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Efinaconazole

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 U.S. manufacturer’s labeling.

Canadian 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: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

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 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

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber severe application site irritation or ingrown toenail (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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