Rx Item-Jublia 10% Solution 8Ml By Valeant Pharma

JUBLIA- efinaconazole solution
Valeant Pharmaceuticals North America LLC

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 the undersurface of the toenail plate, are completely covered.



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

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 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.

Table 1: Adverse Reactions Reported by at Least 1% of Subjects Treated for up to 48 Weeks
Adverse Event, n (%)

JUBLIA N = 1227

Vehicle N = 413

Ingrown toenail

28 (2.3%)

3 (0.7%)

Application site dermatitis

27 (2.2%)

1 (0.2%)

Application site vesicles

20 (1.6%)

0 (0.0%)

Application site pain

13 (1.1%)

1 (0.2%)

7 DRUG INTERACTIONS

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

RX ITEM-Jublia 10% Solution 8Ml By Valea
NDC 00187-5400-08 UPC/GTIN No.3-01875-40008-8 Mfg.Part No.540008

Jublia 10% Solution 8Ml By Valeant Pharm
BRAND: JUBLIA NDC: 00187-5400-08,187540008 UPC: 3-01875-40008-8,301875400088 Valeant Pharma

EFINACONAZOLE TOPICAL SOL
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