Neupro - rotigotine

What is Neupro?

Neupro is a range of transdermal patches (i.e. based on the principle of administering the medicine through the skin). Each patch releases 1, 2, 3, 4, 6 or 8 mg of the active ingredient
rotigotine in the arc of the briefcase.

What is Neupro used for?

Neupro is used to treat the symptoms of the following diseases in adults:

• Parkinson's disease. Neupro is used alone in the early stages of the disease or in combination with levodopa (another medicine used in Parkinson's disease), at any stage of the disease, including terminal stages when levodopa begins to lose its effectiveness;
• moderate to severe restless legs syndrome, a disorder in which the patient feels an uncontrollable need to move the limbs to cushion an uncomfortable, painful or abnormal sensation in the body, usually at night. Neupro is used where the specific cause of the disorder cannot be identified.

The medicine can only be obtained with a prescription.

How is Neupro used?

Neupro is applied once a day, at approximately the same time each day. The patch should be applied to clean, dry and intact skin, around the abdomen (belly), thighs, hips, hips, shoulders or upper arm. The patch remains in contact with the skin for 24 hours and is subsequently replaced by a new patch placed in a different site. Avoid reapplication at the same administration site for 14 days.
In the early stage of Parkinson's disease, the starting dose is 2 mg / 24 h; the dose is increased weekly by 2 mg / 24 h until the effective dose is reached or up to a maximum of 8 mg / 24 h. In most patients, the effective dose is reached within three to four weeks.
For patients starting therapy there is a special pack containing four different strengths. If the medicine is not enough to control the disease, switching to another similar medicine may be of benefit. In advanced disease, the starting dose is 4 mg / 24 h, then increased every week by 2 mg / 24 h until the effective dose is reached or a maximum of 16 mg / 24 h. The application of certain doses may require more than one patch. For restless legs syndrome, the starting dose is 1 mg / 24 h. Depending on the patient's response, the dose may be increased each week by 1 mg / 24 h. 24 h until effective dose is reached or up to a maximum of 3 mg / 24 h The need for continued treatment should be evaluated by a physician every six months.

How does Neupro work?

The active ingredient in Neupro, rotigotine, is a dopamine agonist, which means that it mimics the action of dopamine. Dopamine is a substance responsible for transmitting messages, contained in the brain districts that control movement and coordination. In patients affected by the disease. Parkinson's disease, the cells that produce dopamine begin to die, resulting in a decrease in the amount of dopamine present in the brain. Patients therefore lose the ability to reliably control their movements. Neupro transfers a constant amount to the blood through the skin Rotigotine subsequently stimulates the brain as does dopamine, allowing patients to control their movements and minimize the signs and symptoms of Parkinson's disease including stiffness and slowed movement.
In restless legs syndrome, it is not fully known how rotigotine works. This syndrome is thought to be due to problems related to the way dopamine works in the brain, which can be improved by rigotine.

How has Neupro been studied?

The efficacy of Neupro in treating the early stages of Parkinson's disease was examined
in two studies involving a total of 830 patients. The studies measured the scores obtained, before and after treatment, in a standard questionnaire called Unified Parkinson's Disease Rating Scale (UPDRS, clinical reference scale for the quantification of motor disability and functional loss in Parkinson's disease). A 20% improvement in the post-treatment score was taken as an indicator of benefits that could be considered relevant to patients. In the first study, the efficacy of Neupro was compared to that of placebo (a dummy treatment), while in the second study it was compared with ropinirole (another dopamine agonist) and placebo. In the advanced stage of the disease, Neupro is It was studied in two studies involving a total of 842 patients. The measure of effectiveness was the length of the "gap within a day" in which patients felt "out of the game" (too many Parkinson's disease symptoms to live normally). In the first study, the effectiveness of two different doses of Neupro was compared to that of placebo. In the second study, the comparison was with pramipexole (another dopamine agonist) and placebo.
For restless legs syndrome, Neupro has been observed in two main studies involving a total of 963 patients with moderate to severe syndrome. The efficacy of the medicine, in doses of 0.5 to 3 mg / 24 h, was compared with placebo. The main measure of efficacy was the change in symptoms between the start of the study and after six months of treatment with a constant dose, measured according to two clinical reference scales.

What benefit has Neupro shown during the studies?

Neupro was more effective than placebo in treating Parkinson's disease. In the early stage of the disease, UPDRS scores obtained with Neupro showed an improvement compared to placebo. A 20% improvement in scores was found in 48-52% of patients treated with Neupro and in 19-30% of patients. those treated with placebo. Neupro was less effective than ropinirole: an improvement of 20% was seen in 68% of patients treated with ropinirole. In advanced disease, patients treated with Neupro experienced a greater reduction in intervals " out of the game "compared to those taking placebo (a decrease of 2.1-2.7 hours with Neupro versus 0.9 with placebo). The decrease with pramipexole was 2.8 hours.
For restless legs syndrome, patients given Neupro doses of 1 to 3 mg / 24 h reported more marked improvement than those who received placebo in the two studies, as seen by both studies. reference scales.

What is the risk associated with Neuro?

The most frequent side effects seen with Neupro in patients with Parkinson's disease (seen in more than 1 in 10 patients) are sleepiness, dizziness, nausea and application site reactions such as irritation and burning of the skin. In patients with restless legs syndrome the most common side effects (seen in more than 1 in 10 patients) are nausea, application site reactions, fatigue and headache. To limit skin reactions it is important to follow the patch instructions. Sleepiness may impair the patient's ability to drive. For the full list of side effects reported with Neupro, see the package leaflet.
Neupro must not be used in people who may be hypersensitive (allergic) to rotigotine or any of the ingredients. The reinforcement layer of Neupro contains aluminum. To avoid skin burns, Neupro must be removed if the patient is to undergo nuclear magnetic resonance imaging (MRI) or cardioversion (a process that restores normal heart rhythm). For the complete list of restrictions on use, see the package leaflet.

Why has Neupro been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Neupro's benefits in the symptomatic treatment of moderate to severe idiopathic restless legs syndrome in adult patients and for the treatment of the signs and symptoms of idiopathic Parkinson's disease are greater. at its risks.
The committee therefore recommended that Neupro be given a marketing authorization.

What measures are being taken to ensure the safe use of Neupro?

The company that makes Neupro is carrying out a study of some of the side effects of the medicine seen with similar medicines (fits of sleepiness and development of hard tissue in the valves of the heart).

Other information about Neupro:

On February 15, 2006, the European Commission granted Schwarz Pharma Ltd. a "Marketing Authorization" for Neupro, valid throughout the European Union.
For the complete version of the Neupro EPAR click here.

Last update of this summary: 07 - 2008

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