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U.S. Department of Health and Human Services

Safety

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Exelon (rivastigmine tartrate) capsules and oral solution

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

 

October 2013

Summary View

CONTRAINDICATIONS

  • a previous history of application site reaction with rivastigmine transdermal patch suggestive of allergic contact dermatitis, in the absence of negative allergy testing
  • Isolated cases of generalized skin reactions have been described in postmarketing experience

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions of the Skin
  • 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). Treatment should be discontinued if disseminated hypersensitivity reaction of the skin occurs.  Patients and caregivers should be instructed accordingly.
  • In patients who develop application site reactions suggestive of allergic contact dermatitis to Exelon Patch 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.

ADVERSE REACTIONS

Clinical Trials Experience

Table 3

  • Active-Controlled Study information added to table

Postmarketing Experience

  • Hepatobiliary Disorders: Hepatitis.
  • Psychiatric Disorders: Aggression
  • Skin and Appendages: disseminated cutaneous hypersensitivity reactions