KERYDIN Topical solution (2018)

Βιβλιογραφική αναφορά

Συγγραφείς

PharmaDerm, A division of Fougera Pharmaceuticals Inc.

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1. Indications and Usage

KERYDIN (tavaborole) topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes ...

2. Dosage and Administration

Apply KERYDIN to affected toenails once daily for 48 weeks. KERYDIN should be applied to the entire toenail surface and under the tip of each toenail being treated. KERYDIN is for topical use only and ...

3. Dosage Forms and Strengths

KERYDIN topical solution, 5% is a clear, colorless alcohol-based solution. Each milliliter of solution contains 43.5 mg (5% w/w) of tavaborole.

4. Contraindications

None.

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during postmarketing use of KERYDIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

8.1. Pregnancy

Risk Summary There are no available data on KERYDIN use in pregnant women to inform a drug associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. In oral animal reproductive ...

8.2. Lactation

Risk Summary There is no information available on the presence of KERYDIN in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production after topical application ...

8.4. Pediatric Use

The safety and efficacy of KERYDIN were established in patients 6 years of age and older. Use of KERYDIN in these age groups is supported by evidence from adequate and well-controlled studies of KERYDIN ...

8.5. Geriatric Use

In clinical trials of 791 subjects who were exposed to KERYDIN, 19% were 65 years of age and over, while 4% were 75 years of age and over. No overall differences in safety or effectiveness were observed ...

11. Description

KERYDIN (tavaborole) topical solution, 5% contains tavaborole, 5% (w/w) in a clear, colorless alcohol-based solution for topical use. The active ingredient, tavaborole, is an oxaborole antifungal with ...

12.1. Mechanism of Action

KERYDIN is an oxaborole antifungal [see Clinical Pharmacology (12.4)].

12.2. Pharmacodynamics

At therapeutic doses, KERYDIN is not expected to prolong QTc to any clinically relevant extent.

12.3. Pharmacokinetics

Tavaborole undergoes extensive metabolism. Renal excretion is the major route of elimination of the metabolites. In a clinical pharmacology trial of six healthy adult male volunteers who received a single ...

12.4. Microbiology

Mechanism of Action The mechanism of action of tavaborole is inhibition of fungal protein synthesis. Tavaborole inhibits protein synthesis by inhibition of an aminoacyl-transfer ribonucleic acid (tRNA) ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

In an oral carcinogenicity study in Sprague-Dawley rats, oral doses of 12.5, 25, and 50 mg/kg/day tavaborole were administered to rats once daily for 104 weeks. No drug related neoplastic findings were ...

14. Clinical Studies

The efficacy and safety of KERYDIN was evaluated in two multicenter, double-blind, randomized, vehicle-controlled trials. KERYDIN or vehicle was applied once daily for 48 weeks in subjects with 20% to ...

16.1. How Supplied

KERYDIN (tavaborole) topical solution, 5% is a clear, colorless solution supplied in an amber glass bottle with a screw cap. At initial use, the screw cap is replaced with the dropper assembly. KERYDIN ...

16.2. Storage and Handling

Store at 20–25°C (68–77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. CAUTION: Flammable. Keep away from heat and flame. Discard product within 3 months after insertion ...

17. Patient Counseling Information

See FDA-approved patient labeling (Patient Information and Instructions for Use) The patient should be told the following: The impact of nail polish or other cosmetic nail products on the efficacy of KERYDIN ...