NEUPRO

What it is

Neupro is a transdermal patch containing rotigotine, available in strengths of 1 mg, 2 mg, 3 mg, 4 mg, 6 mg and 8 mg with nominal release rates of 1 mg, 2 mg, 3 mg, 4 mg, 6 mg and 8 mg rotigotine per 24 hours respectively. Neupro is a thin, matrix-type transdermal patch composed of three layers: a flexible, tan-coloured backfilm providing structural support; a self-adhesive drug matrix layer; and a clear protective liner which is removed prior to use. Rotigotine is a non-ergolinic dopamine receptor agonist.

Approved indications

— Treatment of idiopathic Parkinson's disease from early stage to advanced disease, as monotherapy or in combination with levodopa. — Symptomatic treatment of moderate to severe idiopathic restless legs syndrome in adults.

Dosing overview

Neupro is applied once a day at approximately the same time every day, with the patch remaining on the skin for 24 hours before being replaced at a different site.

Key safety warnings

The backing layer of Neupro contains aluminium and should be removed if the patient requires magnetic resonance imaging or cardioversion to avoid skin burns. Dopamine agonists including Neupro can impair systemic blood pressure regulation resulting in orthostatic hypotension, and blood pressure monitoring is recommended especially at the beginning of treatment. Some patients treated with Neupro have exhibited increases in systolic blood pressure greater than 180 mmHg and/or diastolic blood pressure greater than 105 mmHg, or increased pulse greater than 100 beats per minute, and these findings should be considered when treating patients with cardiovascular disease. Patients treated with Neupro have reported falling asleep while engaged in activities of daily living including operation of motor vehicles, sometimes resulting in accidents, with some patients perceiving no warning signs and some events reported as late as one year after initiation. Patients should exercise caution while driving, operating machines or working at heights, and patients who have experienced somnolence or sudden sleep onset should not participate in these activities. Patients can experience intense urges to gamble, increased sexual urges, intense urges to spend money or buying, binge eating, compulsive eating and/or other intense urges with inability to control them, and dopamine dysregulation syndrome has been observed in some patients. Prescribers should specifically ask patients or caregivers about development of new or increased gambling urges, sexual urges, uncontrolled spending or other urges, and should consider dose reduction or stopping the medication if such urges develop. Abnormal thinking and behaviour have been reported with Neupro, consisting of paranoid ideation, hallucinations, confusion, psychotic-like behaviour, disorientation, aggressive behaviour, agitation, delusions and delirium. Neupro transdermal patches contain sodium metabisulfite, which may cause allergic type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. Patients taking Neupro for early stage and advanced stage Parkinson's disease had higher incidence of substantial weight gain (more than 10% of baseline weight) than placebo, frequently associated with peripheral oedema, suggesting that Neupro may cause fluid retention in some patients.

Contraindications

Hypersensitivity to rotigotine or any excipient. Magnetic resonance imaging or cardioversion.

PBS listing

Neupro is PBS-listed in four patch strengths with restricted access: transdermal patch 4.5 mg (2 items, ex-manufacturer price A$54.06); transdermal patch 9 mg (2 items, ex-manufacturer price A$72.07); transdermal patch 13.5 mg (2 items, ex-manufacturer price A$81.78); and transdermal patch 18 mg (2 items, ex-manufacturer price A$90.93).

Regulatory history

Neupro received initial ARTG registration on 22 November 2007 for the 2 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h transdermal patch formulations. The 1 mg/24 h and 3 mg/24 h strengths were added to the ARTG on 19 October 2010.