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Sunitinib oral


Capsules containing sunitinib.

Drugs List

  • sunitinib 12.5mg capsules
  • sunitinib 25mg capsules
  • sunitinib 37.5mg capsules
  • sunitinib 50mg capsules
  • SUTENT 12.5mg capsules
  • SUTENT 25mg capsules
  • SUTENT 50mg capsules
  • Therapeutic Indications


    Advanced and/or metastatic renal cell cancer
    Unresectable or metastatic malignant gastrointestinal stromal tumour (GIST)
    Unresectable or metastatic pancreatic neuroendocrine tumours

    Treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) after failure of imatinib mesilate treatment due to resistance or intolerance.

    Treatment of advanced and/or metastatic renal cell carcinoma (MRCC).

    Treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression (pNET).


    Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.


    Treatment of GIST and MRCC
    The recommended dose is 50 mg once daily for 4 consecutive weeks, followed by a 2 week rest period. (6 weeks is one complete cycle).

    Dose adjustments in 12.5 mg steps may be applied based on individual tolerability.
    Daily dose should not exceed 75 mg or fall below 25 mg.

    Treatment of pNET
    The recommended dose is 37.5 mg once daily without a scheduled rest period.

    Dose adjustments in 12.5 mg steps may be applied based on individual tolerability.
    Daily dose should not exceed 50 mg daily.

    Additional Dosage Information

    If a dose is missed, the patient should not be given an additional dose. The usual prescribed dose should be taken on the following day.


    Children under 18 years
    Congestive cardiac failure
    Long QT syndrome
    Lung cancer
    Severe hepatic impairment - Child-Pugh score greater than or equal to 10
    Torsade de pointes
    Uncontrolled severe hypertension

    Precautions and Warnings

    Family history of long QT syndrome
    Tobacco smoking
    Behcet's disease
    Cardiac disorder
    Cerebrovascular disorder
    Diabetes mellitus
    Electrolyte imbalance
    Giant cell arteritis
    History of aneurysm
    History of cardiac disorder
    History of thromboembolic disorder
    History of torsade de pointes
    Ischaemic heart disease
    Marfan syndrome
    Occlusive peripheral arterial disease
    Renal impairment
    Takayasu arteritis
    Vascular Ehlers-Danlos syndrome

    Correct electrolyte disorders before treatment
    Advise ability to drive/operate machinery may be affected by side effects
    Anti-diarrhoeals, anti-emetics & antacids may be required during therapy
    Consider a dental exam & appropriate preventive dentistry before treatment
    Consider premedication with hypouricaemic agent
    Ensure hypertension is controlled prior to treatment
    Maintain adequate hydration of patient prior / during treatment
    Treatment to be initiated and supervised by a specialist
    Consult local policy on the safe use of oral anti-cancer drugs
    Staff: Not to be handled by pregnant staff
    Measurement of LV ejection fraction recommended before and during treatment
    Monitor hepatic function before treatment and regularly during treatment
    Monitor thyroid function prior to & every 3 months during therapy
    Perform full blood count before each treatment cycle
    Screen patient for hypertension and control as appropriate
    Consider monitoring ECG in patients at risk of QT prolongation
    Diabetic control may need adjustment
    If rash develops, consider possibility of Stevens-Johnson Syndrome
    Monitor blood glucose closely in patients with diabetes mellitus
    Monitor blood pressure regularly
    Monitor for bleeding during treatment
    Monitor for protein in urine
    Monitor for signs of CHF in patients with a history of cardiac events
    Monitor patients for signs of tumour lysis syndrome
    Monitor patients receiving concurrent anticoagulants
    Monitor serum electrolytes
    Advise patient to report headaches, seizures, confusion, visual disturbance
    Advise patient to report symptoms of thrombotic microangiopathy
    Suspend treatment if symptomatic hypoglycaemia occurs
    Symptoms of hypothyroidism should be investigated
    Discontinue before elective surgery: impairs wound healing
    Discontinue if fistulae develop during treatment
    Discontinue if Grade 4 proteinuria occurs (Nephrotic syndrome)
    Discontinue if necrotising fasciitis occurs
    Discontinue if pancreatitis occurs
    Discontinue if posterior reversible encephalopathy syndrome (PRES) develops
    Discontinue if severe skin reaction occurs
    Discontinue if symptoms of hepatic disease occur
    Discontinue if thrombotic microangiopathy is confirmed
    Interrupt treatment and/or reduce dose if LVEF <50% & >20% below baseline
    Interrupt treatment if angioedema due to hypersensitivity occurs
    Suspend treatment in severe hypertension that cannot be controlled
    Advise patient not to take St John's wort concurrently
    Advise patient grapefruit products may increase plasma level
    May cause impaired fertility
    Female: Ensure adequate contraception during treatment
    Advise patient on giving up smoking
    Advise patient urine may be discoloured
    Advise patients that depigmentation of hair and skin may occur

    Haemorrhage and tumour bleeding
    Haemorrhagic events, some of which were fatal, reported in clinical studies with sunitinib and during post-marketing surveillance have included gastrointestinal, respiratory, urinary tract, and brain haemorrhages. Tumour haemorrhage may occur suddenly, and in the case of pulmonary tumours, may present as severe and life-threatening haemoptysis or pulmonary haemorrhage. Cases of pulmonary haemorrhage, some with fatal outcome, have been observed in clinical studies and have been reported in post marketing experience in patients treated with sunitinib for MRCC, GIST, and lung cancer.

