Laboratory Monitoring During Systemic Terbinafine Therapy for Pediatric Onychomycosis

Patel, Deepa; Castelo‐Soccio, Leslie; Rubin, Adam I.; Streicher, Jenna L.

doi:10.1001/jamadermatol.2017.4483

Cited by 35 publications

(31 citation statements)

References 3 publications

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“…The rates of grade 1 and grade 2 ALT and AST measurement elevation, anemia, lymphopenia, and neutropenia for all medications were similar to the baseline rates in our population. Previous studies [4][5][6][7][8][9] have also found low rates of abnormalities. A study by Elewski et al 4 on the safety and efficacy of terbinafine vs griseofulvin in children with tinea capitis found that hematologic and biochemical abnormalities were "infrequent without evidence of drug effect."…”

Section: Discussionmentioning

confidence: 91%

Utility of Laboratory Test Result Monitoring in Patients Taking Oral Terbinafine or Griseofulvin for Dermatophyte Infections

et al. 2018

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IMPORTANCE Terbinafine hydrochloride and griseofulvin are effective oral treatments for dermatophyte infections but have been associated with hepatic and hematologic abnormalities. The prevalence of alanine aminotransferase elevations, aspartate aminotransferase elevations, anemia, lymphopenia, and neutropenia among adults and children taking terbinafine and griseofulvin is unclear. OBJECTIVE To measure the rate of laboratory test result abnormalities in healthy adults and children taking terbinafine or griseofulvin for dermatophyte infections. DESIGN, SETTING, AND PARTICIPANTS This retrospective study assessed adults and children taking terbinafine or griseofulvin for dermatophyte infections from January 1, 2006, to December 31, 2016. Data were collected from one Midwest health care system. Exclusion criteria were preceding diagnosis of hepatic or hematologic condition and preceding or concurrent use of oral ketoconazole, amphotericin, or itraconazole. MAIN OUTCOMES AND MEASURES The rates of elevated alanine aminotransferase measurements, elevated aspartate aminotransferase measurements, anemia, lymphopenia, and neutropenia in adults and children taking terbinafine, griseofulvin microsize, or griseofulvin ultramicrosize were calculated. Secondary measures included rates of baseline abnormalities, frequency of laboratory test results that required additional testing or discontinued use of medication, and laboratory test result monitoring practices. RESULTS This study included laboratory data from 4985 patients (mean [SD] age, 42.8 [20.3] years; 2288 [45.9%] female) receiving 4309 courses of terbinafine, 634 courses of griseofulvin microsize, and 159 courses of griseofulvin ultramicrosize. We identified a low rate of laboratory test result abnormalities in patients taking terbinafine or griseofulvin. When laboratory test result abnormalities occurred, most were low grade (212 [93.4%] grade 1) and did not require subsequent laboratory test result evaluation or discontinued use of medication (15 051 [99.9%]). Elevations in alanine aminotransferase measurements were detected infrequently and were comparable to baseline detection rates (61 [3.5%] vs 95 [3.6%] for terbinafine, 2 [2.1%] vs 3 [3.7%] for griseofulvin microsize, and 0 vs 2 [5.0%] for griseofulvin ultramicrosize). Rates of elevated aspartate aminotransferase measurements, anemia, lymphopenia, and neutropenia were also infrequent and comparable to baseline rates. CONCLUSIONS AND RELEVANCE In this study. the rates of alanine aminotransferase elevations, aspartate aminotransferase elevations, anemia, lymphopenia, and neutropenia in adults and children taking terbinafine or griseofulvin were low and equivalent to the baseline rates of abnormalities in this population. Routine interval laboratory test result monitoring appears to be unnecessary in adults and children without underlying hepatic or hematologic conditions taking terbinafine or griseofulvin for dermatophyte infections. Abandoning frequent laboratory monitoring can decrease unnecessary health care sp...

