efinaconazole

efinaconazole

(eff-in-a-kon-a-zole),

Jublia

(trade name)

Classification

Therapeutic: antifungals
Pharmacologic: triazoles
Pregnancy Category: C

Indications

Topical treatment of onychomycosis of the toenail.

Action

Inhibits synthesis of ergosterol, a component of fungal cell membranes.

Therapeutic effects

Resolution of toenail fungus.
Active against Tricyhophyton rubrum and Trychophyton mentagrophytes.

Pharmacokinetics

Absorption: Minimal systemic absorption follows application to toenails.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: 29.9 hr.

Time/action profile

ROUTEONSETPEAKDURATION
Topical†unknownunknownunknown
† Prolonged treament is necessary due to need for treatment throughout growth of new toenails.

Contraindications/Precautions

Contraindicated in: None noted.
Use Cautiously in: Geriatric: Elderly patients may be more sensitive to drug effects; Obstetric: Use during pregnancy only if potential maternal benefit justifies potential risk to fetus; Lactation: Use cautiously if breastfeeding; Pediatric: Safe and effective use in children has not been established.

Adverse Reactions/Side Effects

Local

  • application site dermatitis
  • application site pain
  • application site vesicles
  • ingrown toenail

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

Topical (Adults) Apply to affected toenails once daily for 48 wk.

Availability

Solution: 10% in 4– and 8–mL bottles (with integrated flow-through applicator brush)

Nursing implications

Nursing assessment

  • Inspect involved areas of skin before and frequently during therapy. Increased skin irritation may indicate need to discontinue medication.

Potential Nursing Diagnoses

Risk for impaired skin integrity (Indications)
Risk for infection (Indications)

Implementation

  • Topical: Apply to affected clean, dry toenails once daily for 48 wks with integrated flow-through brush applicator. Ensure toenail, toenail folds, toenail bed, hyponychium, and undersurface of toenail plate are completely covered. Solution is clear, colorless to pale yellow.

Patient/Family Teaching

  • Instruct patient to apply efinaconazole as directed for full course of therapy, even if feeling better. Emphasize the importance of topical use only, not for oral, ophthalmic or intravaginal use. Advise patient to wait at least 10 min after showering, bathing, or washing before applying. Efinaconazole is flammable; avoid use near heat or open flame.
  • Advise patient to report increased skin irritation (redness, itching, swelling) to health care professional.
  • Caution patient to avoid pedicures, nail polish, and cosmetic nail procedures during therapy.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Resolution of toenail fungus.
References in periodicals archive ?
4 Confirmatory testing was cost-effective prior to efinaconazole but not terbinafine therapy, according to a decision analysis.
For example, the price of a year's supply of efinaconazole (Jublia), used to treat toenail fungus, is several thousand dollars.
Lipner says that there are two newer topical medications, tavaborole (Kerydin) and efinaconazole (Jublia), but they are not covered under all insurance plans, and they are expensive.
The seven new anti-infectives and their indications are dalbavancin (Dalvance) for treatment of skin infections caused by gram-positive organisms; efinaconazole (Jublia) for treatment of fungal infections of the toenails; miltefosine (Impavido) for treatment of visceral, cutaneous, and mucosal infections by various Leishmania species; oritavancin (Orbactiv) for skin infections caused by gram-positive bacteria; peramivir (Rapivab) for acute uncomplicated influenza; tavaborole (Kerydin) for treatment of fungal infections of the toenails; and tedizolid (Sivextro) for treatment of bacterial skin infections.
The seven new anti-infectives and their indications are dalbavancin (Dalvance) for treatment of skin infections caused by gram-positive organisms; efinaconazole (Jublia), for treatment of fungal infections of the toenails; miltefosine (Impavido) for treatment of visceral, cutaneous, and mucosal infections by various Leishmania species; oritavancin (Orbactiv) for skin infections caused by gram-positive bacteria; peramivir (Rapivab), for acute uncomplicated influenza; tavaborole (Kerydin) for treatment of fungal infections of the toenails; and tedizolid (Sivextro) for treatment of bacterial skin infections.
Kaken Pharmaceutical, the licensor and business partner for efinaconazole, has also agreed to provide Valeant with the finished dosage form of Jublia for the United States market.
Efinaconazole (Dermatophytic Onychomycosis) - Forecast and Market Analysis to 2022
These forward looking statements involve known and unknown risks, uncertainties and other factors that could cause actual levels of activity, performance or achievement to differ materially from those expressed or implied by these forward-looking statements, including risks related to the planned NDA filing, risks from competition for tavaborole (in particular efinaconazole from Valeant Pharmaceuticals International Inc.
Potassium hydroxide testing is not cost-effective prior to initiation of efinaconazole therapy.
Patients who have early onychomycosis can be effectively treated with once-daily efinaconazole topical solution, 10%, according to data from more than 1,000 subjects.
Kaken Pharmaceutical, the licensor and business partner for efinaconazole, has agreed to supply Valeant with the finished dosage form of Jublia for the US market.
ABSTRACT Currently approved options for the treatment of onychomycosis include systemic therapy (the antifungal agents fluconazole, itraconazole, and terbinafine), topical agents (ciclopirox, which has been available since 1996, efinaconazole, currently pending approval), and laser systems.