Safety profile of ADLARITY®1

In a Phase 1 study in healthy volunteers, the types of adverse events were consistent between ADLARITY and oral donepezil1

Most common adverse reactions (incidence >3%) occurring in healthy volunteers receiving ADLARITY 10 mg/d (n=60)

Headache 15%
Application site pruritus 9%
Muscle spasms 9%
Insomnia 7%
Abdominal pain 6%
Application site dermatitis 6%
Constipation 6%
Diarrhea 4%
Application site pain 4%
Dizziness 4%
Abnormal dreams 4%
Skin laceration 4%

Incidences of skin irritation with ADLARITY were mild1,a

  • Skin irritation observed 30 minutes after removal of ADLARITY 10 mg/d (n=268) included erythema (64.6%), papules (16.0%), and edema (0.4%)1,2
  • 99.6% of observed incidences of skin irritation were rated as ≤3 in Dermal Response Score2,b
  • No transdermal system was removed due to skin irritation2

No individuals discontinued ADLARITY treatment due to TEAEs in this study.2

aAn open-label study in 60 healthy volunteers who received ADLARITY 5 mg/d for 5 weeks in Period 1 as a titration dose. In Periods 2 and 3, the volunteers received either ADLARITY 10 mg/d for 5 weeks or oral donepezil 10 mg/d tablets for 5 weeks in a randomized, crossover fashion.1

bSkin tolerability was assessed by Dermal Response Scores (range, 0-7), defined as 0=no evidence of irritation; 1=minimal erythema that is barely perceptible; 2=definite erythema that is readily visible and minimal edema, or minimal papular response; 3=erythema and papules; 4=definite edema; 5=erythema, edema, and papules; 6=vesicular eruption; and 7=strong reaction spreading beyond the application site. Among incidences of skin irritation observed, 19.0% were rated as 1, 64.6% were rated as 2, 16.0% were rated as 3, and 0.4% were rated as 5.2

TEAE, treatment-emergent adverse event.

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.