Rotigotine

Rotigotine is a non-ergoline dopamine agonist. The precise mechanism of action of rotigotine as a treatment for Parkinson's disease is unknown, although it is thought to be related to its ability to stimulate dopamine receptors within the caudate-putamen in the brain.

• NEUPRO is a dopamine agonist indicated for the treatment of: Parkinson's disease ( 1.1 ) Moderate-to-severe primary Restless Legs Syndrome ( 1.2 ) 1.1 Parkinson's Disease (PD) NEUPRO is indicated for the treatment of Parkinson's disease. 1.2 Restless Legs Syndrome (RLS) NEUPRO is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome.ICD-10: G20, G25.81

• NEUPRO is contraindicated in patients who have demonstrated hypersensitivity to rotigotine or the components of the transdermal system. History of hypersensitivity to rotigotine or components of the transdermal patch.contraindicated

Parkinson's disease: Initially, 2 mg/24 hours for early-stage disease or 4 mg/24 hours for advanced-stage disease. The dose may be increased as needed by 2 mg/24 hours at weekly intervals, up to 6 mg/24 hours for early-stage disease and up to 8 mg/24 hours for advanced-stage disease. ( 2.1 ) Restless Legs Syndrome: Initially, 1 mg/24 hours, increased as needed by 1 mg/24 hours at weekly intervals, up to 3 mg/24 hours. ( 2.2 ) Apply once a day to the skin; press firmly in place for 30 seconds. Do not place NEUPRO on oily, irritated, or damaged skin, or where it will be rubbed by tight clothing. Do not use the same site more than once every 14 days. The prescribed dose may be achieved using single or multiple patches. ( 2.3 ) To discontinue treatment, reduce the dose gradually until complete withdrawal of NEUPRO. ( 2.4 ) 2.1 Dosage in Parkinson's Disease Early-Stage Parkinson's Disease In patients with early-stage Parkinson's disease, the recommended starting dose for NEUPRO is 2 mg/24 hours. Based upon individual patient clinical response and tolerability, NEUPRO 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 NEUPRO is 4 mg/24 hours.

Contains sodium metabisulfite that may cause allergic-type reactions in those with sulfite sensitivity. ( 5.1 ) Falling asleep during activities of daily living, including the operation of motor vehicles, and somnolence may occur. ( 5.2 ) Hallucinations/psychosis and dyskinesia may occur. ( 5.3 , 5.9 ) Symptomatic postural hypotension and syncope may occur, especially during dose escalation. ( 5.4 , 5.5 ) Consider dose reduction or stopping NEUPRO if patient develops compulsive behaviors. ( 5.6 ) Elevation of blood pressure and heart rate may occur. ( 5.7 ) Application site reactions can occur and may be severe. ( 5.10 ) Hyperpyrexia and confusion may occur with sudden discontinuation or dose reduction. ( 5.14 ) 5.1 Sulfite Sensitivity NEUPRO contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. 5.2 Falling Asleep During Activities of Daily Living and Somnolence Patients with early- and advanced-stage Parkinson's disease and with Restless Legs Syndrome treated with NEUPRO have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents.

The following serious adverse reactions are discussed below and elsewhere in the labeling: Sulfite Sensitivity [see Warnings and Precautions (5.1) ] Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions (5.2) ] Hallucinations/Psychosis [see Warnings and Precautions (5.3) ] Symptomatic Hypotension [see Warnings and Precautions (5.4) ] Syncope [see Warnings and Precautions (5.5) ] Impulse Control/Compulsive Behaviors [see Warnings and Precautions (5.6) ] Elevation of Blood Pressure and Heart Rate [see Warnings and Precautions (5.7) ] Weight Gain and Fluid Retention [see Warnings and Precautions (5.8) ] Dyskinesia [see Warnings and Precautions (5.9) ] Application Site Reactions [see Warnings and Precautions (5.10) ] Augmentation and Rebound in RLS [see Warnings and Precautions (5.11) ] Hyperpyrexia and Confusion [see Warnings and Precautions (5.14) ] Withdrawal Symptoms [see Warnings and Precautions (5.15) ] Fibrotic Complications [see Warnings and Precautions (5.16) ] 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. ( 6.1 ) 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc.

Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 ) 8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of NEUPRO in pregnant women. In animal studies, rotigotine was shown to have adverse effects on embryofetal development when administered during pregnancy at doses similar to or lower than those used clinically [ see Data ]. In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage in the indicated population is unknown. Data Animal Data Rotigotine administered subcutaneously (0, 10, 30, or 90 mg/kg/day) to pregnant mice during organogenesis (gestation days 6 through 15) resulted in increased incidences of delayed skeletal ossification and decreased fetal body weights at the two highest doses and an increase in embryofetal death at the high dose. The no-effect dose for embryofetal developmental toxicity in mice is approximately 6 times the maximum recommended human dose (MRHD) for Parkinson's disease (8 mg/24 hours) on a body surface area (mg/m 2 ) basis.

Metabolism

On average, approximately 45% of the rotigotine from the patch is released within 24 hours (0.2 mg/cm 2 ). Rotigotine is primarily eliminated in the urine as inactive conjugates.

