• Not for oral, ophthalmic, or intravaginal use. (2)
`
`
`
`
` ______________
` _____________
`DOSAGE FORMS AND STRENGTHS
`Solution: 10%. (3)
`
`
`
`___________________ CONTRAINDICATIONS ___________________
`
`
`
`
`None. (4)
`
`
`
`___________________ ADVERSE REACTIONS ___________________
`
`
`
`
`The most common adverse reactions (incidence >1%) were ingrown toenails,
`
`
`
`application site dermatitis, application site vesicles, and application site pain.
`
`
`(6.1)
`
`To report SUSPECTED ADVERSE REACTIONS, contact Valeant
`
`Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800­
`
`
`
`FDA-1088 or www.fda.gov/medwatch.
`
`
`
`See 17 for PATIENT COUNSELING INFORMATION and FDA-
`
`
`
`Approved Patient Labeling
`
`
`Revised: 06/2014
`
`
`
`
`
`12 CLINICAL PHARMACOLOGY
`
`
`
`12.1 Mechanism of Action
`
`
`12.2 Pharmacodynamics
`
`
`12.3 Pharmacokinetics
`
`
`12.4 Microbiology
`
`
`NONCLINICAL TOXICOLOGY
`13
`
`
`13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
`
`
`CLINICAL STUDIES
`14
`
`
`HOW SUPPLIED/STORAGE AND HANDLING
`16
`
`
`
`PATIENT COUNSELING INFORMATION
`17
`
`ctions or subsections omitted from the full prescribing information
`*Se
`
`not listed.
`are
`
`
`
`
` HIGHLIGHTS OF PRESCRIBING INFORMATION
`
`
`
` These highlights do not include all the information needed to use JUBLIA
` safely and effectively. See full prescribing information for JUBLIA.
`
`
`
`JUBLIA® (efinaconazole) topical solution, 10%
`
`
`
`For topical use
`
`Initial U.S. Approval: 2014
`
`
`
`
` __________________
` _________________
`INDICATIONS AND USAGE
`JUBLIA is an azole antifungal indicated for the topical treatment of
`
`
`
`onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton
`
`
`
`
`
`
`
`mentagrophytes. (1)
`
`
`_______________DOSAGE AND ADMINISTRATION
`
`
` ______________
`• Apply JUBLIA to affected toenails once daily for 48 weeks using the
`
`
`
`
`
`
`
`integrated flow-through brush applicator. (2)
`
`
`
`
`• When applying JUBLIA, ensure the toenail, the toenail folds, toenail bed,
`
`
`
`
`
`hyponychium, and the undersurface of the toenail plate, are completely
`
`
`
`
`
`covered. (2)
`
`
`• For topical use only. (2)
`
`
`
`
`
`FULL PRESCRIBING INFORMATION: CONTENTS*
`
`
`
`
`1
`INDICATIONS AND USAGE
`
`
`2
`DOSAGE AND ADMINISTRATION
`
`
`3
`DOSAGE FORMS AND STRENGTHS
`
`
`4
`CONTRAINDICATIONS
`
`
`6
`ADVERSE REACTIONS
`
`
`6.1 Clinical Trials Experience
`
`
`7
`DRUG INTERACTIONS
`
`
`USE IN SPECIFIC POPULATIONS
`8
`
`
`8.1 Pregnancy
`
`
`8.3 Nursing Mothers
`
`
`8.4 Pediatric Use
`
`
`8.5 Geriatric Use
`
`
`11 DESCRIPTION
`
`
`
` 1
`
`Reference ID: 3519795
`
`
`
` 1
`
`
`

`

`
`
`
`
` FULL PRESCRIBING INFORMATION
`
` 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.
`
`
`
`
`
`
`
`
`
`
`
`
`
` CONTRAINDICATIONS
`
` 4
`
`None.
`
`
`
`
`
` 6
`
`
`
` ADVERSE REACTIONS
`
` Clinical Trials Experience
` 6.1
`
`
`
`
` 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.
`
`
`
`
`
`
`Reference ID: 3519795
`
`
`
` 2
`
`
`

