2.1 Recommended Dosage

The recommended starting dosage of ADLARITY is 5 mg/day. After 4 to 6 weeks, the dosage may be increased to the maximum recommended dosage of 10 mg/day. Administer ADLARITY as one transdermal system applied to the skin once weekly [see Dosage and Administration (2.3)].

Doses of the transdermal system higher than the 10 mg/day equivalent have not been evaluated.

2.2 Switching to ADLARITY from Donepezil Hydrochloride Tablets or Donepezil Hydrochloride ODT

Patients treated with donepezil hydrochloride 5 mg or 10 mg tablets may be switched to ADLARITY:

• A patient who is being treated with a total daily dose of 5 mg of oral donepezil hydrochloride can be switched to the once weekly 5 mg/day ADLARITY transdermal system. If a patient has been on 5 mg oral donepezil hydrochloride for at least 4-6 weeks, the patient may be switched immediately to the once weekly 10 mg/day transdermal system.
• A patient who is being treated with a total daily dose of 10 mg of oral donepezil hydrochloride can be switched to the once weekly 10 mg/day ADLARITY transdermal system.

Instruct patients or caregivers to apply the first transdermal system with the last administered oral dose.

Administration Information

Each ADLARITY transdermal system delivers either 5 mg or 10 mg of donepezil daily for 7 days (one week cycle). At the end of 7 days, the used transdermal system is removed, and a new transdermal system is applied. Only one transdermal system should be applied at a time.

See the Instructions for Use for step-by-step instructions.

Preparation

• Remove one ADLARITY transdermal system from the refrigerator and allow the pouch to reach room temperature before opening.

o Do not use external heat sources to warm ADLARITY.
o Do not apply a cold transdermal system.
o Use within 24 hours of removing from the refrigerator.

• Ensure the ADLARITY pouch seal has not been broken. Do not use ADLARITY if the transdermal system is damaged, cut, or altered in any way.
• Select application site:

o The recommended application site is the back (avoiding the spine). If needed, the upper buttocks or the upper outer thigh may be used [see Clinical Studies (14.3)]. Use a location that will not be rubbed by tight clothing.
o Do not use the same location of an application site for at least 2 weeks (14 days) after removal of a transdermal system from that location.
o Do not apply to an area on skin where medication, cream, lotion, or powder has recently been applied.
o Do not apply to skin that is red, irritated, or cut.
o Do not shave the site.

Application

• Apply ADLARITY to skin immediately after removing from the pouch.
• Apply to clean, dry, intact healthy skin with no to minimal hair (see Preparation).
• Press down firmly for 30 seconds to ensure good contact with skin at the edges of the transdermal system.
• ADLARITY use does not need to be interrupted due to bathing or hot weather. Avoid long exposure to external heat sources (e.g., excessive sunlight, saunas, solariums or heating pads).

Missed Dose

If an ADLARITY transdermal system falls off, or if a dose is missed, apply a new transdermal system immediately and then replace this transdermal system 7 days later to start a new one-week cycle [see Dosage and Administration (2.3)].