Adverse events reported by >1% of subjects in Phase 3 studies were
- Ingrown toenail (2.3% vs 0.7% with vehicle)
- Application-site dermatitis (2.2% vs 0.2% with vehicle)
- Application-site vesicles (1.6% vs 0% with vehicle)
- Application-site pain (1.1% vs 0.2% with vehicle)
JUBLIA is a topically applied solution with negligible† systemic absorption and no liver monitoring required1
- No need for patient counseling for potential liver toxicity
- No need for liver function tests
- In vitro liver enzyme studies show that drug interactions are not expected
- Patients should contact their health care professional if a reaction suggesting sensitivity or severe irritation occurs
- JUBLIA is pregnancy category C, and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
†Efinaconazole mean ± SD plasma Cmax on Day 28 was 0.67 ± 0.37 ng/mL and the mean ± SD AUC was 12.15 ± 6.91 ng*h/mL. The plasma concentration versus time profile at steady state was generally flat over a 24-hour dosing interval.
JUBLIA® (efinaconazole) topical solution, 10%, is indicated for the topical treatment of onychomycosis (tinea unguium) of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.
Important Safety Information
- JUBLIA is for topical use only and is not for oral, ophthalmic, or intravaginal use.
- Patients should be instructed to contact their health care professional if a reaction suggesting sensitivity or severe irritation occurs.
- The most common adverse reactions (incidence ≥1%) were (vs vehicle): ingrown toenail (2.3% vs 0.7%), application-site dermatitis (2.2% vs 0.2%), application-site vesicles (1.6% vs 0%), and application-site pain (1.1% vs 0.2%).
- JUBLIA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and should be used with caution in nursing women. The safety and effectiveness in pediatric patients below 6 years of age have not been established.
To report SUSPECTED ADVERSE REACTIONS, contact Ortho Dermatologics at 1-800-321-4576 or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Click here for full Prescribing Information.
Reference: 1. JUBLIA [prescribing information]. Bridgewater, NJ: Bausch Health US, LLC.