Drug reference

Rotigotine

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 467, 468

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

Monotherapy in Parkinson’s disease ▶BY TRANSDERMAL APPLICATION USING PATCHES ▶Adult: Initially 2 mg/24 hours, then increased in steps of 2 mg/24 hours every week if required; maximum 8 mg/24 hours per day Adjunctive therapy with co-beneldopa or co-careldopa in Parkinson’s disease ▶BY TRANSDERMAL APPLICATION USING PATCHES ▶Adult: Initially 4 mg/24 hours, then increased in steps of 2 mg/24 hours every week if required; maximum 16 mg/24 hours per day Moderate to severe restless legs syndrome ▶BY TRANSDERMAL APPLICATION USING PATCHES ▶Adult: Initially 1 mg/24 hours, then increased in steps of 1 mg/24 hours every week if required; maximum 3 mg/24 hours per day

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Cautions

Avoid exposure of patch to heat. remove patch (aluminium-containing) before magnetic resonance imaging or cardioversion

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National Funding Access Decisions

Scottish Medicines Consortium (SMC) decisions The Scottish Medicines Consortium has advised (August 2007) that Neupro ® is accepted for restricted use for the treatment of advanced Parkinson’s disease in combination with levodopa where the transdermal route would facilitate treatment. The Scottish Medicines Consortium has advised (July 2007) that Neupro ® is accepted for use as monotherapy for the treatment of early-stage idiopathic Parkinson’s disease. The Scottish Medicines Consortium has advised (August 2009) that rotigotine (Neupro ®) is accepted for restricted use within NHS Scotland for the symptomatic treatment of moderate to severe idiopathic restless legs syndrome in adults with a baseline score of 15 points or more on the International Restless Legs Scale.

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Safety

Important Safety Information

IMPULSE CONTROL DISORDERS Treatment with dopamine-receptor agonists is associated with impulse control disorders, including pathological gambling, binge eating, and hypersexuality. Patients and their carers should be informed about the risk of impulse control disorders. Ergot- and non-ergot- derived dopamine-receptor agonists do not differ in their propensity to cause impulse control disorders, so switching between dopamine-receptor agonists will not control these side-effects. See Parkinson’s disease p. 429

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Interactions

→Appendix 1: dopamine receptor agonists

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Side Effects

▶Common or very common Asthenia. behaviour abnormal. constipation. dizziness. drowsiness. dry mouth. dyskinesia. eating disorders. fall. gastrointestinal discomfort. hallucinations. headache. hiccups. hyperhidrosis. hypertension. hypotension. loss of consciousness. malaise. nausea. palpitations. pathological gambling. perception altered. peripheral oedema. psychiatric disorders. skin reactions. sleep disorders. syncope. vertigo. vomiting. weight changes ▶Uncommon Agitation. angioedema. arrhythmias. confusion. sexual dysfunction. vision disorders ▶Rare or very rare Delirium. delusions. irritability. psychotic disorder. seizure ▶Frequency not known Dopamine dysregulation syndrome Nervous system

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Pregnancy

Avoid—no information available.

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Breast Feeding

May suppress lactation; avoid—present in milk in animal studies.

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Hepatic Impairment

Manufacturer advises caution in severe impairment (no information available). Dose adjustments Manufacturer advises consider dose reduction in severe impairment.

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Monitoring Requirements

Ophthalmic testing recommended.

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Dose and formulations

Directions For Administration

Manufacturer advises apply patch to clean, dry, intact, healthy and non-irritated skin on torso, thigh, hip, shoulder or upper arm by pressing the patch ﬁrmly against the skin for about 30 seconds. Patches should be removed after 24 hours and the replacement patch applied on a different area (avoid using the same area for 14 days)—consult product literature for further information.

