tavaborole

tavaborole

(ta-va-bor-ole),

Kerydin

(trade name)

Classification

Therapeutic: antifungals
Pharmacologic: temporary class
Pregnancy Category: C

Indications

Topical treatment of toenail onychomycosis.

Action

Inhibits fungal protein synthesis via inhibition of aminoacyl-transfer ribonucleic acid (tRNA) synthetase (AARS).

Therapeutic effects

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

Pharmacokinetics

Absorption: Minimal absorption follows topical administration.
Distribution: Unknown.
Metabolism and Excretion: Extensively metabolized, metabolites are eliminated mostly in urine.
Half-life: Unknown.

Time/action profile (resolution of infection)

ROUTEONSETPEAKDURATION
Topunknownunknown48 wk†
† Length of treatment necessary for resolution of infection.

Contraindications/Precautions

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

Adverse Reactions/Side Effects

Local

  • dermatitis
  • erythema
  • exfoliation
  • ingrown toenail

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

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

Availability

Topical solution: 5% in 12-mL bottle with enclosed dropper

Nursing implications

Nursing assessment

  • Inspect involved areas of skin and mucous membranes 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 daily for 48 wks to clean, dry toenail surface and under tip of toenail. Avoid contact with skin other than skin immediately surrounding treated nail. Wipe excess solution away from surrounding skin. Allow solution to dry following application. Avoid contact with eyes or mucous membranes.

Patient/Family Teaching

  • Instruct patient to apply medication as directed for full course of therapy, even if feeling better. Emphasize the importance of avoiding the eyes. Caution patient that solution is flammable; avoid use near heat or open flame. Discard bottle 3 mo after inserting dropper. Advise patient to read Patient Information sheet prior to starting therapy and with each Rx refill in case of changes.
  • Advise patient to notify health care professional if area of application shows signs of persistent irritation (redness, itching, swelling, skin peeling, ingrown toenail).
  • Advise 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.
Anacor Pharmaceuticals (NASDAQ:ANAC) today announced positive preliminary results from the second of two Phase 3 trials of tavaborole (known as Study 302).
A 5% topical tavaborole solution yielded a completely clear nail in 7% and 9% of patients with onychomycosis after nearly a year of treatment, compared with 0.
In addition to its two lead programs, Anacor has discovered three other wholly-owned clinical product candidates -- AN2718 and AN2898, which are backup compounds to tavaborole and AN2728, respectively, and AN3365 (formerly known as GSK2251052, or GSK '052), an antibiotic for the treatment of infections caused by Gram-negative bacteria, which previously was licensed to GlaxoSmithKline LLC, or GSK.
His extensive experience in launching new products and leading sales and marketing efforts to specialty physicians will be invaluable as we develop a commercial strategy for tavaborole and AN2728.
Phase Ill studies on another topical, tavaborole, have been completed and this medication also shows promise.
Tavaborole achieved a high degree of statistical significance on all primary and secondary endpoints.
Commenting on the results, David Perry, CEO of Anacor Pharmaceuticals, said, "We had a busy second quarter as we finalized preparations for our NDA for tavaborole, which was submitted on July 26th.
Anacor Pharmaceuticals (NASDAQ:ANAC) will release preliminary results from the first of two Phase 3 studies of tavaborole for onychomycosis tomorrow, January 29, 2013 at approximately 7:00 a.
Its lead product candidates include two topically administered dermatologic compounds tavaborole and AN2728.
In addition to its two lead programs, Anacor has discovered three other clinical product candidates -- AN2718 and AN2898, which are backup compounds to tavaborole and AN2728, respectively, and AN3365 (formerly known as GSK2251052, or GSK '052), a systemic antibiotic for the treatment of infections caused by Gram-negative bacteria, which previously was licensed to GlaxoSmithKline LLC, or GSK.
In addition to its two lead programs, Anacor has discovered three other clinical product candidates, AN2718 and AN2898, which are backup compounds to tavaborole and AN2728, respectively and AN3365 (formerly known as GSK2251052, or GSK '052) a systemic antibiotic for the treatment of infections caused by Gram-negative bacteria which previously was licensed to GlaxoSmithKline LLC, or GSK.