ARX-SUNITINIB

What it is

ARX-SUNITINIB is sunitinib malate. ARX-SUNITINIB is supplied as capsules containing sunitinib malate equivalent to sunitinib 12.5 mg, 25 mg, 37.5 mg or 50 mg. ARX-SUNITINIB is supplied as a hard gelatin capsule for oral administration.

Approved indications ARX-SUNITINIB is indicated for:

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

Dosing overview

For advanced renal cell carcinoma, the recommended dose of ARX-SUNITINIB is 50 mg taken orally once daily for four consecutive weeks followed by a two-week rest period (Schedule 4/2) to comprise a complete cycle of six weeks. For gastrointestinal stromal tumour, the recommended dose of ARX-SUNITINIB is 50 mg taken orally once daily for four consecutive weeks followed by a two-week rest period (schedule 4/2) to comprise a complete cycle of six weeks. For pancreatic neuroendocrine tumours, the recommended dose of ARX-SUNITINIB is 37.5 mg taken orally once daily without a scheduled rest period. ARX-SUNITINIB 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 ARX-SUNITINIB. 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, ARX-SUNITINIB 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. These events 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 a fatal outcome, have been observed in clinical trials and have been reported in post-marketing experience. Cardiovascular events, including heart failure, cardiomyopathy, myocardial ischaemia and myocardial infarction, some of which were fatal, have been reported through post-marketing experience. Use ARX-SUNITINIB with caution in patients who are at risk for, or who have a history of, these events. ARX-SUNITINIB should be used with caution in patients with a known history of QT interval prolongation, patients who are taking other drugs known to prolong the QT interval, or with relevant pre-existing cardiac disease, bradycardia, or electrolyte disturbances. Hypertension was a very common adverse reaction reported in clinical trials. Severe hypertension (greater than 200 mmHg systolic or 110 mmHg diastolic) occurred in 4.7% of the 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. Hepatotoxicity has been observed in patients treated with ARX-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 ARX-SUNITINIB is contraindicated in patients with hypersensitivity to sunitinib malate or to any other component of ARX-SUNITINIB capsules.

Regulatory history

ARX-SUNITINIB was first listed on the ARTG (Australian Register of Therapeutic Goods) on 22 February 2021 for all four strengths (12.5 mg, 25 mg, 37.5 mg and 50 mg).