NEUPRO is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome.
IMPORTANT SAFETY INFORMATION
NEUPRO contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people and is seen more frequently in people with asthma.
Patients treated with NEUPRO have reported somnolence and falling asleep without warning signs during activities of daily living, including driving, which sometimes resulted in accidents. Some patients believed they were alert immediately prior to the event. Patients may not recognize or acknowledge increased drowsiness or sleepiness. Therefore, prescribers should directly question patients about these possible occurrences and continually reassess patients, as some events have been reported well after the start of treatment. Patients should be advised to exercise caution while driving, operating heavy machinery, or working at heights during treatment with NEUPRO. If patients develop daytime sleepiness or episodes of falling asleep during activities of daily living, NEUPRO should
Patients may experience new or worsening mental status and behavioral changes, which may be severe, including psychotic behavior during NEUPRO treatment or after starting or increasing the dose of NEUPRO.
NEUPRO may cause symptomatic postural/orthostatic hypotension. Patients treated with dopamine agonists require careful monitoring for signs and symptoms of postural hypotension, especially during dose escalation, and should be informed of this risk. NEUPRO may also cause syncope, elevated blood pressure, and elevated heart rate. These events should be considered when treating patients with cardiovascular disease or concomitant illness.
Patients may 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. Because patients may not recognize these behaviors as abnormal, prescribers should specifically ask patients and their caregivers about 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 can cause application site reactions, and some may be severe. In clinical trials, most reactions were mild or moderate in intensity and were limited to the patch area.
Use of dopaminergic medications, including NEUPRO, may cause augmentation and rebound.
NEUPRO should be removed before magnetic resonance imaging or cardioversion, because the aluminum backing layer in the patch could cause skin burns. Heat application has been shown to increase absorption several fold with other transdermal products. Therefore, patients should be advised to avoid exposing the application site to sources of direct heat, such as heating pads or electric blankets, heat lamps, saunas, hot tubs, heated water beds, and prolonged direct sunlight.
The most common adverse reactions (at least 5% greater than placebo) for NEUPRO in the treatment of Restless Legs Syndrome are application site reactions, nausea, disturbances in initiating and maintaining sleep, somnolence, and headache.
To report suspected adverse reactions, contact UCB, Inc. at UCBCares™ (1-844-599-2273) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.