Drugs List

Therapeutic Indications

Uses

Advanced stage Parkinson's disease
Early stage Parkinson's disease
Moderate to severe idiopathic Restless Legs Syndrome: Symptomatic treatment

Moderate to severe idiopathic Restless Legs Syndrome.

Idiopathic Parkinson's disease either alone (mainly in the early stage) or as an adjunct to levodopa therapy.

Contraindications

Children under 18 years
Breastfeeding
Pregnancy

Precautions and Warnings

Severe hepatic impairment

Advise patient/carer risk of dopamine dysregulation syndrome (DDS)
Advise patient ability to drive or operate machinery may be impaired
Not all available strengths are licensed for all indications
Contains sodium metabisulfite. Caution,may cause allergic reactions
Avoid application to broken skin
Avoid exposing application site to direct external heat
Remove patch prior to MRI scan or cardioversion
Rotate application sites - avoid applying patch to the same site
Monitor blood pressure especially at the start of treatment
Monitor for signs of fibrotic changes - discontinue if they occur
Monitor ophthalmic function
Monitor patients for impulse control disorders
Perform eye tests in any patient with vision change/ophthalmologic symptoms
Review treatment if impulse control disorders symptoms occur
Advise patient of the possibility of excessive daytime sleepiness
Advise patient to report episodes of syncope
Treatment of Restless Legs Syndrome may result in augmentation of symptoms
Avoid abrupt withdrawal: May cause signs of neuroleptic malignant syndrome
To discontinue, reduce dose gradually
Discontinue if severe skin reaction occurs
Reduce dose or discontinue if sudden onset of sleep during daily activities
Consider dose reduction in severe hepatic impairment
Advise that effects are potentiated by CNS depressants (including alcohol)
Female: Ensure adequate contraception during treatment
Advise patient/carer about symptoms of impulse control disorders
Advise patients that hallucinations can occur

Inform patients/carers about the risk of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending, binge eating and compulsive eating. Dose reduction/tapered discontinuation should be considered if such symptoms develop.

Abnormal thinking and behaviour has been reported. This may present as paranoid ideation, delusions, hallucinations, confusion, psychotic-like behaviour, disorientation, aggressive behaviour, agitation and delirium.

Fibrotic complications have been reported in patients receiving ergot derived dopaminergic agents. The risk with non ergot derived dopamine agonists such as ropinirole is unknown.

Application site reactions commonly occur. Reassess the benefits of continued treatment if reactions last more than a few days, are persistent, increase in severity or spread outside the application site. Avoid exposing affected areas to direct sunlight until the skin has healed as skin discolouration may occur. Discontinue treatment if a generalised skin reaction occurs.

An increased incidence of dopaminergic side effects may be seen in patients with Parkinson's disease using concomitant levodopa including hallucinations, dyskinesia and peripheral oedema.

Pregnancy and Lactation

Pregnancy

Rotigotine is contraindicated during pregnancy.

The manufacturer states that rotigotine should not be used during pregnancy. Some animal studies have reported embryo-toxicity. Human pregnancy data is extremely limited and as such the potential risk is unknown.

Lactation

Rotigotine is contraindicated during breastfeeding.

The manufacturer states that breastfeeding should be discontinued during treatment with rotigotine. Animal studies have shown that rotigotine and/or its metabolite(s) are excreted in breast milk. Presence in human breast milk is unknown. Rotigotine is known to decrease prolactin secretion in humans and as such, may affect lactation.

Side Effects

Abdominal pain
Aggression
Aggressive tendencies
Agitation
Altered consciousness
Angioedema
Application site reaction
Asthenia
Atrial fibrillation
Binge eating
Blurred vision
Compulsive behaviour
Compulsive disorders
Confusion
Constipation
Contact dermatitis
Convulsions
Creatine phosphokinase increased
Delirium
Delusions
Dermatitis
Diarrhoea
Disorientation
Dizziness
Dopamine dysregulation syndrome
Dream abnormalities
Dry mouth
Dyskinesia
Dyspepsia
Eczema
Erectile dysfunction
Erythema
Exfoliative rash
Falls
Fatigue
Hallucinations
Headache
Hiccups
Hyperhidrosis
Hypersensitivity reactions
Hypersexuality
Hypertension
Hypotension
Impaired vision
Impulse control disorders
Increased heart rate
Increased libido
Increases in hepatic enzymes
Inflammation (application site)
Insomnia
Irritability
Irritation (localised)
Lethargy
Malaise
Nausea
Nightmares
Oedema of the lips
Orthostatic hypotension
Pain at application site
Palpitations
Papules
Paranoia
Pathological gambling
Perceptual disturbances
Peripheral oedema
Photopsia
Postural dizziness
Pruritus
Psychotic disorder
Punding
Rash
Sexual disturbances
Skin discolouration
Skin irritation
Sleep attacks
Sleep disturbances
Somnolence
Sudden sleep onset episodes
Supraventricular tachycardia
Swelling(localised)
Syncope
Tongue oedema
Urticaria
Vasovagal attacks
Vertigo
Vesicles
Vomiting
Weight gain
Weight loss

