Rivastigmine

EXELON PATCH is an acetylcholinesterase inhibitor indicated for treatment of: • Mild, moderate, and severe dementia of the Alzheimer’s type (AD). ( 1.1 ) • Mild-to-moderate dementia associated with Parkinson’s disease (PD). ( 1.2 ) 1.1 Alzheimer’s Disease EXELON PATCH is indicated for the treatment of dementia of the Alzheimer’s type (AD). Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease. 1.2 Parkinson’s Disease Dementia EXELON PATCH is indicated for the treatment of mild-to-moderate dementia associated with Parkinson’s disease (PDD).

• Apply patch on intact skin for a 24-hour period; replace with a new patch every 24 hours. • Initial Dose: Initiate treatment with 4.6 mg/24 hours EXELON PATCH. • Dose Titration: After a minimum of 4 weeks, if tolerated, increase dose to 9.5 mg/24 hours, which is the minimum effective dose
• Following a minimum additional 4 weeks, may increase dosage to maximum dosage of 13.3 mg/24 hours. • Mild-to-Moderate Alzheimer’s Disease and Parkinson’s Disease Dementia: EXELON PATCH 9.5 mg/24 hours or 13.3 mg/24 hours once daily. • Severe Alzheimer’s Disease: EXELON PATCH 13.3 mg/24 hours once daily. • For treatment interruption longer than 3 days, retitrate dosage starting at 4.6 mg per 24 hours. • Consider dose adjustments in patients with : o Mild-to-moderate hepatic impairment o Low (less than 50 kg) body weight Recommended Dosing Initial Dose Initiate treatment with one 4.6 mg/24 hours EXELON PATCH applied to the skin once daily [see Dosage and Administration ]
• Dose Titration Increase the dose only after a minimum of 4 weeks at the previous dose, and only if the previous dose has been tolerated
• For mild-to-moderate AD and PDD patients, continue the effective dose of 9.5 mg/24 hours for as long as therapeutic benefit persists
• Patients can then be increased to the maximum effective dose of 13.3 mg/24 hours dose
• For patients with severe AD, 13.3 mg/24 hours is the effective dose. …

EXELON PATCH is available in 3 strengths. Each patch has a beige backing layer labeled as either: • EXELON ® PATCH 4.6 mg/24 hours, AMCX • EXELON ® PATCH 9.5 mg/24 hours, BHDI • EXELON ® PATCH 13.3 mg/24 hours, CNFU Patch: 4.6 mg/24 hours or 9.5 mg/24 hours or 13.3 mg/24 hours ( 3 )

• Safety and effectiveness
• In pediatric patients have not been established
• The use of EXELON PATCH
• In pediatric patients (below 18 years of age) is not recommended

Of the total number of patients in clinical studies of EXELON PATCH, 88% were 65 years and over, while 55% were 75 years. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

• Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
• Importance of Correct Usage Inform patients or caregivers of the importance of applying the correct dose on the correct part of the body
• They should be instructed to rotate the application site in order to minimize skin irritation
• The same site should not be used within 14 days
• The previous day’s patch must be removed before applying a new patch to a different skin location
• EXELON PATCH should be replaced every 24 hours and the time of day should be consistent
• It may be helpful for this to be part of a daily routine, such as the daily bath or shower. …

• EXELON PATCH is contraindicated in patients with: • known hypersensitivity to rivastigmine, other carbamate derivatives, or other components of the formulation [see Description ] • previous history of application-site reactions with rivastigmine transdermal patch suggestive of allergic contact dermatitis [see Warnings and Precautions ]
• Isolated cases of generalized skin reactions have been described in postmarketing experience [see Adverse Reactions ] . …

Concomitant use with metoclopramide, beta-blockers, or cholinomimetics and anticholinergic medications is not recommended. ( 7.1 , 7.2 , 7.3 ) 7.1 Metoclopramide Due to the risk of additive extra-pyramidal adverse reactions, the concomitant use of metoclopramide and EXELON PATCH is not recommended. 7.2 Cholinomimetic and Anticholinergic Medications EXELON PATCH may increase the cholinergic effects of other cholinomimetic medications and may also interfere with the activity of anticholinergic medications (e.g., oxybutynin, tolterodine). …

• Hospitalization and, rarely, death have been reported due to application of multiple patches at same time. Ensure patients or caregivers receive instruction on proper dosing and administration. ( 5.1 ) • Gastrointestinal Adverse Reactions: May include significant nausea, vomiting, diarrhea, anorexia/decreased appetite, and weight loss, and may necessitate treatment interruption. Dehydration may result from prolonged vomiting or diarrhea and can be associated with serious outcomes. ( 5.2 ) • Application-site reactions may occur with the patch form of rivastigmine. …

The following clinically significant adverse reactions are described below and elsewhere in the labeling: • Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.2)] • Skin Reactions [see Warnings and Precautions (5.3)] • Other Adverse Reactions from Increased Cholinergic Activity [see Warnings and Precautions (5.4)] Most common adverse reactions (less than 5% and higher than with placebo): Nausea, vomiting, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

8.1 Pregnancy Risk Summary There are no adequate data on the developmental risks associated with the use of EXELON in pregnant women. In animals, no adverse effects on embryo-fetal development were observed at oral doses 2-4 times the maximum recommended human dose (MRHD) (see Data) . The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. …

Overdose with EXELON PATCH has been reported in the postmarketing setting [see Warnings and Precautions (5.1)] . Overdoses have occurred from application of more than one patch at one time and not removing the previous day’s patch before applying a new patch. The symptoms reported in these overdose cases are similar to those seen in cases of overdose associated with rivastigmine oral formulations. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.