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Exelon rivastigmine 13.3 mg/24h Patch, Extended Release — NDC 66758-0144-31 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Exelon rivastigmine 13.3 mg/24h Patch, Extended Release — NDC 66758-144-31 (Billing 66758-0144-31)

by Sandoz Inc · 30 PATCH in 1 CARTON / 24 h in 1 PATCH

This is a package of Exelon rivastigmine 13.3 mg/24h Patch, Extended Release from Sandoz Inc, marketed since Jul 2007 and currently FDA-listed; retail pharmacies pay about $22.01 per unit (NADAC). It is this product's only package size.

NDC 66758-0144-31
🏷️ FDA NDC (as labeled) 66758-144-31 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 66758-144-31
Product NDC 66758-144
11-digit billing NDC 66758014431
NCPDP billing unit EA — each (per item)
RxCUI 725021, 725023, 725105, 751302, 1308569, 1308571
UNII PKI06M3IW0
Application # NDA022083
SPL Set ID b6ed6d15-116d-4596-92ce-3414574d7ba0
Established class (EPC) Cholinesterase Inhibitor
Mechanism of action Cholinesterase Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-07-06
Route TRANSDERMAL
Dosage form PATCH, EXTENDED RELEASE
Substance RIVASTIGMINE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 62051040008540
GCN Seq No 069938
GCN 33208
HICL code 034884
Ingredient (HICL) Rivastigmine
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J1
Therapeutic class — intermediate (HIC2) Cholinergics
HIC3 code J1B
Therapeutic class — specific (HIC3) Cholinesterase Inhibitors
AHFS code 12:04.00.00
AHFS class Parasympathomimetic (Cholinergic Agents)
FDB label name EXELON 13.3 MG/24HR PATCH
FDB brand name Exelon
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 069938
  • GCN: 33208
  • GPI-14 (Medi-Span): 62051040008540
  • HICL (First Databank): 034884
  • AHFS class code: 12:04.00.00
  • RxCUI (RxNorm): 725021
Why two NDCs? The FDA registers this code as 66758-144-31 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 66758-0144-31. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Cholinesterase Inhibitor class.

Pharmacologic class Cholinesterase Inhibitor
Drug family (ATC) Anticholinesterases
How it works Cholinesterase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name EXELON 13.3 MG/24HR PATCH Ingredient Rivastigmine
📖 What it is MedlinePlus · NLM

Rivastigmine transdermal patches are used to treat dementia (a brain disorder that affects memory, thinking, and behavior ) in people with Alzheimer's disease (AD; a brain disease that affects memory, thinking, and behavior) or in people with Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance.). Rivastigmine is in a class of medications called cholinesterase inhibitors. It works by increasing the amount of a certain naturally occurring substance in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats dementia from Alzheimer’s disease and dementia linked to Parkinson’s disease. It can help with symptoms, but it does not change the course of the underlying disease.
  • Capsules are taken twice a day with meals. The patch goes on intact skin once every 24 hours, and the old one must come off first. Your doctor will raise the dose slowly, so follow...
  • Nausea, vomiting, diarrhea, lower appetite and weight loss are the most common, especially early on or after dose increases. Call us if they are severe or last, since dehydration c...
  • No. Wearing multiple patches or leaving the old one on has led to serious overdoses. Use one patch at a time, and ask your doctor before changing anything.
📖 Read our full Rivastigmine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $22.008 $660.23 / 30 patch
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $22.34 $670.24 / 30 patch
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 $22.008 $22.008
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
66758-0144-31 You're viewing this Main listing 30 PATCH in 1 CARTON / 24 h in 1 PATCH 2025-10-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rivastigmine 13.3 mg/24h 00378-9072-93 Mylan 30 patches $1.796 AB Availability likely save 92%
Rivastigmine 13.3 mg/24h 00781-7313-31 Sandoz 30 patches $1.796 AB Availability likely save 92%
Rivastigmine 13.3 mg/24h 16714-0117-02 Northstar 30 pouches $1.796 AB Availability likely save 92%
Rivastigmine Transdermal System 13.3 mg/24h 51991-0899-30 Breckenridge 30 patches $1.796 AB Availability likely save 92%
Rivastigmine 13.3 mg/24h 65162-0749-34 Amneal 30 patches $1.796 AB Availability likely save 92%
Rivastigmine 13.3 mg/24h 70710-1198-07 Zydus 30 pouches $1.796 AB Availability likely save 92%
Exelon 13.3 mg/24h 00078-0503-15 Novartis 30 patches $22.008 AB Availability likely —
Exelon 13.3 mg/24hthis 66758-0144-31 Sandoz 30 patches $22.008 AB Availability likely —
Rivastigmine Transdermal System 13.3 mg/24h 63629-2064-01 Bryant 30 patches — AB FDA listed —
Rivastigmine Transdermal System 13.3 mg/24h 63629-8846-01 Bryant 30 patches — AB FDA listed —
Rivastigmine 13.3 mg/24h 70771-1951-07 Zydus 30 pouches — AB FDA listed —
Rivastigmine Transdermal System 13.3 mg/24h 72162-1610-03 Bryant 30 patches — AB FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2007
On the market since
Jul 2007
📍
2026
Currently FDA-listed
19 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII H4N855PNZ1
    Alpha-tocopherol is a form of vitamin E, a fat-soluble antioxidant derived from natural or synthetic sources. In medicines, it prevents oils and fats from breaking down and becoming rancid, protecting the product's stability and shelf life.

1 inactive ingredient listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerSandoz Inc
Application holderSANDOZ INC
FDA applicationNDA022083 (NDA)
Labeler code66758
First marketedJul 2007
Product typeHuman Prescription Drug
Portfolio391 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 88 words ▾

1 INDICATIONS AND USAGE 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 )

1.1Alzheimer’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.

