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Important Warnings from the Manufacturer Novartis on Drug Product Exelon

Date: 2001-01-26

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BCANS Enquiries

January 26, 2001

IMPORTANT DRUG SAFETY INFORMATION

Dear Healthcare Professional:

Novartis would like to inform you of important proposed changes to the WARNINGS and DOSAGE AND ADMINISTRATION sections of the Product Monograph for EXELON*(rivastigmine). The proposed changes to the monograph provide guidelines for reinitiating therapy in patients who have interrupted treatment with EXELON to reduce the risk of severe vomiting and its potential serious sequelae.

To reduce the possibility of severe vomiting in patients who have interrupted EXELON therapy for longer than several days, treatment should always be reinitiated with the lowest daily dose (i.e. 1.5 mg bid or 1.5 mg od as indicated). After reinitiating therapy, patients should be titrated up to their well tolerated maintenance dose as described in the DOSAGE AND ADMINISTRATION section of the Product Monograph. A case of esophageal rupture secondary to severe vomiting has been reported in a patient who inappropriately reinitiated treatment with a single 4.5 mg dose of EXELON after treatment interruption for eight weeks ¹. This is the only such case reported to date.

The following statements are proposed to be added to the WARNINGS and DOSAGE AND ADMINISTRATION sections of the Product Monograph for EXELON:

• WARNINGS - Gastrointestinal conditions
  
  EXELON is associated with significant gastrointestinal adverse reactions including nausea, vomiting, anorexia and weight loss.
  
  Treatment with EXELON should always be started at a dose of 1.5 mg b.i.d. or 1.5 mg od, as clinically indicated, and patients titrated to their maintenance dose. If treatment with EXELON is interrupted for longer than several days, patients should be instructed to reinitiate treatment with the lowest daily dose and be retitrated (see DOSAGE AND ADMINISTRATION) to reduce the possibility of severe vomiting and its potentially serious sequelae (e.g. there has been one post-marketing report of severe vomiting with esophageal rupture following inappropriate reinitiation of treatment with a 4.5 mg dose after 8 weeks of treatment interruption).
  
  
• DOSAGE AND ADMINISTRATION
  
  
• Anytime treatment is interrupted for longer than several days, patients should be instructed to reinitiate treatment with the lowest daily dose (i.e. 1.5 mg bid or 1.5 mg od, as clinically indicated) and be re-titrated to their maintenance dose as described above (see WARNINGS).
  
  
• The following is proposed to be added to INFORMATION FOR THE PATIENT: If you interrupt treatment with EXELON for longer than several days do NOT re-initiate treatment without contacting your doctor.

Sincerely,

original signed by

Beat Sümegi, M.D. Vice-president, Medical

original signed by

Guy Rousseau, Ph.D. Vice-president, Drug Regulatory Affairs

Novartis is committed to providing you with the most current product information available for the management of patients receiving Exelon. You can further our understanding of adverse events by reporting all cases to:

Novartis Pharmaceuticals Canada Inc., 385 Bouchard Boulevard, Dorval, Quebec, H9S 1A9
by phone at (800) 363-8883 or by fax at (514) 636-3175, or: