rotigotine: clinical use

Prescribing considerations

• Confirm idiopathic moderate to severe restless legs syndrome and consider secondary causes before prescribing.
• Assess baseline sleepiness, cardiovascular symptoms, psychiatric history and previous impulse-control problems.
• Avoid abrupt withdrawal because neuroleptic malignant syndrome and dopamine agonist withdrawal symptoms may occur.
• Reassess benefit, adverse effects and possible augmentation during continued treatment.
• Use caution in severe hepatic impairment and during acute deterioration in renal function.

Contraindications and cautions

• Hypersensitivity to rotigotine or an excipient.
• The aluminium-containing patch must not remain in place during MRI or cardioversion because of burn risk.

Monitoring

• Blood pressure, particularly for postural hypotension.
• Daytime somnolence, sudden sleep episodes and driving risk.
• Impulse-control disorders, dopamine dysregulation syndrome and abnormal thinking or behaviour.
• Application-site and generalised skin reactions.
• New or worsening visual symptoms; regular ophthalmological monitoring is recommended.
• Earlier, more severe or spreading restless legs symptoms suggesting augmentation.

Clinical pharmacology

Rotigotine is a non-ergoline dopamine agonist with greatest functional activity at D2 and D3 receptors and additional activity at other dopamine receptors. Transdermal delivery provides continuous systemic absorption; metabolism involves N-dealkylation and conjugation.

Formulation and product differences

• The selected product is a thin, rectangular matrix patch with an aluminium-containing backing.
• It requires no special storage conditions.
• Used patches retain active substance and should be folded adhesive-side inward before disposal.

Transdermal patch

Route: Transdermal

Strengths: 1 mg/24 hours, 2 mg/24 hours, 3 mg/24 hours, 4 mg/24 hours, 6 mg/24 hours, 8 mg/24 hours