Version May 2024
Onychomycosis, mild to moderate:
Note: For patients with distal subungual onychomycosis involving ≤50% of the nail and sparing the matrix/lunula (Ref).
Topical: Apply to affected toenail(s) once daily for 48 weeks; ensure complete coverage of the toenail, the toenail folds, toenail bed, surrounding skin, and the undersurface of the toenail plate (Ref).
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
(For additional information see "Efinaconazole: Pediatric drug information")
Onychomycosis: Children ≥6 years and Adolescents: Topical: Apply to affected toenail(s) once daily for 48 weeks.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely necessary due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely necessary due to low systemic absorption.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
1% to 10%:
Dermatologic: Ingrown nail (2%)
Local: Application site dermatitis (2%), application site pain (1%), application site vesicles (2%)
Postmarketing:
Dermatologic: Nail discoloration, onychomadesis
Local: Application-site erythema, local skin exfoliation (application site)
There are no contraindications listed in the US manufacturer’s labeling.
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to efinaconazole or any component of the formulation.
Concerns related to adverse events:
• Local irritation: Persistent local pain, irritation, or dermatitis may develop. If this occurs, contact health care provider.
Other warnings/precautions:
• Appropriate use: For topical use only on toenail(s) and surrounding skin. Not for ophthalmologic, oral, or vaginal administration. Use of nail polish or cosmetic nail products has not been evaluated.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, External:
Jublia: 10% (4 mL, 8 mL) [contains edetate (edta) disodium]
No
Solution (Jublia External)
10% (per mL): $228.18
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, External:
Jublia: 10% (6 mL) [contains edetate (edta) disodium]
Topical: Affected toenail(s) should be clean and dry. Wait at least 10 minutes after showering, bathing, or washing the area prior to application. Gently spread the solution completely around the toenail (toenail bed, folds, hyponychium, undersurface of the toenail plate) with the attached applicator brush and let dry thoroughly; wash hands with soap and water after use.
Topical: Affected toenail(s) should be clean and dry. Wait at least 10 minutes after showering, bathing, or washing the area prior to application. Gently spread the solution completely around the toenail (toenail bed, folds, hyponychium, undersurface of the toenail plate) with the attached applicator brush and let dry thoroughly; wash hands with soap and water after use. For external use only (do not use orally, intravaginally, or in the eyes). Do not apply near heat or flame.
Onychomycosis, mild to moderate: Topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.
None known.
There are no known significant interactions.
Small amounts of efinaconazole are absorbed systemically following topical administration. If antifungal treatment cannot be delayed until after pregnancy, topical therapy, when appropriate, is preferred over systemic treatment (Kaul 2017). Information specific to efinaconazole in pregnancy has not been located (Lipner 2015).
It is not known if efinaconazole is present in breast milk.
Small amounts of efinaconazole are absorbed systemically following topical administration. The manufacturer recommends that caution be used if administered to a breastfeeding woman.
An azole antifungal; inhibits fungal lanosterol 14alpha-demethylase involved in the biosynthesis of ergosterol, a constituent of fungal cell membranes, resulting in fungal cell death.
Half-life elimination: 29.9 hours.
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