ADLARITY® consistently delivers donepezil over 7 days1,2

Proprietary Corplex Technology

Pharmacokinetics

Adhesion Data

Innovative once-weekly transdermal system with

proprietary Corplex technology1,3

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Delivers donepezil consistently2,3

Donepezil is continuously converted in the drug matrix for consistent delivery through the skin

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Flexibly conforms to skin movement2,3

Contains a stretch-fabric backing with perforated layers beneath that enables flexibility

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Less than 1 mm thin3,4

Thinner than the average skin thickness of the human back and/or thigh

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Adhesion when bathing or showering2

Even at temperatures up to 108 °F

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Transdermal delivery bypasses the GI tract and avoids first-pass hepatic metabolism2,a

aFirst-pass effect occurs when a drug gets metabolized at a specific location in the body (eg, the liver) and results in a reduced concentration of the active drug upon reaching its site of function or systemic circulation.5

Adhesion is maintained throughout the weekly wear period2

In a Phase 1 study that evaluated the steady-state pharmacokinetics of ADLARITY 5 mg/d and 10 mg/d compared with oral donepezil 10 mg/d in healthy volunteers2

Continuous delivery reduced fluctuations, resulting in a smoother plasma drug level at steady state2

Mean plasma donepezil concentration-time data after weekly application of ADLARITY and daily administration of oral donepezil during Week 5 in healthy volunteers2

Graph of mean plasma concentrations of donepezil after weekly application of ADLARITY® and daily administration of oral donepezil during Week 5 in healthy volunteers. Graph of mean plasma concentrations of donepezil after weekly application of ADLARITY® and daily administration of oral donepezil during Week 5 in healthy volunteers.
Graph displaying oral donepezil showed clinical improvement in ADAS-cog scores. Graph displaying oral donepezil showed clinical improvement in ADAS-cog scores.
Graph of mean plasma concentrations of donepezil after weekly application of ADLARITY® and daily administration of oral donepezil during Week 5 in healthy volunteers.
Graph displaying oral donepezil showed clinical improvement in ADAS-cog scores. Graph displaying oral donepezil showed clinical improvement in ADAS-cog scores.

bApplied weekly for a 7-day wear; removed in the morning on Day 36, with donepezil concentration measured on Days 29 to 36.2

cTaken once daily for 35 days, with donepezil concentration measured on Days 35 to 36 (no dosing on Day 36). Data shown during Hours 0 to 144 represent a projection of measurements taken on Day 35.2

Designed for 7 days of adhesion1

The ADLARITY transdermal system has demonstrated adhesion throughout the weekly (168-hour) wear period1

Percentage of transdermal systems exhibiting ≥80% surface area adhesion on the back at all time points evaluated (every 12 hours) throughout the 7-day wear period in a study of healthy volunteers1,d

ADLARITY 5 mg/d (n=85)

94%

80/85 transdermal systems

ADLARITY 10 mg/d (n=85)

91%

307/338 transdermal systems

None of the transdermal systems fully detached during the study.1

dThe adhesion of ADLARITY 5 mg/d was evaluated over 168 hours for 1 week, and the adhesion of ADLARITY 10 mg/d was evaluated over 168 hours for 4 consecutive weeks.1

In a separate study assessing wear at different application sites (back, thigh, and buttock; N=66)2,e

  • ≥85% of the transdermal systems applied at every site exhibited ≥80% surface area adhesion for the duration of wear (168 hours)
  • 1 full detachment on the back was noted in the study

e183 total transdermal systems were applied (60 on the back, 61 on the thigh, and 62 on the buttock).2

GI, gastrointestinal.

INDICATION

ADLARITY is indicated for the treatment of mild, moderate, and severe dementia of the Alzheimer's type.

IMPORTANT SAFETY INFORMATION

Contraindications

ADLARITY is contraindicated in patients with known hypersensitivity to donepezil or to piperidine derivatives or with a history of allergic dermatitis with use of ADLARITY.

INDICATION

ADLARITY is indicated for the treatment of mild, moderate, and severe dementia of the Alzheimer's type.

IMPORTANT SAFETY INFORMATION

Contraindications

ADLARITY is contraindicated in patients with known hypersensitivity to donepezil or to piperidine derivatives or with a history of allergic dermatitis with use of ADLARITY.

Warnings and Precautions
  • Application site skin reactions: ADLARITY may cause skin application-site reactions. These reactions are not necessarily indicative of sensitization; however, allergic contact dermatitis may occur and should be suspected if application-site reactions spread beyond the size of the transdermal system, there is evidence of a more intense local reaction, and symptoms do not significantly improve within 48 hours of transdermal system removal.
  • Anesthesia: ADLARITY, as a cholinesterase inhibitor, is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia.
  • Cardiovascular conditions: Cholinesterase inhibitors, including ADLARITY, may have vagotonic effects on the sinoatrial and atrioventricular nodes. These effects may manifest as bradycardia or heart block in patients both with and without known underlying cardiac conduction abnormalities. Syncopal episodes have been reported in association with the use of donepezil.
  • Nausea and vomiting: Donepezil, the active ingredient in ADLARITY, may cause diarrhea, nausea, and vomiting. In most cases these effects have been transient, although some cases lasted 1 to 3 weeks. Patients should be monitored closely during initiation of treatment and after dose increases.
  • Peptic ulcer disease and gastrointestinal bleeding: Cholinesterase inhibitors, including ADLARITY, may increase gastric acid secretion. Patients should be monitored closely for active or occult gastrointestinal bleeding, especially those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs).
  • Genitourinary conditions: Although not observed in clinical trials of ADLARITY, bladder outflow obstruction may occur.
  • Seizures: Cholinomimetics, including ADLARITY, are believed to have some potential to cause generalized convulsions; however, seizure activity may also be a manifestation of Alzheimer's disease.
  • Pulmonary conditions: Cholinesterase inhibitors, including ADLARITY, should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.
Adverse Reactions

The most common adverse reactions (greater than 5% with donepezil tablets and twice the placebo rate) are nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and anorexia.

Drug Interactions

Cholinesterase inhibitors, including donepezil, have the potential to interfere with the activity of anticholinergic medications. A synergistic effect may be expected when cholinesterase inhibitors are given concurrently with succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists such as bethanechol.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/MedWatch or call 1‑800‑FDA‑1088. Please click here for Full Prescribing Information.

References: 1. ADLARITY. Prescribing information. Corium, LLC; 2022. 2. Data on file. Corium, LLC. 3. Soo LE, Amit KJ, Parminder S, inventors; Corium International, Inc, assignee. Donepezil transdermal delivery system. U.S. patent 9,993,466. June 12, 2018. 4. Kakasheva-Mazhenkovska L, Milenkova L, Gjokik G, Janevska V. Variations of the histomorphological characteristics of human skin of different body regions in subjects of different age. Prilozi. 2011;32(2):119-128. 5. Herman TF, Santos C. First pass effect. In: StatPearls. StatPearls Publishing; 2021. Accessed January 20, 2023. https://www.ncbi.nlm.nih.gov/books/NBK551679/