1.2Parkinson’s Disease Dementia EXELON PATCH is indicated for the treatment of mild-to-moderate dementia associated with Parkinson’s disease (PDD).

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Apply patch on intact skin for a 24-hour period; replace with a new patch every 24 hours. ( 2.1 , 2.4 ) • Initial Dose: Initiate treatment with 4.6 mg/24 hours EXELON PATCH. ( 2.1 ) • 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. ( 2.1 ) • 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. ( 2.1 ) • Severe Alzheimer’s Disease: EXELON PATCH 13.3 mg/24 hours once daily.

( 2.1 ) • For treatment interruption longer than 3 days, retitrate dosage starting at 4.6 mg per 24 hours. ( 2.1 ) • Consider dose adjustments in patients with ( 2.2 ): o Mild-to-moderate hepatic impairment ( 8.6 ) o Low (less than 50 kg) body weight ( 8.7 )

2.1Recommended Dosing Initial Dose Initiate treatment with one 4.6 mg/24 hours EXELON PATCH applied to the skin once daily [see Dosage and Administration (2.4)] . 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. Doses higher than 13.3 mg/24 hours confer no appreciable additional benefit, and are associated with an increase in the incidence of adverse reactions [see Warnings and Precautions (5.2), Adverse Reactions (6.1)] .

Mild-to-Moderate Alzheimer’s Disease and Mild-to-Moderate Parkinson’s Disease Dementia The effective dosage of EXELON PATCH is 9.5 mg/24 hours or 13.3 mg/24 hours administered once per day; replace with a new patch every 24 hours. Severe Alzheimer’s Disease The effective dosage of EXELON PATCH in patients with severe Alzheimer’s disease is 13.3 mg/24 hours administered once per day; replace with a new patch every 24 hours. Interruption of Treatment If dosing is interrupted for 3 days or fewer, restart treatment with the same or lower strength EXELON PATCH.

If dosing is interrupted for more than 3 days, restart treatment with the 4.6 mg/24 hours EXELON PATCH and titrate as described above.

2.2Dosing in Specific Populations Dosing Modifications in Patients with Hepatic Impairment Consider using the 4.6 mg/24 hours EXELON PATCH as both the initial and maintenance dose in patients with mild (Child-Pugh score 5 to 6) to moderate (Child-Pugh score 7 to 9) hepatic impairment [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)] . Dosing Modifications in Patients with Low Body Weight Carefully titrate and monitor patients with low body weight (less than 50 kg) for toxicities (e.g., excessive nausea, vomiting), and consider reducing the maintenance dose to the 4.6 mg/24 hours EXELON PATCH if such toxicities develop.

2.3Switching to EXELON PATCH from EXELON Capsules or EXELON Oral Solution Patients treated with EXELON Capsules or Oral Solution may be switched to EXELON PATCH as follows: • A patient who is on a total daily dose of less than 6 mg of oral rivastigmine can be switched to the 4.6 mg/24 hours EXELON PATCH. • A patient who is on a total daily dose of 6 mg to 12 mg of oral rivastigmine can be switched to the 9.5 mg/24 hours EXELON PATCH. Instruct patients or caregivers to apply the first patch on the day following the last oral dose.

2.4Important Administration Instructions EXELON PATCH is for transdermal use on intact skin. (a) Do not use the patch if the pouch seal is broken or the patch is cut, damaged, or changed in any way. (b) Apply the EXELON PATCH once a day. • Press down firmly for 30 seconds until the edges stick well when applying to clean, dry, hairless, intact healthy skin in a place that will not be… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 61 words ▾

3 DOSAGE FORMS AND STRENGTHS 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 )

⛔ Contraindications 100 words ▾

4 CONTRAINDICATIONS EXELON PATCH is contraindicated in patients with: • known hypersensitivity to rivastigmine, other carbamate derivatives, or other components of the formulation [see Description (11)] • previous history of application-site reactions with rivastigmine transdermal patch suggestive of allergic contact dermatitis [see Warnings and Precautions (5.3)] . Isolated cases of generalized skin reactions have been described in postmarketing experience [see Adverse Reactions (6.2)] . • Known hypersensitivity to rivastigmine, other carbamate derivatives, or other components of the formulation.

( 4 ) • History of application-site reactions with rivastigmine transdermal patch suggestive of allergic contact dermatitis. ( 4 , 6.2 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • 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. Discontinue treatment if application-site reactions spread beyond the patch size, if there is evidence of a more intense local reaction (e.g., increasing erythema, edema, papules, vesicles), and if symptoms do not significantly improve within 48 hours after patch removal.

( 5.3 )

5.1Medication Errors Resulting in Overdose Medication errors with EXELON PATCH have resulted in serious adverse reactions; some cases have required hospitalization, and rarely, led to death. The majority of medication errors have involved not removing the old patch when putting on a new one and the use of multiple patches at one time. Instruct patients and their caregivers on important administration instructions for EXELON PATCH [see Dosage and Administration (2.4)] .

5.2Gastrointestinal Adverse Reactions EXELON PATCH can cause gastrointestinal adverse reactions, including significant nausea, vomiting, diarrhea, anorexia/decreased appetite, and weight loss. Dehydration may result from prolonged vomiting or diarrhea and can be associated with serious outcomes. The incidence and severity of these reactions are dose-related [see Adverse Reactions (6.1)] .

For this reason, initiate treatment with EXELON PATCH at a dose of 4.6 mg/24 hours, and titrate to a dose of 9.5 mg/24 hours and then to a dose of 13.3 mg/24 hours, if appropriate [see Dosage and Administration (2.1)] . If treatment is interrupted for more than 3 days because of intolerance, reinitiate EXELON PATCH with the 4.6 mg/24 hours dose to reduce the possibility of severe vomiting and its potentially serious sequelae. A postmarketing report described a case of severe vomiting with esophageal rupture following inappropriate reinitiation of treatment of an oral formulation of rivastigmine without retitration after 8 weeks of treatment interruption.

