What is Leganto - rotigotine?
Leganto is a range of transdermal patches (a type of patch that allows a medicine to be administered through the skin). Each patch releases 1, 2, 3, 4, 6 or 8 mg of the active ingredient, rotigotine, over a 24 hour period.
The medicine is identical to Neupro, which is already authorized in the European Union (EU). The pharmaceutical company that makes Neupro has agreed that its scientific data are used for Leganto ("informed consent").
What is Leganto used for?
Leganto is indicated in adults to treat the symptoms of the following diseases:
Parkinson's disease. Leganto is used on its own in the early stage of the disease or in combination with levodopa (another medicine used in Parkinson's disease) at any stage of the disease, including the most advanced when levodopa begins to lose its effectiveness;
Moderate to severe restless legs syndrome (a disorder that prompts you to move your legs uncontrollably to stop feelings of discomfort, pain or discomfort in your body, especially at night). Leganto is used when the disorder is not attributable to a specific cause.
The medicine can only be obtained with a prescription.
How is Leganto used - rotigotine?
Leganto is applied once a day, at approximately the same time each day. The patch should be applied to dry, clean and healthy skin, around the abdomen (belly), thighs, hips, hips, shoulders or upper arms. The patch remains in contact with the skin for twenty-four hours, after which it is replaced with a new patch to be affixed to a different application site. Reapplication at the same site should be avoided for two weeks. At the start of therapy, the dosage of the patch depends on the type of disease being treated and its stage of progression. The dose can then be increased weekly until the effective dose is reached. A special pack with patches of four different strengths is available for Facilitate initiation of therapy for early-stage Parkinson's disease. In patients with early-stage Parkinson's disease, the maximum dose is 8 mg / 24 h, while for advanced patients it can be increased up to 16 mg / 24 h. In restless legs syndrome, the maximum dose is 3 mg / 24 h.
How does Leganto - rotigotine work?
The active ingredient in Leganto, rotigotine, is a dopamine agonist (meaning it mimics the action of dopamine). Dopamine is a messenger substance contained in the brain areas that control movement and coordination. In patients with Parkinson's disease involves a loss of the cells that produce dopamine, therefore a reduction in the amount of this substance present in the brain. This leads to a deterioration of the individual's ability to control his movements reliably. Through the skin, Leganto releases a constant amount of rotigotine into the blood. By stimulating the brain in a similar way to dopamine, rotigotine helps control movement and relieves the signs and symptoms of Parkinson's disease (such as stiffness and slowed movement). The mechanism of action of rotigotine in restless legs syndrome is not yet fully understood. It is believed that this syndrome is caused by alterations in the functioning of dopamine in the brain, which can be improved with rotigotine.
How has Leganto - rotigotine been studied?
In Parkinson's disease, Leganto was compared with placebo (a dummy treatment) in four studies involving 830 early-stage patients and 842 advanced-stage patients. Two of these studies also compared Leganto with other dopamine agonists (ropinirole for early stage patients and pramipexole for advanced stage patients). Early stage studies looked at the number of patients with symptom improvement of at least 20%, as measured by a standardized questionnaire. The late stage studies measured the length of time intervals "off" throughout the day (ie when symptoms of Parkinson's disease were such that they did not allow for a normal life). For moderate to restless legs syndrome. severe, Leganto has been compared with placebo in two main studies involving 963 patients. The main measure of effectiveness was the change in symptoms between study initiation and after six months of constant dose therapy, measured as a function of two clinical reference scales.
What benefit has Leganto - rotigotine shown during the studies?
Leganto was found to be more effective than placebo in treating Parkinson's disease. In early-stage disease, 48-52% of patients treated with Leganto reported an improvement in symptoms compared with 19-30% of those treated with placebo. Leganto was less effective than ropinirole: patients treated with ropinirole reported an improvement in 70% of cases. In advanced Parkinson's disease, patients treated with Leganto experienced a greater decrease in "off" time intervals than those taking placebo (a decrease of 2.1-2.7 hours with Leganto, compared to 0, 9 hours with placebo). The decrease observed with Leganto was similar to that observed with pramipexole (2.8 hours).
In the two studies conducted in restless legs syndrome, patients treated with Leganto doses of 1 to 3 mg / 24 h reported a more significant improvement than those who received placebo, as seen by both reference scales.
What are the risks associated with Leganto - rotigotine?
The most frequent side effects (seen in more than 1 in 10 patients) seen with Leganto in patients with Parkinson's disease are sleepiness, dizziness, headache, nausea, vomiting and application site reactions such as redness, itching and skin irritation. . In patients with restless legs syndrome, the most common side effects (seen in more than 1 in 10 patients) are nausea, application site reactions, asthenic conditions (i.e. fatigue, weakness and malaise) 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 Leganto, see the package leaflet. Leganto must not be used in people who may be hypersensitive (allergic) to rotigotine or any of the other ingredients. The backing layer of Leganto contains aluminum. To avoid skin burns, Leganto must be removed before undergoing magnetic resonance imaging (MRI) or cardioversion (a process that restores normal heart rhythm).
Why has Leganto - rotigotine been approved?
The CHMP decided that Leganto's benefits are greater than its risks and recommended that it be given a Marketing Authorization for the medicine.
Other information about Leganto - rotigotine
On June 16, 2011, the European Commission granted Schwarz Pharma Ltd a "Marketing Authorization" for Leganto, valid throughout the European Union. The "Marketing Authorization" is valid for five years, after which it can be renewed.
For more information on Leganto therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 04-2011.
The information on Leganto - rotigotine published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