Presentation

Transdermal patches containing rotigotine.

Drugs List

Therapeutic Indications

Uses

Advanced stage Parkinson's disease
Early stage Parkinson's disease
Moderate to severe idiopathic Restless Legs Syndrome: Symptomatic treatment

Moderate to severe idiopathic Restless Legs Syndrome.

Idiopathic Parkinson's disease either alone (mainly in the early stage) or as an adjunct to levodopa therapy.

Dosage

Patches should be applied once daily, preferably at the same time each day, and should be replaced every 24 hours, by a new patch at a different site of application.

If a patch is forgotten, or becomes detached, another patch should be applied for the remainder of the day.

Adults

Contraindications

Children under 18 years
Breastfeeding
Pregnancy

Precautions and Warnings

Severe hepatic impairment

Advise patient/carer risk of dopamine dysregulation syndrome (DDS)
Advise patient ability to drive or operate machinery may be impaired
Not all available strengths are licensed for all indications
Contains sodium metabisulfite. Caution,may cause allergic reactions
Avoid application to broken skin
Avoid exposing application site to direct external heat
Remove patch prior to MRI scan or cardioversion
Rotate application sites - avoid applying patch to the same site
Monitor blood pressure especially at the start of treatment
Monitor for signs of fibrotic changes - discontinue if they occur
Monitor ophthalmic function
Monitor patients for impulse control disorders
Perform eye tests in any patient with vision change/ophthalmologic symptoms
Review treatment if impulse control disorders symptoms occur
Advise patient of the possibility of excessive daytime sleepiness
Advise patient to report episodes of syncope
Treatment of Restless Legs Syndrome may result in augmentation of symptoms
Avoid abrupt withdrawal: May cause signs of neuroleptic malignant syndrome
To discontinue, reduce dose gradually
Discontinue if severe skin reaction occurs
Reduce dose or discontinue if sudden onset of sleep during daily activities
Consider dose reduction in severe hepatic impairment
Advise that effects are potentiated by CNS depressants (including alcohol)
Female: Ensure adequate contraception during treatment
Advise patient/carer about symptoms of impulse control disorders
Advise patients that hallucinations can occur

Inform patients/carers about the risk of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending, binge eating and compulsive eating. Dose reduction/tapered discontinuation should be considered if such symptoms develop.

Abnormal thinking and behaviour has been reported. This may present as paranoid ideation, delusions, hallucinations, confusion, psychotic-like behaviour, disorientation, aggressive behaviour, agitation and delirium.

Fibrotic complications have been reported in patients receiving ergot derived dopaminergic agents. The risk with non ergot derived dopamine agonists such as ropinirole is unknown.

Application site reactions commonly occur. Reassess the benefits of continued treatment if reactions last more than a few days, are persistent, increase in severity or spread outside the application site. Avoid exposing affected areas to direct sunlight until the skin has healed as skin discolouration may occur. Discontinue treatment if a generalised skin reaction occurs.

An increased incidence of dopaminergic side effects may be seen in patients with Parkinson's disease using concomitant levodopa including hallucinations, dyskinesia and peripheral oedema.

Pregnancy and Lactation

Pregnancy

Rotigotine is contraindicated during pregnancy.

The manufacturer states that rotigotine should not be used during pregnancy. Some animal studies have reported embryo-toxicity. Human pregnancy data is extremely limited and as such the potential risk is unknown.

Lactation

Rotigotine is contraindicated during breastfeeding.

