First Weekly Transdermal Patch Approved for Alzheimer’s Dementia: ADLARITY

On March 14, 2022: FDA has approved the first and only once-weekly transdermal patch for Alzheimer’s dementia: Adlarity (Donepezil).

Psychiatry Education Forum Academy has summarized this medication in the following sections:

Indication
Mechanism of Action
Route of Administration
Available Doses
How to titrate dose?
Converting from oral donepezil to patch
Managing missed dose
Application sites
Important ten application instructions.
Common adverse events
Important precautions

INDICATION:

Dementia of Alzheimer’s disease: mild, moderate, or severe.

MECHANISM OF ACTION:

Donepezil is a cholinesterase inhibitor, which enhances cholinergic function.

ROUTE OF ADMINISTRATION:

Transdermal patch delivering donepezil.
Applied on a weekly basis.

AVAILABLE DOSES:

Transdermal patch available in:

5 mg/day
10 mg/day
Dose higher than 10mg/day not evaluated

HOW TO TITRATE DOSE?

STARTING DOSE: 5 mg/day.
TITRATION: after 4-6 weeks, dose can be increased to 10mg/day.

CONVERTING FROM ORAL DONEPEZIL TO PATCH

Recommended Starting Dose is 10 mg/day patch if:

patient has been on 5 mg/day oral donepezil for at least 4-6 weeks or
patient on 10 mg/day of oral donepezil

MANAGING MISSED DOSE:

apply the patch immediately and continue the weekly patch application after that.

APPLICATION SITES:

Back: avoid the spine.
Thighs: upper outer thighs preferred.
Buttocks: upper buttocks preferred.
Use a location that will not be rubbed by tight clothing.

IMPORTANT 10 APPLICATION INSTRUCTIONS:

Instruct patients or caregivers to apply the first transdermal system with the last administered oral dose.
Press down firmly for 30 seconds to ensure good contact with the skin at the edges of the patch.
Do not use external heat sources to warm the patch.
Do not apply a cold patch immediately after removing it from the refrigerator.
Use within 24 hours of removing from the refrigerator.
Do not use the same location of an application site for at least 2 weeks (14 days) after removal of the patch from that location.
Do not apply to an area on the skin where medication, cream, lotion, or powder has recently been applied.
Do not apply to skin that is red, irritated, or cut.
Do not shave the site.
Avoid long exposure to external heat sources (e.g., excessive sunlight, saunas, solariums or heating pads).

COMMON ADVERSE EVENTS (INCIDENCE >3%) REPORTED IN TRIALS:

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%).

IMPORTANT PRECAUTIONS:

likely to exaggerate succinylcholine-type muscle relaxation during anesthesia.
may have vagotonic effects on the sinoatrial and atrioventricular nodes manifesting as bradycardia or heart block.
Can cause vomiting: patients should be observed closely at the initiation of treatment and after dose increases.
Patients should be monitored closely for symptoms of active or occult gastrointestinal (GI) bleeding, especially those at increased risk for developing ulcers.
may cause bladder outflow obstructions.
some potential to cause generalized convulsions.
should be prescribed with caution to patients with a history of asthma or obstructive pulmonary disease.

REFERENCES:

Corium press release (weblink)
Adlarity package insert (PDF)

WATCH FOLLOWING DISCUSSION SERIES

[FOR PEFA MEMBERS]

GERIATRIC PSYCHIATRY: NEUROCOGNITIVE DISORDERS

List of chapters included in this section:

(A) Behavioral Symptoms Management in Dementia:

Behavior types & clinical relevance.
Evaluation and Differential diagnosis.
Non-Pharmacological treatment options.
Pharmacological treatment options and management of depression.
Antipsychotics use for Psychosis/Agitation Management in Dementia.
Treatment Options of Sexually Inappropriate Behavior in Dementia

(B) Neurocognitive Disorders:

Evaluating Neurocognitive Domains in Dementia: (a) Complex Attention, (b) Executive Function, (c) Memory & Learning, (d) Language Perceptual-Motor, (e) Social Cognition
Alzheimer’s Disease: Comparing FDA Approved Medications.
Modifiable Predictors of Conversion of Mild Cognitive Impairment to Dementia.
Identifying Dementia Patient at Risk of Unsafe Driving.
How to Screen for Delirium Superimposed on Dementia?
Parkinson’s disease and Impulse Control Disorders.

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