FDA Label for Eskata

1. Indication And Usage

ESKATA is indicated for the treatment of seborrheic keratoses that are raised.

2.1 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.

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.

Preparation of the ESKATA applicator, Step 1 - eskata 01

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 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.

5.1 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.

6.1 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.

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%).

8.2 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.

8.4 Pediatric Use

Seborrheic keratosis is not seen in the pediatric population.

8.5 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.

10. Overdose

Topical overdosing of ESKATA could result in an increased incidence and severity of local skin reactions.

11. Description

ESKATA (hydrogen peroxide) topical solution, 40% (w/w) is a clear, colorless solution for topical administration, which contains the active ingredient, hydrogen peroxide.

The chemical name of hydrogen peroxide is dihydrogen dioxide.

The molecular formula of hydrogen peroxide is H₂O₂ and the molecular weight is 34.01. Hydrogen peroxide is represented by the following structural formula:

Chemical Structure - eskata 05

ESKATA contains 40% (w/w) hydrogen peroxide in an aqueous solution of isopropyl alcohol and water.

12.1 Mechanism Of Action

The mechanism of action for ESKATA for the treatment of seborrheic keratosis is unknown.

12.2 Pharmacodynamics

The pharmacodynamics of ESKATA in the treatment of seborrheic keratosis are unknown.

12.3 Pharmacokinetics

Following application of ESKATA in patients with seborrheic keratosis lesions, hydrogen peroxide rapidly dissociates into water and reactive oxygen species. Indirect assessment of reactive oxygen species in patients with seborrheic keratosis lesions did not demonstrate any systemic absorption of hydrogen peroxide.

13.1 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.

14. Clinical Studies

In two double-blind, vehicle-controlled clinical trials, 937 subjects with 4 clinically typical seborrheic keratoses that are raised on the face, trunk, or extremities were randomized to treatment with either ESKATA or vehicle. Subjects ranged from 42 to 91 years of age (mean 68.7 years), 58% percent were female, and 98% were Caucasian. A total of 925 subjects completed the trials. Each lesion was treated with 4 applications, at baseline and again at Day 22, if needed, and subjects were followed through Day 106.

Efficacy was assessed at Day 106. Success rate was defined as the proportion of subjects achieving “clear” on the Physician’s Lesion Assessment Scale for all 4 treated lesions. Efficacy was also assessed for the proportion of subjects achieving “clear” on the Physician’s Lesion Assessment Scale for at least 3 of 4 lesions. Table 2 presents the efficacy results for the two clinical trials.

16. How Supplied/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:

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).

17. 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 [see Warnings and Precautions (5.1)].

Local Skin Reactions

Inform patients that treatment with ESKATA may lead to local skin reactions [see Warnings and Precautions (5.2)].

Manufactured & Packaged by:
James Alexander Corp.
845 Route 94
Blairstown, NJ 07825
United States

For:
Aclaris Therapeutics, Inc.
101 Lindenwood Drive
Malvern, PA 19355
United States

US Patent Numbers: US 7,381,427 and US 9,675,639

Spl Patient Package Insert

Principal Display Panel - Ndc: 71180-001-03 - 0.7 Ml 3 Unit Carton Label

0.7 mL 3 Unit Carton Label - eskata 06

Principal Display Panel - Ndc: 71180-001-12 - 0.7 Ml 12 Unit Carton Label

0.7 mL 12 Unit Carton Label - eskata 07

Principal Display Panel - Ndc: 71180-001-01 - 0.7 Ml 1 Unit Box Label

Principal Display Panel - Ndc: 71180-001-01 - 0.7 Ml 1 Unit Lidding Label

Principal Display Panel - Ndc: 71180-001-01 - 0.7 Ml 1 Unit Sleeve Label

Principal Display Panel - Ndc: 71180-001-01 - 0.7 Ml 1 Unit Tube Label

Principal Display Panel - Ndc: 71180-001-03 - 0.7 Ml 3 Unit Sample Carton Label

Principal Display Panel - Ndc: 71180-001-01 - 0.7 Ml 1 Unit Sample Box Label

Principal Display Panel - Ndc: 71180-001-01 - 0.7 Ml 1 Unit Sample Lidding Label

Principal Display Panel - Ndc: 71180-001-01 - 0.7 Ml 1 Unit Sample Sleeve Label

Principal Display Panel - Ndc: 71180-001-01 - 0.7 Ml 1 Unit Sample Tube Label

Principal Display Panel - Ndc: 71180-002-03 - 1.3 Ml 3 Unit Carton Label

Principal Display Panel - Ndc: 71180-002-12 - 1.3 Ml 12 Unit Carton Label

Principal Display Panel - Ndc: 71180-002-01 - 1.3 Ml 1 Unit Box Label

Principal Display Panel - Ndc: 71180-002-01 - 1.3 Ml 1 Unit Lidding Label

Principal Display Panel - Ndc: 71180-002-01 - 1.3 Ml 1 Unit Sleeve Label

Principal Display Panel - Ndc: 71180-002-01 - 1.3 Ml 1 Unit Tube Label