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 ?
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.
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.
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.
6% of patients with a baseline disease duration of less than 1 year had a complete cure with efinaconazole, compared with 16.
A new formulation of topical efinaconazole allows the antifungal to penetrate through the nail plate much better than do existing treatments for onychomycosis, a study showed.
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.
Topical Therapy Fingernails and Toenails Ciclopirox 8% Apply daily, up to 48 weeks (10) Efinaconazole Phase Ill clinical trials studied daily application for 48 weeks (11) Tavaborole Phase Ill clinical trial (data available on first of two recently completed) studied daily application for 52 weeks (12) B.
The licensor and business partner for efinaconazole, Kaken Pharmaceutical, has also agreed to supply Valeant with the finished dosage form of Jublia for the U.
Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for efinaconazole for the treatment of onychomycosis.
NYSE: VRX)(TSX: VRX) announced that we agreed this afternoon that the launch of efinaconazole, our topical product candidate for the treatment of onychomycosis, will not occur until after the September 2013 arbitration hearing to resolve the breach of contract dispute with Anacor Pharmaceuticals (NASDAQ: ANAC).
Valeant investigated the safety and efficacy of efinaconazole 10% topical solution (efinaconazole), the first triazole antifungal agent developed for distal lateral subungual onychomycosis (DLSO).
to commercialize efinaconazole in North America, Central America, South America and the European Union.