JUBLIA Solution (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Bausch Health US LLC

Λέξεις κλειδιά

0187-5400

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1. Indications and Usage

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 ...

2. Dosage and Administration

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 ...

3. Dosage Forms and Strengths

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

4. Contraindications

None.

6. Adverse Reactions

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 ...

7. Drug Interactions

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

8.1. Pregnancy

Risk Summary There are no available human data for the use of JUBLIA during pregnancy to inform any drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In ...

8.2. Lactation

Risk Summary 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 ...

8.4. Pediatric Use

The safety and effectiveness of JUBLIA were established in patients 6 years and older. Use of JUBLIA in these age groups is supported by evidence from well-controlled trials in adults with additional data ...

8.5. Geriatric 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 ...

11. Description

JUBLIA (efinaconazole) topical solution, 10% is a clear, colorless to pale yellow solution for topical use. Each gram of JUBLIA contains 100 mg of efinaconazole. Efinaconazole is an azole antifungal with ...

12.1. Mechanism of Action

JUBLIA topical solution is an azole antifungal [see Microbiology (12.4)].

12.2. Pharmacodynamics

The pharmacodynamics of JUBLIA is unknown.

12.3. Pharmacokinetics

Systemic absorption of efinaconazole in 18 adult subjects with severe onychomycosis was determined after application of JUBLIA once daily for 28 days to patients' 10 toenails and 0.5 cm adjacent skin. ...

12.4. Microbiology

Mechanism of Action Efinaconazole is an azole antifungal. Efinaconazole inhibits fungal lanosterol 14α-demethylase involved in the biosynthesis of ergosterol, a constituent of fungal cell membranes. Activity ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

A 2-year dermal carcinogenicity study in mice was conducted with daily topical administration of 3%, 10% and 30% efinaconazole solution. Severe irritation was noted at the treatment site in all dose groups, ...

14. Clinical Studies

The safety and efficacy of once-daily use of JUBLIA for the treatment of onychomycosis of the toenail were assessed in two 52-week prospective, multicenter, randomized, double-blind clinical trials in ...

16.1. How Supplied

JUBLIA (efinaconazole) topical solution, 10% is a clear, colorless to pale yellow solution supplied in a white plastic bottle with an integrated flow-through brush applicator as follows: 4 mL (NDC 0187-5400-04) ...

16.2. Storage and Handling

Storage and Handling Conditions: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Solution is flammable; keep away from heat ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). JUBLIA is for external use only and is not for oral, ophthalmic, or intravaginal use. It is ...