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brand jublia 10% topical solution

In stock Manufacturer VALEANT/BAUSCH 00187540004
$612.04 / 4 Milliliters Squeez Btl

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Uses

Onychomycosis

Efinaconazole 10% solution is used for the topical treatment of onychomycosis of the toenails (tinea unguium, ringworm of the nail) caused by Trichophyton rubrum or T. mentagrophytes.

Safety and efficacy of topical efinaconazole for the treatment of onychomycosis were evaluated in 2 multicenter, double-blind, randomized, vehicle-controlled, phase 3 studies that included 1655 adults 18-70 years of age who had 20-50% clinical involvement of affected toenails without dermatophytomas or lunula (matrix) involvement. Efinaconazole 10% solution or vehicle solution was applied to affected toenails once daily for 48 weeks. Primary efficacy end point was complete cure (0% clinical involvement of target toenails plus negative potassium hydroxide [KOH] microscopic examination and negative fungal culture) at week 52 (i.e., 4 weeks after discontinuance). Secondary efficacy end points included complete or almost complete cure (5% or less involvement of affected target toenail and negative KOH microscopic examination and negative fungal culture) and mycologic cure (negative KOH microscopic examination and negative fungal culture) at week 52. Efinaconazole was superior to vehicle solution in the topical treatment of onychomycosis in both studies. Complete cure rate for efinaconazole versus vehicle solution was 17.8 versus 3.3% in study 1 and 15.2 versus 5.5% in study 2. Complete or almost complete cure rate for efinaconazole versus vehicle solution was 26.4 versus 7% in study 1 and 23.4 versus 7.5% in study 2. Mycologic cure rate for efinaconazole versus vehicle solution was 55.2 versus 16.8% in study 1 and 53.4 versus 16.9% in study 2.

Onychomycosis is a fungal infection of the nails generally caused by dermatophytes (usually T. rubrum or T. mentagrophytes), but sometimes caused by nondermatophytic fungi (e.g., Acremonium, Aspergillus, Candida albicans, Fusarium, Scopulariopsis, Scytalidium). Onychomycosis of the toenails frequently involves several nails, and many patients also have tinea pedis (athlete's foot), especially dry-type (moccasin-type) tinea pedis. Left untreated, onychomycosis may result in progressive destruction and deformity of affected nails and possibly may lead to more widespread cutaneous involvement with spread to other digits and body areas. Selection of the most appropriate regimen for treatment of onychomycosis depends on the severity and extent of nail involvement, organisms involved, reported cure rates, adverse effects, drug interactions, cost, and patient and clinician preference. Onychomycosis generally is treated using an oral antifungal (e.g., itraconazole, terbinafine) and adjunctive physical modalities (nail trimming, aggressive debridement, nail avulsion) with or without a topical antifungal. Use of a topical antifungal alone (e.g., ciclopirox) with adjunctive physical modalities generally has been associated with lower cure rates, possibly because of poor patient compliance with the lengthy duration of treatment and poor drug penetration through the nail plate. Although topical antifungals with improved nail penetration are now available for treatment of onychomycosis (e.g., efinaconazole, tavaborole), additional study is needed to evaluate the comparative efficacy and safety of these antifungals and other topical antifungals or oral antifungals used for treatment of onychomycosis.

Dosage and Administration

Administration

Topical Administration

Efinaconazole 10% solution should be applied topically to affected toenails using the flow-through brush applicator supplied by the manufacturer.

Efinaconazole 10% solution is for external use only. The solution should not be administered orally or intravaginally, and should not be applied topically to the eyes.

Prior to application of efinaconazole 10% topical solution, toenails should be cleaned and dried; the solution should not be applied until at least 10 minutes after showering, bathing, or washing.

