Label: ESKATA- hydrogen peroxide solution

  • NDC Code(s): 71180-001-01, 71180-001-03, 71180-001-12, 71180-002-01, view more
    71180-002-03, 71180-002-12
  • Packager: Aclaris Therapeutics, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated March 27, 2019

If you are a consumer or patient please visit this version.

  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ESKATA® safely and effectively. See full prescribing information for ESKATA®.

    ESKATA® (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 (4)

    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 http://www.fda.gov/medwatch.

    See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

    Revised: 3/2019

  • Table of Contents
  • 1. INDICATION AND USAGE

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

  • 2. DOSAGE AND ADMINISTRATION

    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.

    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.

    2.2 Dosage and Administration Instructions

    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. Do not remove the cap until after completion of Step 4 (below).

    Figure

    Figure

    Step 1: Hold the ESKATA applicator so that the applicator cap is pointing upStep 2: Crush the ampule in the applicator by applying finger pressure to the diamond symbol on the applicator barrel

    Figure

    Figure

    Step 3: Remove the sleeveStep 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 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).

  • 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.

    Table 1. Percentage of Subjects with Local Skin Reactions by Severity
    ESKATA
    N=467
    Vehicle
    N=470
    MildModerateSevereTotalMildModerateSevereTotal
    Erythema13671999295<134
    Stinging3449159791<110
    Edema284815916106
    Scaling4936590285133
    Crusting3438881135119
    Pruritus341855871<18
    Hyperpigmentation327<1391<101
    Vesicles213124<100<1
    Hypopigmentation163<1191<101
    Erosion122115<1001
    Ulceration62<191102
    Atrophy40040000
    Scarring3<1<130000

    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

  • 8. USE IN SPECIFIC POPULATIONS

    8.1 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.

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

  • 12. CLINICAL PHARMACOLOGY

    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. NONCLINICAL TOXICOLOGY

    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 3 presents the efficacy results for the two clinical trials.

    Table 2. Percentage of Subjects Achieving Clearance of Target Lesions at Day 106 in Study 1 and Study 2
    Study 1Study 2
    ESKATA
    N=223
    Vehicle
    N=227
    ESKATA
    N=244
    Vehicle
    N=243
    All 4 lesions "Clear"4%0%8%0%
    At least 3 of 4 lesions "Clear"13%0%23%0%
  • 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:

    Dosage StrengthFill VolumeDeliverable VolumeNumber of unit dose packages per cartonNDC#
    40% (w/w)1.5 mL0.7 mL171180-001-01
    371180-001-03
    1271180-001-12
    2.2 mL1.3 mL171180-002-01
    371180-002-03
    1271180-002-12

    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)].

