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Neupro

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Neupro

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Neupro

SIDE EFFECTS

The following adverse reactions are discussed in more detail in the WARNINGS AND PRECAUTIONS section of labeling.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the incidence of adverse reactions (number of unique patients experiencing an adverse reaction associated with treatment / total number of patients treated) observed in the clinical trials of a drug cannot be directly compared to incidence of adverse reactions in the clinical trials of another drug and may not reflect the incidence of adverse reactions observed in practice.

Adverse Reactions Incidence in Controlled Clinical Studies in Early-Stage Parkinson's Disease

The safety of Neupro was evaluated in a total of 649 early-stage Parkinson's disease patients who participated in three double-blind, placebo-controlled studies with durations of 3 to 9 months. Additional safety information was collected in short term studies, and two open-label extension studies in patients with early-stage Parkinson's disease.

The incidence of adverse reactions in a randomized, double-blinded, placebo-controlled, fixed-dose trial is shown in Table 1. Incidences for the non-recommended 8 mg/24 hour dose are also shown.

In the double-blind, placebo-controlled, Dose-Response study in patients with early-stage Parkinson's disease, the most commonly observed adverse reactions (> 5 % greater than placebo) for the highest recommended dose of Neupro (6 mg/24 hours) were nausea, vomiting, somnolence, application site reactions, dizziness, anorexia, hyperhidrosis, and insomnia.

In this trial, 12% of patients treated with the highest, recommended Neupro dose (6 mg/24 hours) discontinued treatment because of adverse reactions, compared with 6% of patients who received placebo.

Table 1 : Incidence of Treatment-Emergent Adverse Reactions in Placebo-Controlled, Trial of Patients with Early-Stage Parkinson's Disease (Dose-Response Study) Where Incidence Was ≥ 2 % in 6 mg/24 hours Neupro Group and Greater Than the Incidence in Placebo-Treated Patients

Adverse Reactions Placebo
N=64 %
Neupro dose
2 mg/24h
N=67
%
4 mg/24h
N=64
%
6 mg/24h
N=65
%
8 mg/24h
N=70
%
Ear and labyrinth disorders
  Tinnitus 0 0 2 3 0
Gastrointestinal disorders
  Nausea* 13 34 38 48 41
  Vomiting* 3 10 16 20 11
  Anorexia 0 0 2 8 4
  Dyspepsia 0 2 2 3 0
General disorders and administration site conditions
  Application and instillation site reactions 19 24 21 34 46
  Fatigue 3 8 18 6 13
  Oedema peripheral* 2 2 3 3 4
Infections and infestations
  Upper respiratory tract infection 0 3 5 2 0
  Sinusitis 0 2 0 2 1
Injury, poisoning and procedural complications
  Contusion* 0 2 0 2 4
Investigations
  White blood cells urine positive 2 3 3 3 1
  Electrocardiogram T wave abnormal 0 0 2 3 0
  Weight decreased* 0 0 0 2 3
Metabolism and nutrition disorders
  Anorexia 0 2 2 6 1
  Decreased appetite* 0 0 0 3 3
Musculoskeletal and connective tissue disorders
  Muscle spasms* 2 3 2 3 4
Nervous system disorders
  Dizziness 11 21 14 22 20
  Dizziness postural 0 2 2 2 1
  Somnolence* 3 12 14 19 20
  Lethargy 0 2 2 2 1
  Balance disorder 0 0 2 3 0
Psychiatric disorders
  Insomnia 6 5 10 11 7
  Early morning awakening* 0 0 0 2 3
  Abnormal dreams* 0 2 5 3 7
  Depression 0 5 3 2 0
Reproductive system and breast disorders
  Erectile dysfunction* 0 0 0 2 3
Respiratory, thoracic and mediastinal disorders
  Pharyngolaryngeal pain 0 2 2 2 0
  Hiccups* 0 2 2 2 3
Skin and subcutaneous tissue disorders
  Hyperhidrosis 3 3 3 11 3
  Erythema* 3 3 6 5 6
  Rash pruritic* 0 0 0 2 3
*Dose-related
HLT=high level term; MedDRA=Medical Dictionary for Regulatory Activities; PT=preferred term; SOC=system organ class; TEAEs=treatment-emergent adverse events

The incidence of certain adverse reactions with Neupo treatment was notably increased compared to placebo treatment (i.e., Neupro % - placebo % = ≥5 %) in either the titration or maintenance phases of the Dose-Response trial. During the titration phase, an increased incidence ( in descending order of % treatment difference) was observed for nausea, somnolence, vomiting, application site reactions (ASRs), dizziness, sweating increased, anorexia and vision abnormal. During the maintenance phase, an increased incidence was observed for nausea, and ASRs. Some adverse reactions developing in the titration phase persisted ( ≥7 days) into the maintenance phase. These “persistent” adverse reactions included ASRs, anorexia, somnolence, nausea, and vision abnormal.

