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U.S. Department of Health and Human Services

Safety

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Exelon (rivastigmine) Patch

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2013

Summary View

 

CONTRAINDICATIONS

  • previous history of application site reactions with rivastigmine transdermal patch suggestive of allergic contact dermatitis.
 

WARNINGS AND PRECAUTIONS

Skin Reactions
  • 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.
 

ADVERSE REACTIONS

Clinical Trials Experience
Severe Alzheimer’s Disease (additions to entire section)
  • 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…
Postmarketing Experience
  • abnormal liver function tests, disseminated cutaneous hypersensitivity reactions.
 

USE IN SPECIFIC POPULATIONS

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