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Efinaconazole

Medically reviewed by Drugs.com. Last updated on May 1, 2020.

Pronunciation

(ef in a KON a zole)

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]

Brand Names: U.S.

  • Jublia

Pharmacologic Category

  • Antifungal Agent, Topical

Pharmacology

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.

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: Additional contraindications (not in US labeling): Hypersensitivity to efinaconazole or any component of the formulation.

Dosing: Adult

Onychomycosis: Topical: Apply to affected toenail(s) once daily for 48 weeks.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Onychomycosis: Children ≥6 years and Adolescents: Topical: Apply to affected toenail(s) once daily for 48 weeks.

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. 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.

Storage

Solution: 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). 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. Use of nail polish or cosmetic nail products has not been evaluated.

Pregnancy Considerations

Small amounts of efinaconazole are absorbed systemically following topical administration. If antifungal treatment cannot be delayed until after pregnancy, topical therapy, when appropriate, is preferred over systemic treatment (Kaul 2017). Information specific to efinaconazole in pregnancy has not been located (Lipner 2015).

Patient Education

What is this drug used for?

• It is used to treat fungal infections of the toenails.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Severe application site irritation

• Ingrown toenail

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, 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 limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.