tavaborole
Regulatory sources consulted
Approved indications
- Toenail onychomycosis caused by Trichophyton rubrum or T. mentagrophytes.
Clinical warnings
- For topical use only; do not use orally, ophthalmically, or intravaginally. — openFDA Tavaborole topical solution 5% set ID 050f5d10-5591-426e-9020-6516b3363304
- Hypersensitivity and allergic contact dermatitis have been reported postmarketing; discontinue and assess if signs of an allergic reaction develop. — openFDA Tavaborole topical solution 5% set ID 050f5d10-5591-426e-9020-6516b3363304
Adverse events
Common (≥1%)
Application-site exfoliation or erythema · Ingrown toenail · Application-site dermatitis
Pregnancy and lactation
Human data are insufficient. During breastfeeding, weigh the benefits of breastfeeding, maternal need, and potential effects on the infant.
Recent literature (PubMed)
Onychomycosis is a chronic fungal infection of the fingernail or toenail bed leading to brittle, discolored, and thickened nails. Onychomycosis is not just a cosmetic problem. Untreated onychomycosis can cause pain, discomfort, and physical impairment, negatively impacting quality of life. Onychomycosis should be suspected in patients with discolored nails, nail plate thickening, nail separation, and foul-smelling nails. Accurate diagnosis is important before initiating treatment because therapy is lengthy and can cause adverse effects. A potassium hydroxide preparation with confirmatory fungal culture, periodic acid-Schiff stain, or polymerase chain reaction is the preferred diagnostic approach if confirmative testing is cost prohibitive or not available. Treatment decisions should be based on severity, comorbidities, and patient preference. Oral terbinafine is preferred over topical therapy because of better effectiveness and shorter treatment duration. Patients taking terbinafine in combination with tricyclic antidepressants, selective serotonin reuptake inhibitors, atypical antipsychotics, beta blockers, or tamoxifen should be monitored for drug-drug interactions. Topical therapy, including ciclopirox 8%, efinaconazole 10%, and tavaborole 5%, is less effective than oral agents but can be used to treat mild to moderate onychomycosis, with fewer adverse effects and drug-drug interactions. Nail trimming and debridement used concurrently with pharmacologic therapy improve treatment response. Although photodynamic and plasma therapies are newer treatment options that have been explored for the treatment of onychomycosis, larger randomized trials are needed. Preventive measures such as avoiding walking barefoot in public places and disinfecting shoes and socks are thought to reduce the 25% relapse rate.
Onychomycosis is the most common nail disease encountered in clinical practice and can cause pain, difficulty with ambulation, and psycho-social problems. A thorough history and physical examination, including dermoscopy, should be performed for each patient presenting with nail findings suggestive of onychomycosis. Several approaches are available for definitive diagnostic testing, including potassium hydroxide and microscopy, fungal culture, histopathology, polymerase chain reaction, or a combination of techniques. Confirmatory testing should be performed for each patient prior to initiating any antifungal therapies. There are several different therapeutic options available, including oral and topical medications as well as device-based treatments. Oral antifungals are generally recommended for moderate to severe onychomycosis and have higher cure rates, while topical antifungals are recommended for mild to moderate disease and have more favorable safety profiles. Oral terbinafine, itraconazole, and griseofulvin and topical ciclopirox 8% nail lacquer, efinaconazole 10% solution, and tavaborole 5% solution are approved by the Food and Drug Administration for treatment of onychomycosis in the United States and amorolfine 5% nail lacquer is approved in Europe. Laser treatment is approved in the United States for temporary increases in clear nail, but clinical results are suboptimal. Oral fluconazole is not approved in the United States for onychomycosis treatment, but is frequently used off-label with good efficacy. Several novel oral, topical, and over-the-counter therapies are currently under investigation. Physicians should consider the disease severity, infecting pathogen, medication safety, efficacy and cost, and patient age, comorbidities, medication history, and likelihood of compliance when determining management plans. Onychomycosis is a chronic disease with high recurrence rates and patients should be counseled on an appropriate plan to minimize recurrence