Adverse Reactions Incidence in Controlled Clinical Studies in Advanced-Stage Parkinson's Disease

The safety evaluation of Neupro was based on a total of 672 Neupro-treated subjects with advanced-stage Parkinson's disease who participated in 3 double-blind, placebo-controlled studies (2 fixed-dose trials and one flexible dose trial) with durations of 3 to 7 months. Patients received concomitant levodopa in these studies. Additional safety information was collected in earlier short-term studies, and 2 open-label extension studies in subjects with advanced-stage Parkinson's disease.

The incidence of adverse reactions in a randomized, double-blinded, placebo-controlled, fixed-dose trial is shown in Table 2. Incidences for the non-recommended 12 mg/24 hour dose are also shown.

In the Dose-Response, placebo controlled trial for advanced-stage Parkinson's disease, the most common adverse reactions (> 5 % greater than placebo) for the highest recommended dose of Neupro (8 mg) were application site reactions, nausea, somnolence, and headache.

In this trial, approximately 15 % of patients treated with the highest, recommended Neupro dose (8 mg/24 hours) discontinued treatment because of adverse reactions, compared with 9 % of patients who received placebo.

Table 2: Incidence of Treatment-Emergent Adverse Reactions in Placebo-Controlled, Trial of Patients with Advanced-Stage Parkinson's Disease (Dose-Response Study) Where Incidence Was ≥ 2 % in 8 mg/24 hours Neupro Group and Greater Than the Incidence in Placebo-Treated Patients

Adverse Reaction Placebo
N=120
%
Neupro dose
8 mg/24h
N=118
%
12 mg/24h
N=111
%
Gastrointestinal disorders
Nausea 19 28 22
Vomiting 6 10 8
Constipation 6 9 5
Diarrhea 5 7 5
General disorders and administration site conditions
Application and instillation site reactions a * 13 36 46
Edema peripheral* 1 9 14
Asthenia 3 4 3
Musculoskeletal and connective tissue disorders
Musculoskeletal pain 1 2 2
Arthralgia 7 11 8
Nervous system disorders
Somnolence 28 32 32
Dizziness 15 23 14
Dyskinesia* 7 14 17
Headache 8 10 8
Paraesthesias/Dysesthesias* 3 5 6
Tremor 3 4 3
Psychiatric disorders
Disturbances in initiating and maintaining sleep a * 6 9 14
Hallucinations * 3 7 14
Nightmare* 2 3 5
Respiratory, thoracic and mediastinal disorders
Cough 1 3 3
Nasal congestion 0 3 3
Sinus congestion 0 3 2
Skin and subcutaneous tissue disorders
Hyperhidrosis 0 3 1
Erythema 1 3 2
Vascular disorders
Hypertension* 0 3 5
*Dose-related
HLT=high level term; MedDRA=Medical Dictionary for Regulatory Activities; PT=preferred term; SOC=system organ class; TEAEs=treatment-emergent adverse events
aThe following selected HLTs were considered and included, if applicable: application and instillation site reactions, asthenic conditions, and disturbances in initiating and maintaining sleep

The incidence of certain adverse reactions with Neupo treatment was notably increased compared to placebo treatment (i.e., Neupro % - placebo % = ≥ 5 %) in either the titration or maintenance phases of the Dose-Response trial. During the titration phase, an increased incidence (in descending order of % treatment difference) was observed for nausea, hallucinations, constipation, dyskinesia, dizziness. During the maintenance phase, an increased incidence was observed for ASRs, peripheral edema, and dyskinesia. Some adverse reactions developing in the titration phase persisted ( ≥ 7 days) into the maintenance phase. A notably “persistent” adverse reaction was ASRs.

Adverse Reactions Incidence in Controlled Clinical Studies in Restless Legs Syndrome

The safety evaluation of rotigotine was based on a total of 745 Neupro-treated subjects with RLS who participated in 2 double-blind, placebo-controlled studies with maintenance durations of 6 months. Additional safety information was collected in earlier short term studies, and 3 open-label extension studies in subjects with RLS.

The incidence of adverse reactions in two randomized, double-blinded, placebo-controlled, fixed-dose trials are shown in Table 3.

In the two randomized, double-blinded, placebo-controlled, fixed-dose trials for RLS, the most common adverse reactions (> 5 % greater than placebo) for the highest recommended dose of Neupro (3 mg) were application site reactions, nausea, somnolence, and headache.

In the two Dose-Response, placebo controlled trials, 24 % of Neupro-treated patients treated with the highest recommended dose (3 mg) discontinued treatment because of adverse reactions, compared with 3 % of patients who received placebo.