`

`
`
`
`
` 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.
`
` Adverse Reactions Reported by at Least 1% of Subjects Treated for up to 48
`
`
` Table 1:
`
` Weeks
`
`
`
`
`
`
`
`
`
`
`
` Adverse Event, n (%)
`
`Ingrown toenail
`
`
`Application site dermatitis
`
`
`
`Application site vesicles
`
`
`Application site pain
`
`
`
`
` JUBLIA
`
` N = 1227
`
`28 (2.3%)
`
`
`27 (2.2%)
`
`
`20 (1.6%)
`
`
`13 (1.1%)
`
`
`
` Vehicle
`
` N = 413
`
`3 (0.7%)
`
`
`1 (0.2%)
`
`
`0 (0.0%)
`
`
`1 (0.2%)
`
`
`
`
` 7 DRUG INTERACTIONS
`
`
`
`
`
` In vitro studies have shown that JUBLIA, at therapeutic concentrations, neither inhibits nor
`
` induces cytochrome P450 (CYP450) enzymes.
`
`
`
`
` 8 USE IN SPECIFIC POPULATIONS
` 8.1
`
`
` Pregnancy
` Pregnancy Category 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).
`
`
`
`
`
`
`
`
`
`Reference ID: 3519795
`
`
`3
`
`
`

`

`
`
`
` 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).
`
`
`
`
`
` Nursing Mothers
` 8.3
`
`
` 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.
`
`
`
` 8.4
`
`
` Pediatric Use
` Safety and effectiveness of JUBLIA in pediatric subjects have not been established.
`
`
`
`
`
`
`
`
`
`
`
` Geriatric Use
` 8.5
`
`
` 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.
`
`
`
`
`
`
` 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 a chemical name of ((2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidin-1­
`
` yl)-1-(1H-1,2,4-triazol-1-yl) butan-2-ol). The structural formula for efinaconazole is represented
`
`
` below:
`
`Reference ID: 3519795
`
`4
`
`
`
`

`

`
`
`
`
`
` Molecular Formula: C18H22F2N4O Molecular Weight: 348.39
`
`
` JUBLIA contains the following inactive ingredients: alcohol, anhydrous citric acid, butylated
`
`
`
` hydroxytoluene, C12-15 alkyl lactate, cyclomethicone, diisopropyl adipate, disodium edetate,
`
`
`
`
`
` and purified water.
`
`
`
`
`
` 12
`
`
`
` CLINICAL PHARMACOLOGY
`
` 12.1 Mechanism of Action
`
`
`
` JUBLIA topical solution is an azole antifungal [see Clinical Pharmacology (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. The concentration of efinaconazole in plasma was determined at multiple time
` points over the course of 24-hour periods on days 1, 14, and 28. Efinaconazole mean ± SD
`
`
`
`
`
`
`
`
` plasma Cmax on Day 28 was 0.67 ± 0.37 ng/mL and the mean ± SD AUC was 12.15 ± 6.91
`
`
`
`
`
`ng*h/mL. The plasma concentration versus time profile at steady state was generally flat over a
`
`24-hour dosing interval. In a separate study of healthy volunteers, the plasma half-life of
`
`
`
`
`efinaconazole following daily applications when applied to all 10 toenails for 7 days was 29.9
`
`hours.
`
`Drug Interactions
`
`
`
`JUBLIA is considered a non-inhibitor of the CYP450 enzyme family. In in vitro studies using
`
`
`human liver microsomes, efinaconazole did not inhibit CYP1A2, CYP2A6, CYP2C8, CYP2C9,
`
`
`CYP2C19, CYP2D6, CYP2PE1 and CYP3A4 enzyme activities at expected clinical systemic
`
`Reference ID: 3519795
`
`
`5
`
`
`

