EXELON

What it is

Exelon Patch is rivastigmine, available in three strengths: Patch 5 contains 9 mg rivastigmine, Patch 10 contains 18 mg rivastigmine, and Patch 15 contains 27 mg rivastigmine. Exelon Patch is a thin, matrix-type transdermal patch consisting of three layers, one of which contains rivastigmine.

Approved indications —

Exelon is indicated for the treatment of patients with mild, moderate and severe dementia of the Alzheimer's type.

Dosing overview

Treatment is started with Exelon Patch 5 once a day, with dose increases only after a minimum of 4 weeks at the previous dose and only if the previous dose has been well tolerated. For mild and moderate Alzheimer's disease patients the recommended effective dose is Exelon Patch 10 for as long as therapeutic benefit persists; moderate patients can then be increased to the maximum recommended dose of Exelon Patch 15, and for patients with severe Alzheimer's disease Exelon Patch 15 may be used after titration. Rivastigmine transdermal patches should be applied once a day to clean, dry, hairless, intact healthy skin on the upper or lower back, upper arm or chest. Doses higher than Exelon Patch 15 confer no appreciable additional benefit and are associated with an increase in the incidence of adverse events.

Key safety warnings

Medication misuse and dosing errors with Exelon patches have resulted in serious adverse reactions; some cases have required hospitalisation and rarely led to death, with the majority involving not removing the old patch when putting on a new one and the use of multiple patches at one time. Patients and their caregivers must be instructed on important administration instructions. Gastrointestinal disorders such as nausea, vomiting and diarrhoea may occur when initiating treatment and/or increasing the dose, and they may respond to a dose reduction. Patients who show signs or symptoms of dehydration resulting from prolonged vomiting or diarrhoea can be managed with IV fluids and dose reduction or discontinuation if recognised and treated promptly; dehydration can be associated with serious outcomes. Skin application site reactions may occur with Exelon Patch and are usually mild or moderate in intensity, though use of rivastigmine patch may lead to allergic contact dermatitis. Allergic contact dermatitis should be suspected if application site reactions spread beyond the patch size, if there is evidence of a more intense local reaction, and if symptoms do not significantly improve within 48 hours after patch removal; in these cases, treatment should be discontinued. Electrocardiogram QT prolongation may occur in patients treated with rivastigmine, which may cause bradycardia constituting a risk factor in the occurrence of torsade de pointes, predominantly in patients with risk factors such as uncompensated heart failure, recent myocardial infarction, bradyarrhythmias, predisposition to hypokalaemia or hypomagnesemia, personal or family history of QT prolongation, or concomitant use with medicinal products known to induce QT prolongation.

Contraindications

The use of Exelon is contraindicated in patients with known hypersensitivity to rivastigmine or to the excipients of the formulation or to other carbamate derivatives; previous history of application site reactions suggestive of allergic contact dermatitis with rivastigmine transdermal patch; and severe liver impairment since it has not been studied in this population.

PBS listing

Exelon transdermal patches (9 mg, 18 mg, and 27 mg) are PBS listed with streamlined and authority-required restrictions, at an ex-manufacturer price of A$64.64.

Regulatory history

Exelon capsules (1.5 mg, 3 mg, 4.5 mg, and 6 mg rivastigmine as hydrogen tartrate) were first registered on the ARTG on 2000-06-06. Exelon Patch 5 and Exelon Patch 10 were first listed on the ARTG on 2008-03-12, and Exelon Patch 15 was first listed on 2015-04-07.