Neupro Adverse Reactions

Summary of the safety profile: Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 1,307 Neupro- and 607 placebo-treated patients, 72.5% of the patients on Neupro and 58.0% of patients on placebo reported at least one adverse reaction.
At the beginning of therapy dopaminergic adverse reactions such as nausea and vomiting may occur. These are usually mild or moderate in intensity and transient even if treatment is continued.
Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Neupro transdermal patch are nausea, vomiting, application site reactions, somnolence, dizziness and headache.
In trials where the application sites were rotated as reflected in the instructions provided in SmPC and package leaflet, 35.7% of 830 patients using the Neupro transdermal patch, experienced application site reactions. The majority of application site reactions were mild or moderate in intensity, limited to the application areas and resulted in discontinuation of treatment with Neupro in only 4.3% of all subjects receiving Neupro.
Tabulated list of adverse reactions: The following table covers adverse drug reactions from the pooled studies mentioned previously in patients with Parkinson's disease. Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. (See table.)

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Description of selected adverse reactions: Sudden onset of sleep and somnolence: Rotigotine has been associated with somnolence including excessive daytime somnolence and sudden sleep onset episodes. In isolated cases "sudden onset of sleep" occurred while driving and resulted in motor vehicle accidents (see also Precautions).
Impulse control disorders: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including rotigotine (see Precautions).
Special populations: Adverse reactions of increased creatine phosphokinase (CPK) were observed with rotigotine in clinical studies conducted in Japan. These occurred in 3.4% of Japanese subjects on rotigotine compared to 1.9% on placebo in double-blind Parkinson's disease studies. The majority of the adverse reactions of increased CPK observed in all double-blind and open-label studies resolved and were considered mild in severity. CPK levels have not been routinely measured in other populations.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.