`

`
`
`
`
`
`
`
`concentrations. In vitro studies in human primary hepatocytes showed that efinaconazole did not
`
`induce CYP1A2 or CYP3A4 activities.
`
`
`
` 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 In Vitro and In Vivo
`
` Efinaconazole has been shown to be active against isolates of the following microorganisms,
`
`
`
`
`
`
`
` both in vitro and in clinical infections. Efinaconazole exhibits in vitro minimum inhibitory
` concentrations (MICs) of 0.06 μg/mL or less against most (≥90%) isolates of the following
`
`
` microorganisms:
` Trichophyton rubrum
`
`
` Trichophyton mentagrophytes
`
`
` Mechanism of Resistance
` Efinaconazole drug resistance development was studied in vitro against T. mentagrophytes, T.
`
`
`
` rubrum and C. albicans. Serial passage of fungal cultures in the presence of sub-growth
`
` inhibitory concentrations of efinaconazole increased the MIC by up to 4-fold. The clinical
`
` significance of these in vitro results is unknown.
`
`
`
`
` 13
`
`
`
` NONCLINICAL TOXICOLOGY
`
` Carcinogenesis, Mutagenesis, Impairment of Fertility
`
`
` 13.1
`
`
` 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, which was attributed to the vehicle and confounded the interpretation of skin
`
`
` effects by efinaconazole. The high dose group was terminated at week 34 due to severe skin
`
`
`
` reactions. No drug-related neoplasms were noted at doses up to 10% efinaconazole solution (248
`
`
`
` times the MRHD based on AUC comparisons).
`
` Efinaconazole revealed no evidence of mutagenic or clastogenic potential based on the results of
`
`
`
`
` two in vitro genotoxicity tests (Ames assay and Chinese hamster lung cell chromosome
` aberration assay) and one in vivo genotoxicity test (mouse peripheral reticulocyte micronucleus
`
`
`
`
` assay).
`
`
`
`
`
`Reference ID: 3519795
`
`
`
` 6
`
`
`

`

`
`
` No effects on fertility were observed in male and female rats that were administered
`
`
` subcutaneous doses up to 25 mg/kg/day efinaconzole (279 times the MRHD based on AUC
`
`
` comparisons) prior to and during early pregnancy. Efinaconazole delayed the estrous cycle in
` females at 25 mg/kg/day but not at 5 mg/kg/day (56 times MRHD based on AUC comparisons).
`
`
`
`
`
` CLINICAL STUDIES
` 14
`
`
`
`
`
` 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, multi-center, randomized, double-blind
`
`
`
`
`
` clinical trials in patients 18 years and older (18 to 70 years of age) with 20% to 50% clinical
`
` involvement of the target toenail, without dermatophytomas or lunula (matrix) involvement. The
` trials compared 48-weeks of treatment with JUBLIA to the vehicle solution. The Complete Cure
`
`
`
`
` rate was assessed at Week 52 (4-weeks after completion of therapy). Complete cure was defined
`
`
`
` as 0% involvement of the target toenail (no clinical evidence of onychomycosis of the target
`
`
` toenail) in addition to Mycologic Cure, defined as both negative fungal culture and negative
`
`
` KOH. Table 2 lists the efficacy results for trials 1 and 2.
`
`
`
`
`
` Efficacy Endpoints
`
`
`
` Table 2:
`
`
`
`
`
`
`
` Trial 1
`
`
`
` Trial 2
`
`Complete
`
`Curea
`
`
`Complete or
`
`Almost Complete
`
`Cureb
`
`Mycologic Curec
`
`
`JUBLIA
`
`
`N = 656
`
`
`117
`
`
`
`17.8%
`
`173
`
`
`
`26.4%
`
`
`
` 362
`
`55.2%
`
`
`Vehicle
`
`
`N = 214
`
`
`7
`
`
`
`3.3%
`
`15
`
`
`
`7.0%
`
`
`
` 36
`
`16.8%
`
`
`JUBLIA
`
`
`N = 580
`
`
`88
`
`
`
`15.2%
`
`136
`
`
`
`23.4%
`
`
`
` 310
`
`53.4%
`
`
`Vehicle
`
`
`N = 201
`
`
`11
`
`
`
`5.5%
`
`15
`
`
`
`7.5%
`
`
`
` 34
`
`16.9%
`
`
` a Complete cure defined as 0% clinical involvement of the target toenail plus negative KOH and negative culture.
`
`
`
`b Complete or almost complete cure defined as ≤5% affected target toenail area involved and negative KOH and
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`culture.
`
`c Mycologic cure defined as negative KOH and negative culture.
`
`
`
`
`
`
`
`
`Reference ID: 3519795
`
`
`
` 7
`
`
`