Inform caregivers to monitor for gastrointestinal adverse reactions and to inform the physician if they occur. It is critical to inform caregivers that if therapy has been interrupted for more than 3 days because of intolerance, the next dose should not be administered without contacting the physician regarding proper retitration.

5.3Skin Reactions Skin application-site reactions may occur with EXELON PATCH. These reactions are not in themselves an indication of sensitization. However, use of rivastigmine patch may lead to allergic contact dermatitis.

Allergic contact dermatitis should be suspected if application-site reactions spread beyond the patch size, if there is evidence of a more intense local reaction (e.g., increasing erythema, edema, papules, vesicles), and if symptoms do not significantly improve within 48 hours after patch removal. In these cases, treatment should be discontinued [see Contraindications (4)] . In patients who develop application-site reactions to EXELON PATCH, suggestive of allergic contact dermatitis 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. There have been isolated postmarketing reports of patients experiencing disseminated allergic dermatitis when administered rivastigmine irrespective of the route of administration (oral or transdermal). In these cases, treatment should be… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. EXELON PATCH has been administered to 4516 patients with Alzheimer’s disease during clinical trials worldwide. Of these, 3005 patients have been treated for at least 26 weeks, 1771 patients have been treated for at least 52 weeks, 974 patients have been treated for at least 78 weeks, and 24 patients have been treated for at least 104 weeks.

Mild-to-Moderate Alzheimer’s Disease 24-Week International Placebo-Controlled Trial (Study 1) Most Common Adverse Reactions The most common adverse reactions in patients administered EXELON PATCH in Study 1 [see Clinical Studies (14)] , defined as those occurring at a frequency of at least 5% in the 9.5 mg/24 hours EXELON PATCH arm and at a frequency at higher than in the placebo group, were nausea, vomiting, and diarrhea. These reactions were dose-related, with each being more common in patients using the unapproved 17.4 mg/24 hours EXELON PATCH than in those using the 9.5 mg/24 hours EXELON PATCH.

Discontinuation Rates In Study 1, which randomized a total of 1195 patients, the proportions of patients in the EXELON PATCH 9.5 mg/24 hours, EXELON Capsules 6 mg twice daily, and placebo groups who discontinued treatment due to adverse events were 10%, 8%, and 5%, respectively. The most common adverse reactions in the EXELON PATCH-treated groups that led to treatment discontinuation in this study were nausea and vomiting. The proportions of patients who discontinued treatment due to nausea were 0.7%, 1.7%, and 1.3% in the EXELON PATCH 9.5 mg/24 hours, EXELON Capsules 6 mg twice daily, and placebo groups, respectively.

The proportions of patients who discontinued treatment due to vomiting were 0%, 2.0%, and 0.3% in the EXELON PATCH 9.5 mg/24 hours, EXELON Capsules 6 mg twice daily, and placebo groups, respectively. Adverse Reactions Observed at an Incidence of Greater than or Equal to 2% Table 1 lists adverse reactions seen at an incidence of greater than or equal to 2% in either EXELON PATCH-treated group in Study 1, and for which the rate of occurrence was greater for patients treated with that dose of EXELON PATCH than for those treated with placebo.

The unapproved 17.4 mg/24 hours EXELON PATCH arm is included to demonstrate the increased rates of gastrointestinal adverse reactions over those seen with the 9.5 mg/24 hours EXELON PATCH. Table 1: Proportion of Adverse Reactions Observed With a Frequency of Greater Than or Equal to 2% and Occurring at a Rate Greater Than Placebo in Study 1 Abbreviation: ARs, adverse reactions. *Vomiting was severe in 0% of patients who received EXELON PATCH 9.5 mg/24 hours, 1% of patients who received EXELON PATCH 17.4 mg/24 hours, 1% of patients who received the EXELON Capsule at doses up to 6 mg twice daily, and 0% of those who received placebo. **Weight Decreased as presented in Table 1 is based upon clinical observations and/or adverse events reported by patients or caregivers.

Body weight was also monitored at prespecified time points throughout the course of the clinical study. The proportion of patients who had weight loss equal to or greater than 7% of their baseline weight was 8%… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 135 words ▾

7 DRUG INTERACTIONS Concomitant use with metoclopramide, beta-blockers, or cholinomimetics and anticholinergic medications is not recommended. ( 7.1 , 7.2 , 7.3 )

7.1Metoclopramide Due to the risk of additive extra-pyramidal adverse reactions, the concomitant use of metoclopramide and EXELON PATCH is not recommended.

7.2Cholinomimetic 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). Concomitant use of EXELON PATCH with medications having these pharmacologic effects is not recommended unless deemed clinically necessary [see Warnings and Precautions ( 5.5 )] .

7.3Beta-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 is not recommended when signs of bradycardia, including syncope are present.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy 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. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. Data Animal Data Oral administration of rivastigmine to pregnant rats and rabbits throughout organogenesis produced no adverse effects on embryo-fetal development up to the highest dose tested (2.3 mg/kg/day), which is 2 and 4 times, respectively, the MRHD of 12 mg per day on a body surface area (mg/m 2 ) basis.

8.2Lactation Risk Summary There are no data on the presence of rivastigmine in human milk, the effects on the breastfed infant, or the effects of rivastigmine on milk production. Rivastigmine and its metabolites are excreted in rat milk following oral administration of rivastigmine; levels of rivastigmine plus metabolites in rat milk are approximately 2 times that in maternal plasma. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for EXELON and any potential adverse effects on the breastfed infant from EXELON or from the underlying maternal condition.

8.4Pediatric Use 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.

8.5Geriatric Use 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.

