Drug Action
Sunitinib is a tyrosine kinase inhibitor.
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Drug reference
Sunitinib is a tyrosine kinase inhibitor.
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Treatment of unresectable or metastatic malignant gastro-intestinal stromal tumours, after failure of imatinib | Treatment of advanced or metastatic renal cell carcinoma ▶BY MOUTH ▶Adult: 50 mg once daily for 4 weeks, followed by a 2-week treatment-free period to complete 6-week cycle, adjusted in steps of 12.5 mg, doses adjusted according to tolerability; usual dose 25–75 mg daily Treatment of unresectable or metastatic pancreatic neuroendocrine tumours ▶BY MOUTH ▶Adult: 37.5 mg once daily without treatment-free period; adjusted in steps of 12.5 mg, doses adjusted according to tolerability; maximum 50 mg per day
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DUE TO INTERACTIONS ▶Manufacturer advises if concurrent use of potent inducers of CYP3A4 is unavoidable, dose may need to be increased in steps of 12.5 mg to a max. dose of 87.5 mg per day for gastro-intestinal stromal tumours or renal cell carcinoma, or to a max. dose of 62.5 mg per day for pancreatic neuroendocrine tumours. ▶Manufacturer advises if concurrent use of potent inhibitors of CYP3A4 is unavoidable, dose may need to be decreased to a minimum of 37.5 mg per day for gastrointestinal stromal tumours or renal cell carcinoma, or to a minimum of 25 mg per day for pancreatic neuroendocrine tumours.
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Cardiovascular disease—discontinue if congestive heart failure develops. hypertension. increased risk of bleeding. susceptibility to QT-interval prolongation
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NICE decisions ▶Sunitinib for advanced or metastatic renal cell carcinoma (March 2009) NICE TA169 Sunitinib is recommended as first-line treatment for advanced or metastatic renal cell carcinoma in patients who are suitable for immunotherapy and have an Eastern Cooperative Oncology Group performance status of 0 or 1. www.nice.org.uk/TA169 ▶Sunitinib for the treatment of gastrointestinal stromal tumours (September 2009) NICE TA179 Sunitinib is recommended as an option for treatment in patients with unresectable or metastatic gastrointestinal tumours if imatinib treatment has failed because of resistance or intolerance, and the cost of sunitinib for the first treatment cycle is met by the manufacturer. www.nice.org.uk/TA179 ▶Bevacizumab (first-line), sorafenib (first- and second-line), sunitinib (second-line) and temsirolimus (first-line) for the treatment of advanced or metastatic renal cell carcinoma (August 2009) NICE TA178 Sorafenib and sunitinib are not recommended as second- line treatments for people with advanced or metastatic renal cell carcinoma. www.nice.org.uk/TA178 ▶Everolimus and sunitinib for treating unresectable or metastatic neuroendocrine tumours in people with progessive disease (June 2017) NICE TA449 Everolimus and sunitinib are recommended, within their marketing authorisations, as options for treating well- or moderately differentiated unresectable or metastatic neuroendocrine tumours (NETs) of pancreatic origin in adults with progressive disease. www.nice.org.uk/guidance/TA449 Scottish Medicines Consortium (SMC) decisions The Scottish Medicines Consortium has advised (November 2009) that sunitinib (Sutent ®) is accepted for use within Immune system and malignant disease NHS Scotland for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumours after failure of imatinib. The Scottish Medicines Consortium has advised (May 2011) that sunitinib (Sutent ®) is accepted for use within NHS Scotland for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults.
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MHRA/CHM ADVICE: BEVACIZUMAB AND SUNITINIB: RISK OF OSTEONECROSIS OF THE JAW (JANUARY 2011) Treatment with bevacizumab or sunitinib may be a risk factor for the development of osteonecrosis of the jaw. Patients treated with bevacizumab or sunitinib, who have previously received bisphosphonates, or are treated concurrently with bisphosphonates, may be particularly at risk. Dental examination and appropriate preventive dentistry should be considered before treatment with bevacizumab or sunitinib. If possible, invasive dental procedures should be avoided in patients treated with bevacizumab or sunitinib who have previously received, or who are currently receiving, intravenous bisphosphonates. RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES See Cytotoxic drugs p. 938.
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→Appendix 1: sunitinib
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▶Common or very common Abscess. alopecia. anaemia. appetite decreased. arthralgia. burping. chest pain. chills . constipation. cough. dehydration. depression. diarrhoea . dizziness. dry mouth. dysphagia. dyspnoea. embolism and thrombosis. excessive tearing. eye inflammation. fatigue. fever. gastrointestinal discomfort. gastrointestinal disorders. haemorrhage. hair colour changes. headache. hypertension. hypoglycaemia. Immune system and malignant disease hypothyroidism. increased risk of infection. influenza like illness. insomnia. leucopenia. mucositis. muscle complaints. muscle weakness. myocardial ischaemia. nail disorder. nasal complaints. nausea. neutropenia. oedema . oral disorders. oropharyngeal pain. pain. peripheral neuropathy. proteinuria. renal impairment. respiratory disorders. sensation abnormal. sepsis. skin reactions. taste altered. thrombocytopenia. urine discolouration. vasodilation. vomiting. weight decreased ▶Uncommon Anal fistula (interrupt treatment). cardiomyopathy. cerebrovascular insufficiency. cholecystitis. fistula (interrupt treatment). healing impaired. heart failure. hepatic disorders. hypersensitivity. hyperthyroidism. intracranial haemorrhage. myocardial infarction. osteonecrosis of jaw . pancreatitis. pancytopenia. pericardial effusion. QT interval prolongation. tumour haemorrhage ▶Rare or very rare Angioedema. myopathy. nephrotic syndrome. posterior reversible encephalopathy syndrome (PRES). pyoderma gangrenosum. severe cutaneous adverse reactions (SCARs). thrombotic microangiopathy. thyroiditis. torsade de pointes. tumour lysis syndrome
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Effective contraception required during treatment.
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Manufacturer advises avoid unless potential benefit outweighs risk—toxicity in animal studies. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Discontinue breast-feeding.
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Monitor for thyroid dysfunction.
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There can be variation in the licensing of different medicines containing the same drug. Capsule CAUTIONARY AND ADVISORY LABELS 14 ▶Sutent (Pfizer Ltd) Sunitinib (as Sunitinib malate) 12.5 mg Sutent 12.5mg capsules | 28 capsule P £784.70 (Hospital only) Sunitinib (as Sunitinib malate) 25 mg Sutent 25mg capsules | 28 capsule P £1,569.40 (Hospital only) Sunitinib (as Sunitinib malate) 50 mg Sutent 50mg capsules | 28 capsule P £3,138.80 (Hospital only)
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50 mg once daily for 4 weeks, followed by a
First-line fragment. Read the complete Indications and Dose section above.
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37.5 mg once daily without treatment-free
First-line fragment. Read the complete Indications and Dose section above.
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