About MIRAPEX

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MIRAPEX, for moderate-to-severe primary RLS

MIRAPEX was originally approved for the treatment of Parkinson's disease; however, it was later found to be efficacious in the treatment of primary RLS.

How should MIRAPEX be prescribed to treat RLS?

The recommended starting dose is 0.125 mg taken once daily 2 to 3 hours before bedtime. For patients requiring additional symptomatic relief, the dose may be increased every 4 to 7 days. Although the dose of MIRAPEX tablets was increased to 0.75 mg in some patients during long-term open-label treatment, there is no evidence in controlled clinical trials that the 0.75 mg dose provides additional benefit beyond the 0.5 mg dose.

MIRAPEX should be taken every day, even if RLS symptoms do not occur
MIRAPEX can be taken with or without food. Taking MIRAPEX with food may reduce the chance of nausea⁹
If a dose of MIRAPEX is missed, the next dose should not be doubled⁹

MIRAPEX is indicated for the treatment of moderate-to-severe primary RLS. Pramipexole dihydrochloride, the active ingredient in MIRAPEX, is a nonergot dopamine agonist with full intrinsic activity at the D2 subfamily of dopamine receptors, binding with higher affinity to D3 than to D2 or D1 receptor subtypes.

Important facts about MIRAPEX:

The most commonly observed adverse events with MIRAPEX in the treatment of RLS were nausea, headache, and tiredness. Occurrences of nausea and somnolence in clinical trials were generally mild and transient⁹
Patients treated with MIRAPEX have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles which sometimes resulted in accidents. Prescribers should continually reassess patients for drowsiness or sleepiness, especially since some of the events occur well after the start of treatment. Prescribers should also be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities⁹
Dopamine agonists, in clinical trials and clinical experience, may be associated with impairment of the systemic regulation of blood pressure, with resulting orthostatic hypotension, especially during dose escalation. Both Parkinson's disease patients and RLS patients being treated with dopaminergic agonists ordinarily require careful monitoring for signs and symptoms of orthostatic hypotension, especially during dose escalation, and should be informed of this risk⁹
In clinical trials, patients with RLS treated with pramipexole rarely reported hallucinations⁹

Who should not take MIRAPEX?

Patients should not take MIRAPEX if they are allergic to pramipexole or any of the inactive ingredients in MIRAPEX.

Clinical Terminology

A glossary is available to assist healthcare professionals when making a diagnosis for Restless Legs Syndrome (RLS). Clinical terminology

Learn more about clinical evaluation in the diagnosis of Restless Legs Syndrome (RLS)

Learn more about clinical evaluation in the diagnosis of RLS

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.