Exelon Patch (rivastigmine) Approved Uses

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Alzheimer's Disease

Exelon Patch (rivastigmine transdermal system) is indicated for the treatment of mild to moderate dementia of the Alzheimer's type.

Parkinson's Disease Dementia

Exelon Patch (rivastigmine transdermal system) is indicated for the treatment of mild to moderate dementia associated with Parkinson's disease.

The dementia of Parkinson's disease is purportedly characterized by impairments in executive function, memory retrieval, and attention, in patients with an established diagnosis of Parkinson's disease. The diagnosis of the dementia of Parkinson's disease can be made reliably in patients in whom a progressive dementia syndrome occurs (without the necessity to document the specific deficits described above) at least 2 years after a diagnosis of Parkinson's disease has been made, and in whom other causes of dementia have been ruled out.


DOSAGE AND ADMINISTRATION

Alzheimer's Disease

Table 1 Patch Size, Drug Content And Nominal Delivery Rate

Rivastigmine Nominal Dose Rivastigmine Content per Exelon Patch Exelon Patch Size
4.6 mg/24 hours 9 mg 5 cm2
9.5 mg/24 hours 18 mg 10 cm2

Initial Dose: Treatment is started with the Exelon Patch 4.6 mg/24 hours.

After a minimum of four weeks of treatment and if well tolerated, this dose should be increased to Exelon Patch 9.5 mg/24 hours, which is the recommended effective dose.

Maintenance Dose: Dose increases should occur only after a minimum of 4 weeks at the previous dose, and only if the previous dose has been well tolerated. The maximum recommended dose is 9.5 mg/ 24 hours. Higher doses confer no appreciable additional benefit, and are associated with significant increase in the incidence of adverse events (see ADVERSE REACTIONS).

If adverse effects (e.g., nausea, vomiting, diarrhea, loss of appetite) cause intolerance during treatment, the patient should be instructed to discontinue treatment for several days and then restart at the same or next lower dose level. If treatment is interrupted for longer than several days, treatment should be reinitiated with the lowest daily dose and titrated as described above (also see Warnings and PRECAUTIONS).


Switching from Capsules or Oral Solution:

Patients treated with Exelon capsules or oral solution may be switched to Exelon Patches as follows:

A patient who is on a total daily dose of < 6 mg of oral rivastigmine can be switched to Exelon Patch 4.6 mg/24 hours.

A patient who is on a total daily dose of 6 to 12 mg of oral rivastigmine may be directly switched to Exelon Patch 9.5 mg/24 hours.

It is recommended to apply the first patch on the day following the last oral dose.


Method of Administration

Exelon patches should be applied once a day to clean, dry, hairless, intact healthy skin in a place that will not be rubbed against by tight clothing. The upper or lower back is recommended as the site of application because the patch is less likely to be removed by the patient; however, when sites on the back are not accessible the patch can be applied to the upper arm or chest. The patch should not be applied to skin that is red, irritated, or cut. It is recommended that the site of patch application be changed daily to avoid potential irritation, although consecutive patches can be applied to the same anatomic site (e.g., another spot on the upper back). The same site should not be used within 14 days.

The patch should be pressed down firmly until the edges stick well. The patch can be used in situations that include bathing and hot weather.

The patch should be replaced with a new one every 24 hours. Patients and caregivers should be instructed accordingly (See PATIENT INFORMATION).


Incompatibilities

To prevent interference with the adhesive properties of the patch, the patch should not be applied to a skin area where cream, lotion or powder has recently been applied.


Special Populations

Hepatic Impairment: Dosage adjustment is not necessary in hepatically impaired patients, as the dose of drug is individually titrated to tolerability.

Renal Impairment: No dose adjustment is necessary for patients with renal impairment.

Low Body Weight: Patients with body weight below 50 kg may experience more adverse events and may be more likely to discontinue due to adverse events. Particular caution should be exercised in titrating these patients above the recommended maintenance dose of Exelon Patch 9.5 mg/24 hours.



Parkinson's Disease Dementia

See DOSAGE AND ADMINISTRATION.


Dosage Forms And Strengths
Dosage Form

Patch.

Each patch is a thin, matrix-type transdermal system consisting of three layers when worn by the patient. A fourth layer, the release liner, covers the adhesive layer prior to use and is removed at the time the system is applied to the skin.

The outside of the backing layer is beige and labeled for each dose as follows:

-“Exelon® Patch “4.6 mg/24 hours” and “AMCX”

-“Exelon® Patch “9.5 mg/24 hours” and “BHDI”
Dosage Strengths

Table 1 summarizes the available strengths and quantity of rivastigmine provided in each patch:

* Each 5 cm2 patch contains 9 mg rivastigmine base, with in vivo release rate of 4.6 mg/24 hours.
* Each 10 cm2 patch contains 18 mg rivastigmine base, with in vivo release rate of 9.5 mg/24 hours.