RPhLink - Exelon

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FROM: Novartis

EXELON^®

EXELON (rivastigmine tartrate)

March 2003

EXELON Efficacy Demonstrated in Clinical Trials
In clinical trials, patients with Alzheimer's disease (AD) who were treated with EXELON (rivastigmine tartate) demonstrated significant benefit in global functioning based on evaluation of*¹:

Activities of daily living (dressing,feeding, toileting, use of common household implements)

Behavior (agitation, irritability, anxiety, depression)

Cognition (language skills, memory, orientation)

This envelope contains items to help you counsel patients with AD who are being treated with EXELON. When you educate patients about taking EXELON correctly, you are helping patients maximize EXELON's therapeutic benefits and minimize potential adverse events.

Pharmacokinetic Overview
Favorable Pharmacokinetic Profile

Review the enclosed card to find out why some patients may experience gastrointestinal (GI) adverse events when EXELON is at work in the brain and to learn about EXELON's favorable pharmacokinetic profile. We are providing this information so that information so that you have the facts you need to counsel patients who have questions about EXELON therapy

"Take With Meals" Stickers

Affix the enclosed stickers to EXELON prescriptions you fill so patients and their caregivers will be reminded when to take EXELON. Taking EXELON with a full meal delays absorption, reduces peak concentrations, and can manage GI-related adverse events.¹

Appropriate Dosing
To help patients make the most of their therapy, take the opportunity to review these doing instructions with customers when you dispense EXELON:

Patients should follow their physician's instructions exactly

The doctor will start with the lowest dosage of EXELON (1.5 mg BID)

After 4 weeks, the doctor may prescribe a higher dose (3 mg BID) based on the patients response

Over time, the doctor may prescribe higher doses of EXELON

For best results:

Patients should take EXELON twice a day with a full meal

1 capsule with a full morning meal

Bowl of cereal with milk and a piece of fruit

Scrambled eggs with toast

1 capsule with a full evening meal

Salmon with rice, green beans, and a roll

Plate of pasta with sauce

Patients should not stop taking EXELON unless directed by their doctor

What to expect from EXELON Therapy

Patients and caregivers often ask how they can tell whether EXELON is working.

EXELON is working if the person is
(1) Improved
(2) Unchanged for an extended period
(symptoms are not better or worse)
(3) Slightly worse, but better than expected with no treatment
(4) With no treatment, the patient would be expected to decline more rapidly¹

In controlled clinical trials, the most common adverse events were nausea, vomiting, anorexia, dyspepsia, and asthenia. EXELON has been associated with significant gastrointestinal adverse events, including nausea and vomiting, anorexia, and weight loss. If therapy is interrupted for longer than several days, treatment should be reinitiated with the lowest daily dose in order to avoid the possibility of severe vomiting and its potentially serious sequelae. In the controlled trials, 47% of patients experienced nausea and 31% of patients experienced vomiting. Weight loss associated with EXELON occurred more commonly among women receiving high doses in clinical trials. Due to increased cholinergic activity, cholinesterase inhibitors may be expected to increase gastric acid secretion and/or have vagotonic effects on heart rate. Therefore, EXELON should be used with caution in patients with peptic ulcers, gastrointestinal bleeding, and "sick sinus syndrome" or other supraventricular cardiac conduction conditions. (Please see important WARNINGS in complete prescribing information.)

Please see accompanying complete prescribing information.

_{*Measured
by the Clinician's Interview-Based Impression of Change With
Caregiver Input (CIBIC-Plus). is an assessment of overall clinical
effect on global functioning (behavior, cognition, and activities of
daily living), based on}_caregiver_{and physician impressions. CIBIC-Plus is not a single nor a
standardized instrument.}

_{Reference:
1. EXELON}^®_{(package
insert). East Hanover, NJ: Novartis Pharmaceuticals Corp; 2000.}

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