MIRAPEX For Patients and Caregivers

Safety and Tolerability

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Adverse Events

Most patients who take MIRAPEX for moderate-to-severe primary RLS tolerate it well. MIRAPEX has been evaluated for safety in 889 patients, including 427 treated for over 6 months and 75 for over 1 year.9

The main safety appraisal centers on the results of 3 double-blind, placebo-controlled clinical trials involving 575 patients receiving MIRAPEX for RLS for up to 12 weeks.

Treatment-Emergent Adverse Events for MIRAPEX and Placebo in 3 Double-Blind, Placebo-Controlled Trials*

*Occurring in ≥2% of patients taking MIRAPEX and occurring numerically more frequently than in the placebo group.

The most common adverse events in these trials were nausea, headache, and tiredness, occurring in 5% or more of MIRAPEX-treated patients and happening at twice the rate of placebo. However, incidents of nausea and somnolence were generally mild and transient.

It should be noted that these results cannot be used to predict the incidence of adverse events during the course of usual medical practice where a variety of factors differ from those in the clinical trials.

Warnings


Precautions

Renal


Retinal Pathology in Albino Rats


Fibrotic Complications


Melanoma


Impulse Control/Compulsive Behaviors


Augmentation and Rebound

Reports in the literature indicate that the treatment of restless legs syndrome (RLS) with dopaminergic agents may result in 2 separate phenomena known as augmentation and rebound.

Helpful resources to better educate your patients about Restless Legs Syndrome (RLS) and MIRAPEX. Find out more

Helpful resources to better educate your patients about Restless Legs Syndrome (RLS) and MIRAPEX. Find out more [link to: 13.0]

Helpful resources to better educate your patients about Restless Legs Syndrome (RLS) and MIRAPEX. Find out more

Healthcare professionals and patients agree—MIRAPEX can help relieve the symptoms of primary Restless Legs Syndrome (RLS). Learn more

Healthcare professionals and patients agree—MIRAPEX can help relieve the symptoms of primary Restless Legs Syndrome (RLS). Learn more

Healthcare professionals and patients agree—MIRAPEX can help relieve the symptoms of primary Restless Legs Syndrome (RLS). Learn more

IMPORTANT SAFETY INFORMATION ABOUT MIRAPEX: MIRAPEX tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

MIRAPEX may cause patients to fall asleep without any warning, even while doing normal daily activities, such as driving. When taking MIRAPEX, hallucinations may occur and sometimes patients may feel dizzy, sweaty or nauseated upon standing up. The most common side effects in clinical trials for RLS were nausea, headache, and tiredness. Patients should talk with their doctor if they experience these problems.

Patients and caregivers should be informed that impulse control disorders/compulsive behaviors may occur while taking medicines, including pramipexole, to treat Parkinson's disease and RLS.

This information is intended for U.S. residents only. Products discussed herein may have different labeling in different countries.

Please see full Prescribing Information, including patient information.

If you can't afford your MIRAPEX, our patient assistance program may be able to help. Call 1-800-556-8317

If you can't afford your MIRAPEX, our patient assistance program may be able to help. Call 1-800-556-8317