Safety

Exelon (rivastigmine tartrate) capsules and oral solution

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

February 2015

Summary View

WARNINGS AND PRECAUTIONS

Allergic 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). Treatment should be discontinued if disseminated allergic dermatitis occurs.  Patients and caregivers should be instructed accordingly.

ADVERSE REACTIONS

Postmarketing Experience
  • Skin and Appendages: disseminated allergic dermatitis.

DRUG INTERACTIONS

Metoclopramide
  • Due to the risk of additive extrapyramidal adverse reactions, the concomitant use of metoclopramide and Exelon is not recommendedd.
Cholinomimetic and Anticholinergic Medications
  • Exelon 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 with medications having these pharmacologic effects is not recommended unless deemed clinically necessary.
Beta-blockers
  • Additive bradycardic effects resulting in syncope may occur when Exelon is used concomitantly with beta-blockers, especially cardioselective beta-blockers (including atenolol). Concomitant use of Exelon with beta-blockers is not recommended.

 

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

 

Page Last Updated: 03/11/2015
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