SUNITINIB MSN

What it is

Sunitinib MSN is a medicine containing sunitinib malate available in capsule strengths of 12.5 mg, 25 mg, 37.5 mg and 50 mg. It is supplied as a hard gelatin capsule for oral administration.

Approved indications

Sunitinib MSN is indicated for: — 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

Sunitinib MSN may be taken with or without food.

Key safety warnings

Skin discolouration possibly due to the colour of the active drug substance was a very common adverse reaction reported in clinical trials. Patients should be advised that depigmentation of the hair or skin may also occur during treatment with Sunitinib MSN. Other possible dermatologic effects may include dryness, thickness or cracking of the skin, blisters or occasional rash on the palms of the hands and soles of the feet. Severe cutaneous reactions have been reported, including cases of erythema multiforme and cases suggestive of Stevens-Johnson syndrome, some of which were fatal. If signs or symptoms of Stevens-Johnson syndrome or erythema multiforme are present, Sunitinib MSN treatment should be discontinued. Haemorrhagic events reported through post-marketing experience, some of which were fatal, have included gastrointestinal, respiratory, tumour, urinary tract and brain haemorrhages. In clinical trials, treatment-related tumour haemorrhage occurred in approximately 2% of patients with GIST. 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 in subjects with solid tumours. Severe hypertension (>200 mmHg systolic or 110 mmHg diastolic) occurred in 4.7% of this patient population. 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. Baseline laboratory measurement of thyroid function is recommended and patients with hypothyroidism or hyperthyroidism should be treated as per standard medical practice prior to the start of sunitinib treatment. All patients should be observed closely for signs and symptoms of thyroid dysfunction on sunitinib treatment. Hypothyroidism may develop during treatment. Serious, sometimes fatal, gastrointestinal complications, including gastrointestinal perforation, have occurred rarely in patients with intra-abdominal malignancies treated with Sunitinib.

Contraindications

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

PBS listing

Sunitinib MSN is available on the ARTG in strengths of 12.5 mg, 25 mg, 37.5 mg and 50 mg, first listed on 22 July 2022. In November 2014, the PBAC recommended amendments to allow treatment of patients with advanced renal cell carcinoma who have progressed on or after prior treatment with a VEGF-targeted therapy, and treatment of patients with gastrointestinal stromal tumour who have progressed on or after prior treatment with imatinib.

Regulatory history

Sunitinib MSN was first listed on the ARTG on 22 July 2022 in all four strengths (12.5 mg, 25 mg, 37.5 mg and 50 mg) as a registered Australian medicine sponsored by Accelagen. The PBAC recommended amendments to the PBS listing in November 2014 for advanced renal cell carcinoma in patients with prior VEGF-targeted therapy progression, and for gastrointestinal stromal tumour in patients with prior imatinib progression or intolerance.