Loading…
Leganto is a brand name for Rotigotine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Leganto is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS) in adults.
Verbatim from this product's EMA label. Tap a section to expand.
Posology The dose recommendations made are in nominal dose. A single daily dose should be initiated at 1 mg/24 h. Depending on the individual patient response, the dose may be increased in weekly increments of 1 mg/24 h to a maximum dose of 3 mg/24 h.
The need for treatment continuation should be reconsidered every 6 months. Leganto is applied once a day. The patch should be applied at approximately the same time every day. The patch remains on the skin for 24 hours and will then be replaced by a new one at a different site of application.
Medicinal product no longer authorised 3 Treatment discontinuation Leganto should be discontinued gradually. 4). Following this procedure, rebound (worsening of symptoms beyond initial intensity after discontinuation of treatment) has not been observed.
Special populations Hepatic impairment Adjustment of the dose is not necessary in patients with mild to moderate hepatic impairment. Caution is advised when treating patients with severe hepatic impairment, which may result in lower rotigotine clearance.
Rotigotine has not been investigated in this patient group. A dose reduction might be needed in case of worsening of the hepatic impairment. Renal impairment Adjustment of the dose is not necessary in patients with mild to severe renal impairment, including those requiring dialysis.
2). Paediatric population The safety and efficacy of rotigotine in children and adolescents have not yet been established. 2 but no recommendation on a posology can be made. Method of administration Leganto is for transdermal use. The patch should be applied to clean, dry, intact healthy skin on the abdomen, thigh, hip, flank, shoulder, or upper arm.
Reapplication to the same site within 14 days should be avoided. 4). Use and handling Each patch is packed in a sachet and should be applied directly after the sachet has been opened. One half of the release liner should be removed and the sticky side should be applied and pressed firmly to the skin.
Then, the patch is fold back and the second part of the release liner is removed. The sticky side of the patch should not be touched. The patch should be pressed down firmly with the palm of the hand for about 30 seconds, so that it sticks well.
The patch should not be cut into pieces.
2% of patients on placebo reported at least one adverse reaction. At the beginning of therapy dopaminergic adverse reactions such as nausea and vomiting may occur. These are usually mild or moderate in intensity and transient even if treatment is continued.
Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Leganto are nausea, application site reactions, asthenic conditions and headache. 2% of 748 patients using Leganto, experienced application site reactions.
2% of subjects. Discontinuation rate The discontinuation rate was studied in 3 clinical trials ranging up to 3 years in duration. The percentage of subjects discontinuing was 25-38% over the first year, 10% in the second year, and 11% in the third year.
Periodic assessment of efficacy should be performed, along with evaluation of safety, including augmentation. Tabulated list of adverse reactions The following table covers adverse drug reactions from the pooled studies mentioned above in patients with Restless Legs Syndrome and from post-marketing experience.
Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. System/organ classes acc. to MedDRA Very common Common Uncommon Rare Not known Immune system disorders Hypersensitivity, which may include angioedema, tongue oedema and lip oedema Psychiatric disorders Sleep attacks/sudden onset of sleep, sexual desire disordersa (incl.
hypersexuality, libido increased), insomnia, sleep disorder, abnormal Obsessive- compulsive disorder, agitationd Aggressive behaviour/ aggressionb, disorientationd Dopamine dysregulation syndromec, perception disturbancese (incl. hallucination, hallucination visual, hallucination auditory,Medicinal product no longer authorised 8 dreams, impulse- control disordersa,d (incl.
Magnetic resonance imaging and cardioversion The backing layer of Leganto contains aluminium. To avoid skin burns, Leganto should be removed if the patient has to undergo magnetic resonance imaging (MRI) or cardioversion. Orthostatic hypotension Dopamine agonists are known to impair the systemic regulation of the blood pressure resulting in postural/orthostatic hypotension.
These events have also been observed during treatment with rotigotine, but the incidence was similar to that observed in placebo-treated patients. It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the general risk of orthostatic hypotension associated with dopaminergic therapy.
Syncope In clinical studies with rotigotine, syncope has been observed at a rate that was similar to that observed in patients treated with placebo. Because patients with clinically relevant cardiovascular disease were excluded in these studies, patients with severe cardiovascular disease should be asked about symptoms of syncope and pre-syncope.
Sudden onset of sleep and somnolence Rotigotine has been associated with somnolence and episodes of sudden sleep onset. Sudden onset of sleep during daily activities, in some cases without awareness of any warning signs, has been reported.
