Azole AntifungalPrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Jublia
EFINACONAZOLE
1 INDICATIONS AND USAGE 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 . (1)
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Brand names:JUBLIA
Quick Reference
Medicine ClassAzole Antifungal
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- EFINACONAZOLE
- Medicine class
- Azole Antifungal
- Brand names
- JUBLIA
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- Half-life
- half-life of efinaconazole following daily applications when applied to all 10 toenails for 7 days w
- FDA approved
- Yes
What Is Jublia?
1 INDICATIONS AND USAGE 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 . (1)
Jublia (EFINACONAZOLE) belongs to the Azole Antifungal class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Jublia. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Jublia with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Jublia is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
1 INDICATIONS AND USAGE 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 .
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
2 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. 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)
Available Forms
Available Strengths
Side Effects
Common
- 6 ADVERSE REACTIONS 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.
Serious
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
How Jublia Works
12.1 Mechanism of Action JUBLIA topical solution is an azole antifungal [ see Clinical Pharmacology (12.4) ].
Pharmacokinetics
Absorption
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
Half-Life
half-life of efinaconazole following daily applications when applied to all 10 toenails for 7 days w
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Jubliawhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Storage and Handling Conditions: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. • Solution is flammable; keep away from heat or flame. • Protect from freezing. • Keep out of reach of children. • Keep bottle tightly clo
Frequently Asked Questions
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Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Jublia
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.