The manufacturer states that breastfeeding should be discontinued during treatment with rotigotine. Animal studies have shown that rotigotine and/or its metabolite(s) are excreted in breast milk. Presence in human breast milk is unknown. Rotigotine is known to decrease prolactin secretion in humans and as such, may affect lactation.

Counselling

Advise patients to apply the patch to clean, dry, intact healthy skin on the abdomen, thigh, hip, flank, shoulder, or upper arm. They should avoid touching the sticky side of the patch during application and allow at least 14 days before re-applying a patch to same site. Patches must not be cut.

Advise patients to avoid exposing the application site to direct external heat.

Advise patients that skin reactions at application sites are common but to remove the patch and seek medical advice if reactions persist or worsen or if a generalised reaction occurs. Affected areas must be kept out of direct sunlight until the skin has fully healed.

Advise patients that effects may be potentiated by alcohol and other sedative medication.

Advise patients of the risk of impulse control disorders.

Advise patients that abnormal thinking and/or behaviour may occur.

Advise patients (particularly those with severe cardiovascular disease) to report episodes of syncope and pre-syncope.

Advise female patients of child bearing potential to use adequate contraception during treatment.

Advise patients that their ability to drive or operate machinery may be affected by the side effects of rotigotine. If they experience somnolence and/or sudden sleep episodes they must not drive (or engage in activities where impaired alertness may put themselves or others at risk) until these symptoms have resolved.

Side Effects

Abdominal pain
Aggression
Aggressive tendencies
Agitation
Altered consciousness
Angioedema
Application site reaction
Asthenia
Atrial fibrillation
Binge eating
Blurred vision
Compulsive behaviour
Compulsive disorders
Confusion
Constipation
Contact dermatitis
Convulsions
Creatine phosphokinase increased
Delirium
Delusions
Dermatitis
Diarrhoea
Disorientation
Dizziness
Dopamine dysregulation syndrome
Dream abnormalities
Dry mouth
Dyskinesia
Dyspepsia
Eczema
Erectile dysfunction
Erythema
Exfoliative rash
Falls
Fatigue
Hallucinations
Headache
Hiccups
Hyperhidrosis
Hypersensitivity reactions
Hypersexuality
Hypertension
Hypotension
Impaired vision
Impulse control disorders
Increased heart rate
Increased libido
Increases in hepatic enzymes
Inflammation (application site)
Insomnia
Irritability
Irritation (localised)
Lethargy
Malaise
Nausea
Nightmares
Oedema of the lips
Orthostatic hypotension
Pain at application site
Palpitations
Papules
Paranoia
Pathological gambling
Perceptual disturbances
Peripheral oedema
Photopsia
Postural dizziness
Pruritus
Psychotic disorder
Punding
Rash
Sexual disturbances
Skin discolouration
Skin irritation
Sleep attacks
Sleep disturbances
Somnolence
Sudden sleep onset episodes
Supraventricular tachycardia
Swelling(localised)
Syncope
Tongue oedema
Urticaria
Vasovagal attacks
Vertigo
Vesicles
Vomiting
Weight gain
Weight loss

Withdrawal Symptoms and Signs

The following symptoms suggestive of dopamine agonist withdrawal syndrome can be observed: pain, fatigue, depression, sweating, and anxiety with abrupt withdrawal of dopaminergic therapy. Therefore, it is recommended to taper treatment (see 'Treatment Discontinuation' in the Dose section). Following this procedure, rebound (worsening of symptoms beyond initial intensity after discontinuation of treatment) has not been observed.

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: January 2019

Reference Sources

Summary of Product Characteristics: Neupro 1mg/24h Transdermal patch. UCB Pharma Ltd. Revised January 2021.
Summary of Product Characteristics: Neupro 2mg/24h Transdermal patch. UCB Pharma Ltd. Revised January 2021.
Summary of Product Characteristics: Neupro 3mg/24h Transdermal patch. UCB Pharma Ltd. Revised January 2021.
Summary of Product Characteristics: Neupro 4mg/24h Transdermal patch. UCB Pharma Ltd. Revised January 2021.
Summary of Product Characteristics: Neupro 6mg/24h Transdermal patch. UCB Pharma Ltd. Revised January 2021.
Summary of Product Characteristics: Neupro 8mg/24h Transdermal patch. UCB Pharma Ltd. Revised January 2021.

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Rotigotine Last revised: 03 December 2018
Last accessed: 04 January 2019