HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ESKATATM safely and effectively. See full prescribing information for ESKATATM. ESKATATM (hydrogen peroxide) topical solution
Initial U.S. Approval: 2017
INDICATIONS AND USAGE ESKATA is indicated for the treatment of seborrheic
keratoses that are raised. (1)
DOSAGE AND ADMINISTRATION � To be administered by a healthcare provider. (2.1) � For topical use only. Not for ophthalmic use. (2.1) � Do not apply ESKATA topical solution to open or
infected seborrheic keratoses. (2.1)
� Apply 4 times, approximately 1 minute apart, to the targeted lesion(s) during a single in-office treatment session. (2.1) DOSAGE FORMS AND STRENGTHS Topical solution: 40% (w/w) hydrogen peroxide (3) CONTRAINDICATIONS None
WARNINGS AND PRECAUTIONS � Eye Disorders: Avoid eye exposure. Eye disorders including corneal injury (erosion, ulceration, perforation, and scarring), chemical conjunctivitis, eyelid edema, severe eye pain, or permanent eye injury, including blindness can occur after exposure. If accidental exposure occurs, flush eyes with water for 15 to 30 minutes and initiate monitoring, and further evaluation as appropriate. (5.1) � Local Skin Reactions: severe reactions, including ulcerations and scarring, may occur. Do not retreat with ESKATA until the skin has recovered from any reaction caused by the previous treatment (5.2) ADVERSE REACTIONS Common adverse reactions include erythema (99%), stinging (97%), edema (91%), scaling (90%), crusting (81%), and pruritus (58%). (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aclaris Therapeutics, Inc. at 1-833-225-2747 or FDA at 1-800-FDA-1088 or https://www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION
FULL PRESCRIBING INFORMATION 1. INDICATION AND USAGE ESKATA is indicated for the treatment of seborrheic keratoses that are raised. 2. DOSAGE AND ADMINISTRATION 2.1Important 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.
During a single in-office treatment session, apply ESKATA to seborrheic keratosis lesions 4 times, approximately 1 minute apart. After one use, discard the unit dose applicator.
If the treated lesions have not completely cleared approximately 3 weeks after treatment, another treatment may be administered following the same procedure. 2.2 Dosage and Administration Instructions Preparation of lesions Prior to application of ESKATA, clean seborrheic keratoses to be treated using an alcohol wipe. When treating seborrheic keratoses on the face, take appropriate actions to ensure that ESKATA will not come into contact with the eyes.
Preparation of the ESKATA applicator 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.
Application of ESKATA topical solution Following release of the solution from the ampule, remove the cap from the ESKATA applicator. Gently squeeze the applicator barrel to express a drop of ESKATA and ensure wetting of the applicator tip. Apply 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. During the application, remove any excess solution from the surrounding skin using a clean absorbent wipe (do not use paper towels or tissue). Apply again in the same manner, 3 additional applications 1 minute apart.
3. DOSAGE FORMS AND STRENGTHS ESKATA topical solution is a clear, colorless solution containing 40% (w/w) hydrogen peroxide. 4. CONTRAINDICATIONS None. 5. WARNINGS AND PRECAUTIONS 5.1 Eye Disorders Do not apply to the eyes or mucous membranes. Avoid treating seborrheic keratoses within the orbital rim. Direct contact with the eye can cause corneal injury (erosion, ulceration, perforation, and scarring), chemical conjunctivitis, eyelid edema, severe eye pain, or permanent eye injury, including blindness.
If accidental exposure occurs, flush with water for 15 to 30 minutes and initiate monitoring, and further evaluation as appropriate. 5.2 Local Skin Reactions Skin reactions occurred in the treatment area after application of ESKATA. Severe local skin reactions included erosion, ulceration, vesiculation and scarring [See Adverse Reactions (6.1)]. Do not initiate a second treatment course with ESKATA until the skin has recovered from any reaction caused by the previous treatment.
6. ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to ESKATA or vehicle in a total of 937 subjects with seborrheic keratoses that are raised. Overall, 42% of the subjects were male and 58% were female. Ninety-eight (98) percent of the subjects were Caucasian and the mean age was 68.7 years.
At each visit, local skin reactions were graded for severity to determine the maximum severity after treatment. Table 1 presents the percentage of subjects with the local adverse reactions by the most severe grade reported during the course of the trials.
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