Dosing and uses of Jublia (efinaconazole)
Adult dosage forms and strengths
topical solution
- 10%
Onychomycosis
Indicated for onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes
Apply to affected toenail(s) qDay for 48 weeks using the integrated flow-through brush applicator
Pediatric dosage forms and strengths
Safety and efficacy not established
Jublia (efinaconazole) adverse (side) effects
1-10%
Ingrown toenail (2.3%)
Application site dermatitis (2.2%)
Application site vesicles (1.6%)
Application site pain (1.1%)
Warnings
Contraindications
None
Cautions
For topical use only
Not for oral, ophthalmic, or intravaginal use
Instruct patient to avoid using nail polish or cosmetic nail products
Persistent local pain, irritation, or dermatitis may develop; contact health provider if it occurs
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown if distributed in human breast milk
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Jublia (efinaconazole)
Mechanism of action
Triazole antifungal agent; inhibits fungal lanosterol 14α-demethylase involved in the biosynthesis of ergosterol, a constituent of fungal cell membranes
Pharmacokinetics
Peak plasma concentration (day 28): 0.67 ng/mL
AUC: 12.15 ng•h/mL
Metabolism: Neither inhibits nor induces CYP450 enzymes
Half-life (day 7): 29.9 hr
