Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, External:
Jublia: 10% (4 mL, 8 mL) [contains edetate disodium]
Pharmacology
Mechanism of Action
An azole antifungal; inhibits fungal lanosterol 14alpha-demethylase involved in the biosynthesis of ergosterol, a constituent of fungal cell membranes, resulting in fungal cell death.
Pharmacokinetics/Pharmacodynamics
Half-Life Elimination
29.9 hours.
Use: Labeled Indications
Onychomycosis: Topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes
Contraindications
There are no contraindications listed in the US manufacturer’s labeling.
Canadian labeling: Hypersensitivity to efinaconazole or any component of the formulation.
Dosage and Administration
Dosing: Adult
Onychomycosis: Topical: Apply to affected toenail(s) once daily for 48 weeks.
Dosing: Geriatric
Refer to adult dosing.
Administration
Topical: Affected toenail(s) should be clean and dry. Wait at least 10 minutes after showering, bathing, or washing the area prior to application. Remove bottle cap and hold the bottle directly over the affected toenail. Squeeze the bottle and apply one drop onto the toenail. If the great toe is affected, apply a second drop to the end of the toenail. Gently spread the solution completely around the toenail (toenail bed, folds, hyponychium, undersurface of the toenail plate) with the attached applicator brush and let dry thoroughly; wash hands with soap and water after use. Patient should avoid pedicures, use of nail polish, or cosmetic nail products while using the solution.
Storage
Solution: Store at 20°C to 25°C (68°F to 77°F). Keep away from heat or flame; protect from freezing; keep bottle tightly closed and stored in upright position.
Drug Interactions
There are no known significant interactions.
Adverse Reactions
1% to 10%:
Dermatologic: Ingrown nail (2%)
Local: Application site dermatitis (2%), application site vesicles (2%), application site pain (1%)
Warnings/Precautions
Concerns related to adverse events:
- Local irritation: Persistent local pain, irritation, or dermatitis may develop. If this occurs, contact health care provider.
Other warnings/precautions:
- Appropriate use: For topical use only on toenail(s) and surrounding skin. Not for ophthalmologic, oral, or vaginal administration. Pedicures, use of nail polish, or cosmetic nail products should be avoided while using the solution.
Pregnancy
Pregnancy Risk Factor
C
Pregnancy Considerations
Adverse events were observed in some animal reproduction studies following SubQ administration. Small amounts of efinaconazole are absorbed systemically following topical administration.
Patient Education
What is this drug used for?
- It is used to treat fungal infections of the toenails.
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Severe application site irritation
- Ingrown toenail
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