8.6Hepatic Impairment Increased exposure to rivastigmine was observed in patients with mild or moderate hepatic impairment with oral rivastigmine. Patients with mild or moderate hepatic impairment may be able to only tolerate lower doses [see Dosage and Administration (2.2), Clinical Pharmacology (12.3)] . No data are available on the use of rivastigmine in patients with severe hepatic impairment.

8.7Low or High Body Weight Because rivastigmine blood levels vary with weight, careful titration and monitoring should be performed in patients with low or high body weights [see Dosage and Administration (2.2), Clinical Pharmacology (12.3)] .

🤰 Pregnancy 137 words ▾

8.1Pregnancy 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. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. Data Animal Data Oral administration of rivastigmine to pregnant rats and rabbits throughout organogenesis produced no adverse effects on embryo-fetal development up to the highest dose tested (2.3 mg/kg/day), which is 2 and 4 times, respectively, the MRHD of 12 mg per day on a body surface area (mg/m 2 ) basis.

🧒 Pediatric Use 29 words ▾

8.4Pediatric Use 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.

🧓 Geriatric Use 69 words ▾

8.5Geriatric Use 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.

🆘 Overdosage ~1 min read ▾

10 OVERDOSAGE 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.

Because strategies for the management of overdose are continually evolving, it is advisable to contact a Poison Control Center to determine the latest recommendations for the management of an overdose of any drug. As rivastigmine has a plasma half-life of about 3.4 hours after patch administration and a duration of acetylcholinesterase inhibition of about 9 hours, it is recommended that in cases of asymptomatic overdose the patch should be immediately removed and no further patch should be applied for the next 24 hours.

As in any case of overdose, general supportive measures should be utilized. Overdosage with cholinesterase inhibitors can result in cholinergic crisis characterized by severe nausea, vomiting, salivation, sweating, bradycardia, hypotension, respiratory depression, and convulsions. Increasing muscle weakness is a possibility and may result in death if respiratory muscles are involved.

Atypical responses in blood pressure and heart rate have been reported with other drugs that increase cholinergic activity when coadministered with quaternary anticholinergics, such as glycopyrrolate. Additional symptoms associated with rivastigmine overdose are diarrhea, abdominal pain, dizziness, tremor, headache, somnolence, confusional state, hyperhidrosis, hypertension, hallucinations and malaise. Due to the short plasma elimination half-life of rivastigmine after patch administration, dialysis (hemodialysis, peritoneal dialysis, or hemofiltration) would not be clinically indicated in the event of an overdose.

In overdose accompanied by severe nausea and vomiting, the use of antiemetics should be considered. A fatal outcome has rarely been reported with rivastigmine overdose.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Although the precise mechanism of action of rivastigmine is unknown, it is thought to exert its therapeutic effect by enhancing cholinergic function. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by cholinesterase. The effect of rivastigmine may lessen as the disease process advances and fewer cholinergic neurons remain functionally intact.

There is no evidence that rivastigmine alters the course of the underlying dementing process.

12.2Pharmacodynamics After a 6-mg oral dose of rivastigmine in humans, anticholinesterase activity is present in cerebrospinal fluid for about 10 hours, with a maximum inhibition of about 60% 5 hours after dosing. In vitro and in vivo studies demonstrate that the inhibition of cholinesterase by rivastigmine is not affected by the concomitant administration of memantine, an N-methyl-D-aspartate receptor antagonist.

12.3Pharmacokinetics Absorption After the initial application of EXELON PATCH, there is a lag time of 0.5 to 1 hour in the absorption of rivastigmine. Concentrations then rise slowly typically reaching a maximum after 8 hours, although maximum values (C max ) can also occur later (at 10 to 16 hours). After the peak, plasma concentrations slowly decrease over the remainder of the 24-hour period of application.

At steady state, trough levels are approximately 60% to 80% of peak levels. EXELON PATCH 9.5 mg/24 hours gave exposure approximately the same as that provided by an oral dose of 6 mg twice daily (i.e., 12 mg/day). Inter-subject variability in exposure was lower (43% to 49%) for the EXELON PATCH formulation as compared with the oral formulations (73% to 103%).

Fluctuation (between C max and C min ) is less for EXELON PATCH than for the oral formulation of rivastigmine. Figure 2 displays rivastigmine plasma concentrations over 24 hours for the 3 available patch strengths. Figure 2: Rivastigmine Plasma Concentrations Following Dermal 24-Hour Patch Application Over a 24-hour dermal application, approximately 50% of the drug content of the patch is released from the system.

Exposure area under the plasma concentration-time curve from time zero to infinity (AUC ∞ ) to rivastigmine (and metabolite NAP226-90) was highest when the patch was applied to the upper back, chest, or upper arm. Two other sites (abdomen and thigh) could be used if none of the 3 other sites is available, but the practitioner should be aware that the rivastigmine plasma exposure associated with these sites was approximately 20% to 30% lower. There was no relevant accumulation of rivastigmine or the metabolite NAP226-90 in plasma in patients with Alzheimer’s disease with daily dosing.

The pharmacokinetic profile of rivastigmine transdermal patches was comparable in patients with Alzheimer’s disease and in patients with dementia associated with Parkinson’s disease. Distribution Rivastigmine is weakly bound to plasma proteins (approximately 40%) over the therapeutic range. It readily crosses the blood-brain barrier, reaching CSF peak concentrations in 1.4 to 2.6 hours.

It has an apparent volume of distribution in the range of 1.8 to

2.7L/kg. Metabolism Rivastigmine is extensively metabolized primarily via cholinesterase-mediated hydrolysis to the decarbamylated metabolite NAP226-90. In vitro , this metabolite shows minimal inhibition of acetylcholinesterase (less than 10%).

