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U.S. Department of Health and Human Services

Safety

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Neupro (Rotigotine) Transdermal System

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Falling Asleep During Activities of Daily Living and Somnolence

  • Patients with early and advanced Parkinson’s disease and with Restless Legs Syndrome treated with Neupro have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents...
 
Hallucinations/Psychotic-Like Behavior
  • There was an increased risk for hallucinations in patients with advanced-stage Parkinson's disease treated with Neupro. For the highest recommended Neupro dose, the incidence of the treatment difference (Neupro % - Placebo %) for hallucinations was 4% for patients with advanced-stage Parkinson’s disease, and this difference increased with increasing dose…
 
Symptomatic Hypotension
  • Dopaminergic agonists, in clinical studies and clinical experience, appear to impair the systemic regulation of blood pressure, resulting in postural/orthostatic hypotension, especially during dose escalation. Parkinson's disease patients, in addition, appear to have an impaired capacity to respond to a postural challenge.
 
Impulse Control/Compulsive Behavior
  • Case reports suggest that patients can experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge eating, and/or other intense urges, and the inability to control these urges while taking one or more of the medications, including Neupro, that increase central dopaminergic tone and that are generally used for the treatment of Parkinson’s disease…
 
Elevation of Blood Pressure And Heart Rate
  • Mild-moderate increases in systolic blood pressure (> 20 mm Hg) and in diastolic blood pressure (> 10 mm Hg) occurred more frequently (Neupro % > 5 % greater than placebo %) in all patients (i.e., early and advanced-stage Parkinson's disease and Restless Legs Syndrome) with the highest recommended Neupro dose…
  • In the placebo-controlled trials, there was an increased risk for hypertension as an adverse reaction with the highest recommended dose for advanced…
 
Augmentation and Rebound in RLS
  • Augmentation is a worsening of RLS symptoms during treatment, leading to an increase in overall symptom severity or earlier time of symptom onset each day compared to before initiation of treatment. Dopaminergic medicinal products, including rotigotine, may result in augmentation.
  • Rebound, an exacerbation of RLS symptoms, is considered to be an end of dose effect, related to the half-life of the therapeutic agent. Reports in the published literature indicate discontinuation or wearing off of dopaminergic medications can result in rebound.