What is Tavaborole
Tavaborole is an oxaborole antifungal indicated for the topical treatment of onchomycosis of the toenails caused by Trichophyton rubrum and Trichophyton mentagrophytes.
Approval was based on the results of two randomized, double-blind, vehicle-controlled clinical trials involving adults with onychomycosis of the toenail (baseline clinical involvement of the target toenail ranged from 20—60%).
In these trials, complete cure (defined as 0% clinical involvement of the target toenail plus negative KOH and negative culture) at 4 weeks post-treatment was achieved in 6.5% and 9.1% of tavaborole recipients compared to 0.5% and 1.5% of patients receiving the vehicle solution.
Tavaborole was FDA approved for use in patients >= 18 years of age in July 2014.
Brand Name
KERYDIN
Indications
- onychomycosis
- Trichophyton mentagrophytes
- Trichophyton rubrum
Side Effects
- contact dermatitis
- erythema
- skin irritation
Adverse events reported more frequently by tavaborole recipients (n = 791) than subjects receiving the vehicle solution (n = 395) included onychocryptosis or ingrown toenail (2.5% vs. 0.3%), application site exfoliation (2.7% vs. 0.3%), application site erythema (1.6% vs. 0%), and application site dermatitis (1.3% vs. 0%).
Cases of hypersensitivity, skin irritation, contact dermatitis have been noted during postmarketing use. Due to the voluntary nature of postmarketing reports, neither a frequency nor a definitive causal relationship can be established.
Monitoring Parameters
- laboratory monitoring not necessary
Contraindications
- breast-feeding
- ocular exposure
- ophthalmic administration
- pregnancy
- tobacco smoking
- vaginal administration
Interactions
There are no drug interactions associated with Tavaborole products.
