Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS
- Skin application site reactions may occur with Exelon Patch. These reactions are not in themselves an indication of sensitization. However, use of rivastigmine patch may lead to allergic contact dermatitis
- There have been isolated postmarketing reports of patients experiencing disseminated allergic dermatitis when administered rivastigmine irrespective of the route of administration (oral or transdermal).
- disseminated allergic dermatitis, and tremor
- Due to the risk of additive extra-pyramidal adverse reactions, the concomitant use of metoclopramide and Exelon Patch is not recommended.
Cholinomimetic and Anticholinergic Medications
- Exelon Patch may increase the cholinergic effects of other cholinomimetic medications and may also interfere with the activity of anticholinergic medications (e.g., oxybutynin, tolterodine). Concomitant use of Exelon PATCH with medications having these pharmacologic effects is not recommended unless deemed clinically necessary.
- Additive bradycardic effects resulting in syncope may occur when Exelon is used concomitantly with betablockers, especially cardioselective beta-blockers (including atenolol). Concomitant use is not recommended when signs of bradycardia including syncope are present.
- previous history of application site reactions with rivastigmine transdermal patch suggestive of allergic contact dermatitis.
WARNINGS AND PRECAUTIONS
- Skin application site reactions may occur with Exelon Patch and are usually mild or moderate in intensity. These reactions are not in themselves an indication of sensitization. However, 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 (e.g. increasing erythema, edema, papules, vesicles) and if symptoms do not significantly improve within 48 hours after patch removal. In these cases, treatment should be discontinued.
- In patients who develop application site reactions to Exelon Patch suggestive of allergic contact dermatitis and who still require rivastigmine, treatment should be switched to oral rivastigmine only after negative allergy testing and under close medical supervision. It is possible that some patients sensitized to rivastigmine by exposure to rivastigmine patch may not be able to take rivastigmine in any form.
- There have been isolated postmarketing reports of patients experiencing disseminated hypersensitivity reactions of the skin when administered rivastigmine irrespective of the route of administration (oral or transdermal). In these cases, treatment should be discontinued. Patients and caregivers should be instructed accordingly.
Clinical Trials Experience
- 24-Week US Controlled Trial (Study 3)
- Most Commonly Observed Adverse Reactions
- The most commonly observed adverse reactions in patients administered Exelon Patch in the controlled clinical trial, defined as those occurring at a frequency of at least 5% in the 13.3 mg/24 hours Exelon Patch…
- Discontinuation Rates…
- Parkinson’s Disease Dementia…
- abnormal liver function tests, disseminated cutaneous hypersensitivity reactions.
USE IN SPECIFIC POPULATIONS
- No dose adjustment is necessary for patients with renal impairment