Based on evidence from in vitro and animal studies, the major cytochrome P450 isoenzymes are minimally involved in rivastigmine metabolism. The metabolite-to-parent AUC ∞ ratio was about 0.7 after EXELON PATCH application versus 3.5 after oral administration, indicating that much less metabolism occurred after dermal treatment. Less NAP226-90 is formed following patch application, presumably because of the lack of presystemic (hepatic first pass) metabolism.

Based on in vitro studies, no unique metabolic routes were detected in h… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 75 words ▾

12.1Mechanism of Action Although the precise mechanism of action of rivastigmine is unknown, it is thought to exert its therapeutic effect by enhancing cholinergic function. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by cholinesterase. The effect of rivastigmine may lessen as the disease process advances and fewer cholinergic neurons remain functionally intact.

There is no evidence that rivastigmine alters the course of the underlying dementing process.

📦 How Supplied / Storage and Handling 143 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING EXELON PATCH: 4.6 mg/24 hours Each patch of 5 cm 2 contains 9 mg rivastigmine base with in vivo release rate of 4.6 mg/24 hours. Carton of 30………………………NDC 66758-142-31 EXELON PATCH: 9.5 mg/24 hours Each patch of 10 cm 2 contains 18 mg rivastigmine base with in vivo release rate of 9.5 mg/24 hours. Carton of 30……………………….NDC 66758-143-31 EXELON PATCH: 13.3 mg/24 hours Each patch of 15 cm 2 contains 27 mg rivastigmine base with in vivo release rate of 13.3 mg/24 hours.

Carton of 30………………………NDC 66758-144-31 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Keep EXELON PATCH in the individual sealed pouch until use. Each pouch contains 1 patch.

Used systems should be folded, with the adhesive surfaces pressed together, and discarded safely.

📋 Description 193 words ▾

11 DESCRIPTION EXELON PATCH (rivastigmine transdermal system) contains rivastigmine, a reversible cholinesterase inhibitor known chemically as (S)-3-[1-(dimethylamino) ethyl]phenyl ethylmethylcarbamate. It has an empirical formula of C 14 H 22 N 2 O 2 as the base and a molecular weight of 250.34 g/mol (as the base). Rivastigmine is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate.

The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27. EXELON PATCH is for transdermal administration. The patch is a 4-layer laminate containing the backing layer, drug matrix, adhesive matrix and overlapping release liner (see Figure 1).

The release liner is removed and discarded prior to use. Figure 1: Cross Section of the EXELON PATCH Layer 1: Backing Film Layer 2: Drug Product (Acrylic) Matrix Layer 3: Adhesive (Silicone) Matrix Layer 4: Release Liner (removed at time of use) Excipients within the formulation include acrylic copolymer, poly (butylmethacrylate, methylmethacrylate), silicone adhesive applied to a flexible polymer backing film, silicone oil, and vitamin E. rivastigmine chemical structure Figure 1: Cross Section of the EXELON PATCH

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION 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. Only 1 patch should be worn at a time [see Dosage and Administration (2.4), Warnings and Precautions (5.1)] . Instruct patients or caregivers to avoid exposure of the patch to external heat sources (excessive sunlight, saunas, solariums) for long periods of time.

Instruct patients who have missed a dose to apply a new patch immediately. They may apply the next patch at the usual time the next day. Instruct patients to not apply 2 patches to make up for 1 missed.

Inform the patient or caregiver to contact the physician for retitration instructions if treatment has been interrupted. Discarding Used Patches Instruct patients or caregivers to fold the patch in half after use, return the used patch to its original pouch, and discard it out of the reach and sight of children and pets. They should also be informed that drug still remains in the patch after 24-hour usage.

They should be instructed to avoid eye contact and to wash their hands after handling the patch. In case of accidental contact with the eyes, or if their eyes become red after handling the patch, they should be instructed to rinse immediately with plenty of water and to seek medical advice if symptoms do not resolve [see Dosage and Administration (2.4)] . Gastrointestinal Adverse Reactions Inform patients or caregivers of the potential gastrointestinal adverse reactions, such as nausea, vomiting, and diarrhea, including the possibility of dehydration due to these symptoms.

Explain that EXELON PATCH may affect the patient’s appetite and/or the patient’s weight. Patients and caregivers should be instructed to look for these adverse reactions, in particular when treatment is initiated or the dose is increased. Instruct patients and caregivers to inform a physician if these adverse reactions persist [see Warnings and Precautions (5.2)] .

Skin Reactions Inform patients or caregivers about the potential for allergic contact dermatitis reactions to occur. Patients or caregivers should be instructed to inform a physician if application-site reactions spread beyond the patch size, if there is evidence of a more intense local reaction (e.g., increasing erythema, edema, papules, vesicles) and if symptoms do not significantly improve within 48 hours after patch removal [see Warnings and Precautions (5.3)] . Concomitant Use of Drugs With Cholinergic Action Inform patients or caregivers that while wearing EXELON PATCH, patients should not be taking EXELON Capsules or EXELON Oral Solution or other drugs with cholinergic effects [see Warnings and Precautions (5.4)] .

Pregnancy Advise patients to notify their healthcare provider if they are pregnant or plan to become pregnant. Manufactured by LTS Lohmann Therapie-Systeme AG, Andernach, Germany for Sandoz Inc., Princeton, NJ 08540

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption After the initial application of EXELON PATCH, there is a lag time of 0.5 to 1 hour in the absorption of rivastigmine. Concentrations then rise slowly typically reaching a maximum after 8 hours, although maximum values (C max ) can also occur later (at 10 to 16 hours). After the peak, plasma concentrations slowly decrease over the remainder of the 24-hour period of application.

At steady state, trough levels are approximately 60% to 80% of peak levels. EXELON PATCH 9.5 mg/24 hours gave exposure approximately the same as that provided by an oral dose of 6 mg twice daily (i.e., 12 mg/day). Inter-subject variability in exposure was lower (43% to 49%) for the EXELON PATCH formulation as compared with the oral formulations (73% to 103%).

