ESKATA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ESKATA (ESKATA).
ESKATA (hydrogen peroxide) 40% topical solution deflates and scleroses mechanobullous lesions associated with seborrheic keratoses through oxidative tissue destruction.
| Metabolism | Not systemically absorbed; degradation by catalase in tissue produces oxygen and water. |
| Excretion | Renal: <1% as unchanged drug; biliary/fecal: not established; hydrogen peroxide is rapidly decomposed to water and oxygen, with no significant renal or biliary excretion. |
| Half-life | Not determined; hydrogen peroxide is rapidly degraded by catalase and other peroxidases in tissues, with an estimated half-life of minutes locally. |
| Protein binding | Not applicable; hydrogen peroxide is not protein bound. |
| Volume of Distribution | Not determined for topical application; systemic absorption is minimal (<0.5% of applied dose), with Vd considered negligible. |
| Bioavailability | Topical: systemic absorption <0.5% of applied dose; thus, bioavailability is negligible. |
| Onset of Action | Topical application: clinical effect (lesion clearance) observed within 2–4 weeks after repeated treatments; immediate localized tissue whitening and necrosis within minutes of application. |
| Duration of Action | Duration of clinical effect after completion of treatment course (typically 2–3 applications over 2–3 weeks): sustained lesion clearance for weeks, with recurrence possible; localized tissue damage resolves over 1–2 weeks. |
ESKATA (hydrogen peroxide 40% topical solution) is applied topically to seborrheic keratoses using the supplied single-use applicator. Each lesion is treated once during a single office visit. The solution is applied to the lesion surface for 1 minute after puncturing the ampule. Do not repeat treatment to the same lesion within 2 weeks.
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment is required for renal impairment. ESKATA is a topical agent with minimal systemic absorption; renal function does not affect local therapy. |
| Liver impairment | No dose adjustment is required for hepatic impairment. ESKATA is a topical agent with minimal systemic absorption; hepatic function does not affect local therapy. |
| Pediatric use | Safety and effectiveness in pediatric patients have not been established. ESKATA is not recommended for use in children. |
| Geriatric use | No specific dose adjustment is required for geriatric patients. Clinical studies included patients aged 65 years and older; no overall differences in safety or efficacy were observed compared to younger adults. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ESKATA (ESKATA).
| Breastfeeding | No data on excretion into human milk. M/P ratio unknown. Due to potential for local irritation and systemic absorption, avoid breastfeeding during treatment or pump and discard for 24 hours after application. |
| Teratogenic Risk | No human data; pregnancy category N (not classified). In animal studies, no evidence of teratogenicity at systemic exposures up to 2.6 times the human dose. However, ESKATA contains hydrogen peroxide, which may cause oxidative injury. Risk cannot be excluded; avoid use in pregnancy. |
■ FDA Black Box Warning
Not indicated for the treatment of seborrheic keratoses on the face, or for lesions suspected to be skin cancer.
| Serious Effects |
["Hypersensitivity to hydrogen peroxide or any component of the formulation"]
| Precautions | ["Do not apply to irritated or broken skin.","Avoid contact with eyes and mucous membranes.","Do not use on the face.","May cause stinging, burning, or erythema at application site."] |
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| Fetal Monitoring |
| No specific monitoring required; monitor for local skin reactions and signs of systemic toxicity (e.g., methemoglobinemia) if applied to large areas. |
| Fertility Effects | No fertility studies in humans. Animal studies show no impairment of fertility at doses up to 2.6 times the human dose. No known effects on human fertility. |