Prescribing Information
See Summary of Product Characteristics (SmPC) before prescribing.
Presentations: Transdermal System: 1 mg/24 hours, 2 mg/24 hours, 3 mg/24 hours, 4 mg/24 hours, 6 mg/24 hours, and 8mg/24 hours of rotigotine. Indication: Parkinson’s Disease (PD) rotigotine is indicated for the treatment of Parkinson’s disease. Restless Legs Syndrome (RLS) rotigotine is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome. Dosage and administration: Early-Stage Parkinson’s Disease In patients with early-stage Parkinson’s disease, the recommended starting dose for rotigotine is 2 mg/24 hours. Based upon individual patient clinical response and tolerability, rotigotine dosage may be increased weekly by 2 mg/24 hours if additional therapeutic effect is needed. The lowest effective dose is 4 mg/24 hours. The maximum recommended dose for early-stage Parkinson’s disease is 6 mg/24 hours. Advanced-Stage Parkinson’s Disease In patients with advanced-stage Parkinson’s disease, the recommended starting dose for rotigotine is 4 mg/24hours. Based upon individual patient clinical response and tolerability, rotigotine dosage may be increased weekly by 2 mg/24 hours if additional therapeutic effect is needed. The maximum recommended dose for advanced-stage Parkinson’s disease is 8 mg/24 hours. Dosage in Restless Legs Syndrome In patients with Restless Legs Syndrome, the recommended starting dose for rotigotine is 1 mg/24 hours. Based upon individual patient clinical response and tolerability, rotigotine dosage may be increased weekly by 1mg/24 hours if additional therapeutic effect is needed. The lowest effective dose is 1 mg/24 hours. The maximum recommended dose is 3 mg/24 hours. Method of Administration Rotigotine is applied once a day. The adhesive side of the transdermal system should be applied to clean, dry, intact healthy skin on the front of the abdomen, thigh, hip, flank, shoulder, or upper arm. The transdermal system should be applied at approximately the same time every day, at a convenient time for the patient. Because rotigotine is administered transdermally, food is not expected to affect absorption, and it can be applied irrespective of the timing of meals. The application site for rotigotine should be moved daily (for example, from the right side to the left side and from the upper body to the lower body). Rotigotine should not be applied to the same application site more than once every 14 days and should not be placed on skin that is oily, irritated, or damaged, or where it will be rubbed by tight clothing. If it is necessary to apply rotigotine to a hairy area, the area should be shaved at least 3 days prior to rotigotine application. The system should be applied immediately after opening the pouch and removing the protective liner. The system should be pressed firmly in place for 30 seconds, making sure there is good contact, especially around the edges. If the patient forgets to replace rotigotine, or if the transdermal system becomes dislodged, another transdermal system should be applied for the remainder of the day. The prescribed dose may be achieved using single or multiple patches. Special populations: Pregnancy: Based on animal data, may cause fetal harm. Safety and effectiveness in paediatric patients for any indication have not been established. Geriatric Use of patients receiving rotigotine in clinical studies for the treatment of Parkinson’s disease, approximately 50% were age 65 and over, and approximately 11% were age 75 and over. Among patients receiving rotigotine in clinical studies for the treatment of RLS, 26% were age 65 and over. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No overall differences in plasma levels of rotigotine were observed between patients who were 65 to 80 years old compared with younger patients receiving the same rotigotine doses. Common Adverse Reactions: Parkinson’s disease: Most common adverse reactions (at least 5% greater than placebo) were nausea, vomiting, somnolence, application site reactions, dizziness, anorexia, disturbances in initiating and maintaining sleep, hyperhidrosis, visual disturbance, peripheral edema, and dyskinesia. Restless Legs Syndrome: Most common adverse reactions (at least 5% greater than placebo) were application site reactions, nausea, disturbances in initiating and maintaining sleep, somnolence, and headache. (Please consult the full SmPC for other adverse reactions.) Contraindications: History of hypersensitivity to rotigotine or components of the transdermal patch. Warnings and Precautions: Falling asleep during activities of daily living, including the operation of motor vehicles, and somnolence may occur. Hallucinations/psychosis and dyskinesia may occur. Symptomatic postural hypotension and syncope may occur, especially during dose escalation. Consider dose reduction or stopping rotigotine if patient develops compulsive behaviours. Elevation of blood pressure and heart rate may occur. Application site reactions can occur and may be severe. Hyperpyrexia and confusion may occur with sudden discontinuation or dose reduction. Other warnings and precautions for discontinuation of rotigotine in patients with Parkinson’s disease, reduce the daily dose by a maximum of 2mg every 24 hours preferably every other day, until complete withdrawal of rotigotine is achieved. For discontinuation of rotigotine in patients with Restless Legs Syndrome, reduce the daily dose by 1 mg every 24 hours preferably every other day, until complete withdrawal of rotigotine is achieved. Interactions: Refer to the SmPC for full details. Dopamine antagonists, such as antipsychotics or metoclopramide, may diminish the effectiveness of rotigotine. Rotigotine and other medicines may affect each other causing side effects. Rotigotine may affect the way other medicines work, and other medicines may affect how rotigotine works. Especially tell your doctor if you take other medicines that can make you sleepy such as sleep medicines, antidepressants, or antipsychotics. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. Effects on ability to drive and use machines: Parkinsons disease may cause gradual impairment of driving performance or compromise the ability to use machines. Marketing Authorisation Number and Basic NHS Price: Rotigotine Luye transdermal patches; 28 patches 1mg/24hrs PLGB 50827/0031 £77.24, 2mg/24hrs PLGB 50827/0032 £81.10, 3mg/24hrs PLGB 50827/0033, £102.35 4mg/24hrs PLGB 50827/0034 £123.60, 6mg/24hrs PLGB 50827/0035 £149.93, 8mg/24hrs PLGB 50827/0036 £149.93. Marketing Authorization Holder: Luye Pharma Ltd 40 Occam Road, Guildford, GU2 7YG, United Kingdom. Legal Category: POM. Further information: Luye Pharma Ltd., 40 Occam Road, Guildford, GU2 7YG. info@luyepharma.co.uk Date of preparation: March 2025. Item number: UK-ROT-1
Adverse events should be reported
Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/.
Adverse events should also be reported to Luye Pharma Ltd at safety@luyepharma.co.uk.