`

`
`
` 16
`
`
`
` HOW SUPPLIED/STORAGE AND HANDLING
`
`
`
` 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)
`
`
`
` • 8 mL (NDC 0187-5400-08)
`
` Storage and Handling Conditions:
`
`
`
` Store at 20°C - 25°C (68°F - 77°F); excursions permitted to 15°C - 30°C (59°F - 86°F) [see USP
`
`
` Controlled Room Temperature].
`
`
`
`
`
`
`
`
`
`
`
`
` • Solution is flammable; keep away from heat or flame
`
`
`
`
` • Protect from freezing
`
`
`
`
` • Keep out of the reach of children
`
`
`
`
`
`
`
`
` • Keep bottle tightly closed
`
`
`
`
` • Store in upright position
`
`
`
` PATIENT COUNSELING INFORMATION
` 17
`
`
`
` See FDA-Approved Patient Labeling (Patient Information)
`
`
`•
`
` JUBLIA is for external use only and is not for ophthalmic, oral, or intravaginal use. It is
`
`
` for use on toenails and immediately adjacent skin only.
`
`
`
`
`
`
`
` • Apply JUBLIA once daily to clean dry toenails. Wait for at least 10 minutes after
`
`
`
` showering, bathing, or washing before applying.
`
`
`
`
`
`
`
` • Use JUBLIA only on the affected toenails, as directed by your healthcare provider.
`
`
`
`
`
`
`
`•
`
`
` Inform a health care professional if the area of application shows signs of persistent
` irritation (for example, redness, itching, swelling).
`
`
`
`
`
`
`
`
` • Avoid pedicures, the use of nail polish, and cosmetic nail products while using JUBLIA.
`
`
`
`
`
`
`
`
` • Flammable, avoid use near heat or open flame.
`
`
`
`
`
`Reference ID: 3519795
`
`8
`
`
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA
`
`
`
`
`Manufactured by: Kaken Pharmaceutical Co. Ltd, Shizuoka, Japan
`
`
`
`Product of Japan
`
`
`U.S. Patents 8,039,494; 7,214,506
`
`9391900
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Issued: 06/2014
`
`
`
`Reference ID: 3519795
`
`
`9
`
`
`
`

