Neupro Special Precautions

If a Parkinson's disease patient is insufficiently controlled while on treatment with rotigotine switching to another dopamine agonist might provide additional benefit (see Pharmacology: Pharmacodynamics under Actions).
Magnetic resonance imaging and cardioversion: The backing layer of Neupro contains aluminium. To avoid skin burns, Neupro should be removed if the patient has to undergo magnetic resonance imaging (MRI) or cardioversion.
Orthostatic hypotension: Dopamine agonists are known to impair the systemic regulation of the blood pressure resulting in postural/orthostatic hypotension. These events have also been observed during treatment with Neupro, but the incidence was similar to that observed in placebo-treated patients.
It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the general risk of orthostatic hypotension associated with dopaminergic therapy.
Syncope: In clinical studies with rotigotine, syncope has been observed at a rate that was similar to that observed in patients treated with placebo. Because patients with clinically relevant cardiovascular disease were excluded in these studies, patients with severe cardiovascular disease should be asked about symptoms of syncope and pre-syncope.
Sudden onset of sleep and somnolence: Neupro has been associated with somnolence and episodes of sudden sleep onset. Sudden onset of sleep during daily activities, in some cases without awareness of any warning signs, has been reported. Prescribers should continually reassess patients for drowsiness or sleepiness, as patients may not acknowledge drowsiness or sleepiness until directly questioned. A reduction of dosage or termination of therapy should be carefully considered.
Impulse control disorders: Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathologic gambling, increased libido hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists, including rotigotine. Dose reduction/tapered discontinuation should be considered if such symptoms develop.
Neuroleptic malignant syndrome: Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy. Therefore it is recommended to taper treatment (see Dosage & Administration).
Abnormal thinking and behaviour: Abnormal thinking and behaviour have been reported and can consist of a variety of manifestations including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behaviour, disorientation, aggressive behaviour, agitation, and delirium.
Fibrotic complications: Cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, pericarditis and cardiac valvulopathy have been reported in some patients treated with ergot-derived dopaminergic agents. While these complications may resolve when treatment is discontinued, complete resolution does not always occur.
Although these adverse reactions are believed to be related to the ergoline structure of these compounds, whether other, nonergot derived dopamine agonists can cause them is unknown.
Neuroleptics: Neuroleptics given as antiemetic should not be given to patients taking dopamine agonists (see also Interactions).
Ophthalmologic monitoring: Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Heat application: External heat (excessive sunlight, heating pads and other sources of heat such as sauna, hot bath) should not be applied to the area of the patch.
Application site reactions: Application site skin reactions may occur and are usually mild or moderate in intensity. It is recommended that the application site should be rotated on a daily basis (e.g. from the right side to the left side and from the upper body to the lower body). The same site should not be used within 14 days. If application site reactions occur which last for more than a few days or are persistent, if there is an increase in severity, or if the skin reaction spreads outside the application site, an assessment of the risk/benefit balance for the individual patient should be conducted.
If there is a skin rash or irritation from the transdermal system, direct sunlight on the area should be avoided until the skin heals, as exposure could lead to changes in the skin color.
If a generalised skin reaction (e.g. allergic rash, including erythematous, macular, papular rash or pruritus) associated with the use of Neupro is observed, Neupro should be discontinued.
Peripheral oedema: In clinical studies in Parkinson's patients, the 6 month-specific rates of peripheral oedema remained at about 4% through the entire observation period up to 36 months.
Dopaminergic adverse reactions: The incidence of some dopaminergic adverse reactions, such as hallucinations, dyskinesia, and peripheral oedema generally is higher when given in combination with L-dopa in Parkinson's patients. This should be considered when prescribing rotigotine.
Sulphite sensitivity: Neupro contains sodium metabisulphite, a sulphite that may cause allergic-type reactions including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible people.
Effects on ability to drive and use machines: Rotigotine may have major influence on the ability to drive and use machines.
Patients being treated with rotigotine and presenting with somnolence and/or sudden sleep episodes must be informed not to drive or engage in activities (e.g. operating machines) where impaired alertness may put themselves or others at risk of serious injury or death until such recurrent episodes and somnolence have resolved (see also Precautions and Interactions).
Women of childbearing potential, contraception in females: Women of childbearing potential should use effective contraception to prevent pregnancy during treatment with rotigotine.
Fertility: For information on fertility studies, please see Pharmacology: Toxicology: Preclinical safety data under Actions.