Fluctuation (between C max and C min ) is less for EXELON PATCH than for the oral formulation of rivastigmine. Figure 2 displays rivastigmine plasma concentrations over 24 hours for the 3 available patch strengths. Figure 2: Rivastigmine Plasma Concentrations Following Dermal 24-Hour Patch Application Over a 24-hour dermal application, approximately 50% of the drug content of the patch is released from the system.

Exposure area under the plasma concentration-time curve from time zero to infinity (AUC ∞ ) to rivastigmine (and metabolite NAP226-90) was highest when the patch was applied to the upper back, chest, or upper arm. Two other sites (abdomen and thigh) could be used if none of the 3 other sites is available, but the practitioner should be aware that the rivastigmine plasma exposure associated with these sites was approximately 20% to 30% lower. There was no relevant accumulation of rivastigmine or the metabolite NAP226-90 in plasma in patients with Alzheimer’s disease with daily dosing.

The pharmacokinetic profile of rivastigmine transdermal patches was comparable in patients with Alzheimer’s disease and in patients with dementia associated with Parkinson’s disease. Distribution Rivastigmine is weakly bound to plasma proteins (approximately 40%) over the therapeutic range. It readily crosses the blood-brain barrier, reaching CSF peak concentrations in 1.4 to 2.6 hours.

It has an apparent volume of distribution in the range of 1.8 to

2.7L/kg. Metabolism Rivastigmine is extensively metabolized primarily via cholinesterase-mediated hydrolysis to the decarbamylated metabolite NAP226-90. In vitro , this metabolite shows minimal inhibition of acetylcholinesterase (less than 10%).

Based on evidence from in vitro and animal studies, the major cytochrome P450 isoenzymes are minimally involved in rivastigmine metabolism. The metabolite-to-parent AUC ∞ ratio was about 0.7 after EXELON PATCH application versus 3.5 after oral administration, indicating that much less metabolism occurred after dermal treatment. Less NAP226-90 is formed following patch application, presumably because of the lack of presystemic (hepatic first pass) metabolism.

Based on in vitro studies, no unique metabolic routes were detected in human skin. Elimination Renal excretion of the metabolites is the major route of elimination. Unchanged rivastigmine is found in trace amounts in the urine.

Following administration of 14 C-rivastigmine, renal elimination was rapid and essentially complete (greater than 90%) within 24 hours. Less than 1% of the administered dose is excreted in the feces. The apparent elimination half-life in plasma is approximately 3 hours after patch removal.

Renal clearance was approximately 2.1 to

2.8L/hr. Age Age had no impact on the exposure to rivastigmine in Alzheimer’s disease patients treated with EXELON PATCH. Gender and Race No specific pharmacokinetic study was conducted to investigate the effect of gender and race on the disposition of EXELON PATCH.

A population pharmacokinetic analysis of oral rivastigmine indicated that neither gender (n = 277 males and 348 females) nor race (n = 575 Caucasian, 34 black, 4 Asian, and 12 Other) affected clearance of the drug. Similar… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 60 words ▾

12.2Pharmacodynamics After a 6-mg oral dose of rivastigmine in humans, anticholinesterase activity is present in cerebrospinal fluid for about 10 hours, with a maximum inhibition of about 60% 5 hours after dosing. In vitro and in vivo studies demonstrate that the inhibition of cholinesterase by rivastigmine is not affected by the concomitant administration of memantine, an N-methyl-D-aspartate receptor antagonist.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The effectiveness of the EXELON PATCH in dementia of the Alzheimer’s type and dementia associated with Parkinson’s disease was based on the results of 3 controlled trials of EXELON PATCH in patients with Alzheimer’s disease (Studies 1, 2, and 3) (see below); 3 controlled trials of oral rivastigmine in patients with dementia of the Alzheimer’s type; and 1 controlled trial of oral rivastigmine in patients with dementia associated with Parkinson’s disease. See the prescribing information for oral rivastigmine for details of the four studies of oral rivastigmine.

Mild-to-Moderate Alzheimer’s Disease International 24-Week Study of EXELON PATCH in Dementia of the Alzheimer’s Type (Study 1) This study was a randomized double-blind, double dummy clinical investigation in patients with Alzheimer’s disease [diagnosed by NINCDS-ADRDA and DSM-IV criteria, Mini-Mental Status Examination (MMSE) score greater than or equal to 10 and less than or equal to 20] (Study 1). The mean age of patients participating in this trial was 74 years with a range of 50 to 90 years. Approximately 67% of patients were women, and 33% were men.

The racial distribution was Caucasian 75%, black 1%, Asian 9%, and other races 15%. The effectiveness of the EXELON PATCH was evaluated in Study 1 using a dual outcome assessment strategy, evaluating for changes in both cognitive performance and overall clinical effect. The ability of the EXELON PATCH to improve cognitive performance was assessed with the cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-Cog), a multi-item instrument that has been extensively validated in longitudinal cohorts of Alzheimer’s-disease patients.

The ADAS-Cog examines selected aspects of cognitive performance, including elements of memory, orientation, attention, reasoning, language, and praxis. The ADAS-Cog scoring range is from 0 to 70, with higher scores indicating greater cognitive impairment. Elderly normal adults may score as low as 0 or 1, but it is not unusual for non-demented adults to score slightly higher.

The ability of the EXELON PATCH to produce an overall clinical effect was assessed using the Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC). The ADCS-CGIC is a more standardized form of the Clinician's Interview-Based Impression of Change-Plus (CIBIC-Plus) and is also scored as a 7-point categorical rating; scores range from 1, indicating “markedly improved,” to 4, indicating “no change,” to 7, indicating “marked worsening.” In Study 1, 1195 patients were randomized to 1 of the following 4 treatments: EXELON PATCH 9.5 mg/24 hours, EXELON PATCH 17.4 mg/24 hours, EXELON Capsules in a dose of 6 mg twice daily, or placebo.