`

`
` PATIENT INFORMATION
`
`
` JUBLIA (joo-blee-uh)
`
`
`
` (efinaconazole) topical solution, 10%
`
` Important information: JUBLIA is for use on toenails and surrounding skin only. Do not
`
`
`
`
`
` use JUBLIA in your mouth, eyes, or vagina.
`
`
`
`
`
`
`What is JUBLIA?
`
`
`
`JUBLIA is a prescription medicine used to treat fungal infections of the toenails.
`
`
`
`
`
`
`
`
`
`
`
`It is not known if JUBLIA is safe and effective in children.
`
`
`
`
`
`
`
`
`
`
`
`
` What should I tell my healthcare provider before using JUBLIA?
`
`
`
`
`
`
`
`
`
` Before you use JUBLIA, tell your healthcare provider about all your medical conditions, including if
`
`
`
`
`
`
`
`
` you:
`
` • are pregnant or plan to become pregnant. It is not known if JUBLIA can harm your unborn
`
` baby.
`
` • are breastfeeding or plan to breastfeed. It is not known if JUBLIA passes into your breast milk.
`
`
`
`
`
`
`
`
`
`
`
`
`
`Tell your healthcare provider about all the medicines you take, including prescription and
`
`
`
`
`
`
`
`
`
`
`
`
`
` over-the-counter medicines, vitamins, and herbal supplements.
`
`
`
`
`
`
` How should I use JUBLIA?
`
`
`
`
`
`
`
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` • Use JUBLIA exactly as your healthcare provider tells you to use it. Apply JUBLIA to your
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` washing before applying JUBLIA. JUBLIA is used for 48 weeks.
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`What should I avoid while using JUBLIA?
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`JUBLIA is flammable. Avoid heat and flame while applying JUBLIA to your toenail.
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` • Avoid pedicures, use of nail polish, or cosmetic nail products, while using JUBLIA.
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`What are the possible side effects of JUBLIA?
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`JUBLIA may cause irritation at the treated site. The most common side effects include: ingrown
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`toenail, redness, itching, swelling, burning or stinging, blisters, and pain. Tell your healthcare
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`provider if you have any side effects that bother you or that does not go away.
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`These are not all the possible side effects of JUBLIA.
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`Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1­
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`800-FDA-1088.
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`How should I store JUBLIA?
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`• Store JUBLIA at room temperature, between 68°F to 77°F (20°C to 25°C). Do not freeze
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`JUBLIA.
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`• Keep the bottle tightly closed and store in an upright position.
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`JUBLIA is flammable. Keep away from heat and flame.
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`Keep JUBLIA and all medicines out of the reach of children.
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`General information about the safe and effective use of JUBLIA
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`Medicines are sometimes prescribed for purposes other than those listed in a Patient Information
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`leaflet. You can ask your pharmacist or healthcare provider for information about JUBLIA that is
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`written for health professionals. Do not use JUBLIA for a condition for which it was not prescribed.
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`Do not give JUBLIA to other people, even if they have the same condition you have. It may harm
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`them.
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`Reference ID: 3519795
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` What are the ingredients in JUBLIA?
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` Active ingredients: efinaconazole
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` Inactive ingredients: alcohol, anhydrous citric acid, butylated hydroxytoluene, C12-15 alkyl
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` lactate, cyclomethicone, diisopropyl adipate, disodium edetate, and purified water.
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`Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807
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`Manufactured by: Kaken Pharmaceutical Co. Ltd, Shizuoka, Japan. Product of Japan
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` For more information, call 1-800-321-4576.
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` This Patient Information has been approved by the U.S. Food and Drug Administration.
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` Issued: 06/2014
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`Reference ID: 3519795
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` Instructions for Use
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` JUBLIA® (joo-blee-uh)
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`(efinaconazole) topical solution, 10%
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` Important information: JUBLIA is for use on toenails and surrounding skin only. Do
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` Read the Instructions for Use that comes with JUBLIA before you start using it. Talk to your
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` How to apply JUBLIA:
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` Your toenails should be clean and dry before you apply JUBLIA.
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` Step 1: Before you apply JUBLIA to your affected toenail, remove the cap from
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` the JUBLIA bottle (See Figure A).
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`Step 2: Hold the bottle directly over the affected toenail and gently squeeze the bottle to
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`apply one drop of JUBLIA onto the toenail (See Figure B).
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`Step 3: For the big toenail, also apply a second drop to the end of the toenail (See Figure
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`C).
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` Step 4: Use the brush attached to the bottle to gently spread JUBLIA around the entire
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` toenail including: the cuticle, folds of the skin next to the sides of the toenail, and
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` underneath the nail (See Figure D). Do not squeeze the bottle while spreading
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`Step 5: Repeat Steps 2 to 4 to apply JUBLIA to each affected toenail.
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`Step 6: Let JUBLIA dry completely.
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`Step 7: After applying JUBLIA to your affected toenails, place the cap on the bottle and
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`screw it on tightly.
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`Step 8: Wash your hands with soap and water after applying JUBLIA.
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`This Patient Information and Instructions for Use has been approved by the U.S. Food and
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`Drug Administration.
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`Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA
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`Manufactured by: Kaken Pharmaceutical Co. Ltd, Shizuoka, Japan.
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`Product of Japan
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`Issued: 06/2014
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`Reference ID: 3519795
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