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Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Transdermal patch CAUTIONARY AND ADVISORY LABELS 10 ▶Neupro (UCB Pharma Ltd) Rotigotine 1 mg per 24 hour Neupro 1mg/24hours transdermal patches | 28 patch P £77.24 DT = £77.24 Rotigotine 2 mg per 24 hour Neupro 2mg/24hours transdermal patches | 28 patch P £81.10 DT = £81.10 Rotigotine 3 mg per 24 hour Neupro 3mg/24hours transdermal patches | 28 patch P £102.35 DT = £102.35 Rotigotine 4 mg per 24 hour Neupro 4mg/24hours transdermal patches | 28 patch P £123.60 DT = £123.60 Rotigotine 6 mg per 24 hour Neupro 6mg/24hours transdermal patches | 28 patch P £149.93 DT = £149.93 Rotigotine 8 mg per 24 hour Neupro 8mg/24hours transdermal patches | 28 patch P £149.93 DT = £149.93 DOPAMINERGIC DRUGS › MONOAMINE-OXIDASE B INHIBITORS

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Clinical care

Treatment Cessation

Antiparkinsonian drug therapy should never be stopped abruptly as this carries a small risk of neuroleptic malignant syndrome.

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Patient And Carer Advice

Manufacturer advises patients and their carers should be informed of the risk of developing dopamine dysregulation syndrome; addiction- like symptoms should be reported. Driving and skilled tasks Sudden onset of sleep Excessive daytime sleepiness and sudden onset of sleep can occur with dopamine-receptor agonists. Patients starting treatment with these drugs should be warned of the risk and of the need to exercise caution when driving or operating machinery. Those who have experienced excessive sedation or sudden onset of sleep should refrain from driving or operating machines until these effects have stopped occurring. Management of excessive daytime sleepiness should focus on the identiﬁcation of an underlying cause, such as depression or concomitant medication. Patients should be counselled on improving sleep behaviour. Hypotensive reactions Hypotensive reactions can occur in some patients taking dopamine-receptor agonists; these can be particularly problematic during the ﬁrst few days of treatment and care should be exercised when driving or operating machinery.

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Dose text by age group

Adult

Initially 2 mg/24 hours, then increased in steps

First-line fragment. Read the complete Indications and Dose section above.

PDF page 467

Adult

Initially 4 mg/24 hours, then increased in steps

First-line fragment. Read the complete Indications and Dose section above.

PDF page 467

Adult

Initially 1 mg/24 hours, then increased in steps

First-line fragment. Read the complete Indications and Dose section above.

PDF page 467

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.

Drug reference

Rotigotine

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 467, 468

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

PDF page 467

Cautions

Avoid exposure of patch to heat. remove patch (aluminium-containing) before magnetic resonance imaging or cardioversion

PDF page 467

National Funding Access Decisions

PDF page 468

Safety

Important Safety Information

PDF page 467

Interactions

→Appendix 1: dopamine receptor agonists

PDF page 467

Side Effects

PDF pages 467, 468

Pregnancy

Avoid—no information available.

PDF page 468

Breast Feeding

May suppress lactation; avoid—present in milk in animal studies.

PDF page 468

Hepatic Impairment

Manufacturer advises caution in severe impairment (no information available). Dose adjustments Manufacturer advises consider dose reduction in severe impairment.

PDF page 468

Monitoring Requirements

Ophthalmic testing recommended.

PDF page 468

Dose and formulations

Directions For Administration

PDF page 468

Medicinal Forms

PDF page 468

Clinical care

Treatment Cessation

Antiparkinsonian drug therapy should never be stopped abruptly as this carries a small risk of neuroleptic malignant syndrome.

PDF page 468

Patient And Carer Advice

PDF page 468

Dose text by age group

Adult

Initially 2 mg/24 hours, then increased in steps

First-line fragment. Read the complete Indications and Dose section above.

PDF page 467

Adult

Initially 4 mg/24 hours, then increased in steps

First-line fragment. Read the complete Indications and Dose section above.

PDF page 467

Adult

Initially 1 mg/24 hours, then increased in steps

First-line fragment. Read the complete Indications and Dose section above.

PDF page 467

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.