ESKATA is indicated for the
treatment of seborrheic keratoses that are raised.
DOSAGE AND ADMINISTRATION
Important Administration Information
ESKATA is to be administered by
a health care provider.
For topical use only. Not for
oral, ophthalmic, or intravaginal use.
Do not apply ESKATA topical
solution to open or infected seborrheic keratoses.
Prior to application of ESKATA,
ensure the surface of seborrheic keratosis lesion is clear of oil and debris
(an alcohol wipe can be used).
During a single in-office
treatment session, apply ESKATA to seborrheic keratosis lesions 4 times,
approximately 1 minute apart. After one use, replace the cap and discard the
unit dose applicator.
When treating seborrheic
keratoses on the face, take appropriate actions to ensure that ESKATA will not
come into contact with the eyes.
If the treated lesions have not
completely cleared approximately 3 weeks after treatment, another treatment may
be administered following the same procedure.
Dosage And Administration Instructions
Preparation Of The
Wear nitrile or vinyl
examination gloves during the activation of the ESKATA applicator and during
the administration of the solution to the lesion(s).
The method for preparing the
ESKATA applicator for use is illustrated below. While activating the
applicator, hold it away from the patient. Do not remove the cap until after
completion of Step 4 (below).
Step 1: Hold the ESKATA applicator so that the
applicator cap is pointing up
Step 2: Crush the ampule in the applicator by applying
finger pressure to the diamond symbol on the applicator barrel
Step 3: Remove the sleeve.
Step 4: Holding the
applicator with cap pointing up, tap the bottom of the applicator to separate
the solution from the crushed ampule.
Application Of ESKATA Topical
Following release of the
solution from the ampule, remove the cap from the ESKATA applicator. Gently
squeeze the applicator barrel to express the solution to the applicator tip.
Using the applicator, apply the solution directly to the seborrheic keratosis
in a circular motion. Apply enough solution to uniformly wet the lesion
surface, including the edges without excess running or dripping.
Wait 1 minute and observe.
Whitening of the lesion may occur.
Do not progress to subsequent
applications if severe erythema/edema or pain occur. Apply again in the same
manner 3 additional applications 1 minute apart.
Minimize the amount of drug
that comes into contact with surrounding skin. If ESKATA does come into contact
with surrounding skin, use an absorbent wipe to remove any excess solution (do
not use paper towels or tissue).
Dosage Forms And Strengths
ESKATA topical solution is a
clear, colorless solution containing 40% (w/w) hydrogen peroxide.
Storage And Handling
ESKATA (hydrogen peroxide)
topical solution, 40% (w/w) is a clear, colorless solution and is supplied in a
unit dose package. The available carton packages are presented below:
||Number of unit dose packages per carton
Store ESKATA at controlled room
temperature of 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C
and 30°C (59° F and 86° F).
Manufactured & Packaged by:
James Alexander Corp., 845 Route 94, Blairstown, NJ 07825,
United States. For: Aclaris Therapeutics, Inc., 640 Lee Road, Suite 200, Wayne,
PA 19087, United States. Revised: Feb 2019