Hydrogen peroxide (Eskata)

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# Overview
Hydrogen peroxide (Eskata) is a topical solution that is FDA approved for the treatment of seborrheic keratoses that are raised.   Common adverse reactions include erythema (99%), stinging (97%), edema (91%), scaling (90%), crusting (81%), and pruritus (58%).

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- Hydrogen peroxide is indicated for the treatment of seborrheic keratoses that are raised.
- Hydrogen peroxide topical solution is a clear, colorless solution containing 40% (w/w) hydrogen peroxide.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding hydrogen peroxide Off-Label Non-Guideline-Supported Use and Dosage (Adult) in the drug label.

### NonGuideline-Supported Use
There is limited information regarding hydrogen peroxide Off-Label Non-Guideline-Supported Use and Dosage (Adult) in the drug label.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Hydrogen peroxide (Eskata) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding hydrogen peroxide Off-Label Guideline-Supported Use and Dosage (Pediatric) in the drug label.

### NonGuideline-Supported Use
There is limited information regarding hydrogen peroxide Off-Label Non-Guideline-Supported Use and Dosage (Pediatric) in the drug label.

# Contraindications
- None.

# Warnings
- 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.
- Skin reactions occurred in the treatment area after application of hydrogen peroxide. Severe local skin reactions included erosion, ulceration, vesiculation and scarring. Do not initiate a second treatment course with hydrogen peroxide 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 hydrogen peroxide 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 hydrogen peroxide include eyelid edema (0.6%) and herpes zoster (0.6%).

## Postmarketing Experience
There is limited information regarding Hydrogen peroxide (Eskata) Postmarketing Experience in the drug label.

# Drug Interactions
There is limited information regarding Hydrogen peroxide (Eskata) Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA):
- Hydrogen peroxide is not absorbed systemically following topical administration, and maternal use is not expected to result in fetal exposure to the drug.
Pregnancy Category (AUS): 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Hydrogen peroxide (Eskata) in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Hydrogen peroxide (Eskata) during labor and delivery.

### Nursing Mothers
- 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.

### Geriatic 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.

### Gender
There is no FDA guidance on the use of Hydrogen peroxide (Eskata) with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Hydrogen peroxide (Eskata) with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Hydrogen peroxide (Eskata) in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Hydrogen peroxide (Eskata) in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Hydrogen peroxide (Eskata) in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Hydrogen peroxide (Eskata) in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Hydrogen peroxide is to be administered by a health care provider.
- For topical use only. Not for oral, ophthalmic, or intravaginal use.
- Do not apply hydrogen peroxide topical solution to open or infected seborrheic keratoses.
- During a single in-office treatment session, apply hydrogen peroxide 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.
Preparation of lesions
- Prior to application of hydrogen peroxide, clean seborrheic keratoses to be treated using an alcohol wipe. When treating seborrheic keratoses on the face, take appropriate actions to ensure that hydrogen peroxide will not come into contact with the eyes.
Preparation of the hydrogen peroxide applicator
- Wear nitrile or vinyl examination gloves during the activation of the hydrogen peroxide applicator and during the administration of the solution to the lesion(s).
- The method for preparing the hydrogen peroxide applicator for use is illustrated below. While activating the applicator, hold it away from the patient.
- Following release of the solution from the ampule, remove the cap from the hydrogen peroxide applicator. Gently squeeze the applicator barrel to express a drop of hydrogen peroxide 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.

### Monitoring
- Improvement or resolution of seborrheic keratotic lesions may be indicative of efficacy.

# IV Compatibility
There is limited information regarding the compatibility of Hydrogen peroxide (Eskata) and IV administrations.

# Overdosage
- Topical overdosing of hydrogen peroxide could result in an increased incidence and severity of local skin reactions.

# Pharmacology

## Mechanism of Action
- The mechanism of action for hydrogen peroxide for the treatment of seborrheic keratosis is unknown.

## Structure

## Pharmacodynamics
- The pharmacodynamics of hydrogen peroxide in the treatment of seborrheic keratosis are unknown.

## Pharmacokinetics
- Following application of hydrogen peroxide 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.

## Nonclinical Toxicology
- Long-term animal studies have not been performed to evaluate the carcinogenic potential of 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.

# 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 Physicians Lesion Assessment Scale for all 4 treated lesions. Efficacy was also assessed for the proportion of subjects achieving clear on the Physicians Lesion Assessment Scale for at least 3 of 4 lesions. TABLE 2 presents the efficacy results for the two clinical trials.

# How Supplied
- 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:

## Storage
- Store hydrogen peroxide at controlled room temperature of 20C to 25C (68F to 77F), excursions permitted between 15C and 30C (59 F and 86 F).

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
- Advise the patient to read the FDA-approved patient labeling.
- Inform patients that severe eye injury can occur with hydrogen peroxide application. Advise patients to inform the healthcare provider immediately if hydrogen peroxide runs into eyes, mouth, or nose during administration.
- Inform patients that treatment with hydrogen peroxide may lead to local skin reactions.

# Precautions with Alcohol
Alcohol-Hydrogen peroxide (Eskata) interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

# Brand Names
- Eskata

# Look-Alike Drug Names
There is limited information regarding Hydrogen peroxide (Eskata) Look-Alike Drug Names in the drug label.

# Drug Shortage Status
Drug Shortage

# Price