Efinaconazole

JUBLIA topical solution is an azole antifungal [ see Clinical Pharmacology (12.4) ].

• JUBLIA (efinaconazole) topical solution, 10% is an azole antifungal indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes . JUBLIA is an azole antifungal indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes .ICD-10: B35.1

• None. None.contraindicated

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. JUBLIA is for topical use only and not for oral, ophthalmic, or intravaginal use. • Apply JUBLIA to affected toenails once daily for 48 weeks using the integrated flow-through brush applicator. (2) • When applying JUBLIA, ensure the toenail, the toenail folds, toenail bed, hyponychium, and the undersurface of the toenail plate, are completely covered. (2) • For topical use only. Not for oral, ophthalmic, or intravaginal use. (2)

The most common adverse reactions (incidence >1%) were ingrown toenails, application site dermatitis, application site vesicles, and application site pain. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two clinical trials, 1227 subjects were treated with JUBLIA, 1161 for at least 24 weeks and 780 for 48 weeks. Adverse reactions reported within 48 weeks of treatment and in at least 1% of subjects treated with JUBLIA and those reported in subjects treated with the vehicle are presented in Table 1 . Table 1: Adverse Reactions Reported by at Least 1% of Subjects Treated for up to 48 Weeks Adverse Event, n (%) JUBLIA (N=1,227) Vehicle (N=413) Ingrown toenail 28 (2.3%) 3 (0.7%) Application site dermatitis 27 (2.2%) 1 (0.2%) Application site vesicles 20 (1.6%) 0 (0.0%) Application site pain 13 (1.1%) 1 (0.2%) 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of JUBLIA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.

8.1 Pregnancy Risk Summary There are no available human data for the use of JUBLIA during pregnancy to inform any drug associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, efinaconazole did not cause malformations or any harm to the fetus when administered to pregnant rabbits and rats during the period of organogenesis at subcutaneous doses up to 112 and 154 times, respectively, the Maximum Recommended Human Dose (MRHD) based on Area Under the Curve (AUC) comparisons. Embryolethality was observed only in rats in the presence of maternal toxicity at systemic exposures 559 times the MRHD based on AUC comparisons. Subcutaneous efinaconazole administration to pregnant rats from the beginning of organogenesis through the end of lactation did not cause embryofetal toxicity or developmental effects at systemic exposures 17 times the MRHD based on AUC comparisons (see Data) . The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies. Data Animal Data Systemic embryofetal development studies were conducted in rats and rabbits.

Metabolism

Systemic absorption of efinaconazole in 18 adult subjects with severe onychomycosis was determined after application of JUBLIA once daily for 28 days to patients’ 10 toenails and 0.5 cm adjacent skin. The concentration of efinaconazole in plasma was determined at multiple time points over the course of 24-hour periods on days 1, 14, and 28.

• Jun 6, 2014NDANDA203567Bausch

1. 1Drug Ineffective40921%
2. 2Fatigue23612%
3. 3Pain22412%
4. 4Headache20511%
5. 5Asthenia20311%
6. 6Drug Hypersensitivity1739.0%
7. 7Oedema Peripheral1729.0%
8. 8Pyrexia1648.6%
9. 9Anaemia1638.5%
10. 10Cough1618.4%
11. 11Dyspnoea1568.2%
12. 12Product Dose Omission Issue1568.2%
13. 13Asthma1548.1%
14. 14Tremor1548.1%
15. 15Blood Creatinine Increased1538.0%

The 7 most recently updated of 7 ClinicalTrials.gov registrations naming Efinaconazole as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Phase 2 Study to Assess the Effectiveness of Topical Terbinafine in Participants With Mild to Moderate Onychomycosis of the Toenails
  Not yet recruiting · Phase 2 · Interventional · 200 enrolled · Onyx Axiom
  NCT07382427updated 2026-02-04
• Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis
  Completed · Phase 4 · Interventional · 62 enrolled · Bausch Health Americas, Inc.
  NCT02812771updated 2021-11-01
• Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Jublia® in Mild to Moderate Toenail Onychomycosis
  Completed · Phase 4 · Interventional · 97 enrolled · Dong-A ST Co., Ltd.
  NCT03280927updated 2021-04-27
• Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients
  Completed · Phase 3 · Interventional · 40 enrolled · Western University of Health Sciences
  NCT03168841updated 2020-10-30
• Real-World Evaluation of the Effect of Jublia on Nail Polish
  Completed · Interventional · 5 enrolled · University of Alabama at Birmingham
  NCT03022916updated 2020-01-06
• Study Evaluating the Effect of Jublia on Dermatophytomas
  Completed · Phase 4 · Interventional · 19 enrolled · University of Alabama at Birmingham
  NCT03098615updated 2019-12-10
• Evaluating the Efficacy and Compatibility of Efinaconazole 10% Solution (Jublia) for the Treatment of Toenail Onychomycosis in Patients Wearing Toenail Polish Compared to Those Without Polish
  Completed · Phase 4 · Interventional · 13 enrolled · University of Alabama at Birmingham
  NCT03110029updated 2019-06-27

Frequently asked questions

How does Efinaconazole work?

JUBLIA topical solution is an azole antifungal [ see Clinical Pharmacology (12.4) ].

What is Efinaconazole used for?

According to FDA labeling, Efinaconazole carries indications including: JUBLIA (efinaconazole) topical solution, 10% is an azole antifungal indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes . JUBLIA is an azole antifungal indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Efinaconazole?

Efinaconazole is classified as Imidazole and triazole derivatives, Azole Antifungal, 14-alpha Demethylase Inhibitors, Ergosterol Synthesis Inhibitors, Decreased Cell Membrane Integrity.

What are the brand names for Efinaconazole?

Efinaconazole is marketed under brand names including Jublia.

What are the contraindications for Efinaconazole?

Efinaconazole labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.