Using the integrated flow-through brush applicator supplied by the manufacturer on the bottle, a single drop of efinaconazole 10% solution should be placed on each affected toenail and the brush applicator should then be used to gently spread the solution evenly over the entire toenail surface, including the cuticle, folds of skin next to the sides of the toenail, toenail bed, hyponychium (thickened epidermis underneath toenail tip), and the undersurface of the toenail tip. For the big toenail, a second drop of efinaconazole solution should be applied at the end of the toenail. The bottle should not be squeezed while efinaconazole solution is being spread over the toenails. The solution should be allowed to dry on the toenails. The hands should be washed with soap and water following application of the drug.

Pedicures and use of nail polish and other cosmetic nail products should be avoided during efinaconazole treatment.

Efinaconazole 10% solution should be stored at 20-25°C, but may be exposed to 15-30°C, and should not be frozen. The solution is flammable and should not be stored or used near heat or open flame.(See Description.) The bottle containing efinaconazole 10% solution should be kept tightly closed and stored in an upright position.

Dosage

Onychomycosis

For the topical treatment of onychomycosis of the toenails in adults, efinaconazole 10% solution should be applied to affected toenails once daily for 48 weeks. The amount of solution used on each affected toenail should be sufficient to cover the entire toenail surface and under the toenail tip.(See Topical Administration under Dosage and Administration: Administration.)

Special Populations

The manufacturer makes no special population dosage recommendations for efinaconazole.

Cautions

Contraindications

The manufacturer states there are no known contraindications to use of efinaconazole 10% topical solution.

Warnings/Precautions

Sensitivity Reactions

Efinaconazole 10% topical solution may cause application site irritation (e.g., redness, swelling, burning, itching, blisters); there is no evidence to date that the solution causes contact sensitization.

In a 21-day cumulative irritation test that included 37 healthy adults 18-65 years of age, efinaconazole 1, 5, and 10% topical solutions, vehicle solution, positive irritant control (sodium lauryl sulfate 0.2% solution), and negative irritant control (deionized water) were applied simultaneously once daily at separate sites on the back, occluded, and the sites were then evaluated for signs of local irritation. Efinaconazole solutions caused minimal skin irritation; reactions to efinaconazole solutions were comparable to reactions to the vehicle solution and less than reactions to the positive irritant control.

The potential of efinaconazole 10% topical solution to cause sensitization was evaluated in a double-blind, vehicle-controlled study that included 239 healthy adults 18-70 years of age. Efinaconazole 10% topical solution and vehicle solution were applied simultaneously at separate sites on the back, occluded, and the sites were then evaluated for signs of local irritation. The study consisted of an induction phase (21 days), rest period (17-24 days), and challenge phase. There was no evidence of sensitization.

Administration Precautions

Efinaconazole 10% solution is for topical use only. The topical solution should not be used orally or intravaginally, and should not be applied to the eyes.

Selection and Use of Antifungals

Prior to treatment of onychomycosis, the diagnosis should be confirmed by direct microscopic examination of scrapings from infected toenails mounted in potassium hydroxide (KOH) or by culture.

Specific Populations

Pregnancy

Category C.

Lactation

It is not known whether efinaconazole is distributed into human milk following topical application; the drug is distributed into milk of rats after subcutaneous administration. Efinaconazole 10% topical solution should be used with caution in nursing women.

Pediatric Use

Safety and efficacy of efinaconazole 10% topical solution have not been established in pediatric patients.

Geriatric Use

Although no overall differences in safety or efficacy of efinaconazole 10% topical solution were observed between geriatric and younger adults in clinical trials, the possibility of greater sensitivity of some older individuals cannot be ruled out.

Common Adverse Effects

Adverse effects reported in at least 1% of adults treated with efinaconazole 10% topical solution and more frequently than with topical vehicle solution include application site dermatitis, ingrown toenail, application site vesicles, and application site pain.

Drug Interactions

Formal drug interaction studies have not been performed to date with efinaconazole 10% topical solution.

In vitro studies indicate that efinaconazole does not inhibit cytochrome P-450 (CYP) isoenzymes 1A2, 2A6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4 at concentrations expected clinically, and does not induce CYP1A2 or 3A4.

Clinically important interactions with CYP inhibitors or inducers are unlikely because systemic exposure is low following topical application of efinaconazole to toenails.

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