10.1 Overdose Symptoms The most likely symptoms of overdose would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hypotension, involuntary movements, hallucinations, confusion, convulsions, and other signs of excessive dopaminergic stimulation. 10.2 Overdose Management There is no known antidote for overdosage of dopamine agonists. In case of suspected overdose, the excess transdermal system(s) should immediately be removed from the patient. Concentrations of rotigotine decrease after patch removal. The terminal half-life of rotigotine is 5 to 7 hours. The pharmacokinetic profile showed a biphasic elimination with an initial half-life of 3 hours. The patient's heart rate, heart rhythm, and blood pressure should be monitored. As shown in a study of renally impaired patients, dialysis is not expected to be beneficial. Treatment of overdose may require general supportive measures to maintain vital signs. If it is necessary to discontinue use of rotigotine after overdose, it should be discontinued gradually to prevent hyperpyrexia and confusion [see Dosage and Administration (2.4) and Warnings and Precautions (5.14) ].

• May 9, 2007NDANDA021829Ucb Inc

1. 1Product Adhesion Issue1,85713%
2. 2Drug Ineffective1,1258.0%
3. 3Fall9606.8%
4. 4Death9226.6%
5. 5Off Label Use8486.0%
6. 6Parkinson^s Disease7645.4%
7. 7Hallucination7115.1%
8. 8Dyskinesia6434.6%
9. 9Tremor6194.4%
10. 10Nausea5273.7%
11. 11Dizziness4963.5%
12. 12Somnolence4583.3%
13. 13Insomnia4473.2%
14. 14Application Site Erythema4413.1%
15. 15Application Site Pruritus4393.1%

The 10 most recently updated of 108 ClinicalTrials.gov registrations naming Rotigotine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Safety of RotigotiNe in Patients With Autosomal Dominant Polycystic Kidney Disease
  Recruiting · Phase 2 · Interventional · 120 enrolled · University Hospital, Rouen
  NCT06291116updated 2026-06-09
• Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder
  Recruiting · Phase 2 · Interventional · 40 enrolled · Virginia Commonwealth University
  NCT05886582updated 2025-09-29
• Quality Improvement and Practice Based Research in Neurology Using the EMR
  Enrolling by invitation · Phase 4 · Interventional · 3,300 enrolled · Endeavor Health
  NCT02670161updated 2025-08-24
• Adhesion and Safety of Rotigexole Compared to Neupro®
  Not yet recruiting · Interventional · 40 enrolled · Eva Pharma
  NCT07015346updated 2025-08-07
• Infusion of Apomorphine: Long-term Safety Study
  Active not recruiting · Phase 3 · Interventional · 99 enrolled · MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals
  NCT02339064updated 2025-06-19
• Sleep Efficiency Assessed by Polysomnography (PSG Sleep Lab Testing) in Advanced Parkinson's Disease
  Terminated · Phase 4 · Interventional · 1 enrolled · UCB Pharma SA
  NCT01519882updated 2025-04-03
• A Phase 3 Study of Rotigotine in Combination with Rivastigmine in Mild to Moderate Alzheimer's Disease
  Recruiting · Phase 3 · Interventional · 348 enrolled · I.R.C.C.S. Fondazione Santa Lucia
  NCT06702124updated 2025-01-22
• Dopaminergic Therapy for Frontotemporal Dementia Patients
  Completed · Phase 2 · Interventional · 75 enrolled · I.R.C.C.S. Fondazione Santa Lucia
  NCT04937452updated 2024-10-22
• Clinical Trial to Investigate Patch Adhesion of Rotigotine Containing Patches in Patients With Parkinson's Disease
  Completed · Phase 2 · Interventional · 38 enrolled · SocraTec R&D GmbH
  NCT06247410updated 2024-05-01
• A Follow-up Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome
  Terminated · Phase 3 · Interventional · 10 enrolled · UCB Biopharma SRL
  NCT03992196updated 2023-10-30

Frequently asked questions

How does Rotigotine work?

Rotigotine is a non-ergoline dopamine agonist. The precise mechanism of action of rotigotine as a treatment for Parkinson's disease is unknown, although it is thought to be related to its ability to stimulate dopamine receptors within the caudate-putamen in the brain.

What is Rotigotine used for?

According to FDA labeling, Rotigotine carries indications including: NEUPRO is a dopamine agonist indicated for the treatment of: Parkinson's disease ( 1.1 ) Moderate-to-severe primary Restless Legs Syndrome ( 1.2 ) 1.1 Parkinson's Disease (PD) NEUPRO is indicated for the treatment of Parkinson's disease. 1.2 Restless Legs Syndrome (RLS) NEUPRO is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Rotigotine?

Rotigotine is classified as Dopamine agonists, Nonergot Dopamine Agonist, Dopamine Agonists, Increased Central Nervous System Dopamine Activity.

What are the brand names for Rotigotine?

Rotigotine is marketed under brand names including Neupro.

What are the contraindications for Rotigotine?

Rotigotine labeling lists contraindications including: NEUPRO is contraindicated in patients who have demonstrated hypersensitivity to rotigotine or the components of the transdermal system. History of hypersensitivity to rotigotine or components of the transdermal patch.. Always consult the full prescribing information and a clinician.