  • SPL UNCLASSIFIED SECTION

    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

    US Patent Numbers: US 7,381,427, US 9,675,639, US 9,980,983 and US 10,098,910

  • PATIENT PACKAGE INSERT

    This Patient Information has been approved by the U.S. Food and Drug AdministrationIssued: December 2017
    Patient Information
    ESKATA® (es-KAH-tah)
    (hydrogen peroxide), topical solution
    IMPORTANT: ESKATA topical solution is for use as an in-office treatment. ESKATA is applied by your healthcare provider and is not for use at home.
    What is ESKATA ?
    ESKATA is a prescription medicine used to treat seborrheic keratoses that are raised.
    Before treatment with ESKATA, tell your healthcare provider about all of your medical conditions, including if you:
    • are being treated or have had treatments for seborrheic keratosis
    • have other skin problems
    • are pregnant or plan to become pregnant.
    • are breastfeeding or plan to breastfeed.
    Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
    How should I receive ESKATA ?
    • Your healthcare provider will apply ESKATA to your seborrheic keratosis lesions.
    • Your healthcare provider may apply ESKATA again, about 3 weeks after your treatment if your treated lesions are not completely gone.
    What are the possible side effects with ESKATA?
    ESKATA can cause serious side effects, including:
    • Eye problems. Eye problems can happen if ESKATA gets into your eyes, including:
    • ulcers or small holes in your eyes
    • scarring
    • redness
    • irritation
    • eyelid swelling
    • severe eye pain
    • permanent eye injury, including blindness
    If ESKATA accidentally gets into your eyes, your healthcare provider will tell you to flush them well with water for 15 to 30 minutes. Your healthcare provider may send you to another healthcare care provider if needed.
    • Local skin reactions. Skin reactions have happened in and around the treatment area after application of ESKATA. Severe skin reactions can include: breakdown of the outer layer of the skin (erosion), ulcers, blisters and scarring. Tell your healthcare provider if you have any skin reactions during treatment with ESKATA.
    The most common side effects of ESKATA include: itching, stinging, crusting, swelling, redness and scaling.
    Your healthcare provider will not apply another treatment of ESKATA if your treated area is still irritated from the previous treatment.
    Tell your healthcare provider right away if ESKATA gets into your eyes, mouth or nose during application.
    These are not all of the possible side effects of ESKATA.
    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
    General information about the safe and effective use of ESKATA.
    Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information that is written for healthcare professionals.
    What are the ingredients in ESKATA?
    Active ingredient: hydrogen peroxide
    Inactive ingredients: isopropyl alcohol and water.
    Manufactured & Packaged by: James Alexander Corp., 845 Route 94, Blairstown, NJ 07825 United States
    For: Aclaris Therapeutics, Inc., 640 Lee Rd, Suite 200, Wayne, PA 19087 United States
    US Patent Number: US 7,381,427, US 9,675,639, US 9,980,983 and US 10,098,910
  • PRINCIPAL DISPLAY PANEL - 0.7 mL Applicator Carton

    NDC: 71180-001-03

    3 Units
    Rx Only
    Store at 20-25°C

    ACLARIS
    THERAPEUTICS

    eskata™
    (hydrogen peroxide) topical solution, 40% (w/w)

    Single use applicator/0.7 mL. For Topical Use Only.

    Marketed by
    Aclaris Therapeutics, Inc.
    Malvern, PA 19355
    www.aclaristx.com

    US Patent 7,381,427

    PRINCIPAL DISPLAY PANEL - 0.7 mL Applicator Carton
  • PRINCIPAL DISPLAY PANEL - 1.3 mL Applicator Carton

    NDC: 71180-002-03

    3 Units
    Rx Only
    Store at 20-25°C

    ACLARIS
    THERAPEUTICS

    eskata™
    (hydrogen peroxide) topical solution, 40% (w/w)

    Single use applicator/1.3 mL. For Topical Use Only.

    Marketed by
    Aclaris Therapeutics, Inc.
    Malvern, PA 19355
    www.aclaristx.com

    US Patent 7,381,427

    PRINCIPAL DISPLAY PANEL - 1.3 mL Applicator Carton
  • INGREDIENTS AND APPEARANCE
    ESKATA 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71180-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE40 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71180-001-011 in 1 CARTON12/14/2017
    1280 mg in 1 APPLICATOR; Type 0: Not a Combination Product
    2NDC:71180-001-033 in 1 CARTON12/14/2017
    2280 mg in 1 APPLICATOR; Type 0: Not a Combination Product
    3NDC:71180-001-1212 in 1 CARTON12/14/2017
    3280 mg in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20930512/14/2017
    ESKATA 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71180-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE40 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71180-002-011 in 1 CARTON12/14/2017
    1520 mg in 1 APPLICATOR; Type 0: Not a Combination Product
    2NDC:71180-002-033 in 1 CARTON12/14/2017
    2520 mg in 1 APPLICATOR; Type 0: Not a Combination Product
    3NDC:71180-002-1212 in 1 CARTON12/14/2017
    3520 mg in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20930512/14/2017
    Labeler - Aclaris Therapeutics, Inc. (032365882)
    Establishment
    NameAddressID/FEIBusiness Operations
    James Alexander Corp.040756421ANALYSIS(71180-001, 71180-002) , LABEL(71180-001, 71180-002) , MANUFACTURE(71180-001, 71180-002)