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Section: Discussionmentioning

confidence: 91%

Utility of Laboratory Test Result Monitoring in Patients Taking Oral Terbinafine or Griseofulvin for Dermatophyte Infections

et al. 2018

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“…Very few clinical trials have been published on the efficacy and safety of onychomycosis treatments in children with preliminary evidence suggesting currently available onychomycosis treatments are effective and appear safe to use in children . Dosing regimens must be readjusted according to the child's weight . As the pharmacokinetics of antifungals are generally different in children versus adults, understanding the adverse effects associated with antifungal medications is an important factor in appropriately managing fungal infections …”

Section: Special Populationsmentioning

confidence: 99%

“…69 Dosing regimens must be readjusted according to the child's weight. 67,70 As the pharmacokinetics of antifungals are generally different in children versus adults, understanding the adverse effects associated with antifungal medications is an important factor in appropriately managing fungal infections. 71,72…”

Section: Childrenmentioning

confidence: 99%

Global perspectives for the management of onychomycosis

et al. 2018

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Onychomycosis is a fungal nail infection caused by dermatophytes, nondermatophyte molds, and yeasts. This difficult‐to‐treat chronic infection has a tendency to relapse despite treatment. This paper aims to offer a global perspective on onychomycosis management from expert physicians from around the world. Overall, the majority of experts surveyed used systemic, topical, and combination treatments approved in their countries and monitored patients based on the product insert or government recommendations. Although the basics of treating onychomycosis were similar between countries, slight differences in onychomycosis management between countries were found. These differences were mainly due to different approaches to adjunctive therapy, rating the severity of disease and use of prophylaxis treatment. A global perspective on the treatment of onychomycosis provides a framework of success for the committed clinician with appreciation of how onychomycosis is managed worldwide.

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“…Routine4 laboratory monitoring should be considered in any child receiving oral antifungal agents for onychomycosis. [17][18][19] On the contrary, topical therapy has minimal adverse effects and is considered safe.…”

Section: Discussionmentioning

confidence: 99%

Labeled use of efinaconazole topical solution 10% in treating onychomycosis in children and a review of the management of pediatric onychomycosis

Gupta

Venkataraman

Shear

et al. 2020

Dermatologic Therapy

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Onychomycosis is a difficult to treat condition whose prevalence is increasing. Until recently, there was no FDA approved antifungal agent for the treatment of onychomycosis in children. Although systemic antifungal agents are effective, their use is restricted by the potential adverse events and drug‐drug interactions. There is evidence regarding the safety and efficacy of topical antifungal agents for pediatric onychomycosis. We have summarized the results of a recently published study using efinaconazole topical solution 10% to treat onychomycosis in children and discuss management of pediatric onychomycosis. In a multicenter, open‐label phase 4 study, efinaconazole 10% solution was applied topically once daily in children aged 6 to 16 years with mild to severe, culture positive, distal and lateral subungual onychomycosis. Treatment was for 48 weeks with a follow‐up at week 52. Pharmacokinetics was performed in a subset of patients. There were 62 patients enrolled in the study. At week 52, the efficacy was mycological cure rate 65% and complete cure rate 40%. All treatment‐emergent adverse events (TEAE) were mild to moderate in severity with none resulting in study discontinuation. The only treatment‐related TEAE was ingrown toenail. Efinaconazole was detected at low levels in plasma. Efinaconazole topical solution 10% is effective and safe in treating onychomycosis in children age 6 to 16 years and was recently FDA‐approved for this indication. The on‐label use of other topical agents, tavaborole solution 5% and ciclopirox nail lacquer solution 8% is reviewed. We also briefly discuss the use of oral agents, terbinafine, itraconazole, and fluconazole in pediatric onychomycosis.

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Laboratory Monitoring During Systemic Terbinafine Therapy for Pediatric Onychomycosis

Abstract: Dr Adotama and Mr Tinker had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Adotama, Glass, Allen.

Cited by 35 publications

References 3 publications

Utility of Laboratory Test Result Monitoring in Patients Taking Oral Terbinafine or Griseofulvin for Dermatophyte Infections

Utility of Laboratory Test Result Monitoring in Patients Taking Oral Terbinafine or Griseofulvin for Dermatophyte Infections

Global perspectives for the management of onychomycosis

Labeled use of efinaconazole topical solution 10% in treating onychomycosis in children and a review of the management of pediatric onychomycosis

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