Eskata

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

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%).

Included as part of the "PRECAUTIONS" Section

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-thecounter 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-FDA1088.

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.

This Patient Information has been approved by the U.S. Food and Drug Administration.

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

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%).

Read the entire FDA prescribing information for Eskata (Hydrogen Peroxide Topical Solution)

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.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Eskata (hydrogen peroxide solution (seborrheic keratoses)), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.