This 24-week study was divided into a 16-week titration phase followed by an 8-week maintenance phase. In the active treatment arms of this study, doses below the target dose were permitted during the maintenance phase in the event of poor tolerability. Figure 3 illustrates the time course for the change from baseline in ADAS-Cog scores for all 4 treatment groups over the 24-week study.

At 24 weeks, the mean differences in the ADAS-Cog change scores for the EXELON-treated patients compared to the patients on placebo, were 1.8, 2.9, and 1.8 units for the EXELON PATCH 9.5 mg/24 hours, EXELON PATCH 17.4 mg/24 hours, and EXELON Capsule 6 mg twice daily groups, respectively. The difference between each of these groups and placebo was statistically significant. Although a slight improvement was observed with the 17.4 mg/24 hours patch compared to the 9.5 mg/24 hours patch on this outcome measure, no meaningful difference between the two was seen on the global evaluation (see Figure 4).

Figure 3: Time Course of the Change from Baseline in ADAS-Cog Score for Patients Observed at Each Time Point in Study 1 Figure 4 presents the distribution of patients’ scores on the ADCS-CGIC for all 4 treatment groups. At 24 weeks, the mean difference in the ADC… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 157 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In oral carcinogenicity studies conducted at doses up to 1.1 mg/kg/day in rats and 1.6 mg/kg/day in mice, rivastigmine was not carcinogenic. In a dermal carcinogenicity study conducted at doses up to 0.75 mg base/kg/day in mice, rivastigmine was not carcinogenic. The mean rivastigmine plasma exposure (AUC) at this dose was less than that in humans at the maximum recommended human dose (13.3 mg/24 hours).

Mutagenesis Rivastigmine was clastogenic in in vitro chromosomal aberration assays in mammalian cells in the presence, but not the absence, of metabolic activation. Rivastigmine was negative in an in vitro bacterial reverse mutation (Ames) assay, an in vitro HGPRT assay, and in an in vivo mouse micronucleus test. Impairment of Fertility No fertility or reproduction studies of dermal rivastigmine have been conducted in animals.

Rivastigmine had no effect on fertility or reproductive performance in rats at oral doses up to 1.1 mg/kg/day.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 154 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In oral carcinogenicity studies conducted at doses up to 1.1 mg/kg/day in rats and 1.6 mg/kg/day in mice, rivastigmine was not carcinogenic. In a dermal carcinogenicity study conducted at doses up to 0.75 mg base/kg/day in mice, rivastigmine was not carcinogenic. The mean rivastigmine plasma exposure (AUC) at this dose was less than that in humans at the maximum recommended human dose (13.3 mg/24 hours).

Mutagenesis Rivastigmine was clastogenic in in vitro chromosomal aberration assays in mammalian cells in the presence, but not the absence, of metabolic activation. Rivastigmine was negative in an in vitro bacterial reverse mutation (Ames) assay, an in vitro HGPRT assay, and in an in vivo mouse micronucleus test. Impairment of Fertility No fertility or reproduction studies of dermal rivastigmine have been conducted in animals.

Rivastigmine had no effect on fertility or reproductive performance in rats at oral doses up to 1.1 mg/kg/day.

📄 Patient Package Insert ~3 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 06/2020 Patient Information EXELON ® (ECS-‘el-on) PATCH (rivastigmine transdermal system) What is the most important information I should know about EXELON PATCH?

EXELON PATCH is for skin use only. What is EXELON PATCH? EXELON PATCH is a prescription medicine used to treat: • Mild, moderate, and severe memory problems (dementia) associated with Alzheimer’s disease. • Mild-to-moderate memory problems (dementia) associated with Parkinson’s disease (PD).

Based on clinical trials conducted over 6 to 12 months, EXELON PATCH was shown to help with cognition which includes (memory, understanding communication, and reasoning) and with doing daily tasks. EXELON PATCH does not work the same in all people. Some people treated with EXELON PATCH may: • Seem much better • Get better in small ways or stay the same • Get worse but slower than expected • Not change and then get worse as expected Some patients will not benefit from treatment with EXELON Patch.

EXELON PATCH does not cure Alzheimer’s disease. All patients with Alzheimer’s disease get worse over time. EXELON PATCH comes as a transdermal system that delivers rivastigmine (the medicine in EXELON PATCH) through the skin.

It is not known if EXELON PATCH is safe or effective in children under 18 years of age. Who should not use EXELON PATCH? Do not use EXELON PATCH if you: • are allergic to rivastigmine, carbamate derivatives, or any of the ingredients in EXELON PATCH.

See the end of this leaflet for a complete list of ingredients in EXELON PATCH. • have had a skin reaction that: o spread beyond the EXELON PATCH size o had blisters, increased skin redness, or swelling o did not get better within 48 hours after you removed the EXELON PATCH Ask your healthcare provider if you are not sure if you should use EXELON PATCH. What should I tell my healthcare provider before using EXELON PATCH? Before you use EXELON PATCH, tell your healthcare provider if you: • have or have had a stomach ulcer • are planning to have surgery • have or have had problems with your heart • have problems passing urine • have or have had seizures • have problems with movement (tremors) • have asthma or breathing problems • have a loss of appetite or are losing weight • have had a skin reaction to rivastigmine (the medicine in EXELON PATCH) in the past • have any other medical conditions • are pregnant or plan to become pregnant.

It is not known if the medicine in EXELON PATCH will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant. • are breastfeeding or plan to breastfeed. It is not known if the medicine in EXELON PATCH passes into your breast milk.