Prescribers should continually reassess patients for drowsiness or sleepiness, as patients may not acknowledge drowsiness or sleepiness until directly questioned. A reduction of dosage or termination of therapy should be carefully considered.
Impulse control and other related disorders Patients should be regularly monitored for the development of impulse control disorders and related disorders including dopamine dysregulation syndrome. Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathologic gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists, including rotigotine.
1. Medicinal product no longer authorised 4
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Rotigotine in European Union.
Know a brand we are missing in European Union? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
pathological gambling, stereotypy/ punding, binge eating/eating disorderb, compulsive shoppingc) illusion), nightmaree, paranoiae, confusional statee, psychotic disordere, delusione, deliriume Nervous system disorders Headache Somnolence Dizzinesse, disturbances in consciousness NECe (incl.
syncope, syncope vasovagal, loss of consciousness), dyskinesiae, dizziness posturale, lethargye, convulsione Eye disorders Vision blurrede, visual impairmente, photopsiae Ear and labyrinth disorders Vertigoe Cardiac disorders Palpitationse, atrial fibrillatione, supraventricular tachycardiae Vascular disorders Hypertension Orthostatic hypotension Hypotensione Respiratory, thoracic and mediastinal disorders Hiccupse Gastrointestinal disorders Nausea Vomiting, dyspepsia Constipatione, dry mouthe, abdominal paine, diarrhoeac Skin and subcutaneous tissue disorders Pruritus Erythemae, hyperhidrosise, pruritus generalisede, skin irritatione, dermatitis contacte, rash generalisedeMedicinal product no longer authorised 9 Reproductive system and breast disorder Erectile dysfunctione General disorders and administration site conditions Application and instillation site reactionsa (incl.
erythema, pruritus, irritation, rash, dermatitis, vesicles, pain, eczema, inflammation, swelling, discolouration, papules, exfoliation, urticaria, hypersensitivity), asthenic conditionsa (incl. fatigue, asthenia, malaise) Irritability, oedema peripheral Investigations Weight decreasede, hepatic enzyme increasede (incl.
AST, ALT, GGT), weight increasede, heart rate increasede, CPK increasedd,e Injury, poisoning and procedural complications Falle Musculoskeletal and connective tissue disorders Rhabdomyolysisc a High Level Term b Observed in open-label studies c Observed during post-marketing d Observed in 2011 data pool of double-blind placebo-controlled studies e Observed in studies performed in patients with Parkinson’s disease Description of selected adverse reactions Sudden onset of sleep and somnolence Rotigotine has been associated with somnolence including excessive daytime somnolence and sudden sleep onset episodes.
4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
In some patients, dopamine dysregulation syndrome was observed under the treatment with rotigotine. Dose reduction/tapered discontinuation should be considered if such symptoms develop. Neuroleptic malignant syndrome Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy.
2). 2). Medicinal product no longer authorised 5 Fibrotic complications Cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, pericarditis and cardiac valvulopathy have been reported in some patients treated with ergot-derived dopaminergic agents.
While these complications may resolve when treatment is discontinued, complete resolution does not always occur. Although these adverse reactions are believed to be related to the ergoline structure of these compounds, whether other, nonergot derived dopamine agonists can cause them is unknown.
5). Ophthalmologic monitoring Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur. Heat application External heat (excessive sunlight, heating pads and other sources of heat such as sauna, hot bath) should not be applied to the area of the patch.
Application site reactions Application site skin reactions may occur and are usually mild or moderate in intensity. g. from the right side to the left side and from the upper body to the lower body). The same site should not be used within 14 days.
If application site reactions occur which last for more than a few days or are persistent, if there is an increase in severity, or if the skin reaction spreads outside the application site, an assessment of the risk/benefit balance for the individual patient should be conducted.
If there is a skin rash or irritation from the transdermal system, direct sunlight on the area should be avoided until the skin heals, as exposure could lead to changes in the skin color. g. allergic rash, including erythematous, macular, papular rash or pruritus) associated with the use of Leganto is observed, Leganto should be discontinued.
Peripheral oedema Peripheral oedema has been observed in clinical trials conducted in patients with RLS. Augmentation Augmentation may occur. Augmentation refers to the earlier onset of symptoms in the evening (or even the afternoon), increase in severity of symptoms, and spread of symptoms to involve other body parts.
In long-term clinical studies with rotigotine, the majority of augmentation episodes were seen in the first and second years of treatment. 1). Medicinal product no longer authorised 6