Journal of Clinical and Aesthetic Dermatology

MAY 2018

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

Issue link: https://jcadonline.epubxp.com/i/979610

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ESKATA TM (hydrogen peroxide) topical solution, 40% (w/w) BRIEF SUMMARY OF PRESCRIBING INFORMATION INDICATION AND USAGE 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 healthcare 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 keratoses 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. DOSAGE FORMS AND STRENGTHS ESKATA topical solution is a clear, colorless solution containing 40% (w/w) hydrogen peroxide. CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS 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. Local Skin Reactions Skin reactions occurred in the treatment area after application of ESKATA. Severe local skin reactions included erosion, ulceration, vesiculation and scarring. Do not initiate a second treatment course with ESKATA until the skin has recovered from any reaction caused by the previous treatment. ADVERSE REACTIONS 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. Table 1. Percentage of Subjects with Local Skin Reactions by Severity ESKATA N=467 Vehicle N=470 Mild Moderate Severe Total Mild Moderate Severe Total Erythema 13 67 19 99 29 5 <1 34 Stinging 34 49 15 97 9 1 <1 10 Edema 28 48 15 91 6 1 0 6 Scaling 49 36 5 90 28 5 1 33 Crusting 34 38 8 81 13 5 1 19 Pruritus 34 18 5 58 7 1 <1 8 Hyperpig- mentation 32 7 <1 39 1 <1 0 1 Vesicles 21 3 1 24 <1 0 0 <1 ESKATA N=467 Vehicle N=470 Mild Moderate Severe Total Mild Moderate Severe Total Hypopig- mentation 16 3 <1 19 1 <1 0 1 Erosion 12 2 1 15 <1 0 0 1 Ulceration 6 2 <1 9 1 1 0 2 Atrophy 4 0 0 4 0 0 0 0 Scarring 3 <1 <1 3 0 0 0 0 Common local skin reactions observed 10 minutes after treatment include: erythema (98%), stinging (93%), edema (85%), pruritus (32%), and vesiculation (18%). Common local skin reactions observed 1 week after treatment are scaling (72%), erythema (66%), crusting (67%), pruritus (18%), erosion (9%), and ulceration (4%). Common local skin reactions observed 15 weeks after the initial treatment are erythema (21%), hyperpigmentation (18%), scaling (16%), crusting (12%), and hypopigmentation (7%). Less common adverse reactions occurring in ≥0.5% of subjects treated with ESKATA include eyelid edema (0.6%) and herpes zoster (0.6%). USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary Hydrogen peroxide is not absorbed systemically following topical administration, and maternal use is not expected to result in fetal exposure to the drug. Lactation Risk Summary Hydrogen peroxide is not absorbed systemically by the mother following topical administration, and breastfeeding is not expected to result in exposure of the child to hydrogen peroxide. Pediatric Use Seborrheic keratosis is not seen in the pediatric population. Geriatric Use Of the 841 subjects treated with ESKATA in the clinical trials, 70% were 65 years of age and older and 26% were 75 years of age and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. OVERDOSE Topical overdosing of ESKATA could result in an increased incidence and severity of local skin reactions. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of ESKATA or hydrogen peroxide. Hydrogen peroxide has been found to exhibit positive results in in vitro tests for genotoxicity, but has not exhibited positive results in in vivo tests for genotoxicity, presumably due to the rapid metabolism of hydrogen peroxide. The effects of hydrogen peroxide on fertility have not been evaluated. Hydrogen peroxide has been associated with effects on sperm function and elevated testicular hydrogen peroxide concentration has been implicated in male infertility, although in vivo, no effect of hydrogen peroxide on sperm function has been demonstrated. PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Ophthalmic Adverse Reactions Inform patients that severe eye injury can occur with ESKATA application. Advise patients to inform the healthcare provider immediately if ESKATA runs into eyes, mouth, or nose during administration Local Skin Reactions Inform patients that treatment with ESKATA may lead to local skin reactions Rx only This Brief Summary is based on ESKATA Prescribing Information, issued December 2017. Manufactured by: James Alexander Corp., Blairstown, NJ 07825 Marketed by: Aclaris Therapeutics, Inc., Malvern, PA 19355 Table 1. Percentage of Subjects with Local Skin Reactions by Severity (Cont'd)

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