Efinaconazole

Efinaconazole
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Overview

Efinaconazole is a azole antifungal that is FDA approved for the treatment of onychomycosis of the toenail(s). Common adverse reactions include ingrown toenails, application site dermatitis, application site vesicles, and application site pain.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• JUBLIA (efinaconazole) topical solution, 10% is an azole antifungal indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.

Dosage

Apply JUBLIA to affected toenails once daily for 48 weeks, using the integrated flow-through brush applicator. When applying JUBLIA, ensure the toenail, the toenail folds, toenail bed, hyponychium, and the undersurface of the toenail plate, are completely covered.

JUBLIA is for topical use only and not for oral, ophthalmic, or intravaginal use.

DOSAGE FORMS AND STRENGTHS

• JUBLIA (efinaconazole) topical solution, 10% contains 100 mg of efinaconazole in each gram of clear, colorless to pale yellow solution.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Efinaconazole in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Efinaconazole in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Efinaconazole in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Efinaconazole in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Efinaconazole in pediatric patients.

Contraindications

• None

Warnings

There is limited information regarding Efinaconazole Warnings' in the drug label.

Adverse Reactions

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 drug and may not reflect the rates observed in practice.

In two clinical trials, 1227 subjects were treated with JUBLIA, 1161 for at least 24 weeks and 780 for 48 weeks. Adverse reactions reported within 48 weeks of treatment and in at least 1% of subjects treated with JUBLIA and those reported in subjects treated with the vehicle are presented in Table 1.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Efinaconazole in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• In vitro studies have shown that JUBLIA, at therapeutic concentrations, neither inhibits nor induces cytochrome P450 (CYP450) enzymes.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

• There are no adequate and well-controlled studies with JUBLIA in pregnant women. JUBLIA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Systemic embryofetal development studies were conducted in rats and rabbits. Subcutaneous doses of 2, 10 and 50 mg/kg/day efinaconazole were administered during the period of organogenesis (gestational days 6-16) to pregnant female rats. In the presence of maternal toxicity, embryofetal toxicity (increased embryofetal deaths, decreased number of live fetuses, and placental effects) was noted at 50 mg/kg/day [559 times the Maximum Recommended Human Dose (MRHD) based on Area Under the Curve (AUC) comparisons]. No embryofetal toxicity was noted at 10 mg/kg/day (112 times the MRHD based on AUC comparisons). No malformations were observed at 50 mg/kg/day (559 times the MRHD based on AUC comparisons).

Subcutaneous doses of 1, 5, and 10 mg/kg/day efinaconazole were administered during the period of organogenesis (gestational days 6-19) to pregnant female rabbits. In the presence of maternal toxicity, there was no embryofetal toxicity or malformations at 10 mg/kg/day (154 times the MRHD based on AUC comparisons).

In a pre- and post-natal development study in rats, subcutaneous doses of 1, 5 and 25 mg/kg/day efinaconazole were administered from the beginning of organogenesis (gestation day 6) through the end of lactation (lactation day 20). In the presence of maternal toxicity, embryofetal toxicity (increased prenatal pup mortality, reduced live litter sizes and increased postnatal pup mortality) was noted at 25 mg/kg/day. No embryofetal toxicity was noted at 5 mg/kg/day (17 times the MRHD based on AUC comparisons). No effects on postnatal development were noted at 25 mg/kg/day (89 times the MRHD based on AUC comparisons).
Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Efinaconazole in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Efinaconazole during labor and delivery.

Nursing Mothers

• It is not known whether efinaconazole is excreted in human milk. After repeated subcutaneous administration, efinaconazole was detected in milk of nursing rats. Because many drugs are excreted in human milk, caution should be exercised when JUBLIA is administered to nursing women.

Pediatric Use

• Safety and effectiveness of JUBLIA in pediatric subjects have not been established.

Geriatic Use

• Of the total number of subjects in clinical trials of JUBLIA, 11.3% were 65 and over, while none were 75 and over. No overall differences in safety and effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and the younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

Gender

There is no FDA guidance on the use of Efinaconazole with respect to specific gender populations.

Race

There is no FDA guidance on the use of Efinaconazole with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Efinaconazole in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Efinaconazole in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Efinaconazole in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Efinaconazole in patients who are immunocompromised.

Administration and Monitoring

Administration

• topical

Monitoring

There is limited information regarding Monitoring of Efinaconazole in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Efinaconazole in the drug label.

Overdosage

There is limited information regarding Overdose of Efinaconazole in the drug label.

Pharmacology

There is limited information regarding Efinaconazole Pharmacology in the drug label.

Mechanism of Action

Structure

File:Efinaconazole01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Efinaconazole in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Efinaconazole in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Efinaconazole in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Efinaconazole in the drug label.

How Supplied

Storage

There is limited information regarding Efinaconazole Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Efinaconazole in the drug label.

Precautions with Alcohol

• Alcohol-Efinaconazole interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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