Talk to your doctor about the best way to feed your baby if you take EXELON PATCH. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take: • a medicine used to treat inflammation [nonsteroidal anti-inflammatory drugs (NSAIDs)] • other medicines used to treat Alzheimer’s or Parkinson’s disease • an anticholinergic medicine, such as an allergy or cold medicine, a medicine to treat bladder or bowel spasms, or certain asthma medicines, or certain medicines to prevent motion or travel sickness • metoclopramide, a drug given to relieve symptoms of nausea, gastroesophageal reflux disease (GERD), or nausea and vomiting after surgery or chemotherapy treatment • If you are undergoing surgery while using EXELON PATCH, inform your doctor because EXELON PATCH may exaggerate the effects of anesthesia, or the effects of a beta-blocker, a type of medicine given for high blood pressure, heart disease, and other medical conditions Ask your healthcare provider if you are not sure if your medicine is one listed above.

Know the medicines you take. Keep a list of them to show to your healthcare provi… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

Instructions for Use EXELON ® (ECS-‘el-on) PATCH (rivastigmine transdermal system) You will need the following supplies (See Figure A): EXELON PATCH is supplied in cartons containing 30 patches (See Figure A) Figure A • EXELON PATCH is a thin, beige, plastic patch that sticks to the skin. Each EXELON PATCH is sealed in a pouch that protects it until you are ready to put it on (See Figure A). • Only 1 EXELON PATCH should be worn at a time. Do not apply more than 1 EXELON PATCH at a time to the body. • Do not open the pouch or remove the EXELON PATCH until you are ready to apply it.

Using EXELON PATCH: Step 1. Choose an area to apply the EXELON PATCH (See Figure B). • Instructions for Caregivers: Apply EXELON PATCH to the upper or lower back if it is likely that the patient will remove it. If this is not a concern, the EXELON PATCH can be applied instead to the upper arm or chest.

Do not apply the EXELON PATCH to areas where it can be rubbed off by tight clothing or belts. • Only apply the EXELON PATCH to healthy skin that is clean, dry, hairless, and free of redness, irritation, burns or cuts. Figure B The diagram represents areas on the body where EXELON PATCH may be applied. Only 1 patch should be worn at a time.

Do not apply multiple patches to the body. Step 2. Remove the EXELON PATCH from the pouch (See Figure C).

Carefully cut the pouch along the dotted line to open and remove the EXELON PATCH. Save the pouch for later use. Figure C • Do not cut or fold the EXELON PATCH itself.

Step 3. Remove 1 side of the adhesive liner (See Figure D). • A protective liner covers the sticky (adhesive) side of the EXELON PATCH. Peel off 1 side of the protective cover.

Do not touch the sticky part of the EXELON PATCH with your fingers. Figure D Step 4. Apply the EXELON PATCH to your skin (See Figure E). • Apply the sticky (adhesive) side of the EXELON PATCH to your chosen area of skin and then peel off the other side of the protective cover.

Figure E • Press down on the EXELON PATCH firmly for 30 seconds to make sure that the edges stick to your skin (See Figure F). Figure F Step 5: Wash your hands with soap and water right away. Note: • If your EXELON PATCH falls off, select a new area, and repeat Steps 2 to 5 to apply a new EXELON PATCH. • Be sure to replace the new EXELON PATCH the next day at the same time as usual.

Removing your EXELON PATCH: Step 6. Remove the EXELON PATCH from the skin (See Figure G). • Gently pull on 1 edge of the EXELON PATCH to remove it from your skin. Figure G Throwing away the used EXELON PATCH: Step 7.

Throw away the used EXELON PATCH (See Figure H). • Fold the used EXELON PATCH in half (with the sticky sides together) and put it back into the pouch that you saved. Figure H • Throw away the used EXELON PATCH safely and out of the reach of children and pets. • Some medicine stays in the patch for 24 hours after you use it and should be folded together (sticky side together) and safely thrown away. Do not try to re-use EXELON PATCHes.

Step 8: Wash your hands with soap and water right away. • After you remove the EXELON PATCH, if any adhesive remains on your skin, you can use soap and water or an oil-based substance (such as baby oil) to remove the adhesive. Alcohol or other dissolving liquids (such as nail polish remover) should not be used. This Instructions for Use have been approved by the U.S.

Food and Drug Administration. Revised: 12/2018 Manufactured by LTS Lohmann Therapie-Systeme AG, Andernach, Germany for Sandoz Inc., Princeton, NJ 08540 figurea Cut the pouch along the dotted line and remove the patch. figurec Put the sticky side of the patch on the upper or lower back, upper arm or chest and then peel off the second side of the protective liner. Press the patch firmly in place with the hand to make sure that the edges stick well.

Figure F Figure G figureh

📄 Package Label / Principal Display Panel 84 words ▾

PRINCIPAL DISPLAY PANEL NDC 66758-142-31 Rx only EXELON ® PATCH (rivastigmine transdermal system) Each System Delivers 4.6 mg/24 hours For Transdermal Use Only Contains 30 Systems SANDOZ 4.6mgcarton

PRINCIPAL DISPLAY PANEL NDC 66758-143-31 Rx only EXELON ® PATCH (rivastigmine transdermal system) Each System Delivers 9.5 mg/24 hours For Transdermal Use Only Contains 30 Systems SANDOZ 9.5mgcarton

PRINCIPAL DISPLAY PANEL NDC 6758-144-31 Rx only EXELON ® PATCH (rivastigmine transdermal system) Each System Delivers 13.3 mg/24 hours For Transdermal Use Only Contains 30 Systems SANDOZ 13.3mgcarton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Exelon — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Exelon. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$491.5K
Claims incl. refills
626
Beneficiaries
324
Spend / beneficiary
$1,516.85
Spend / claim
$785.08
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 66758-0143-31 · Sandoz 66758-0145-83 · Sandoz →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.