efinaconazole
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 Jublia set ID 922d4d25-c530-11e1-9b21-0800200c9a66
Adverse events
Common (≥1%)
Ingrown toenail · Application-site dermatitis, vesicles, or pain
Pregnancy and lactation
Human data are insufficient. It is unknown whether it is excreted in human milk; consider maternal need and the benefits of breastfeeding.
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
Onychomycosis is a fungal nail infection that causes nail discoloration, nail plate thickening, and onycholysis. Efinaconazole 10% topical solution is an FDA-approved treatment for onychomycosis patients aged 6 years and above. The drug functions as an antifungal by disrupting ergosterol synthesis in the fungal cell membrane. It exhibits higher in vitro activity against dermatophytes than other available antifungals such as ciclopirox and itraconazole, and the activity is comparable to amorolfine and terbinafine. Efinaconazole also provides enhanced nail penetration compared with other topical antifungals due to low surface tension, poor water solubility, and low keratin affinity. The pharmacokinetic studies suggest that the efinaconazole topical delivery to the nail bed is not markedly affected by the presence of disease. There is a subset of onychomycosis patients who are more likely to respond to efinaconazole 10% solution: female patients, those with lower BMI, mild onychomycosis, a short disease duration, no infected non-target toenails (large toenail disease only), and when concomitant tinea pedis is treated. Experts recommend efinaconazole 10% topical solution as the first line for mild-to-moderate onychomycosis, pediatric onychomycosis, those with liver or kidney disease, and as maintenance therapy to prevent relapse. The side effects of topical efinaconazole are minimal: most commonly ingrown toenails, dermatitis, vesicles, and pain at the application site. Altogether, phase I and phase III clinical trials, and post-hoc analyses indicate that efinaconazole 10% topical solution is a safe and effective treatment for adult and pediatric onychomycosis, with a satisfactory mycological and clinical cure.
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.