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First assessment of individual RLS domains in new post-hoc analyses of Neupro® studies
Date:4/25/2012

tion. Neupro® should be used with caution in patients with severe cardiovascular disease.

Case reports suggest that patients can experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge eating, and other intense urges, and the inability to control these urges while taking medications, including Neupro®, that increase central dopaminergic tone and that are generally used for the treatment of Parkinson's disease. Patients should be monitored for the development of new or increased urges while being treated with Neupro®. Dose reduction or discontinuation of Neupro® should be considered if such urges develop.

Neupro® may increase the dopaminergic side effects of levodopa and may cause and/or exacerbate pre-existing dyskinesia. In clinical trials for the highest recommended Neupro® dose, the incidence of the treatment difference between Neupro® and placebo for dyskinesia was 7% for advanced-stage Parkinson's disease, and this difference increased with increasing dose.

Neupro® can cause application site reactions, and some may be severe. In clinical trials for the highest recommended Neupro® dose, the incidence of the treatment difference between Neupro® and placebo for application site reactions was 15% for early-stage Parkinson's disease, 23% for advanced-stage Parkinson's disease, and 39% for Restless Legs Syndrome. Most reactions were mild or moderate in intensity and were limited to the patch area.

Patients with Parkinson's disease have a higher risk of developing melanoma than the general population. Patients should be monitored for melanomas frequently when using Neupro®.
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