possible, the dose of Sunitinib may need to be reduced to a minimum of 37.5 mg daily for GIST and MRCC or 25 mg daily for pNET, based on careful monitoring of tolerability (see section 4.2).
Effect of Breast Cancer Resistance Protein (BCRP) inhibitors
Limited clinical data are available on the interaction between sunitinib and BCRP inhibitors and the possibility of an interaction between sunitinib and other BCRP inhibitors cannot be excluded (see section 5.2).
Medicinal products that may decrease sunitinib plasma concentrations
Effect of CYP3A4 inducers
In healthy volunteers, concomitant administration of a single dose of sunitinib with the CYP3A4 inducer rifampicin resulted in a reduction of the combined [sunitinib + primary metabolite] Cmax and AUC0- ∞ values of 23% and 46%, respectively.
Administration of sunitinib with potent CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or herbal preparations containing St. John's Wort/Hypericum perforatum) may decrease sunitinib concentrations. Combination with CYP3A4 inducers should therefore be avoided, or selection of an alternate concomitant medicinal product, with no or minimal potential to induce CYP3A4 should be considered. If this is not possible, the dose of Sunitinib may need to be increased in 12.5 mg increments (up to 87.5 mg per day for GIST and MRCC or 62.5 mg per day for pNET), based on careful monitoring of tolerability (see section 4.2).
Contraception in males and females
Women of childbearing potential should be advised to use effective contraception and avoid becoming pregnant while receiving treatment with Sunitinib.
Pregnancy
There are no studies in pregnant women using sunitinib. Studies in animals have shown reproductive toxicity including foetal malformations (see section 5.3). Sunitinib should not be used during pregnancy or in women not using effective contraception, unless the potential benefit justifies the potential risk to the foetus. If Sunitinib is used during pregnancy or if the patient becomes pregnant while on treatment with Sunitinib, the patient should be apprised of the potential hazard to the foetus.
Breast-feeding
Sunitinib and/or its metabolites are excreted in rat milk. It is not known whether sunitinib or its primary active metabolite is excreted in human milk. Because active substances are commonly excreted in human milk and because of the potential for serious adverse reactions in breast-feeding infants, women should not breast-feed while taking Sunitinib.
Fertility
Based on nonclinical findings, male and female fertility may be compromised by treatment with sunitinib (see section 5.3).
Sunitinib has minor influence on the ability to drive and use machines. Patients should be advised that they may experience dizziness during treatment with sunitinib.
There is no specific antidote for overdose with Sunitinib and treatment of overdose should consist of general supportive measures. If indicated, elimination of unabsorbed active substance may be achieved by emesis or gastric lavage. Cases of overdose have been reported; some cases were associated with adverse reactions consistent with the known safety profile of sunitinib.
Ask anything about Sunitinib Eugia 25 mg hard capsules. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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