SUTENT

What it is

SUTENT contains sunitinib malate and is available in 12.5 mg, 25 mg, 37.5 mg and 50 mg capsule strengths. SUTENT is supplied as a hard gelatin capsule for oral administration.

Approved indications —

Treatment of advanced renal cell carcinoma (RCC) — Treatment of gastrointestinal stromal tumour (GIST) after failure of imatinib mesilate treatment due to resistance or intolerance — Treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic NET)

Dosing overview

SUTENT may be taken with or without food. For GIST and mRCC, dose modifications in 12.5 mg steps may be applied based on individual safety and tolerability, with the daily dose not exceeding 75 mg nor being decreased below 25 mg.

Key safety warnings

Severe cutaneous reactions have been reported, including cases of erythema multiforme and Stevens-Johnson syndrome, some of which were fatal. If signs or symptoms of Stevens-Johnson syndrome or erythema multiforme are present, SUTENT treatment should be discontinued. If the diagnosis of Stevens-Johnson syndrome is confirmed, treatment must not be re-started. Haemorrhagic events have been reported through post-marketing experience, some of which were fatal, including gastrointestinal, respiratory, tumour, urinary tract and brain haemorrhages. These events may occur suddenly and, in the case of pulmonary tumours, may present as severe and life-threatening haemoptysis or pulmonary haemorrhage. Cardiovascular events, including heart failure, cardiomyopathy, myocardial ischaemia and myocardial infarction, some of which were fatal, have been reported through post-marketing experience. Use sunitinib with caution in patients who are at risk for, or who have a history of, these events. Hypertension was a very common adverse reaction reported in clinical trials. Severe hypertension (>200 mmHg systolic or 110 mmHg diastolic) occurred in 4.7% of patients. Patients should be screened for hypertension and controlled as appropriate. Temporary suspension is recommended in patients with severe hypertension that is not controlled with medical management. Serious, sometimes fatal, gastrointestinal complications, including gastrointestinal perforation, have occurred rarely in patients with intra-abdominal malignancies treated with SUTENT. Hepatotoxicity has been observed in patients treated with sunitinib. Cases of hepatic failure, some with a fatal outcome, were observed in less than 1% of solid tumour patients treated with sunitinib.

Contraindications

Use of SUTENT is contraindicated in patients with hypersensitivity to sunitinib malate or to any other component of SUTENT capsules.

PBS listing

SUTENT is not listed on the PBS.

Regulatory history

SUTENT sunitinib malate 12.5 mg, 25 mg and 50 mg capsules were first registered on the ARTG on 14 September 2006. The 37.5 mg capsule strength was first listed on 10 February 2010. On 24 February 2011, the TGA approved an extension of indications for SUTENT for the treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours, including a new continuous daily dosing schedule of 37.5 mg once daily.