Efinaconazole topical

Indications

Efinaconazole topical is used for: Onychomycosis

Adult Dose

Topical Onychomycosis Indicated for onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes Apply to affected toenail(s) once daily for 48 weeks

Child Dose

Onychomycosis Indicated for onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes in children aged >6 yr <6 years: Safety and efficacy not established >6 years Apply to affected toenail(s) once daily for 48 weeks

Renal Dose

Administration

For topical use only. Not for oral, ophthalmic, or intravaginal use. Apply to affected toenail(s) using the integrated flow-through brush applicator When applying with flow-through brush applicator, ensure toenail, toenail folds, toenail bed, hyponychium, and undersurface of toenail plate are completely covered

Contra Indications

Precautions

For topical use only Instruct patient to avoid using nail polish or cosmetic nail products Persistent local pain, irritation, or dermatitis may develop; contact health provider if it occurs

Pregnancy-Lactation

Pregnancy Data are not available for use during pregnancy to inform any drug associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes Animal data In animal reproduction studies, efinaconazole did not cause malformations or any harm to the fetus when administered to pregnant rabbits and rats during organogenesis at SC doses up to 112 and 154 times, respectively, the maximum recommended human dose (MRHD) based on area under the curve (AUC) comparisons Lactation Unknown if excreted in human milk; after repeated SC administration, efinaconazole was detected in milk of nursing rats Consider developmental and health benefits of breastfeeding, along with mother’s clinical need for therapy, and any potential adverse effects on breastfed infant from drug

Interactions

Adverse Effects

Side effects of Efinaconazole topical : 1-10% Ingrown toenail (2.3%) Application site dermatitis (2.2%) Application site vesicles (1.6%) Application site pain (1.1%)

Mechanism of Action

Triazole antifungal agent; inhibits fungal lanosterol 14α-demethylase involved in the biosynthesis of ergosterol, a constituent of fungal cell membranes.