tavaborole (Rx)

1-10%

Application site exfoliation (2.7%)

Ingrown toenail (2.5%)

Application site erythema (1.6%)

Application site dermatitis (1.3%)

Postmarketing Reports

Hypersensitivity, contact allergy

Contraindications

None reported by manufacturer

Cautions

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

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

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

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

Elimination

Excretion: Urine (primarily)