    Haematological disorders
    Decreased absolute neutrophil counts and platelet counts were reported in association with sunitinib. Anaemia has been observed to occur early as well as late with treatment with sunitinib.

    Posterior Reversible Encephalopathy Syndrome (PRES) also known as Reversible Posterior Leucoencephalopathy Syndrome (RPLS)
    Posterior reversible encephalopathy syndrome (PRES) has been reported in some patients treated with this agent. If patients present with symptoms indicating PRES such as headache, altered mental state, seizures and visual disturbances, an MRI should be performed. If PRES is diagnosed, treatment should be discontinued and adequate blood pressure and seizure control administration is advisable. The safety of reinstating treatment in patients previously experiencing PRES is unknown.

    Thrombotic Microangiopathy (TMA)
    TMA including thrombotic thrombocytopaenia purpura (TTP) and haemolytic uraemic syndrome (HUS), sometimes leading to renal failure or fatal outcomes has been reported in patients treated with sunitinib. TMA should be considered in patients presenting with haemolytic anaemia, thrombocytopenia, fatigue, fluctuating neurologic manifestation, renal impairment and fever. If TMA develops sunitinib should be discontinued and prompt treatment initiated.

    Thyroid dysfunction
    Baseline laboratory measurement of thyroid function is recommended in all patients. Patients with pre-existing thyroid dysfunction should be treated as per standard medical practice prior to the start of sunitinib treatment. In addition, patients should be observed closely for signs and symptoms of thyroid dysfunction during treatment, and patients who develop any signs/symptoms should have laboratory testing of thyroid function as clinically indicated.

    Risk factors for aneurysm and artery dissection
    Use of systemic VEGF inhibitors may promote the formation of aneurysms or artery dissections, mainly in relation to aortic aneurysm rupture and aortic dissection. It is therefore important to consider the risk of aneurysm and artery dissection in patients with risk factors such as hypertension, history of aneurysm, smoking, diabetes, coronary, cerebrovascular or peripheral arterial disease, and hyperlipidaemia. Other risk factors include Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, and the use of fluoroquinolones. In patients receiving VEGF inhibitors, any modifiable risk factors such as smoking and hypertension should be reduced as far as possible.

    Osteonecrosis of the jaw (ONJ)
    Treatment with sunitinib may be a risk for the development of ONJ. Patients treated with sunitinib who have previously received bisphosphonates, or treated concurrently with bisphosphonates, may be particularly at risk. Invasive dental procedures should be avoided in patients who have previously received or who are currently receiving, intravenous bisphosphonates.

    Pregnancy and Lactation


    Sunitinib is contraindicated during pregnancy.

    The manufacturer does not recommend using sunitinib during pregnancy unless the potential benefit outweighs the potential risk to the foetus. If the patient becomes pregnant they should be made aware of the potential hazard. Animal studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out.


    Sunitinib is contraindicated during breastfeeding.

    Use of sunitinib when breastfeeding is contraindicated by the manufacturer. Animal data reports significant levels of sunitinib in the breast milk, however presence in human breast milk is unknown. Effects on exposed infants are unknown.

    Side Effects

    Abdominal distension
    Acute adrenal insufficiency
    Artery dissection
    Cardiac failure
    Cerebrovascular accident
    Congestive cardiac failure
    Creatine phosphokinase increased
    Decreased ejection fraction
    Dry mouth
    Dry skin
    Elevated amylase levels
    Elevated serum lipase
    Elevated TSH
    Erythema multiforme
    Exfoliative dermatitis
    Gastro-intestinal haemorrhage
    Gastro-intestinal perforation
    Gastro-intestinal symptoms
    Hepatic failure
    Increase in serum ALT/AST
    Increased lacrimation
    Intravascular coagulation (disseminated)
    Mouth ulcers
    Mucosal inflammation
    Muscle spasm
    Nasal congestion
    Nephrotic syndrome
    Osteonecrosis (primarily of the jaw)
    Palmar-plantar erythrodysaesthesia
    Periorbital oedema
    Peripheral neuropathy
    Peritoneal haemorrhage
    Pleural effusion
    Prolongation of QT interval
    Pulmonary embolism
    Pulmonary haemorrhage
    Pyoderma gangrenosum
    Respiratory failure
    Reversible posterior leucoencephalopathy syndrome (RPLS)
    Skin discolouration
    Stevens-Johnson syndrome
    Thrombotic microangiopathy
    Toxic epidermal necrolysis
    Tumour haemorrhage
    Weight loss
    Wound healing retarded


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: June 2019

    Reference Sources

    MHRA Drug Safety Update July 2020
    Available at:
    Last accessed: 10 November 2020

    Summary of Product Characteristics: Sunitinib Accord 37.5mg hard capsules. Accord Healthcare Limited. Revised May 2021.

    Summary of Product Characteristics: Sutent capsules. Pfizer Limited. Revised October 2019.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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