Table 3 : Incidence of Treatment-Emergent Adverse Reactions in Placebo-Controlled, Trial of Patients with Restless Legs Syndrome (North American and Foreign Multinational Studies) Where Incidence Was ≥ 2 % in 2 mg or 3 mg/24 hours Neupro Groups and Greater Than the Incidence in Placebo-Treated Patients

Adverse Reaction Placebo
N=217
Neupro Dose
0.5 mg/24h
N=99
%
1 mg/24h
N=215
%
2 mg/24h
N=211
%
3 mg/24h
N=220
%
Ear and labyrinth disorders
Vertigo 1 0 4 3 1
Gastrointestinal disorders
Nausea 10 18 15 23 21
Dry mouth* 4 3 3 3 7
Constipation 3 6 3 2 5
Vomiting* 1 2 2 4 4
Dyspepsia* 1 2 1 2 3
General disorders and administration site conditions
Application and instillation site reactions a * 4 23 27 38 43
Asthenic conditions a * 8 11 7 14 12
Infections and infestations
Nasopharyngitis 7 5 10 7 8
Sinusitis* 1 2 1 2 3
Investigations
Serum ferritin decreased* 1 2 1 1 2
Musculoskeletal and connective tissue disorders
Muscle spasms 1 3 1 4 1
Nervous system disorders
Headache 11 21 15 18 16
Somnolence* 4 8 5 8 10
Dizziness 6 7 5 9 6
Psychiatric disorders
Disturbances in initiating and/or maintaining sleep a * 3 2 4 3 10
Sleep disorder* 1 0 2 3 3
Abnormal dreams* 0 2 1 2 3
Sleep attacks* 0 0 1 0 2
Skin and subcutaneous tissue disorders
Pruritus 3 9 4 3 7
Hyperhidrosis* 2 1 3 5 3
Erythema* 1 1 1 0 2
Vascular disorders
Hypertension* 0 3 1 1 4
Hot flush 1 4 1 3 0
*Dose-related
HLT=high level term; MedDRA=Medical Dictionary for Regulatory Activities; PT=preferred term; SOC=system organ class
aThe following selected HLTs were considered and included, if applicable: application and instillation site reactions, asthenic conditions (i.e., asthenia, malaise, fatigue), and disturbances in initiating and maintaining sleep.

The incidence of certain adverse reactions with Neupo treatment was notably increased compared to placebo treatment (i.e., Neupro % - placebo % = ≥5 %) in either the titration or maintenance phases of the Dose-Response trial. During the titration phase, an increased incidence (in descending order of % treatment difference) was observed for ASRs, and disturbances in initiating and/or maintaining sleep. During the maintenance phase, an increased incidence was observed for ASRs. Some adverse reactions developing in the titration phase persisted (> 7 days) into the maintenance phase. These “persistent” adverse reactions were ASRs, nausea, and disturbances in initiating and/or maintaining sleep.

Laboratory Changes

Some clinical laboratory analytes were abnormal for patients treated with the highest recommended Neupro dose in the dose-response trials for patients with early-stage and advanced-stage Parkinson's disease and with RLS.

There was a treatment difference (Neupro % - placebo %) of 6 % for decreased hemoglobin (below the normal reference range) and of 3 % for decreased hematocrit (below the normal reference range) in patients with early-stage Parkinson's disease. There was a treatment difference of 4 % for a decreased hemoglobin (below the normal reference range) and of 3 % for decreased hematocrit (below the normal reference range) in patients with advanced-stage Parkinson's disease. There was a treatment difference of 3 % for a decreased hemoglobin (below the normal reference range) in patients with RLS. There was also a treatment difference of 2 % for markedly decreased hemoglobin and hematocrit in patients with advanced Parkinson's disease and of 1 % for markedly decreased hematocrit in patients with RLS.

There was a treatment difference of 9 % for increased serum BUN (above the normal reference range) in patients with early-stage Parkinson's disease. There was a treatment difference of 1 % for markedly increased serum BUN in patients with advanced-stage Parkinson's disease.

There was a treatment difference of 9 % for decreased serum glucose (below the normal reference range) in patients with early-stage Parkinson's disease and of 3 % in patients with advanced-stage Parkinson's disease. There was a treatment difference of 1 % for markedly decreased serum glucose in patients with advanced-stage Parkinson's disease.

Read the Neupro (rotigotine transdermal system) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Dopamine Antagonists

It is possible that dopamine antagonists, such as antipsychotics or metoclopramide, could diminish the effectiveness of rotigotine.

Drug Abuse And Dependence

Controlled Substance

Rotigotine is not a controlled substance

Dependence

Animal studies and human clinical trials with rotigotine did not reveal potential for drug-seeking behavior or physical dependence.

Last reviewed on RxList: 4/13/2012
This monograph has been modified to include the generic and brand name in many instances.

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Neupro - User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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