Onychomycosis is a fungal infection of the nail unit that affects a large patient population globally. Onychomycosis, or tinea unguium, has a benign chronic clinical course; however, it can cause complications in certain patient populations suffering from diabetes and peripheral vascular disease. As nails grow slowly, onychomycosis requires a lengthy treatment plan, and choosing appropriate treatments can be challenging. There are a variety of treatment modalities available for patients including topical, oral, laser, light therapy, procedures such as avulsion and matrixectomy, supplements, over-the-counter medication, and plasma therapy that can be used as monotherapy or in combination for patient satisfaction. We sought to review treatment options for onychomycosis, taking into consideration the efficacy, side effect profiles, practicality of treatment (adherence), and costs to help healthcare providers offer ethically appropriate treatment regimens to their patients. A literature search was conducted using electronic databases (PubMed, Embase, Medline, CINAHL, EBSCO) and textbooks, in addition to the clinical experiences of the authors and other practitioners in treating onychomycosis, and a summary of the findings are presented here. Although topical (efinaconazole, tavaborole, ciclopirox), oral (terbinafine, itraconazole), and laser (1064nm Nd:YAG lasers, both short-pulsed and Q-switched lasers, carbon dioxide lasers, and the diode 870, 930nm) are the current Food and Drug Administration (FDA)-approved treatments for onychomycosis, they are just a fraction of available treatment options. New and emerging therapies including new topical and oral medications, combination therapy, photodynamic light therapy, procedural, supplements, over-the-counter medication, and plasma therapy are discussed in our review. Onychomycosis has high reinfection and recurrence rates, and the treatment remains challenging as treatment selection involves ethical, evidence-based decisio
Dermatophytomas are characterized as a hyperkeratotic fungal mass in the subungual space, showing as dense white or yellow, typically in longitudinal streaks or patches. Masses can be visualized by traditional microscopy or histology. Newer technologies such as dermoscopy and optical coherence tomography also provide visual features for dermatophytoma diagnosis. The density of fungal mass, and lack of adherence to the nail structures, as well as possible biofilm development, may play a role in the reduction in drug penetration and subsequent lack of efficacy with traditional oral therapies such as terbinafine and itraconazole. A combination of drug treatment with mechanical or chemical debridement/avulsion has been recommended to increase efficacy. The topical antifungal solutions such as tavaborole, efinaconazole, and luliconazole may reach the dermatophytoma by both the transungual and subungual routes, due to low affinity for keratin and low surface tension. Current data indicates these topicals may provide efficacy for dermatophytoma treatment without debridement/avulsion. Similarly, fosravuconazole (F-RVCZ) has an improved pharmacological profile versus ravuconazole and may be an improved treatment option versus traditional oral therapies. The availability of improved treatments for dermatophytomas is crucial, as resistance to traditional therapies is on the increase.
With the widespread use of antifungals to treat superficial mycoses, reports of antifungal resistance are increasing. Antifungal resistance is becoming a public health challenge and needs to be addressed in parallel with antibacterial and antiviral resistance. We review the growing resistance of fungal pathogens such as Trichophyton species and the emergence of novel pathogens, including multidrug-resistant strains in superficial mycoses. We also discuss the importance of laboratory diagnosis and antifungal susceptibility testing (AFST) in the management of recalcitrant infections. Antifungal resistance can occur naturally or develop over time when fungi are exposed to antifungals. The frequency of terbinafine-resistant Trichophyton isolates is increasing. Opportunistic pathogens such as Aspergillus and Candida species have developed resistance to classic azoles such as itraconazole and fluconazole, and the newer azoles such as posaconazole and voriconazole. Although uncommon, topical antifungals such as efinaconazole and tavaborole have shown to induce resistance in Trichophyton rubrum. The emergence of multidrug-resistant Trichophyton mentagrophytes/interdigitale, Candida auris, and Aspergillus species causing severe infections is highly concerning. Routine AFST should be considered to determine the most effective treatment, especially if there is failure to therapy. Combination treatment of oral and topical antifungals may be a consideration for managing recalcitrant infections.