Tavaborole topical

Indications

Tavaborole topical is used for: Onychomycosis of the Toenail

Adult Dose

Onychomycosis of the Toenail Indicated for onychomycosis of the toenail(s) due to Trichophyton rubrum or Trichophyton mentagrophytes Apply to affected toenails qDay for 48 weeks

Child Dose

Onychomycosis of the Toenail <6 years Safety and efficacy not established >6 years Indicated for onychomycosis of toenail(s) due to Trichophyton rubrum or Trichophyton mentagrophytes Apply to affected toenails qDay for 48 weeks

Renal Dose

Administration

Clean and dry nails prior to use; apply to completely cover nail surface and under tip of each nail being treated; allow solution to dry following application

Contra Indications

Precautions

Not for oral, ophthalmic, or intravaginal use Avoid contact with eyes, mouth, vagina, or skin immediately surrounding treated nail; wipe away excess solution from surrounding skin Product is flammable; avoid use near heat or open flame

Pregnancy-Lactation

Pregnancy There are no available data on use in pregnant women to inform a drug associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes; in oral animal reproductive studies, administration of tavaborole during the period of organogenesis resulted in embryofetal toxicity and malformations at 570 times the Maximum Recommended Human Dose (MRHD) based on Area Under the Curve (AUC) comparisons in rats and embryofetal toxicity at 155 times the MRHD based on AUC comparisons in rabbits; embryofetal toxicity was noted following dermal administration in rabbits up to 36 times the MRHD based on AUC comparisons Lactation There is no information available on presence in human milk, effects on breastfed infant or on milk production in women who are breastfeeding; drug is systemically absorbed; lack of clinical data during lactation precludes a clear determination of risk of therapy to a breastfed infant; therefore, the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from treatment or from underlying maternal condition

Interactions

Adverse Effects

Side effects of Tavaborole topical : 1-10% Application site exfoliation (2.7%) Ingrown toenail (2.5%) Application site erythema (1.6%) Application site dermatitis (1.3%)

Mechanism of Action

An oxaborole antifungal (boron-containing compound); inhibits protein synthesis by inhibition of an aminoacyl-transfer ribonucleic acid (tRNA) synthetase (AARS)