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warnings and cautions
5. 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 ) 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 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 http://www.fda.gov/medwatch . 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. 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 Hyperpigmentation 32 7 <1 39 1 <1 0 1 Vesicles 21 3 1 24 <1 0 0 <1 Hypopigmentation 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%). 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of ESKATA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and subcutaneous tissues disorders : crepitus