JUBLIA®

By Gary M. White, MD


Note, this is a summary only

What?

Efinaconazole topical solution, 10% For topical use

Indications And Usage

JUBLIA is an azole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton mentagrophytes.

Dosage And Administration

Apply JUBLIA to affected toenails once daily for 48 weeks using the integrated flow-through brush applicator.

When applying JUBLIA, ensure the toenail, the toenail folds, toenail bed, hyponychium, and the undersurface of the toenail plate, are completely covered.

Not for oral, ophthalmic, or intravaginal use.

How supplied

Topical solution 10%

Contraindications

None.

Adverse Reactions

The most common adverse reactions (incidence >1%) were ingrown toenails, application site dermatitis, application site vesicles, and application site pain.

The impact of nail polish or other cosmetic nail products on the efficacy of Jublia has not been established.

There are no concerns for systemic side effects such as drug-drug interactions or acute liver injury.

Efficacy

From the 2 pivotal studies, complete cure at week 52 was obtained in 17.8% and 15.2% of subjects treated with Jublia® compared to only 3.3% and 5.5% of subjects treated with vehicle.

Complete cure defined as 0% clinical involvement of the target toenail plus negative KOH and negative culture.

Mycologic cure defined as negative KOH and negative culture was achieved in over 50% of patients.

Pregnancy Category

C

Nursing Mothers and Pediatrics

no information.

Instructions for Patients

RegionalDerm

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